European SPCs Unravelled

Name: European SPCs Unravelled | A Practitioner's Guide to Supplementary Protection Certificates in Europe
Brand: Kluwer Law International
Price: 274.99 EUR
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A Practitioner's Guide to Supplementary Protection Certificates in Europe

Oswin Ridderbusch(Herausgeber*in)

Kluwer Law International (Verlag)

Erschienen am 18. Juni 2021

1064 Seiten

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Beschreibung

While supplementary protection certificates (SPCs) are governed by the same substantive rules in all Member States of the European Union and the European Economic Area (EEA), they are national intellectual property rights. The formal requirements and procedural practices of the national patent offices granting SPCs still differ significantly, and these divergences can have a substantial impact on the prosecution of SPCs across Europe. This one-of-a-kind handbook provides an in-depth review of SPC law in Europe, covering all substantive and procedural aspects of prosecution, enforcement and invalidation, as well as SPC-related aspects of unfair competition law. Following an overarching European chapter, which addresses general considerations and the relevant European Union law, including the jurisprudence of the Court of Justice (CJEU) and the EFTA Court, this book contains detailed national chapters for all European states that provide SPCs i.e., the twenty-seven EU Member States (Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, and Sweden), the EEA/EFTA states Norway and Iceland, as well as the United Kingdom, Switzerland/Liechtenstein, Serbia, Bosnia and Herzegovina, Albania, and North Macedonia. The contributors to this book, all seasoned experts in the field of SPCs in their respective jurisdictions, provide clear and hands-on guidance on the most pertinent SPC-related topics of practical and strategic relevance. The considerably expanded second edition of this handbook offers a comprehensive analysis of European SPC law and practice, covering all European states with SPC systems in detailed national chapters. As such, this book provides invaluable assistance to IP practitioners in devising successful pan-European SPC filing and litigation strategies. Its practice-oriented approach, in combination with a country-by-country format where all chapters follow the same structure, makes it easy to compare the national practices and the respective national case law of the different European countries. ';The present work fills a gap and provides, for the first time, an overview of the SPC practice in the EU Member States, which despite the intended harmonization by the respective EU legislation is still decidedly inconsistent in some areas. Altogether, this successful work, with its streamlined structure and clear language that is immediately comprehensible even to non-native speakers, functions not ';only' as a source of information for European attorneys, authorities and courts. It also conveys perhaps not at all intended by the authors the unique diversity of this European legal regime, which for many exerts a special fascination. The present Practitioner's Guide can be recommended without reservation and should not be missing in any specialist library.' Jurgen Schell, Judge at the German Federal Patent Court, on the first edition of this book.

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Inhalt

Intro
Half-Title
Title Page
Copyright Page
Editors
Contributors
Summary of Contents
Overview
Preface
Acknowledgements
Introduction
I. Historical Perspective
[A] Supplementary Protection Certificates: Dysfunctional and Not Fit for Purpose?
[B] The Making of the Regulation (EEC) 1768/92
[C] The Commission Proposal
[D] The Adoption of the Regulation
II. Future Perspective: A Unitary SPC System?
[A] The Unitary Patent Package
[B] SPCs under the Jurisdiction of the Unified Patent Court
[C] The Prospect of a Future Unitary SPC Title
[D] Different Options for the Creation of a Unitary SPC
CHAPTER 1 European Union: General Considerations and Case Law of the CJEU and the EFTA Court
§1.01 LEGAL BASIS
§1.02 SUBSTANTIVE REQUIREMENTS FOR OBTAINING AN SPC
[A] Types of Products That Can Be Protected
[1] Practical Considerations: What Is the Active Ingredient or Combination of Active Ingredients That Can Form the Basis for an SPC?
[2] Active Ingredient or Combination of Active Ingredients of a Medicinal Product
[3] Active Substance or Combination of Active Substances of a Plant Protection Product
[4] Fixed-Dose and Loose Combinations
[5] Limitation to Products Subjected to a Specific Marketing Authorization Procedure
[B] Basic Patent
[1] Requirement for the Product to Be 'Protected' by the Basic Patent
[a] Small Molecules
[b] Polymers
[c] Antibodies, Enzymes and Other Proteins
[d] Nucleic Acids
[2] Basic Patent Claiming the Product, i.e., the Active Ingredient(s), but Not the Corresponding Authorized Medicinal Product (or Plant Protection Product)
[3] Requirement for the Product to Constitute 'the Invention' of the Basic Patent
[4] Criteria for Choosing the Basic Patent among Various Available Patents
[C] The Marketing Authorization Forming Basis for an SPC
[1] Combinations of Active Ingredients
[a] The Marketing Authorization Refers to Fewer Active Ingredients than the SPC Application
[b] The Marketing Authorization Refers to More Active Ingredients than the SPC Application
[c] The Marketing Authorization Indicates That a Medicinal Product Containing a Single Active Ingredient Is Authorized for Use in Combination with a Further Active Ingredient
[2] The Marketing Authorization Has Not Yet Been Granted at the Time the SPC Application Is Filed
[3] The Holder of the Marketing Authorization
[4] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Medicinal Products
[5] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Plant Protection Products
[6] The Product in Question Is Contained in the Authorized Medicinal Product (or the Authorized Plant Protection Product) but Is Not Identified as an Active Ingredient in the Corresponding Marketing Authorization
[7] The Notion of the 'First' Marketing Authorization
[a] Marketing Authorization for a New Therapeutic Application of a Previously Authorized Product
[b] Marketing Authorization for a New Formulation of a Previously Authorized Product
[c] Marketing Authorization for a New Specific Salt, Ester or Other Derivative of a Previously Authorized Active Ingredient
[d] Marketing Authorization for a New Specific Enantiomer of an Active Ingredient Previously Authorized in Racemic Form
[e] The Product Has Already Been Placed on the Market Before, but Without an Authorization Granted under Directive 2001/83/EC or Directive 2001/82/EC
[f] Prior Marketing Authorization Which Refers to Fewer Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[g] Prior Marketing Authorization Which Refers to More Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[D] Preclusion of New SPCs by an Earlier SPC
[1] The 'One SPC per Product per Patent Holder' Rule
[2] Consequences of an Earlier Third-Party SPC for the Same Product
[a] Earlier SPC Granted to an Affiliated Third Party
[b] Partial Overlap Between the Holders of the Earlier SPC and the Applicants for the New SPC
[c] Earlier Third-Party SPC Has Been Licensed-In
[3] Consequences of an Own Earlier SPC for the Same Product
[a] Own Earlier SPC Application Not Yet Granted
[b] Revocation, Surrender or Lapse of the Own Earlier SPC after Grant
[c] Transfer of the Own Earlier SPC to a Third Party
[d] Acquisition of an SPC Granted to a Third Party
[4] Consequences of an Own Earlier SPC for a Different Product
[a] Required Distinction from the Product of the Own Earlier SPC
[b] Combinations of Active Ingredients
[c] New Therapeutic Applications of Previously Approved Active Ingredients
[d] SPCs for a Specific Salt, Ester or Other Derivative Where an Own Earlier SPC Has Already Been Granted for the Corresponding Active Ingredient
[e] SPCs for a Specific Enantiomer Where an Own Earlier SPC Has Already Been Granted for the Corresponding Racemate
[5] Grant of More than One SPC on the Basis of the Same Patent
§1.03 EXTENT OF PROTECTION AND ENFORCEMENT OF SPCS
[A] The Protection Conferred by an SPC
[B] The Scope of an SPC in Relation to Derivatives of an Active Ingredient
[1] The Relationship Between the Definition of the Active Ingredient(s) in an SPC and Its Scope of Protection
[C] Enforcement of an SPC
[D] The Manufacturing Waiver
§1.04 DETERMINATION OF THE SPC TERM
[A] The Calculation of the SPC Term
[1] The Relevant Marketing Authorization for the Term of an SPC
[2] The Expiration Date of an SPC
[B] Correction of the SPC Term
[C] The Term of a Paediatric Extension
§1.05 PROCEDURE OF FILING AN SPC APPLICATION
[A] Entitlement to an SPC Application
[B] The Time Limit for Filing an SPC Application
[C] The Filing of an SPC at the National Patent Office
[D] The Documentation Required for an SPC Application
[E] The Definition of the Product in an SPC Application
[F] SPC Examination Procedure and Appeal Procedure
[G] Publication of SPC Applications and Issued SPCs
[H] Renewal Fees
[I] Applications for a Paediatric Extension
§1.06 PROCEDURE OF INVALIDATING AN SPC
[A] Grounds for the Invalidation of an SPC
[B] The Filing of an Invalidation Suit
[C] Invalidation Procedure and the Corresponding Appeal Procedure
[D] The Revocation of a Paediatric Extension
§1.07 UNFAIR COMPETITION LAW
CHAPTER 2 Albania
§2.01 LEGAL BASIS
§2.02 SUBSTANTIVE REQUIREMENTS FOR OBTAINING AN SPC
[A] Types of Products That Can Be Protected
[1] Practical Considerations: What Is the Active Ingredient or Combination of Active Ingredients That Can Form the Basis for an SPC?
[2] Active Ingredient or Combination of Active Ingredients of a Medicinal Product
[3] Active Substance or Combination of Active Substances of a Plant Protection Product
[4] Fixed-Dose and Loose Combinations
[5] Limitation to Products Subjected to a Specific Marketing Authorization Procedure
[B] Basic Patent
[1] Requirement for the Product to Be 'Protected' by the Basic Patent
[a] Small Molecules
[b] Polymers
[c] Antibodies, Enzymes and Other Proteins
[d] Nucleic Acids
[2] Basic Patent Claiming the Product, i.e., the Active Ingredient(s), but Not the Corresponding Authorized Medicinal Product (or Plant Protection Product)
[3] Requirement for the Product to Constitute 'the Invention' of the Basic Patent
[4] Criteria for Choosing the Basic Patent among Various Available Patents
[C] The Marketing Authorization Forming Basis for an SPC
[1] Combinations of Active Ingredients
[a] The Marketing Authorization Refers to Fewer Active Ingredients than the SPC Application
[b] The Marketing Authorization Refers to More Active Ingredients than the SPC Application
[c] The Marketing Authorization Indicates That a Medicinal Product Containing a Single Active Ingredient Is Authorized for Use in Combination with a Further Active Ingredient
[2] The Marketing Authorization Has Not Yet Been Granted at the Time the SPC Application Is Filed
[3] The Holder of the Marketing Authorization
[4] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Medicinal Products
[5] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Plant Protection Products
[6] The Product in Question Is Contained in the Authorized Medicinal Product (or the Authorized Plant Protection Product) but Is Not Identified as an Active Ingredient in the Corresponding Marketing Authorization
[7] The Notion of the 'First' Marketing Authorization
[a] Marketing Authorization for a New Therapeutic Application of a Previously Authorized Product
[b] Marketing Authorization for a New Formulation of a Previously Authorized Product
[c] Marketing Authorization for a New Specific Salt, Ester or Other Derivative of a Previously Authorized Active Ingredient
[d] Marketing Authorization for a New Specific Enantiomer of an Active Ingredient Previously Authorized in Racemic Form
[e] The Product Has Already Been Placed on the Market Before, but Without an Authorization Granted under Directive 2001/83/EC or Directive 2001/82/EC
[f] Prior Marketing Authorization Which Refers to Fewer Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[g] Prior Marketing Authorization Which Refers to More Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[D] Preclusion of New SPCs by an Earlier SPC
[1] The 'One SPC per Product per Patent Holder' Rule
[2] Consequences of an Earlier Third-Party SPC for the Same Product
[a] Earlier SPC Granted to an Affiliated Third Party
[b] Partial Overlap Between the Holders of the Earlier SPC and the Applicants for the New SPC
[c] Earlier Third-Party SPC Has Been Licensed-In
[3] Consequences of an Own Earlier SPC for the Same Product
[a] Own Earlier SPC Application Not Yet Granted
[b] Revocation, Surrender or Lapse of the Own Earlier SPC after Grant
[c] Transfer of the Own Earlier SPC to a Third Party
[d] Acquisition of an SPC Granted to a Third Party
[4] Consequences of an Own Earlier SPC for a Different Product
[a] Required Distinction from the Product of the Own Earlier SPC
[b] Combinations of Active Ingredients
[c] New Therapeutic Applications of Previously Approved Active Ingredients
[d] SPCs for a Specific Salt, Ester or Other Derivative Where an Own Earlier SPC Has Already Been Granted for the Corresponding Active Ingredient
[e] SPCs for a Specific Enantiomer Where an Own Earlier SPC Has Already Been Granted for the Corresponding Racemate
[5] Grant of More than One SPC on the Basis of the Same Patent
§2.03 EXTENT OF PROTECTION AND ENFORCEMENT OF SPCS
[A] The Protection Conferred by an SPC
[B] The Scope of an SPC in Relation to Derivatives of an Active Ingredient
[1] The Relationship Between the Definition of the Active Ingredient(s) in an SPC and Its Scope of Protection
[C] Enforcement of an SPC
[D] The Manufacturing Waiver
§2.04 DETERMINATION OF THE SPC TERM
[A] The Calculation of the SPC Term
[1] The Relevant Marketing Authorization for the Term of an SPC
[2] The Expiration Date of an SPC
[B] Correction of the SPC Term
[C] The Term of a Paediatric Extension
§2.05 PROCEDURE OF FILING AN SPC APPLICATION
[A] Entitlement to an SPC Application
[B] The Time Limit for Filing an SPC Application
[C] The Filing of an SPC at the National Patent Office
[D] The Documentation Required for an SPC Application
[E] The Definition of the Product in an SPC Application
[F] SPC Examination Procedure and Appeal Procedure
[G] Publication of SPC Applications and Issued SPCs
[H] Renewal Fees
[I] Applications for a Paediatric Extension
§2.06 PROCEDURE OF INVALIDATING AN SPC
[A] Grounds for the Invalidation of an SPC
[B] The Filing of an Invalidation Suit
[C] Invalidation Procedure and the Corresponding Appeal Procedure
[D] The Revocation of a Paediatric Extension
§2.07 UNFAIR COMPETITION LAW
CHAPTER 3 Austria
§3.01 LEGAL BASIS
§3.02 SUBSTANTIVE REQUIREMENTS FOR OBTAINING AN SPC
[A] Types of Products That Can Be Protected
[1] Practical Considerations: What Is the Active Ingredient or Combination of Active Ingredients That Can Form the Basis for an SPC?
[2] Active Ingredient or Combination of Active Ingredients of a Medicinal Product
[3] Active Substance or Combination of Active Substances of a Plant Protection Product
[4] Fixed-Dose and Loose Combinations
[5] Limitation to Products Subjected to a Specific Marketing Authorization Procedure
[B] Basic Patent
[1] Requirement for the Product to Be 'Protected' by the Basic Patent
[a] Small Molecules
[b] Polymers
[c] Antibodies, Enzymes and Other Proteins
[d] Nucleic Acids
[2] Basic Patent Claiming the Product, i.e., the Active Ingredient(s), but Not the Corresponding Authorized Medicinal Product (or Plant Protection Product)
[3] Requirement for the Product to Constitute 'the Invention' of the Basic Patent
[4] Criteria for Choosing the Basic Patent among Various Available Patents
[C] The Marketing Authorization Forming Basis for an SPC
[1] Combinations of Active Ingredients
[a] The Marketing Authorization Refers to Fewer Active Ingredients than the SPC Application
[b] The Marketing Authorization Refers to More Active Ingredients than the SPC Application
[c] The Marketing Authorization Indicates That a Medicinal Product Containing a Single Active Ingredient Is Authorized for Use in Combination with a Further Active Ingredient
[2] The Marketing Authorization Has Not Yet Been Granted at the Time the SPC Application Is Filed
[3] The Holder of the Marketing Authorization
[4] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Medicinal Products
[5] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Plant Protection Products
[6] The Product in Question Is Contained in the Authorized Medicinal Product (or the Authorized Plant Protection Product) but Is Not Identified as an Active Ingredient in the Corresponding Marketing Authorization
[7] The Notion of the 'First' Marketing Authorization
[a] Marketing Authorization for a New Therapeutic Application of a Previously Authorized Product
[b] Marketing Authorization for a New Formulation of a Previously Authorized Product
[c] Marketing Authorization for a New Specific Salt, Ester or Other Derivative of a Previously Authorized Active Ingredient
[d] Marketing Authorization for a New Specific Enantiomer of an Active Ingredient Previously Authorized in Racemic Form
[e] The Product Has Already Been Placed on the Market Before, but Without an Authorization Granted under Directive 2001/83/EC or Directive 2001/82/EC
[f] Prior Marketing Authorization Which Refers to Fewer Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[g] Prior Marketing Authorization Which Refers to More Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[D] Preclusion of New SPCs by an Earlier SPC
[1] The 'One SPC per Product per Patent Holder' Rule
[2] Consequences of an Earlier Third-Party SPC for the Same Product
[a] Earlier SPC Granted to an Affiliated Third Party
[b] Partial Overlap Between the Holders of the Earlier SPC and the Applicants for the New SPC
[c] Earlier Third-Party SPC Has Been Licensed-In
[3] Consequences of an Own Earlier SPC for the Same Product
[a] Own Earlier SPC Application Not Yet Granted
[b] Revocation, Surrender or Lapse of the Own Earlier SPC after Grant
[c] Transfer of the Own Earlier SPC to a Third Party
[d] Acquisition of an SPC Granted to a Third Party
[4] Consequences of an Own Earlier SPC for a Different Product
[a] Required Distinction from the Product of the Own Earlier SPC
[b] Combinations of Active Ingredients
[c] New Therapeutic Applications of Previously Approved Active Ingredients
[d] SPCs for a Specific Salt, Ester or Other Derivative Where an Own Earlier SPC Has Already Been Granted for the Corresponding Active Ingredient
[e] SPCs for a Specific Enantiomer Where an Own Earlier SPC Has Already Been Granted for the Corresponding Racemate
[5] Grant of More than One SPC on the Basis of the Same Patent
§3.03 EXTENT OF PROTECTION AND ENFORCEMENT OF SPCS
[A] The Protection Conferred by an SPC
[B] The Scope of an SPC in Relation to Derivatives of an Active Ingredient
[1] The Relationship Between the Definition of the Active Ingredient(s) in an SPC and Its Scope of Protection
[C] Enforcement of an SPC
[D] The Manufacturing Waiver
§3.04 DETERMINATION OF THE SPC TERM
[A] The Calculation of the SPC Term
[1] The Relevant Marketing Authorization for the Term of an SPC
[2] The Expiration Date of an SPC
[B] Correction of the SPC Term
[C] The Term of a Paediatric Extension
§3.05 PROCEDURE OF FILING AN SPC APPLICATION
[A] Entitlement to an SPC Application
[B] The Time Limit for Filing an SPC Application
[C] The Filing of an SPC at the National Patent Office
[D] The Documentation Required for an SPC Application
[E] The Definition of the Product in an SPC Application
[F] SPC Examination Procedure and Appeal Procedure
[G] Publication of SPC Applications and Issued SPCs
[H] Renewal Fees
[I] Applications for a Paediatric Extension
§3.06 PROCEDURE OF INVALIDATING AN SPC
[A] Grounds for the Invalidation of an SPC
[B] The Filing of an Invalidation Suit
[C] Invalidation Procedure and the Corresponding Appeal Procedure
[D] The Revocation of a Paediatric Extension
§3.07 UNFAIR COMPETITION LAW
CHAPTER 4 Belgium
§4.01 LEGAL BASIS
§4.02 SUBSTANTIVE REQUIREMENTS FOR OBTAINING AN SPC
[A] Types of Products That Can Be Protected
[1] Practical Considerations: What Is the Active Ingredient or Combination of Active Ingredients That Can Form the Basis for an SPC?
[2] Active Ingredient or Combination of Active Ingredients of a Medicinal Product
[3] Active Substance or Combination of Active Substances of a Plant Protection Product
[4] Fixed-Dose and Loose Combinations
[5] Limitation to Products Subjected to a Specific Marketing Authorization Procedure
[B] Basic Patent
[1] Requirement for the Product to Be 'Protected' by the Basic Patent
[a] Small Molecules
[b] Polymers
[c] Antibodies, Enzymes and Other Proteins
[d] Nucleic Acids
[2] Basic Patent Claiming the Product, i.e., the Active Ingredient(s), but Not the Corresponding Authorized Medicinal Product (or Plant Protection Product)
[3] Requirement for the Product to Constitute 'the Invention' of the Basic Patent
[4] Criteria for Choosing the Basic Patent among Various Available Patents
[C] The Marketing Authorization Forming Basis for an SPC
[1] Combinations of Active Ingredients
[a] The Marketing Authorization Refers to Fewer Active Ingredients than the SPC Application
[b] The Marketing Authorization Refers to More Active Ingredients than the SPC Application
[c] The Marketing Authorization Indicates That a Medicinal Product Containing a Single Active Ingredient Is Authorized for Use in Combination with a Further Active Ingredient
[2] The Marketing Authorization Has Not Yet Been Granted at the Time the SPC Application Is Filed
[3] The Holder of the Marketing Authorization
[4] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Medicinal Products
[5] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Plant Protection Products
[6] The Product in Question Is Contained in the Authorized Medicinal Product (or the Authorized Plant Protection Product) but Is Not Identified as an Active Ingredient in the Corresponding Marketing Authorization
[7] The Notion of the 'First' Marketing Authorization
[a] Marketing Authorization for a New Therapeutic Application of a Previously Authorized Product
[b] Marketing Authorization for a New Formulation of a Previously Authorized Product
[c] Marketing Authorization for a New Specific Salt, Ester or Other Derivative of a Previously Authorized Active Ingredient
[d] Marketing Authorization for a New Specific Enantiomer of an Active Ingredient Previously Authorized in Racemic Form
[e] The Product Has Already Been Placed on the Market Before, but Without an Authorization Granted under Directive 2001/83/EC or Directive 2001/82/EC
[f] Prior Marketing Authorization Which Refers to Fewer Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[g] Prior Marketing Authorization Which Refers to More Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[D] Preclusion of New SPCs by an Earlier SPC
[1] The 'One SPC per Product per Patent Holder' Rule
[2] Consequences of an Earlier Third-Party SPC for the Same Product
[a] Earlier SPC Granted to an Affiliated Third Party
[b] Partial Overlap Between the Holders of the Earlier SPC and the Applicants for the New SPC
[c] Earlier Third-Party SPC Has Been Licensed-In
[3] Consequences of an Own Earlier SPC for the Same Product
[a] Own Earlier SPC Application Not Yet Granted
[b] Revocation, Surrender or Lapse of the Own Earlier SPC after Grant
[c] Transfer of the Own Earlier SPC to a Third Party
[d] Acquisition of an SPC Granted to a Third Party
[4] Consequences of an Own Earlier SPC for a Different Product
[a] Required Distinction from the Product of the Own Earlier SPC
[b] Combinations of Active Ingredients
[c] New Therapeutic Applications of Previously Approved Active Ingredients
[d] SPCs for a Specific Salt, Ester or Other Derivative Where an Own Earlier SPC Has Already Been Granted for the Corresponding Active Ingredient
[e] SPCs for a Specific Enantiomer Where an Own Earlier SPC Has Already Been Granted for the Corresponding Racemate
[5] Grant of More than One SPC on the Basis of the Same Patent
§4.03 EXTENT OF PROTECTION AND ENFORCEMENT OF SPCS
[A] The Protection Conferred by an SPC
[B] The Scope of an SPC in Relation to Derivatives of an Active Ingredient
[1] The Relationship Between the Definition of the Active Ingredient(s) in an SPC and Its Scope of Protection
[C] Enforcement of an SPC
[D] The Manufacturing Waiver
§4.04 DETERMINATION OF THE SPC TERM
[A] The Calculation of the SPC Term
[1] The Relevant Marketing Authorization for the Term of an SPC
[2] The Expiration Date of an SPC
[B] Correction of the SPC Term
[C] The Term of a Paediatric Extension
§4.05 PROCEDURE OF FILING AN SPC APPLICATION
[A] Entitlement to an SPC Application
[B] The Time Limit for Filing an SPC Application
[C] The Filing of an SPC at the National Patent Office
[D] The Documentation Required for an SPC Application
[E] The Definition of the Product in an SPC Application
[F] SPC Examination Procedure and Appeal Procedure
[G] Publication of SPC Applications and Issued SPCs
[H] Renewal Fees
[I] Applications for a Paediatric Extension
§4.06 PROCEDURE OF INVALIDATING AN SPC
[A] Grounds for the Invalidation of an SPC
[B] The Filing of an Invalidation Suit
[C] Invalidation Procedure and the Corresponding Appeal Procedure
[D] The Revocation of a Paediatric Extension
§4.07 UNFAIR COMPETITION LAW
CHAPTER 5 Bosnia and Herzegovina
§5.01 LEGAL BASIS
§5.02 SUBSTANTIVE REQUIREMENTS FOR OBTAINING AN SPC
[A] Types of Products That Can Be Protected
[1] Practical Considerations: What Is the Active Ingredient or Combination of Active Ingredients That Can Form the Basis for an SPC?
[2] Active Ingredient or Combination of Active Ingredients of a Medicinal Product
[3] Active Substance or Combination of Active Substances of a Plant Protection Product
[4] Fixed-Dose and Loose Combinations
[5] Limitation to Products Subjected to a Specific Marketing Authorization Procedure
[B] Basic Patent
[1] Requirement for the Product to Be 'Protected' by the Basic Patent
[a] Small Molecules
[b] Polymers
[c] Antibodies, Enzymes and Other Proteins
[d] Nucleic Acids
[2] Basic Patent Claiming the Product, i.e., the Active Ingredient(s), but Not the Corresponding Authorized Medicinal Product (or Plant Protection Product)
[3] Requirement for the Product to Constitute 'the Invention' of the Basic Patent
[4] Criteria for Choosing the Basic Patent among Various Available Patents
[C] The Marketing Authorization Forming Basis for an SPC
[1] Combinations of Active Ingredients
[a] The Marketing Authorization Refers to Fewer Active Ingredients than the SPC Application
[b] The Marketing Authorization Refers to More Active Ingredients than the SPC Application
[c] The Marketing Authorization Indicates That a Medicinal Product Containing a Single Active Ingredient Is Authorized for Use in Combination with a Further Active Ingredient
[2] The Marketing Authorization Has Not Yet Been Granted at the Time the SPC Application Is Filed
[3] The Holder of the Marketing Authorization
[4] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Medicinal Products
[5] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Plant Protection Products
[6] The Product in Question Is Contained in the Authorized Medicinal Product (or the Authorized Plant Protection Product) but Is Not Identified as an Active Ingredient in the Corresponding Marketing Authorization
[7] The Notion of the 'First' Marketing Authorization
[a] Marketing Authorization for a New Therapeutic Application of a Previously Authorized Product
[b] Marketing Authorization for a New Formulation of a Previously Authorized Product
[c] Marketing Authorization for a New Specific Salt, Ester or Other Derivative of a Previously Authorized Active Ingredient
[d] Marketing Authorization for a New Specific Enantiomer of an Active Ingredient Previously Authorized in Racemic Form
[e] The Product Has Already Been Placed on the Market Before, but Without an Authorization Granted under Directive 2001/83/EC or Directive 2001/82/EC
[f] Prior Marketing Authorization Which Refers to Fewer Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[g] Prior Marketing Authorization Which Refers to More Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[D] Preclusion of New SPCs by an Earlier SPC
[1] The 'One SPC per Product per Patent Holder' Rule
[2] Consequences of an Earlier Third-Party SPC for the Same Product
[a] Earlier SPC Granted to an Affiliated Third Party
[b] Partial Overlap Between the Holders of the Earlier SPC and the Applicants for the New SPC
[c] Earlier Third-Party SPC Has Been Licensed-In
[3] Consequences of an Own Earlier SPC for the Same Product
[a] Own Earlier SPC Application Not Yet Granted
[b] Revocation, Surrender or Lapse of the Own Earlier SPC after Grant
[c] Transfer of the Own Earlier SPC to a Third Party
[d] Acquisition of an SPC Granted to a Third Party
[4] Consequences of an Own Earlier SPC for a Different Product
[a] Required Distinction from the Product of the Own Earlier SPC
[b] Combinations of Active Ingredients
[c] New Therapeutic Applications of Previously Approved Active Ingredients
[d] SPCs for a Specific Salt, Ester or Other Derivative Where an Own Earlier SPC Has Already Been Granted for the Corresponding Active Ingredient
[e] SPCs for a Specific Enantiomer Where an Own Earlier SPC Has Already Been Granted for the Corresponding Racemate
[5] Grant of More than One SPC on the Basis of the Same Patent
§5.03 EXTENT OF PROTECTION AND ENFORCEMENT OF SPCS
[A] The Protection Conferred by an SPC
[B] The Scope of an SPC in Relation to Derivatives of an Active Ingredient
[1] The Relationship Between the Definition of the Active Ingredient(s) in an SPC and Its Scope of Protection
[C] Enforcement of an SPC
[D] The Manufacturing Waiver
§5.04 DETERMINATION OF THE SPC TERM
[A] The Calculation of the SPC Term
[1] The Relevant Marketing Authorization for the Term of an SPC
[2] The Expiration Date of an SPC
[B] Correction of the SPC Term
[C] The Term of a Paediatric Extension
§5.05 PROCEDURE OF FILING AN SPC APPLICATION
[A] Entitlement to an SPC Application
[B] The Time Limit for Filing an SPC Application
[C] The Filing of an SPC at the National Patent Office
[D] The Documentation Required for an SPC Application
[E] The Definition of the Product in an SPC Application
[F] SPC Examination Procedure and Appeal Procedure
[G] Publication of SPC Applications and Issued SPCs
[H] Renewal Fees
[I] Applications for a Paediatric Extension
§5.06 PROCEDURE OF INVALIDATING AN SPC
[A] Grounds for the Invalidation of an SPC
[B] The Filing of an Invalidation Suit
[C] Invalidation Procedure and the Corresponding Appeal Procedure
[D] The Revocation of a Paediatric Extension
§5.07 UNFAIR COMPETITION LAW
CHAPTER 6 Bulgaria
§6.01 LEGAL BASIS
§6.02 SUBSTANTIVE REQUIREMENTS FOR OBTAINING AN SPC
[A] Types of Products That Can Be Protected
[1] Practical Considerations: What Is the Active Ingredient or Combination of Active Ingredients That Can Form the Basis for an SPC?
[2] Active Ingredient or Combination of Active Ingredients of a Medicinal Product
[3] Active Substance or Combination of Active Substances of a Plant Protection Product
[4] Fixed-Dose and Loose Combinations
[5] Limitation to Products Subjected to a Specific Marketing Authorization Procedure
[B] Basic Patent
[1] Requirement for the Product to Be 'Protected' by the Basic Patent
[a] Small Molecules
[b] Polymers
[c] Antibodies, Enzymes and Other Proteins
[d] Nucleic Acids
[2] Basic Patent Claiming the Product, i.e., the Active Ingredient(s), but Not the Corresponding Authorized Medicinal Product (or Plant Protection Product)
[3] Requirement for the Product to Constitute 'the Invention' of the Basic Patent
[4] Criteria for Choosing the Basic Patent among Various Available Patents
[C] The Marketing Authorization Forming Basis for an SPC
[1] Combinations of Active Ingredients
[a] The Marketing Authorization Refers to Fewer Active Ingredients than the SPC Application
[b] The Marketing Authorization Refers to More Active Ingredients than the SPC Application
[c] The Marketing Authorization Indicates That a Medicinal Product Containing a Single Active Ingredient Is Authorized for Use in Combination with a Further Active Ingredient
[2] The Marketing Authorization Has Not Yet Been Granted at the Time the SPC Application Is Filed
[3] The Holder of the Marketing Authorization
[4] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Medicinal Products
[5] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Plant Protection Products
[6] The Product in Question Is Contained in the Authorized Medicinal Product (or the Authorized Plant Protection Product) but Is Not Identified as an Active Ingredient in the Corresponding Marketing Authorization
[7] The Notion of the 'First' Marketing Authorization
[a] Marketing Authorization for a New Therapeutic Application of a Previously Authorized Product
[b] Marketing Authorization for a New Formulation of a Previously Authorized Product
[c] Marketing Authorization for a New Specific Salt, Ester or Other Derivative of a Previously Authorized Active Ingredient
[d] Marketing Authorization for a New Specific Enantiomer of an Active Ingredient Previously Authorized in Racemic Form
[e] The Product Has Already Been Placed on the Market Before, but Without an Authorization Granted under Directive 2001/83/EC or Directive 2001/82/EC
[f] Prior Marketing Authorization Which Refers to Fewer Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[g] Prior Marketing Authorization Which Refers to More Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[D] Preclusion of New SPCs by an Earlier SPC
[1] The 'One SPC per Product per Patent Holder' Rule
[2] Consequences of an Earlier Third-Party SPC for the Same Product
[a] Earlier SPC Granted to an Affiliated Third Party
[b] Partial Overlap Between the Holders of the Earlier SPC and the Applicants for the New SPC
[c] Earlier Third-Party SPC Has Been Licensed-In
[3] Consequences of an Own Earlier SPC for the Same Product
[a] Own Earlier SPC Application Not Yet Granted
[b] Revocation, Surrender or Lapse of the Own Earlier SPC after Grant
[c] Transfer of the Own Earlier SPC to a Third Party
[d] Acquisition of an SPC Granted to a Third Party
[4] Consequences of an Own Earlier SPC for a Different Product
[a] Required Distinction from the Product of the Own Earlier SPC
[b] Combinations of Active Ingredients
[c] New Therapeutic Applications of Previously Approved Active Ingredients
[d] SPCs for a Specific Salt, Ester or Other Derivative Where an Own Earlier SPC Has Already Been Granted for the Corresponding Active Ingredient
[e] SPCs for a Specific Enantiomer Where an Own Earlier SPC Has Already Been Granted for the Corresponding Racemate
[5] Grant of More than One SPC on the Basis of the Same Patent
§6.03 EXTENT OF PROTECTION AND ENFORCEMENT OF SPCS
[A] The Protection Conferred by an SPC
[B] The Scope of an SPC in Relation to Derivatives of an Active Ingredient
[1] The Relationship Between the Definition of the Active Ingredient(s) in an SPC and Its Scope of Protection
[C] Enforcement of an SPC
[D] The Manufacturing Waiver
§6.04 DETERMINATION OF THE SPC TERM
[A] The Calculation of the SPC Term
[1] The Relevant Marketing Authorization for the Term of an SPC
[2] The Expiration Date of an SPC
[B] Correction of the SPC Term
[C] The Term of a Paediatric Extension
§6.05 PROCEDURE OF FILING AN SPC APPLICATION
[A] Entitlement to an SPC Application
[B] The Time Limit for Filing an SPC Application
[C] The Filing of an SPC at the National Patent Office
[D] The Documentation Required for an SPC Application
[E] The Definition of the Product in an SPC Application
[F] SPC Examination Procedure and Appeal Procedure
[G] Publication of SPC Applications and Issued SPCs
[H] Renewal Fees
[I] Applications for a Paediatric Extension
§6.06 PROCEDURE OF INVALIDATING AN SPC
[A] Grounds for the Invalidation of an SPC
[B] The Filing of an Invalidation Suit
[C] Invalidation Procedure and the Corresponding Appeal Procedure
[D] The Revocation of a Paediatric Extension
§6.07 UNFAIR COMPETITION LAW
CHAPTER 7 Croatia
§7.01 LEGAL BASIS
§7.02 SUBSTANTIVE REQUIREMENTS FOR OBTAINING AN SPC
[A] Types of Products That Can Be Protected
[1] Practical Considerations: What Is the Active Ingredient or Combination of Active Ingredients That Can Form the Basis for an SPC?
[2] Active Ingredient or Combination of Active Ingredients of a Medicinal Product
[3] Active Substance or Combination of Active Substances of a Plant Protection Product
[4] Fixed-Dose and Loose Combinations
[5] Limitation to Products Subjected to a Specific Marketing Authorization Procedure
[B] Basic Patent
[1] Requirement for the Product to Be 'Protected' by the Basic Patent
[a] Small Molecules
[b] Polymers
[c] Antibodies, Enzymes and Other Proteins
[d] Nucleic Acids
[2] Basic Patent Claiming the Product, i.e., the Active Ingredient(s), but Not the Corresponding Authorized Medicinal Product (or Plant Protection Product)
[3] Requirement for the Product to Constitute 'the Invention' of the Basic Patent
[4] Criteria for Choosing the Basic Patent among Various Available Patents
[C] The Marketing Authorization Forming Basis for an SPC
[1] Combinations of Active Ingredients
[a] The Marketing Authorization Refers to Fewer Active Ingredients than the SPC Application
[b] The Marketing Authorization Refers to More Active Ingredients than the SPC Application
[c] The Marketing Authorization Indicates That a Medicinal Product Containing a Single Active Ingredient Is Authorized for Use in Combination with a Further Active Ingredient
[2] The Marketing Authorization Has Not Yet Been Granted at the Time the SPC Application Is Filed
[3] The Holder of the Marketing Authorization
[4] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Medicinal Products
[5] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Plant Protection Products
[6] The Product in Question Is Contained in the Authorized Medicinal Product (or the Authorized Plant Protection Product) but Is Not Identified as an Active Ingredient in the Corresponding Marketing Authorization
[7] The Notion of the 'First' Marketing Authorization
[a] Marketing Authorization for a New Therapeutic Application of a Previously Authorized Product
[b] Marketing Authorization for a New Formulation of a Previously Authorized Product
[c] Marketing Authorization for a New Specific Salt, Ester or Other Derivative of a Previously Authorized Active Ingredient
[d] Marketing Authorization for a New Specific Enantiomer of an Active Ingredient Previously Authorized in Racemic Form
[e] The Product Has Already Been Placed on the Market Before, but Without an Authorization Granted under Directive 2001/83/EC or Directive 2001/82/EC
[f] Prior Marketing Authorization Which Refers to Fewer Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[g] Prior Marketing Authorization Which Refers to More Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[D] Preclusion of New SPCs by an Earlier SPC
[1] The 'One SPC per Product per Patent Holder' Rule
[2] Consequences of an Earlier Third-Party SPC for the Same Product
[a] Earlier SPC Granted to an Affiliated Third Party
[b] Partial Overlap Between the Holders of the Earlier SPC and the Applicants for the New SPC
[c] Earlier Third-Party SPC Has Been Licensed-In
[3] Consequences of an Own Earlier SPC for the Same Product
[a] Own Earlier SPC Application Not Yet Granted
[b] Revocation, Surrender or Lapse of the Own Earlier SPC after Grant
[c] Transfer of the Own Earlier SPC to a Third Party
[d] Acquisition of an SPC Granted to a Third Party
[4] Consequences of an Own Earlier SPC for a Different Product
[a] Required Distinction from the Product of the Own Earlier SPC
[b] Combinations of Active Ingredients
[c] New Therapeutic Applications of Previously Approved Active Ingredients
[d] SPCs for a Specific Salt, Ester or Other Derivative Where an Own Earlier SPC Has Already Been Granted for the Corresponding Active Ingredient
[e] SPCs for a Specific Enantiomer Where an Own Earlier SPC Has Already Been Granted for the Corresponding Racemate
[5] Grant of More than One SPC on the Basis of the Same Patent
§7.03 EXTENT OF PROTECTION AND ENFORCEMENT OF SPCS
[A] The Protection Conferred by an SPC
[B] The Scope of an SPC in Relation to Derivatives of an Active Ingredient
[1] The Relationship Between the Definition of the Active Ingredient(s) in an SPC and Its Scope of Protection
[C] Enforcement of an SPC
[D] The Manufacturing Waiver
§7.04 DETERMINATION OF THE SPC TERM
[A] The Calculation of the SPC Term
[1] The Relevant Marketing Authorization for the Term of an SPC
[2] The Expiration Date of an SPC
[B] Correction of the SPC Term
[C] The Term of a Paediatric Extension
§7.05 PROCEDURE OF FILING AN SPC APPLICATION
[A] Entitlement to an SPC Application
[B] The Time Limit for Filing an SPC Application
[C] The Filing of an SPC at the National Patent Office
[D] The Documentation Required for an SPC Application
[E] The Definition of the Product in an SPC Application
[F] SPC Examination Procedure and Appeal Procedure
[G] Publication of SPC Applications and Issued SPCs
[H] Renewal Fees
[I] Applications for a Paediatric Extension
§7.06 PROCEDURE OF INVALIDATING AN SPC
[A] Grounds for the Invalidation of an SPC
[B] The Filing of an Invalidation Suit
[C] Invalidation Procedure and the Corresponding Appeal Procedure
[D] The Revocation of a Paediatric Extension
§7.07 UNFAIR COMPETITION LAW
CHAPTER 8 Cyprus
§8.01 LEGAL BASIS
§8.02 SUBSTANTIVE REQUIREMENTS FOR OBTAINING AN SPC
[A] Types of Products That Can Be Protected
[1] Practical Considerations: What Is the Active Ingredient or Combination of Active Ingredients That Can Form the Basis for an SPC?
[2] Active Ingredient or Combination of Active Ingredients of a Medicinal Product
[3] Active Substance or Combination of Active Substances of a Plant Protection Product
[4] Fixed-Dose and Loose Combinations
[5] Limitation to Products Subjected to a Specific Marketing Authorization Procedure
[B] Basic Patent
[1] Requirement for the Product to Be 'Protected' by the Basic Patent
[a] Small Molecules
[b] Polymers
[c] Antibodies, Enzymes and Other Proteins
[d] Nucleic Acids
[2] Basic Patent Claiming the Product, i.e., the Active Ingredient(s), but Not the Corresponding Authorized Medicinal Product (or Plant Protection Product)
[3] Requirement for the Product to Constitute 'the Invention' of the Basic Patent
[4] Criteria for Choosing the Basic Patent among Various Available Patents
[C] The Marketing Authorization Forming Basis for an SPC
[1] Combinations of Active Ingredients
[a] The Marketing Authorization Refers to Fewer Active Ingredients than the SPC Application
[b] The Marketing Authorization Refers to More Active Ingredients than the SPC Application
[c] The Marketing Authorization Indicates That a Medicinal Product Containing a Single Active Ingredient Is Authorized for Use in Combination with a Further Active Ingredient
[2] The Marketing Authorization Has Not Yet Been Granted at the Time the SPC Application Is Filed
[3] The Holder of the Marketing Authorization
[4] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Medicinal Products
[5] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Plant Protection Products
[6] The Product in Question Is Contained in the Authorized Medicinal Product (or the Authorized Plant Protection Product) but Is Not Identified as an Active Ingredient in the Corresponding Marketing Authorization
[7] The Notion of the 'First' Marketing Authorization
[a] Marketing Authorization for a New Therapeutic Application of a Previously Authorized Product
[b] Marketing Authorization for a New Formulation of a Previously Authorized Product
[c] Marketing Authorization for a New Specific Salt, Ester or Other Derivative of a Previously Authorized Active Ingredient
[d] Marketing Authorization for a New Specific Enantiomer of an Active Ingredient Previously Authorized in Racemic Form
[e] The Product Has Already Been Placed on the Market Before, but Without an Authorization Granted under Directive 2001/83/EC or Directive 2001/82/EC
[f] Prior Marketing Authorization Which Refers to Fewer Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[g] Prior Marketing Authorization Which Refers to More Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[D] Preclusion of New SPCs by an Earlier SPC
[1] The 'One SPC per Product per Patent Holder' Rule
[2] Consequences of an Earlier Third-Party SPC for the Same Product
[a] Earlier SPC Granted to an Affiliated Third Party
[b] Partial Overlap Between the Holders of the Earlier SPC and the Applicants for the New SPC
[c] Earlier Third-Party SPC Has Been Licensed-In
[3] Consequences of an Own Earlier SPC for the Same Product
[a] Own Earlier SPC Application Not Yet Granted
[b] Revocation, Surrender or Lapse of the Own Earlier SPC after Grant
[c] Transfer of the Own Earlier SPC to a Third Party
[d] Acquisition of an SPC Granted to a Third Party
[4] Consequences of an Own Earlier SPC for a Different Product
[a] Required Distinction from the Product of the Own Earlier SPC
[b] Combinations of Active Ingredients
[c] New Therapeutic Applications of Previously Approved Active Ingredients
[d] SPCs for a Specific Salt, Ester or Other Derivative Where an Own Earlier SPC Has Already Been Granted for the Corresponding Active Ingredient
[e] SPCs for a Specific Enantiomer Where an Own Earlier SPC Has Already Been Granted for the Corresponding Racemate
[5] Grant of More than One SPC on the Basis of the Same Patent
§8.03 EXTENT OF PROTECTION AND ENFORCEMENT OF SPCS
[A] The Protection Conferred by an SPC
[B] The Scope of an SPC in Relation to Derivatives of an Active Ingredient
[1] The Relationship Between the Definition of the Active Ingredient(s) in an SPC and Its Scope of Protection
[C] Enforcement of an SPC
[D] The Manufacturing Waiver
§8.04 DETERMINATION OF THE SPC TERM
[A] The Calculation of the SPC Term
[1] The Relevant Marketing Authorization for the Term of an SPC
[2] The Expiration Date of an SPC
[B] Correction of the SPC Term
[C] The Term of a Paediatric Extension
§8.05 PROCEDURE OF FILING AN SPC APPLICATION
[A] Entitlement to an SPC Application
[B] The Time Limit for Filing an SPC Application
[C] The Filing of an SPC at the National Patent Office
[D] The Documentation Required for an SPC Application
[E] The Definition of the Product in an SPC Application
[F] SPC Examination Procedure and Appeal Procedure
[G] Publication of SPC Applications and Issued SPCs
[H] Renewal Fees
[I] Applications for a Paediatric Extension
§8.06 PROCEDURE OF INVALIDATING AN SPC
[A] Grounds for the Invalidation of an SPC
[B] The Filing of an Invalidation Suit
[C] Invalidation Procedure and the Corresponding Appeal Procedure
[D] The Revocation of a Paediatric Extension
§8.07 UNFAIR COMPETITION LAW
CHAPTER 9 Czech Republic
§9.01 LEGAL BASIS
§9.02 SUBSTANTIVE REQUIREMENTS FOR OBTAINING AN SPC
[A] Types of Products That Can Be Protected
[1] Practical Considerations: What Is the Active Ingredient or Combination of Active Ingredients That Can Form the Basis for an SPC?
[2] Active Ingredient or Combination of Active Ingredients of a Medicinal Product
[3] Active Substance or Combination of Active Substances of a Plant Protection Product
[4] Fixed-Dose and Loose Combinations
[5] Limitation to Products Subjected to a Specific Marketing Authorization Procedure
[B] Basic Patent
[1] Requirement for the Product to Be 'Protected' by the Basic Patent
[a] Small Molecules
[b] Polymers
[c] Antibodies, Enzymes and Other Proteins
[d] Nucleic Acids
[2] Basic Patent Claiming the Product, i.e., the Active Ingredient(s), but Not the Corresponding Authorized Medicinal Product (or Plant Protection Product)
[3] Requirement for the Product to Constitute 'the Invention' of the Basic Patent
[4] Criteria for Choosing the Basic Patent among Various Available Patents
[C] The Marketing Authorization Forming Basis for an SPC
[1] Combinations of Active Ingredients
[a] The Marketing Authorization Refers to Fewer Active Ingredients than the SPC Application
[b] The Marketing Authorization Refers to More Active Ingredients than the SPC Application
[c] The Marketing Authorization Indicates That a Medicinal Product Containing a Single Active Ingredient Is Authorized for Use in Combination with a Further Active Ingredient
[2] The Marketing Authorization Has Not Yet Been Granted at the Time the SPC Application Is Filed
[3] The Holder of the Marketing Authorization
[4] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Medicinal Products
[5] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Plant Protection Products
[6] The Product in Question Is Contained in the Authorized Medicinal Product (or the Authorized Plant Protection Product) but Is Not Identified as an Active Ingredient in the Corresponding Marketing Authorization
[7] The Notion of the 'First' Marketing Authorization
[a] Marketing Authorization for a New Therapeutic Application of a Previously Authorized Product
[b] Marketing Authorization for a New Formulation of a Previously Authorized Product
[c] Marketing Authorization for a New Specific Salt, Ester or Other Derivative of a Previously Authorized Active Ingredient
[d] Marketing Authorization for a New Specific Enantiomer of an Active Ingredient Previously Authorized in Racemic Form
[e] The Product Has Already Been Placed on the Market Before, but Without an Authorization Granted under Directive 2001/83/EC or Directive 2001/82/EC
[f] Prior Marketing Authorization Which Refers to Fewer Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[g] Prior Marketing Authorization Which Refers to More Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[D] Preclusion of New SPCs by an Earlier SPC
[1] The 'One SPC per Product per Patent Holder' Rule
[2] Consequences of an Earlier Third-Party SPC for the Same Product
[a] Earlier SPC Granted to an Affiliated Third Party
[b] Partial Overlap Between the Holders of the Earlier SPC and the Applicants for the New SPC
[c] Earlier Third-Party SPC Has Been Licensed-In
[3] Consequences of an Own Earlier SPC for the Same Product
[a] Own Earlier SPC Application Not Yet Granted
[b] Revocation, Surrender or Lapse of the Own Earlier SPC after Grant
[c] Transfer of the Own Earlier SPC to a Third Party
[d] Acquisition of an SPC Granted to a Third Party
[4] Consequences of an Own Earlier SPC for a Different Product
[a] Required Distinction from the Product of the Own Earlier SPC
[b] Combinations of Active Ingredients
[c] New Therapeutic Applications of Previously Approved Active Ingredients
[d] SPCs for a Specific Salt, Ester or Other Derivative Where an Own Earlier SPC Has Already Been Granted for the Corresponding Active Ingredient
[e] SPCs for a Specific Enantiomer Where an Own Earlier SPC Has Already Been Granted for the Corresponding Racemate
[5] Grant of More than One SPC on the Basis of the Same Patent
§9.03 EXTENT OF PROTECTION AND ENFORCEMENT OF SPCS
[A] The Protection Conferred by an SPC
[B] The Scope of an SPC in Relation to Derivatives of an Active Ingredient
[1] The Relationship Between the Definition of the Active Ingredient(s) in an SPC and Its Scope of Protection
[C] Enforcement of an SPC
[D] The Manufacturing Waiver
§9.04 DETERMINATION OF THE SPC TERM
[A] The Calculation of the SPC Term
[1] The Relevant Marketing Authorization for the Term of an SPC
[2] The Expiration Date of an SPC
[B] Correction of the SPC Term
[C] The Term of a Paediatric Extension
§9.05 PROCEDURE OF FILING AN SPC APPLICATION
[A] Entitlement to an SPC Application
[B] The Time Limit for Filing an SPC Application
[C] The Filing of an SPC at the National Patent Office
[D] The Documentation Required for an SPC Application
[E] The Definition of the Product in an SPC Application
[F] SPC Examination Procedure and Appeal Procedure
[G] Publication of SPC Applications and Issued SPCs
[H] Renewal Fees
[I] Applications for a Paediatric Extension
§9.06 PROCEDURE OF INVALIDATING AN SPC
[A] Grounds for the Invalidation of an SPC
[B] The Filing of an Invalidation Suit
[C] Invalidation Procedure and the Corresponding Appeal Procedure
[D] The Revocation of a Paediatric Extension
§9.07 UNFAIR COMPETITION LAW
CHAPTER 10 Denmark
§10.01 LEGAL BASIS
§10.02 SUBSTANTIVE REQUIREMENTS FOR OBTAINING AN SPC
[A] Types of Products That Can Be Protected
[1] Practical Considerations: What Is the Active Ingredient or Combination of Active Ingredients That Can Form the Basis for an SPC?
[2] Active Ingredient or Combination of Active Ingredients of a Medicinal Product
[3] Active Substance or Combination of Active Substances of a Plant Protection Product
[4] Fixed-Dose and Loose Combinations
[5] Limitation to Products Subjected to a Specific Marketing Authorization Procedure
[B] Basic Patent
[1] Requirement for the Product to Be 'Protected' by the Basic Patent
[a] Small Molecules
[b] Polymers
[c] Antibodies, Enzymes and Other Proteins
[d] Nucleic Acids
[2] Basic Patent Claiming the Product, i.e., the Active Ingredient(s), but Not the Corresponding Authorized Medicinal Product (or Plant Protection Product)
[3] Requirement for the Product to Constitute 'the Invention' of the Basic Patent
[4] Criteria for Choosing the Basic Patent among Various Available Patents
[C] The Marketing Authorization Forming Basis for an SPC
[1] Combinations of Active Ingredients
[a] The Marketing Authorization Refers to Fewer Active Ingredients than the SPC Application
[b] The Marketing Authorization Refers to More Active Ingredients than the SPC Application
[c] The Marketing Authorization Indicates That a Medicinal Product Containing a Single Active Ingredient Is Authorized for Use in Combination with a Further Active Ingredient
[2] The Marketing Authorization Has Not Yet Been Granted at the Time the SPC Application Is Filed
[3] The Holder of the Marketing Authorization
[4] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Medicinal Products
[5] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Plant Protection Products
[6] The Product in Question Is Contained in the Authorized Medicinal Product (or the Authorized Plant Protection Product) but Is Not Identified as an Active Ingredient in the Corresponding Marketing Authorization
[7] The Notion of the 'First' Marketing Authorization
[a] Marketing Authorization for a New Therapeutic Application of a Previously Authorized Product
[b] Marketing Authorization for a New Formulation of a Previously Authorized Product
[c] Marketing Authorization for a New Specific Salt, Ester or Other Derivative of a Previously Authorized Active Ingredient
[d] Marketing Authorization for a New Specific Enantiomer of an Active Ingredient Previously Authorized in Racemic Form
[e] The Product Has Already Been Placed on the Market Before, but Without an Authorization Granted under Directive 2001/83/EC or Directive 2001/82/EC
[f] Prior Marketing Authorization Which Refers to Fewer Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[g] Prior Marketing Authorization Which Refers to More Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[D] Preclusion of New SPCs by an Earlier SPC
[1] The 'One SPC per Product per Patent Holder' Rule
[2] Consequences of an Earlier Third-Party SPC for the Same Product
[a] Earlier SPC Granted to an Affiliated Third Party
[b] Partial Overlap Between the Holders of the Earlier SPC and the Applicants for the New SPC
[c] Earlier Third-Party SPC Has Been Licensed-In
[3] Consequences of an Own Earlier SPC for the Same Product
[a] Own Earlier SPC Application Not Yet Granted
[b] Revocation, Surrender or Lapse of the Own Earlier SPC after Grant
[c] Transfer of the Own Earlier SPC to a Third Party
[d] Acquisition of an SPC Granted to a Third Party
[4] Consequences of an Own Earlier SPC for a Different Product
[a] Required Distinction from the Product of the Own Earlier SPC
[b] Combinations of Active Ingredients
[c] New Therapeutic Applications of Previously Approved Active Ingredients
[d] SPCs for a Specific Salt, Ester or Other Derivative Where an Own Earlier SPC Has Already Been Granted for the Corresponding Active Ingredient
[e] SPCs for a Specific Enantiomer Where an Own Earlier SPC Has Already Been Granted for the Corresponding Racemate
[5] Grant of More than One SPC on the Basis of the Same Patent
§10.03 EXTENT OF PROTECTION AND ENFORCEMENT OF SPCS
[A] The Protection Conferred by an SPC
[B] The Scope of an SPC in Relation to Derivatives of an Active Ingredient
[1] The Relationship Between the Definition of the Active Ingredient(s) in an SPC and Its Scope of Protection
[C] Enforcement of an SPC
[D] The Manufacturing Waiver
§10.04 DETERMINATION OF THE SPC TERM
[A] The Calculation of the SPC Term
[1] The Relevant Marketing Authorization for the Term of an SPC
[2] The Expiration Date of an SPC
[B] Correction of the SPC Term
[C] The Term of a Paediatric Extension
§10.05 PROCEDURE OF FILING AN SPC APPLICATION
[A] Entitlement to an SPC Application
[B] The Time Limit for Filing an SPC Application
[C] The Filing of an SPC at the National Patent Office
[D] The Documentation Required for an SPC Application
[E] The Definition of the Product in an SPC Application
[F] SPC Examination Procedure and Appeal Procedure
[G] Publication of SPC Applications and Issued SPCs
[H] Renewal Fees
[I] Applications for a Paediatric Extension
§10.06 PROCEDURE OF INVALIDATING AN SPC
[A] Grounds for the Invalidation of an SPC
[B] The Filing of an Invalidation Suit
[C] Invalidation Procedure and the Corresponding Appeal Procedure
[D] The Revocation of a Paediatric Extension
§10.07 UNFAIR COMPETITION LAW
CHAPTER 11 Estonia
§11.01 LEGAL BASIS
§11.02 SUBSTANTIVE REQUIREMENTS FOR OBTAINING AN SPC
[A] Types of Products That Can Be Protected
[1] Practical Considerations: What Is the Active Ingredient or Combination of Active Ingredients That Can Form the Basis for an SPC?
[2] Active Ingredient or Combination of Active Ingredients of a Medicinal Product
[3] Active Substance or Combination of Active Substances of a Plant Protection Product
[4] Fixed-Dose and Loose Combinations
[5] Limitation to Products Subjected to a Specific Marketing Authorization Procedure
[B] Basic Patent
[1] Requirement for the Product to Be 'Protected' by the Basic Patent
[a] Small Molecules
[b] Polymers
[c] Antibodies, Enzymes and Other Proteins
[d] Nucleic Acids
[2] Basic Patent Claiming the Product, i.e., the Active Ingredient(s), but Not the Corresponding Authorized Medicinal Product (or Plant Protection Product)
[3] Requirement for the Product to Constitute 'the Invention' of the Basic Patent
[4] Criteria for Choosing the Basic Patent among Various Available Patents
[C] The Marketing Authorization Forming Basis for an SPC
[1] Combinations of Active Ingredients
[a] The Marketing Authorization Refers to Fewer Active Ingredients than the SPC Application
[b] The Marketing Authorization Refers to More Active Ingredients than the SPC Application
[c] The Marketing Authorization Indicates That a Medicinal Product Containing a Single Active Ingredient Is Authorized for Use in Combination with a Further Active Ingredient
[2] The Marketing Authorization Has Not Yet Been Granted at the Time the SPC Application Is Filed
[3] The Holder of the Marketing Authorization
[4] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Medicinal Products
[5] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Plant Protection Products
[6] The Product in Question Is Contained in the Authorized Medicinal Product (or the Authorized Plant Protection Product) but Is Not Identified as an Active Ingredient in the Corresponding Marketing Authorization
[7] The Notion of the 'First' Marketing Authorization
[a] Marketing Authorization for a New Therapeutic Application of a Previously Authorized Product
[b] Marketing Authorization for a New Formulation of a Previously Authorized Product
[c] Marketing Authorization for a New Specific Salt, Ester or Other Derivative of a Previously Authorized Active Ingredient
[d] Marketing Authorization for a New Specific Enantiomer of an Active Ingredient Previously Authorized in Racemic Form
[e] The Product Has Already Been Placed on the Market Before, but Without an Authorization Granted under Directive 2001/83/EC or Directive 2001/82/EC
[f] Prior Marketing Authorization Which Refers to Fewer Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[g] Prior Marketing Authorization Which Refers to More Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[D] Preclusion of New SPCs by an Earlier SPC
[1] The 'One SPC per Product per Patent Holder' Rule
[2] Consequences of an Earlier Third-Party SPC for the Same Product
[a] Earlier SPC Granted to an Affiliated Third Party
[b] Partial Overlap Between the Holders of the Earlier SPC and the Applicants for the New SPC
[c] Earlier Third-Party SPC Has Been Licensed-In
[3] Consequences of an Own Earlier SPC for the Same Product
[a] Own Earlier SPC Application Not Yet Granted
[b] Revocation, Surrender or Lapse of the Own Earlier SPC after Grant
[c] Transfer of the Own Earlier SPC to a Third Party
[d] Acquisition of an SPC Granted to a Third Party
[4] Consequences of an Own Earlier SPC for a Different Product
[a] Required Distinction from the Product of the Own Earlier SPC
[b] Combinations of Active Ingredients
[c] New Therapeutic Applications of Previously Approved Active Ingredients
[d] SPCs for a Specific Salt, Ester or Other Derivative Where an Own Earlier SPC Has Already Been Granted for the Corresponding Active Ingredient
[e] SPCs for a Specific Enantiomer Where an Own Earlier SPC Has Already Been Granted for the Corresponding Racemate
[5] Grant of More than One SPC on the Basis of the Same Patent
§11.03 EXTENT OF PROTECTION AND ENFORCEMENT OF SPCS
[A] The Protection Conferred by an SPC
[B] The Scope of an SPC in Relation to Derivatives of an Active Ingredient
[1] The Relationship Between the Definition of the Active Ingredient(s) in an SPC and Its Scope of Protection
[C] Enforcement of an SPC
[D] The Manufacturing Waiver
§11.04 DETERMINATION OF THE SPC TERM
[A] The Calculation of the SPC Term
[1] The Relevant Marketing Authorization for the Term of an SPC
[2] The Expiration Date of an SPC
[B] Correction of the SPC Term
[C] The Term of a Paediatric Extension
§11.05 PROCEDURE OF FILING AN SPC APPLICATION
[A] Entitlement to an SPC Application
[B] The Time Limit for Filing an SPC Application
[C] The Filing of an SPC at the National Patent Office
[D] The Documentation Required for an SPC Application
[E] The Definition of the Product in an SPC Application
[F] SPC Examination Procedure and Appeal Procedure
[G] Publication of SPC Applications and Issued SPCs
[H] Renewal Fees
[I] Applications for a Paediatric Extension
§11.06 PROCEDURE OF INVALIDATING AN SPC
[A] Grounds for the Invalidation of an SPC
[B] The Filing of an Invalidation Suit
[C] Invalidation Procedure and the Corresponding Appeal Procedure
[D] The Revocation of a Paediatric Extension
§11.07 UNFAIR COMPETITION LAW
CHAPTER 12 Finland
§12.01 LEGAL BASIS
§12.02 SUBSTANTIVE REQUIREMENTS FOR OBTAINING AN SPC
[A] Types of Products That Can Be Protected
[1] Practical Considerations: What Is the Active Ingredient or Combination of Active Ingredients That Can Form the Basis for an SPC?
[2] Active Ingredient or Combination of Active Ingredients of a Medicinal Product
[3] Active Substance or Combination of Active Substances of a Plant Protection Product
[4] Fixed-Dose and Loose Combinations
[5] Limitation to Products Subjected to a Specific Marketing Authorization Procedure
[B] Basic Patent
[1] Requirement for the Product to Be 'Protected' by the Basic Patent
[a] Small Molecules
[b] Polymers
[c] Antibodies, Enzymes and Other Proteins
[d] Nucleic Acids
[2] Basic Patent Claiming the Product, i.e., the Active Ingredient(s), but Not the Corresponding Authorized Medicinal Product (or Plant Protection Product)
[3] Requirement for the Product to Constitute 'the Invention' of the Basic Patent
[4] Criteria for Choosing the Basic Patent among Various Available Patents
[C] The Marketing Authorization Forming Basis for an SPC
[1] Combinations of Active Ingredients
[a] The Marketing Authorization Refers to Fewer Active Ingredients than the SPC Application
[b] The Marketing Authorization Refers to More Active Ingredients than the SPC Application
[c] The Marketing Authorization Indicates That a Medicinal Product Containing a Single Active Ingredient Is Authorized for Use in Combination with a Further Active Ingredient
[2] The Marketing Authorization Has Not Yet Been Granted at the Time the SPC Application Is Filed
[3] The Holder of the Marketing Authorization
[4] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Medicinal Products
[5] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Plant Protection Products
[6] The Product in Question Is Contained in the Authorized Medicinal Product (or the Authorized Plant Protection Product) but Is Not Identified as an Active Ingredient in the Corresponding Marketing Authorization
[7] The Notion of the 'First' Marketing Authorization
[a] Marketing Authorization for a New Therapeutic Application of a Previously Authorized Product
[b] Marketing Authorization for a New Formulation of a Previously Authorized Product
[c] Marketing Authorization for a New Specific Salt, Ester or Other Derivative of a Previously Authorized Active Ingredient
[d] Marketing Authorization for a New Specific Enantiomer of an Active Ingredient Previously Authorized in Racemic Form
[e] The Product Has Already Been Placed on the Market Before, but Without an Authorization Granted under Directive 2001/83/EC or Directive 2001/82/EC
[f] Prior Marketing Authorization Which Refers to Fewer Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[g] Prior Marketing Authorization Which Refers to More Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[D] Preclusion of New SPCs by an Earlier SPC
[1] The 'One SPC per Product per Patent Holder' Rule
[2] Consequences of an Earlier Third-Party SPC for the Same Product
[a] Earlier SPC Granted to an Affiliated Third Party
[b] Partial Overlap Between the Holders of the Earlier SPC and the Applicants for the New SPC
[c] Earlier Third-Party SPC Has Been Licensed-In
[3] Consequences of an Own Earlier SPC for the Same Product
[a] Own Earlier SPC Application Not Yet Granted
[b] Revocation, Surrender or Lapse of the Own Earlier SPC after Grant
[c] Transfer of the Own Earlier SPC to a Third Party
[d] Acquisition of an SPC Granted to a Third Party
[4] Consequences of an Own Earlier SPC for a Different Product
[a] Required Distinction from the Product of the Own Earlier SPC
[b] Combinations of Active Ingredients
[c] New Therapeutic Applications of Previously Approved Active Ingredients
[d] SPCs for a Specific Salt, Ester or Other Derivative Where an Own Earlier SPC Has Already Been Granted for the Corresponding Active Ingredient
[e] SPCs for a Specific Enantiomer Where an Own Earlier SPC Has Already Been Granted for the Corresponding Racemate
[5] Grant of More than One SPC on the Basis of the Same Patent
§12.03 EXTENT OF PROTECTION AND ENFORCEMENT OF SPCS
[A] The Protection Conferred by an SPC
[B] The Scope of an SPC in Relation to Derivatives of an Active Ingredient
[1] The Relationship Between the Definition of the Active Ingredient(s) in an SPC and Its Scope of Protection
[C] Enforcement of an SPC
[D] The Manufacturing Waiver
§12.04 DETERMINATION OF THE SPC TERM
[A] The Calculation of the SPC Term
[1] The Relevant Marketing Authorization for the Term of an SPC
[2] The Expiration Date of an SPC
[B] Correction of the SPC Term
[C] The Term of a Paediatric Extension
§12.05 PROCEDURE OF FILING AN SPC APPLICATION
[A] Entitlement to an SPC Application
[B] The Time Limit for Filing an SPC Application
[C] The Filing of an SPC at the National Patent Office
[D] The Documentation Required for an SPC Application
[E] The Definition of the Product in an SPC Application
[F] SPC Examination Procedure and Appeal Procedure
[G] Publication of SPC Applications and Issued SPCs
[H] Renewal Fees
[I] Applications for a Paediatric Extension
§12.06 PROCEDURE OF INVALIDATING AN SPC
[A] Grounds for the Invalidation of an SPC
[B] The Filing of an Invalidation Suit
[C] Invalidation Procedure and the Corresponding Appeal Procedure
[D] The Revocation of a Paediatric Extension
§12.07 UNFAIR COMPETITION LAW
CHAPTER 13 France
§13.01 LEGAL BASIS
§13.02 SUBSTANTIVE REQUIREMENTS FOR OBTAINING AN SPC
[A] Types of Products That Can Be Protected
[1] Practical Considerations: What Is the Active Ingredient or Combination of Active Ingredients That Can Form the Basis for an SPC?
[2] Active Ingredient or Combination of Active Ingredients of a Medicinal Product
[3] Active Substance or Combination of Active Substances of a Plant Protection Product
[4] Fixed-Dose and Loose Combinations
[5] Limitation to Products Subjected to a Specific Marketing Authorization Procedure
[B] Basic Patent
[1] Requirement for the Product to Be 'Protected' by the Basic Patent
[a] Small Molecules
[b] Polymers
[c] Antibodies, Enzymes and Other Proteins
[d] Nucleic Acids
[2] Basic Patent Claiming the Product, i.e., the Active Ingredient(s), but Not the Corresponding Authorized Medicinal Product (or Plant Protection Product)
[3] Requirement for the Product to Constitute 'the Invention' of the Basic Patent
[4] Criteria for Choosing the Basic Patent among Various Available Patents
[C] The Marketing Authorization Forming Basis for an SPC
[1] Combinations of Active Ingredients
[a] The Marketing Authorization Refers to Fewer Active Ingredients than the SPC Application
[b] The Marketing Authorization Refers to More Active Ingredients than the SPC Application
[c] The Marketing Authorization Indicates That a Medicinal Product Containing a Single Active Ingredient Is Authorized for Use in Combination with a Further Active Ingredient
[2] The Marketing Authorization Has Not Yet Been Granted at the Time the SPC Application Is Filed
[3] The Holder of the Marketing Authorization
[4] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Medicinal Products
[5] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Plant Protection Products
[6] The Product in Question Is Contained in the Authorized Medicinal Product (or the Authorized Plant Protection Product) but Is Not Identified as an Active Ingredient in the Corresponding Marketing Authorization
[7] The Notion of the 'First' Marketing Authorization
[a] Marketing Authorization for a New Therapeutic Application of a Previously Authorized Product
[b] Marketing Authorization for a New Formulation of a Previously Authorized Product
[c] Marketing Authorization for a New Specific Salt, Ester or Other Derivative of a Previously Authorized Active Ingredient
[d] Marketing Authorization for a New Specific Enantiomer of an Active Ingredient Previously Authorized in Racemic Form
[e] The Product Has Already Been Placed on the Market Before, but Without an Authorization Granted under Directive 2001/83/EC or Directive 2001/82/EC
[f] Prior Marketing Authorization Which Refers to Fewer Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[g] Prior Marketing Authorization Which Refers to More Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[D] Preclusion of New SPCs by an Earlier SPC
[1] The 'One SPC per Product per Patent Holder' Rule
[2] Consequences of an Earlier Third-Party SPC for the Same Product
[a] Earlier SPC Granted to an Affiliated Third Party
[b] Partial Overlap Between the Holders of the Earlier SPC and the Applicants for the New SPC
[c] Earlier Third-Party SPC Has Been Licensed-In
[3] Consequences of an Own Earlier SPC for the Same Product
[a] Own Earlier SPC Application Not Yet Granted
[b] Revocation, Surrender or Lapse of the Own Earlier SPC after Grant
[c] Transfer of the Own Earlier SPC to a Third Party
[d] Acquisition of an SPC Granted to a Third Party
[4] Consequences of an Own Earlier SPC for a Different Product
[a] Required Distinction from the Product of the Own Earlier SPC
[b] Combinations of Active Ingredients
[c] New Therapeutic Applications of Previously Approved Active Ingredients
[d] SPCs for a Specific Salt, Ester or Other Derivative Where an Own Earlier SPC Has Already Been Granted for the Corresponding Active Ingredient
[e] SPCs for a Specific Enantiomer Where an Own Earlier SPC Has Already Been Granted for the Corresponding Racemate
[5] Grant of More than One SPC on the Basis of the Same Patent
§13.03 EXTENT OF PROTECTION AND ENFORCEMENT OF SPCS
[A] The Protection Conferred by an SPC
[B] The Scope of an SPC in Relation to Derivatives of an Active Ingredient
[1] The Relationship Between the Definition of the Active Ingredient(s) in an SPC and Its Scope of Protection
[C] Enforcement of an SPC
[D] The Manufacturing Waiver
§13.04 DETERMINATION OF THE SPC TERM
[A] The Calculation of the SPC Term
[1] The Relevant Marketing Authorization for the Term of an SPC
[2] The Expiration Date of an SPC
[B] Correction of the SPC Term
[C] The Term of a Paediatric Extension
§13.05 PROCEDURE OF FILING AN SPC APPLICATION
[A] Entitlement to an SPC Application
[B] The Time Limit for Filing an SPC Application
[C] The Filing of an SPC at the National Patent Office
[D] The Documentation Required for an SPC Application
[E] The Definition of the Product in an SPC Application
[F] SPC Examination Procedure and Appeal Procedure
[G] Publication of SPC Applications and Issued SPCs
[H] Renewal Fees
[I] Applications for a Paediatric Extension
§13.06 PROCEDURE OF INVALIDATING AN SPC
[A] Grounds for the Invalidation of an SPC
[B] The Filing of an Invalidation Suit
[C] Invalidation Procedure and the Corresponding Appeal Procedure
[D] The Revocation of a Paediatric Extension
§13.07 UNFAIR COMPETITION LAW
CHAPTER 14 Germany
§14.01 LEGAL BASIS
§14.02 SUBSTANTIVE REQUIREMENTS FOR OBTAINING AN SPC
[A] Types of Products That Can Be Protected
[1] Practical Considerations: What Is the Active Ingredient or Combination of Active Ingredients That Can Form the Basis for an SPC?
[2] Active Ingredient or Combination of Active Ingredients of a Medicinal Product
[3] Active Substance or Combination of Active Substances of a Plant Protection Product
[4] Fixed-Dose and Loose Combinations
[5] Limitation to Products Subjected to a Specific Marketing Authorization Procedure
[B] Basic Patent
[1] Requirement for the Product to Be 'Protected' by the Basic Patent
[a] Small Molecules
[b] Polymers
[c] Antibodies, Enzymes and Other Proteins
[d] Nucleic Acids
[2] Basic Patent Claiming the Product, i.e., the Active Ingredient(s), but Not the Corresponding Authorized Medicinal Product (or Plant Protection Product)
[3] Requirement for the Product to Constitute 'the Invention' of the Basic Patent
[4] Criteria for Choosing the Basic Patent among Various Available Patents
[C] The Marketing Authorization Forming Basis for an SPC
[1] Combinations of Active Ingredients
[a] The Marketing Authorization Refers to Fewer Active Ingredients than the SPC Application
[b] The Marketing Authorization Refers to More Active Ingredients than the SPC Application
[c] The Marketing Authorization Indicates That a Medicinal Product Containing a Single Active Ingredient Is Authorized for Use in Combination with a Further Active Ingredient
[2] The Marketing Authorization Has Not Yet Been Granted at the Time the SPC Application Is Filed
[3] The Holder of the Marketing Authorization
[4] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Medicinal Products
[5] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Plant Protection Products
[6] The Product in Question Is Contained in the Authorized Medicinal Product (or the Authorized Plant Protection Product) but Is Not Identified as an Active Ingredient in the Corresponding Marketing Authorization
[7] The Notion of the 'First' Marketing Authorization
[a] Marketing Authorization for a New Therapeutic Application of a Previously Authorized Product
[b] Marketing Authorization for a New Formulation of a Previously Authorized Product
[c] Marketing Authorization for a New Specific Salt, Ester or Other Derivative of a Previously Authorized Active Ingredient
[d] Marketing Authorization for a New Specific Enantiomer of an Active Ingredient Previously Authorized in Racemic Form
[e] The Product Has Already Been Placed on the Market Before, but Without an Authorization Granted under Directive 2001/83/EC or Directive 2001/82/EC
[f] Prior Marketing Authorization Which Refers to Fewer Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[g] Prior Marketing Authorization Which Refers to More Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[D] Preclusion of New SPCs by an Earlier SPC
[1] The 'One SPC per Product per Patent Holder' Rule
[2] Consequences of an Earlier Third-Party SPC for the Same Product
[a] Earlier SPC Granted to an Affiliated Third Party
[b] Partial Overlap Between the Holders of the Earlier SPC and the Applicants for the New SPC
[c] Earlier Third-Party SPC Has Been Licensed-In
[3] Consequences of an Own Earlier SPC for the Same Product
[a] Own Earlier SPC Application Not Yet Granted
[b] Revocation, Surrender or Lapse of the Own Earlier SPC after Grant
[c] Transfer of the Own Earlier SPC to a Third Party
[d] Acquisition of an SPC Granted to a Third Party
[4] Consequences of an Own Earlier SPC for a Different Product
[a] Required Distinction from the Product of the Own Earlier SPC
[b] Combinations of Active Ingredients
[c] New Therapeutic Applications of Previously Approved Active Ingredients
[d] SPCs for a Specific Salt, Ester or Other Derivative Where an Own Earlier SPC Has Already Been Granted for the Corresponding Active Ingredient
[e] SPCs for a Specific Enantiomer Where an Own Earlier SPC Has Already Been Granted for the Corresponding Racemate
[5] Grant of More than One SPC on the Basis of the Same Patent
§14.03 EXTENT OF PROTECTION AND ENFORCEMENT OF SPCS
[A] The Protection Conferred by an SPC
[B] The Scope of an SPC in Relation to Derivatives of an Active Ingredient
[1] The Relationship Between the Definition of the Active Ingredient(s) in an SPC and Its Scope of Protection
[C] Enforcement of an SPC
[D] The Manufacturing Waiver
§14.04 DETERMINATION OF THE SPC TERM
[A] The Calculation of the SPC Term
[1] The Relevant Marketing Authorization for the Term of an SPC
[2] The Expiration Date of an SPC
[B] Correction of the SPC Term
[C] The Term of a Paediatric Extension
§14.05 PROCEDURE OF FILING AN SPC APPLICATION
[A] Entitlement to an SPC Application
[B] The Time Limit for Filing an SPC Application
[C] The Filing of an SPC at the National Patent Office
[D] The Documentation Required for an SPC Application
[E] The Definition of the Product in an SPC Application
[F] SPC Examination Procedure and Appeal Procedure
[G] Publication of SPC Applications and Issued SPCs
[H] Renewal Fees
[I] Applications for a Paediatric Extension
§14.06 PROCEDURE OF INVALIDATING AN SPC
[A] Grounds for the Invalidation of an SPC
[B] The Filing of an Invalidation Suit
[C] Invalidation Procedure and the Corresponding Appeal Procedure
[D] The Revocation of a Paediatric Extension
§14.07 UNFAIR COMPETITION LAW
CHAPTER 15 Greece
§15.01 LEGAL BASIS
§15.02 SUBSTANTIVE REQUIREMENTS FOR OBTAINING AN SPC
[A] Types of Products That Can Be Protected
[1] Practical Considerations: What Is the Active Ingredient or Combination of Active Ingredients That Can Form the Basis for an SPC?
[2] Active Ingredient or Combination of Active Ingredients of a Medicinal Product
[3] Active Substance or Combination of Active Substances of a Plant Protection Product
[4] Fixed-Dose and Loose Combinations
[5] Limitation to Products Subjected to a Specific Marketing Authorization Procedure
[B] Basic Patent
[1] Requirement for the Product to Be 'Protected' by the Basic Patent
[a] Small Molecules
[b] Polymers
[c] Antibodies, Enzymes and Other Proteins
[d] Nucleic Acids
[2] Basic Patent Claiming the Product, i.e., the Active Ingredient(s), but Not the Corresponding Authorized Medicinal Product (or Plant Protection Product)
[3] Requirement for the Product to Constitute 'the Invention' of the Basic Patent
[4] Criteria for Choosing the Basic Patent among Various Available Patents
[C] The Marketing Authorization Forming Basis for an SPC
[1] Combinations of Active Ingredients
[a] The Marketing Authorization Refers to Fewer Active Ingredients than the SPC Application
[b] The Marketing Authorization Refers to More Active Ingredients than the SPC Application
[c] The Marketing Authorization Indicates That a Medicinal Product Containing a Single Active Ingredient Is Authorized for Use in Combination with a Further Active Ingredient
[2] The Marketing Authorization Has Not Yet Been Granted at the Time the SPC Application Is Filed
[3] The Holder of the Marketing Authorization
[4] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Medicinal Products
[5] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Plant Protection Products
[6] The Product in Question Is Contained in the Authorized Medicinal Product (or the Authorized Plant Protection Product) but Is Not Identified as an Active Ingredient in the Corresponding Marketing Authorization
[7] The Notion of the 'First' Marketing Authorization
[a] Marketing Authorization for a New Therapeutic Application of a Previously Authorized Product
[b] Marketing Authorization for a New Formulation of a Previously Authorized Product
[c] Marketing Authorization for a New Specific Salt, Ester or Other Derivative of a Previously Authorized Active Ingredient
[d] Marketing Authorization for a New Specific Enantiomer of an Active Ingredient Previously Authorized in Racemic Form
[e] The Product Has Already Been Placed on the Market Before, but Without an Authorization Granted under Directive 2001/83/EC or Directive 2001/82/EC
[f] Prior Marketing Authorization Which Refers to Fewer Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[g] Prior Marketing Authorization Which Refers to More Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[D] Preclusion of New SPCs by an Earlier SPC
[1] The 'One SPC per Product per Patent Holder' Rule
[2] Consequences of an Earlier Third-Party SPC for the Same Product
[a] Earlier SPC Granted to an Affiliated Third Party
[b] Partial Overlap Between the Holders of the Earlier SPC and the Applicants for the New SPC
[c] Earlier Third-Party SPC Has Been Licensed-In
[3] Consequences of an Own Earlier SPC for the Same Product
[a] Own Earlier SPC Application Not Yet Granted
[b] Revocation, Surrender or Lapse of the Own Earlier SPC after Grant
[c] Transfer of the Own Earlier SPC to a Third Party
[d] Acquisition of an SPC Granted to a Third Party
[4] Consequences of an Own Earlier SPC for a Different Product
[a] Required Distinction from the Product of the Own Earlier SPC
[b] Combinations of Active Ingredients
[c] New Therapeutic Applications of Previously Approved Active Ingredients
[d] SPCs for a Specific Salt, Ester or Other Derivative Where an Own Earlier SPC Has Already Been Granted for the Corresponding Active Ingredient
[e] SPCs for a Specific Enantiomer Where an Own Earlier SPC Has Already Been Granted for the Corresponding Racemate
[5] Grant of More than One SPC on the Basis of the Same Patent
§15.03 EXTENT OF PROTECTION AND ENFORCEMENT OF SPCS
[A] The Protection Conferred by an SPC
[B] The Scope of an SPC in Relation to Derivatives of an Active Ingredient
[1] The Relationship Between the Definition of the Active Ingredient(s) in an SPC and Its Scope of Protection
[C] Enforcement of an SPC
[D] The Manufacturing Waiver
§15.04 DETERMINATION OF THE SPC TERM
[A] The Calculation of the SPC Term
[1] The Relevant Marketing Authorization for the Term of an SPC
[2] The Expiration Date of an SPC
[B] Correction of the SPC Term
[C] The Term of a Paediatric Extension
§15.05 PROCEDURE OF FILING AN SPC APPLICATION
[A] Entitlement to an SPC Application
[B] The Time Limit for Filing an SPC Application
[C] The Filing of an SPC at the National Patent Office
[D] The Documentation Required for an SPC Application
[E] The Definition of the Product in an SPC Application
[F] SPC Examination Procedure and Appeal Procedure
[G] Publication of SPC Applications and Issued SPCs
[H] Renewal Fees
[I] Applications for a Paediatric Extension
§15.06 PROCEDURE OF INVALIDATING AN SPC
[A] Grounds for the Invalidation of an SPC
[B] The Filing of an Invalidation Suit
[C] Invalidation Procedure and the Corresponding Appeal Procedure
[D] The Revocation of a Paediatric Extension
§15.07 UNFAIR COMPETITION LAW
CHAPTER 16 Hungary
§16.01 LEGAL BASIS
§16.02 SUBSTANTIVE REQUIREMENTS FOR OBTAINING AN SPC
[A] Types of Products That Can Be Protected
[1] Practical Considerations: What Is the Active Ingredient or Combination of Active Ingredients That Can Form the Basis for an SPC?
[2] Active Ingredient or Combination of Active Ingredients of a Medicinal Product
[3] Active Substance or Combination of Active Substances of a Plant Protection Product
[4] Fixed-Dose and Loose Combinations
[5] Limitation to Products Subjected to a Specific Marketing Authorization Procedure
[B] Basic Patent
[1] Requirement for the Product to Be 'Protected' by the Basic Patent
[a] Small Molecules
[b] Polymers
[c] Antibodies, Enzymes and Other Proteins
[d] Nucleic Acids
[2] Basic Patent Claiming the Product, i.e., the Active Ingredient(s), but Not the Corresponding Authorized Medicinal Product (or Plant Protection Product)
[3] Requirement for the Product to Constitute 'the Invention' of the Basic Patent
[4] Criteria for Choosing the Basic Patent among Various Available Patents
[C] The Marketing Authorization Forming Basis for an SPC
[1] Combinations of Active Ingredients
[a] The Marketing Authorization Refers to Fewer Active Ingredients than the SPC Application
[b] The Marketing Authorization Refers to More Active Ingredients than the SPC Application
[c] The Marketing Authorization Indicates That a Medicinal Product Containing a Single Active Ingredient Is Authorized for Use in Combination with a Further Active Ingredient
[2] The Marketing Authorization Has Not Yet Been Granted at the Time the SPC Application Is Filed
[3] The Holder of the Marketing Authorization
[4] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Medicinal Products
[5] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Plant Protection Products
[6] The Product in Question Is Contained in the Authorized Medicinal Product (or the Authorized Plant Protection Product) but Is Not Identified as an Active Ingredient in the Corresponding Marketing Authorization
[7] The Notion of the 'First' Marketing Authorization
[a] Marketing Authorization for a New Therapeutic Application of a Previously Authorized Product
[b] Marketing Authorization for a New Formulation of a Previously Authorized Product
[c] Marketing Authorization for a New Specific Salt, Ester or Other Derivative of a Previously Authorized Active Ingredient
[d] Marketing Authorization for a New Specific Enantiomer of an Active Ingredient Previously Authorized in Racemic Form
[e] The Product Has Already Been Placed on the Market Before, but Without an Authorization Granted under Directive 2001/83/EC or Directive 2001/82/EC
[f] Prior Marketing Authorization Which Refers to Fewer Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[g] Prior Marketing Authorization Which Refers to More Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[D] Preclusion of New SPCs by an Earlier SPC
[1] The 'One SPC per Product per Patent Holder' Rule
[2] Consequences of an Earlier Third-Party SPC for the Same Product
[a] Earlier SPC Granted to an Affiliated Third Party
[b] Partial Overlap Between the Holders of the Earlier SPC and the Applicants for the New SPC
[c] Earlier Third-Party SPC Has Been Licensed-In
[3] Consequences of an Own Earlier SPC for the Same Product
[a] Own Earlier SPC Application Not Yet Granted
[b] Revocation, Surrender or Lapse of the Own Earlier SPC after Grant
[c] Transfer of the Own Earlier SPC to a Third Party
[d] Acquisition of an SPC Granted to a Third Party
[4] Consequences of an Own Earlier SPC for a Different Product
[a] Required Distinction from the Product of the Own Earlier SPC
[b] Combinations of Active Ingredients
[c] New Therapeutic Applications of Previously Approved Active Ingredients
[d] SPCs for a Specific Salt, Ester or Other Derivative Where an Own Earlier SPC Has Already Been Granted for the Corresponding Active Ingredient
[e] SPCs for a Specific Enantiomer Where an Own Earlier SPC Has Already Been Granted for the Corresponding Racemate
[5] Grant of More than One SPC on the Basis of the Same Patent
§16.03 EXTENT OF PROTECTION AND ENFORCEMENT OF SPCS
[A] The Protection Conferred by an SPC
[B] The Scope of an SPC in Relation to Derivatives of an Active Ingredient
[1] The Relationship Between the Definition of the Active Ingredient(s) in an SPC and Its Scope of Protection
[C] Enforcement of an SPC
[D] The Manufacturing Waiver
§16.04 DETERMINATION OF THE SPC TERM
[A] The Calculation of the SPC Term
[1] The Relevant Marketing Authorization for the Term of an SPC
[2] The Expiration Date of an SPC
[B] Correction of the SPC Term
[C] The Term of a Paediatric Extension
§16.05 PROCEDURE OF FILING AN SPC APPLICATION
[A] Entitlement to an SPC Application
[B] The Time Limit for Filing an SPC Application
[C] The Filing of an SPC at the National Patent Office
[D] The Documentation Required for an SPC Application
[E] The Definition of the Product in an SPC Application
[F] SPC Examination Procedure and Appeal Procedure
[G] Publication of SPC Applications and Issued SPCs
[H] Renewal Fees
[I] Applications for a Paediatric Extension
§16.06 PROCEDURE OF INVALIDATING AN SPC
[A] Grounds for the Invalidation of an SPC
[B] The Filing of an Invalidation Suit
[C] Invalidation Procedure and the Corresponding Appeal Procedure
[D] The Revocation of a Paediatric Extension
§16.07 UNFAIR COMPETITION LAW
CHAPTER 17 Iceland
§17.01 LEGAL BASIS
§17.02 SUBSTANTIVE REQUIREMENTS FOR OBTAINING AN SPC
[A] Types of Products That Can Be Protected
[1] Practical Considerations: What Is the Active Ingredient or Combination of Active Ingredients That Can Form the Basis for an SPC?
[2] Active Ingredient or Combination of Active Ingredients of a Medicinal Product
[3] Active Substance or Combination of Active Substances of a Plant Protection Product
[4] Fixed-Dose and Loose Combinations
[5] Limitation to Products Subjected to a Specific Marketing Authorization Procedure
[B] Basic Patent
[1] Requirement for the Product to Be 'Protected' by the Basic Patent
[a] Small Molecules
[b] Polymers
[c] Antibodies, Enzymes and Other Proteins
[d] Nucleic Acids
[2] Basic Patent Claiming the Product, i.e., the Active Ingredient(s), but Not the Corresponding Authorized Medicinal Product (or Plant Protection Product)
[3] Requirement for the Product to Constitute 'the Invention' of the Basic Patent
[4] Criteria for Choosing the Basic Patent among Various Available Patents
[C] The Marketing Authorization Forming Basis for an SPC
[1] Combinations of Active Ingredients
[a] The Marketing Authorization Refers to Fewer Active Ingredients than the SPC Application
[b] The Marketing Authorization Refers to More Active Ingredients than the SPC Application
[c] The Marketing Authorization Indicates That a Medicinal Product Containing a Single Active Ingredient Is Authorized for Use in Combination with a Further Active Ingredient
[2] The Marketing Authorization Has Not Yet Been Granted at the Time the SPC Application Is Filed
[3] The Holder of the Marketing Authorization
[4] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Medicinal Products
[5] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Plant Protection Products
[6] The Product in Question Is Contained in the Authorized Medicinal Product (or the Authorized Plant Protection Product) but Is Not Identified as an Active Ingredient in the Corresponding Marketing Authorization
[7] The Notion of the 'First' Marketing Authorization
[a] Marketing Authorization for a New Therapeutic Application of a Previously Authorized Product
[b] Marketing Authorization for a New Formulation of a Previously Authorized Product
[c] Marketing Authorization for a New Specific Salt, Ester or Other Derivative of a Previously Authorized Active Ingredient
[d] Marketing Authorization for a New Specific Enantiomer of an Active Ingredient Previously Authorized in Racemic Form
[e] The Product Has Already Been Placed on the Market Before, but Without an Authorization Granted under Directive 2001/83/EC or Directive 2001/82/EC
[f] Prior Marketing Authorization Which Refers to Fewer Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[g] Prior Marketing Authorization Which Refers to More Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[D] Preclusion of New SPCs by an Earlier SPC
[1] The 'One SPC per Product per Patent Holder' Rule
[2] Consequences of an Earlier Third-Party SPC for the Same Product
[a] Earlier SPC Granted to an Affiliated Third Party
[b] Partial Overlap Between the Holders of the Earlier SPC and the Applicants for the New SPC
[c] Earlier Third-Party SPC Has Been Licensed-In
[3] Consequences of an Own Earlier SPC for the Same Product
[a] Own Earlier SPC Application Not Yet Granted
[b] Revocation, Surrender or Lapse of the Own Earlier SPC after Grant
[c] Transfer of the Own Earlier SPC to a Third Party
[d] Acquisition of an SPC Granted to a Third Party
[4] Consequences of an Own Earlier SPC for a Different Product
[a] Required Distinction from the Product of the Own Earlier SPC
[b] Combinations of Active Ingredients
[c] New Therapeutic Applications of Previously Approved Active Ingredients
[d] SPCs for a Specific Salt, Ester or Other Derivative Where an Own Earlier SPC Has Already Been Granted for the Corresponding Active Ingredient
[e] SPCs for a Specific Enantiomer Where an Own Earlier SPC Has Already Been Granted for the Corresponding Racemate
[5] Grant of More than One SPC on the Basis of the Same Patent
§17.03 EXTENT OF PROTECTION AND ENFORCEMENT OF SPCS
[A] The Protection Conferred by an SPC
[B] The Scope of an SPC in Relation to Derivatives of an Active Ingredient
[1] The Relationship Between the Definition of the Active Ingredient(s) in an SPC and Its Scope of Protection
[C] Enforcement of an SPC
[D] The Manufacturing Waiver
§17.04 DETERMINATION OF THE SPC TERM
[A] The Calculation of the SPC Term
[1] The Relevant Marketing Authorization for the Term of an SPC
[2] The Expiration Date of an SPC
[B] Correction of the SPC Term
[C] The Term of a Paediatric Extension
§17.05 PROCEDURE OF FILING AN SPC APPLICATION
[A] Entitlement to an SPC Application
[B] The Time Limit for Filing an SPC Application
[C] The Filing of an SPC at the National Patent Office
[D] The Documentation Required for an SPC Application
[E] The Definition of the Product in an SPC Application
[F] SPC Examination Procedure and Appeal Procedure
[G] Publication of SPC Applications and Issued SPCs
[H] Renewal Fees
[I] Applications for a Paediatric Extension
§17.06 PROCEDURE OF INVALIDATING AN SPC
[A] Grounds for the Invalidation of an SPC
[B] The Filing of an Invalidation Suit
[C] Invalidation Procedure and the Corresponding Appeal Procedure
[D] The Revocation of a Paediatric Extension
§17.07 UNFAIR COMPETITION LAW
CHAPTER 18 Ireland
§18.01 LEGAL BASIS
§18.02 SUBSTANTIVE REQUIREMENTS FOR OBTAINING AN SPC
[A] Types of Products That Can Be Protected
[1] Practical Considerations: What Is the Active Ingredient or Combination of Active Ingredients That Can Form the Basis for an SPC?
[2] Active Ingredient or Combination of Active Ingredients of a Medicinal Product
[3] Active Substance or Combination of Active Substances of a Plant Protection Product
[4] Fixed-Dose and Loose Combinations
[5] Limitation to Products Subjected to a Specific Marketing Authorization Procedure
[B] Basic Patent
[1] Requirement for the Product to Be 'Protected' by the Basic Patent
[a] Small Molecules
[b] Polymers
[c] Antibodies, Enzymes and Other Proteins
[d] Nucleic Acids
[2] Basic Patent Claiming the Product, i.e., the Active Ingredient(s), but Not the Corresponding Authorized Medicinal Product (or Plant Protection Product)
[3] Requirement for the Product to Constitute 'the Invention' of the Basic Patent
[4] Criteria for Choosing the Basic Patent among Various Available Patents
[C] The Marketing Authorization Forming Basis for an SPC
[1] Combinations of Active Ingredients
[a] The Marketing Authorization Refers to Fewer Active Ingredients than the SPC Application
[b] The Marketing Authorization Refers to More Active Ingredients than the SPC Application
[c] The Marketing Authorization Indicates That a Medicinal Product Containing a Single Active Ingredient Is Authorized for Use in Combination with a Further Active Ingredient
[2] The Marketing Authorization Has Not Yet Been Granted at the Time the SPC Application Is Filed
[3] The Holder of the Marketing Authorization
[4] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Medicinal Products
[5] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Plant Protection Products
[6] The Product in Question Is Contained in the Authorized Medicinal Product (or the Authorized Plant Protection Product) but Is Not Identified as an Active Ingredient in the Corresponding Marketing Authorization
[7] The Notion of the 'First' Marketing Authorization
[a] Marketing Authorization for a New Therapeutic Application of a Previously Authorized Product
[b] Marketing Authorization for a New Formulation of a Previously Authorized Product
[c] Marketing Authorization for a New Specific Salt, Ester or Other Derivative of a Previously Authorized Active Ingredient
[d] Marketing Authorization for a New Specific Enantiomer of an Active Ingredient Previously Authorized in Racemic Form
[e] The Product Has Already Been Placed on the Market Before, but Without an Authorization Granted under Directive 2001/83/EC or Directive 2001/82/EC
[f] Prior Marketing Authorization Which Refers to Fewer Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[g] Prior Marketing Authorization Which Refers to More Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[D] Preclusion of New SPCs by an Earlier SPC
[1] The 'One SPC per Product per Patent Holder' Rule
[2] Consequences of an Earlier Third-Party SPC for the Same Product
[a] Earlier SPC Granted to an Affiliated Third Party
[b] Partial Overlap Between the Holders of the Earlier SPC and the Applicants for the New SPC
[c] Earlier Third-Party SPC Has Been Licensed-In
[3] Consequences of an Own Earlier SPC for the Same Product
[a] Own Earlier SPC Application Not Yet Granted
[b] Revocation, Surrender or Lapse of the Own Earlier SPC after Grant
[c] Transfer of the Own Earlier SPC to a Third Party
[d] Acquisition of an SPC Granted to a Third Party
[4] Consequences of an Own Earlier SPC for a Different Product
[a] Required Distinction from the Product of the Own Earlier SPC
[b] Combinations of Active Ingredients
[c] New Therapeutic Applications of Previously Approved Active Ingredients
[d] SPCs for a Specific Salt, Ester or Other Derivative Where an Own Earlier SPC Has Already Been Granted for the Corresponding Active Ingredient
[e] SPCs for a Specific Enantiomer Where an Own Earlier SPC Has Already Been Granted for the Corresponding Racemate
[5] Grant of More than One SPC on the Basis of the Same Patent
§18.03 EXTENT OF PROTECTION AND ENFORCEMENT OF SPCS
[A] The Protection Conferred by an SPC
[B] The Scope of an SPC in Relation to Derivatives of an Active Ingredient
[1] The Relationship Between the Definition of the Active Ingredient(s) in an SPC and Its Scope of Protection
[C] Enforcement of an SPC
[D] The Manufacturing Waiver
§18.04 DETERMINATION OF THE SPC TERM
[A] The Calculation of the SPC Term
[1] The Relevant Marketing Authorization for the Term of an SPC
[2] The Expiration Date of an SPC
[B] Correction of the SPC Term
[C] The Term of a Paediatric Extension
§18.05 PROCEDURE OF FILING AN SPC APPLICATION
[A] Entitlement to an SPC Application
[B] The Time Limit for Filing an SPC Application
[C] The Filing of an SPC at the National Patent Office
[D] The Documentation Required for an SPC Application
[E] The Definition of the Product in an SPC Application
[F] SPC Examination Procedure and Appeal Procedure
[G] Publication of SPC Applications and Issued SPCs
[H] Renewal Fees
[I] Applications for a Paediatric Extension
§18.06 PROCEDURE OF INVALIDATING AN SPC
[A] Grounds for the Invalidation of an SPC
[B] The Filing of an Invalidation Suit
[C] Invalidation Procedure and the Corresponding Appeal Procedure
[D] The Revocation of a Paediatric Extension
§18.07 UNFAIR COMPETITION LAW
CHAPTER 19 Italy
§19.01 LEGAL BASIS
§19.02 SUBSTANTIVE REQUIREMENTS FOR OBTAINING AN SPC
[A] Types of Products That Can Be Protected
[1] Practical Considerations: What Is the Active Ingredient or Combination of Active Ingredients That Can Form the Basis for an SPC?
[2] Active Ingredient or Combination of Active Ingredients of a Medicinal Product
[3] Active Substance or Combination of Active Substances of a Plant Protection Product
[4] Fixed-Dose and Loose Combinations
[5] Limitation to Products Subjected to a Specific Marketing Authorization Procedure
[B] Basic Patent
[1] Requirement for the Product to Be 'Protected' by the Basic Patent
[a] Small Molecules
[b] Polymers
[c] Antibodies, Enzymes and Other Proteins
[d] Nucleic Acids
[2] Basic Patent Claiming the Product, i.e., the Active Ingredient(s), but Not the Corresponding Authorized Medicinal Product (or Plant Protection Product)
[3] Requirement for the Product to Constitute 'the Invention' of the Basic Patent
[4] Criteria for Choosing the Basic Patent among Various Available Patents
[C] The Marketing Authorization Forming Basis for an SPC
[1] Combinations of Active Ingredients
[a] The Marketing Authorization Refers to Fewer Active Ingredients than the SPC Application
[b] The Marketing Authorization Refers to More Active Ingredients than the SPC Application
[c] The Marketing Authorization Indicates That a Medicinal Product Containing a Single Active Ingredient Is Authorized for Use in Combination with a Further Active Ingredient
[2] The Marketing Authorization Has Not Yet Been Granted at the Time the SPC Application Is Filed
[3] The Holder of the Marketing Authorization
[4] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Medicinal Products
[5] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Plant Protection Products
[6] The Product in Question Is Contained in the Authorized Medicinal Product (or the Authorized Plant Protection Product) but Is Not Identified as an Active Ingredient in the Corresponding Marketing Authorization
[7] The Notion of the 'First' Marketing Authorization
[a] Marketing Authorization for a New Therapeutic Application of a Previously Authorized Product
[b] Marketing Authorization for a New Formulation of a Previously Authorized Product
[c] Marketing Authorization for a New Specific Salt, Ester or Other Derivative of a Previously Authorized Active Ingredient
[d] Marketing Authorization for a New Specific Enantiomer of an Active Ingredient Previously Authorized in Racemic Form
[e] The Product Has Already Been Placed on the Market Before, but Without an Authorization Granted under Directive 2001/83/EC or Directive 2001/82/EC
[f] Prior Marketing Authorization Which Refers to Fewer Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[g] Prior Marketing Authorization Which Refers to More Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[D] Preclusion of New SPCs by an Earlier SPC
[1] The 'One SPC per Product per Patent Holder' Rule
[2] Consequences of an Earlier Third-Party SPC for the Same Product
[a] Earlier SPC Granted to an Affiliated Third Party
[b] Partial Overlap Between the Holders of the Earlier SPC and the Applicants for the New SPC
[c] Earlier Third-Party SPC Has Been Licensed-In
[3] Consequences of an Own Earlier SPC for the Same Product
[a] Own Earlier SPC Application Not Yet Granted
[b] Revocation, Surrender or Lapse of the Own Earlier SPC after Grant
[c] Transfer of the Own Earlier SPC to a Third Party
[d] Acquisition of an SPC Granted to a Third Party
[4] Consequences of an Own Earlier SPC for a Different Product
[a] Required Distinction from the Product of the Own Earlier SPC
[b] Combinations of Active Ingredients
[c] New Therapeutic Applications of Previously Approved Active Ingredients
[d] SPCs for a Specific Salt, Ester or Other Derivative Where an Own Earlier SPC Has Already Been Granted for the Corresponding Active Ingredient
[e] SPCs for a Specific Enantiomer Where an Own Earlier SPC Has Already Been Granted for the Corresponding Racemate
[5] Grant of More than One SPC on the Basis of the Same Patent
§19.03 EXTENT OF PROTECTION AND ENFORCEMENT OF SPCS
[A] The Protection Conferred by an SPC
[B] The Scope of an SPC in Relation to Derivatives of an Active Ingredient
[1] The Relationship Between the Definition of the Active Ingredient(s) in an SPC and Its Scope of Protection
[C] Enforcement of an SPC
[D] The Manufacturing Waiver
§19.04 DETERMINATION OF THE SPC TERM
[A] The Calculation of the SPC Term
[1] The Relevant Marketing Authorization for the Term of an SPC
[2] The Expiration Date of an SPC
[B] Correction of the SPC Term
[C] The Term of a Paediatric Extension
§19.05 PROCEDURE OF FILING AN SPC APPLICATION
[A] Entitlement to an SPC Application
[B] The Time Limit for Filing an SPC Application
[C] The Filing of an SPC at the National Patent Office
[D] The Documentation Required for an SPC Application
[E] The Definition of the Product in an SPC Application
[F] SPC Examination Procedure and Appeal Procedure
[G] Publication of SPC Applications and Issued SPCs
[H] Renewal Fees
[I] Applications for a Paediatric Extension
§19.06 PROCEDURE OF INVALIDATING AN SPC
[A] Grounds for the Invalidation of an SPC
[B] The Filing of an Invalidation Suit
[C] Invalidation Procedure and the Corresponding Appeal Procedure
[D] The Revocation of a Paediatric Extension
§19.07 UNFAIR COMPETITION LAW
CHAPTER 20 Latvia
§20.01 LEGAL BASIS
§20.02 SUBSTANTIVE REQUIREMENTS FOR OBTAINING AN SPC
[A] Types of Products That Can Be Protected
[1] Practical Considerations: What Is the Active Ingredient or Combination of Active Ingredients That Can Form the Basis for an SPC?
[2] Active Ingredient or Combination of Active Ingredients of a Medicinal Product
[3] Active Substance or Combination of Active Substances of a Plant Protection Product
[4] Fixed-Dose and Loose Combinations
[5] Limitation to Products Subjected to a Specific Marketing Authorization Procedure
[B] Basic Patent
[1] Requirement for the Product to Be 'Protected' by the Basic Patent
[a] Small Molecules
[b] Polymers
[c] Antibodies, Enzymes and Other Proteins
[d] Nucleic Acids
[2] Basic Patent Claiming the Product, i.e., the Active Ingredient(s), but Not the Corresponding Authorized Medicinal Product (or Plant Protection Product)
[3] Requirement for the Product to Constitute 'the Invention' of the Basic Patent
[4] Criteria for Choosing the Basic Patent among Various Available Patents
[C] The Marketing Authorization Forming Basis for an SPC
[1] Combinations of Active Ingredients
[a] The Marketing Authorization Refers to Fewer Active Ingredients than the SPC Application
[b] The Marketing Authorization Refers to More Active Ingredients than the SPC Application
[c] The Marketing Authorization Indicates That a Medicinal Product Containing a Single Active Ingredient Is Authorized for Use in Combination with a Further Active Ingredient
[2] The Marketing Authorization Has Not Yet Been Granted at the Time the SPC Application Is Filed
[3] The Holder of the Marketing Authorization
[4] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Medicinal Products
[5] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Plant Protection Products
[6] The Product in Question Is Contained in the Authorized Medicinal Product (or the Authorized Plant Protection Product) but Is Not Identified as an Active Ingredient in the Corresponding Marketing Authorization
[7] The Notion of the 'First' Marketing Authorization
[a] Marketing Authorization for a New Therapeutic Application of a Previously Authorized Product
[b] Marketing Authorization for a New Formulation of a Previously Authorized Product
[c] Marketing Authorization for a New Specific Salt, Ester or Other Derivative of a Previously Authorized Active Ingredient
[d] Marketing Authorization for a New Specific Enantiomer of an Active Ingredient Previously Authorized in Racemic Form
[e] The Product Has Already Been Placed on the Market Before, but Without an Authorization Granted under Directive 2001/83/EC or Directive 2001/82/EC
[f] Prior Marketing Authorization Which Refers to Fewer Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[g] Prior Marketing Authorization Which Refers to More Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[D] Preclusion of New SPCs by an Earlier SPC
[1] The 'One SPC per Product per Patent Holder' Rule
[2] Consequences of an Earlier Third-Party SPC for the Same Product
[a] Earlier SPC Granted to an Affiliated Third Party
[b] Partial Overlap Between the Holders of the Earlier SPC and the Applicants for the New SPC
[c] Earlier Third-Party SPC Has Been Licensed-In
[3] Consequences of an Own Earlier SPC for the Same Product
[a] Own Earlier SPC Application Not Yet Granted
[b] Revocation, Surrender or Lapse of the Own Earlier SPC after Grant
[c] Transfer of the Own Earlier SPC to a Third Party
[d] Acquisition of an SPC Granted to a Third Party
[4] Consequences of an Own Earlier SPC for a Different Product
[a] Required Distinction from the Product of the Own Earlier SPC
[b] Combinations of Active Ingredients
[c] New Therapeutic Applications of Previously Approved Active Ingredients
[d] SPCs for a Specific Salt, Ester or Other Derivative Where an Own Earlier SPC Has Already Been Granted for the Corresponding Active Ingredient
[e] SPCs for a Specific Enantiomer Where an Own Earlier SPC Has Already Been Granted for the Corresponding Racemate
[5] Grant of More than One SPC on the Basis of the Same Patent
§20.03 EXTENT OF PROTECTION AND ENFORCEMENT OF SPCS
[A] The Protection Conferred by an SPC
[B] The Scope of an SPC in Relation to Derivatives of an Active Ingredient
[1] The Relationship Between the Definition of the Active Ingredient(s) in an SPC and Its Scope of Protection
[C] Enforcement of an SPC
[D] The Manufacturing Waiver
§20.04 DETERMINATION OF THE SPC TERM
[A] The Calculation of the SPC Term
[1] The Relevant Marketing Authorization for the Term of an SPC
[2] The Expiration Date of an SPC
[B] Correction of the SPC Term
[C] The Term of a Paediatric Extension
§20.05 PROCEDURE OF FILING AN SPC APPLICATION
[A] Entitlement to an SPC Application
[B] The Time Limit for Filing an SPC Application
[C] The Filing of an SPC at the National Patent Office
[D] The Documentation Required for an SPC Application
[E] The Definition of the Product in an SPC Application
[F] SPC Examination Procedure and Appeal Procedure
[G] Publication of SPC Applications and Issued SPCs
[H] Renewal Fees
[I] Applications for a Paediatric Extension
§20.06 PROCEDURE OF INVALIDATING AN SPC
[A] Grounds for the Invalidation of an SPC
[B] The Filing of an Invalidation Suit
[C] Invalidation Procedure and the Corresponding Appeal Procedure
[D] The Revocation of a Paediatric Extension
§20.07 UNFAIR COMPETITION LAW
CHAPTER 21 Lithuania
§21.01 LEGAL BASIS
§21.02 SUBSTANTIVE REQUIREMENTS FOR OBTAINING AN SPC
[A] Types of Products That Can Be Protected
[1] Practical Considerations: What Is the Active Ingredient or Combination of Active Ingredients That Can Form the Basis for an SPC?
[2] Active Ingredient or Combination of Active Ingredients of a Medicinal Product
[3] Active Substance or Combination of Active Substances of a Plant Protection Product
[4] Fixed-Dose and Loose Combinations
[5] Limitation to Products Subjected to a Specific Marketing Authorization Procedure
[B] Basic Patent
[1] Requirement for the Product to Be 'Protected' by the Basic Patent
[a] Small Molecules
[b] Polymers
[c] Antibodies, Enzymes and Other Proteins
[d] Nucleic Acids
[2] Basic Patent Claiming the Product, i.e., the Active Ingredient(s), but Not the Corresponding Authorized Medicinal Product (or Plant Protection Product)
[3] Requirement for the Product to Constitute 'the Invention' of the Basic Patent
[4] Criteria for Choosing the Basic Patent among Various Available Patents
[C] The Marketing Authorization Forming Basis for an SPC
[1] Combinations of Active Ingredients
[a] The Marketing Authorization Refers to Fewer Active Ingredients than the SPC Application
[b] The Marketing Authorization Refers to More Active Ingredients than the SPC Application
[c] The Marketing Authorization Indicates That a Medicinal Product Containing a Single Active Ingredient Is Authorized for Use in Combination with a Further Active Ingredient
[2] The Marketing Authorization Has Not Yet Been Granted at the Time the SPC Application Is Filed
[3] The Holder of the Marketing Authorization
[4] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Medicinal Products
[5] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Plant Protection Products
[6] The Product in Question Is Contained in the Authorized Medicinal Product (or the Authorized Plant Protection Product) but Is Not Identified as an Active Ingredient in the Corresponding Marketing Authorization
[7] The Notion of the 'First' Marketing Authorization
[a] Marketing Authorization for a New Therapeutic Application of a Previously Authorized Product
[b] Marketing Authorization for a New Formulation of a Previously Authorized Product
[c] Marketing Authorization for a New Specific Salt, Ester or Other Derivative of a Previously Authorized Active Ingredient
[d] Marketing Authorization for a New Specific Enantiomer of an Active Ingredient Previously Authorized in Racemic Form
[e] The Product Has Already Been Placed on the Market Before, but Without an Authorization Granted under Directive 2001/83/EC or Directive 2001/82/EC
[f] Prior Marketing Authorization Which Refers to Fewer Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[g] Prior Marketing Authorization Which Refers to More Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[D] Preclusion of New SPCs by an Earlier SPC
[1] The 'One SPC per Product per Patent Holder' Rule
[2] Consequences of an Earlier Third-Party SPC for the Same Product
[a] Earlier SPC Granted to an Affiliated Third Party
[b] Partial Overlap Between the Holders of the Earlier SPC and the Applicants for the New SPC
[c] Earlier Third-Party SPC Has Been Licensed-In
[3] Consequences of an Own Earlier SPC for the Same Product
[a] Own Earlier SPC Application Not Yet Granted
[b] Revocation, Surrender or Lapse of the Own Earlier SPC after Grant
[c] Transfer of the Own Earlier SPC to a Third Party
[d] Acquisition of an SPC Granted to a Third Party
[4] Consequences of an Own Earlier SPC for a Different Product
[a] Required Distinction from the Product of the Own Earlier SPC
[b] Combinations of Active Ingredients
[c] New Therapeutic Applications of Previously Approved Active Ingredients
[d] SPCs for a Specific Salt, Ester or Other Derivative Where an Own Earlier SPC Has Already Been Granted for the Corresponding Active Ingredient
[e] SPCs for a Specific Enantiomer Where an Own Earlier SPC Has Already Been Granted for the Corresponding Racemate
[5] Grant of More than One SPC on the Basis of the Same Patent
§21.03 EXTENT OF PROTECTION AND ENFORCEMENT OF SPCS
[A] The Protection Conferred by an SPC
[B] The Scope of an SPC in Relation to Derivatives of an Active Ingredient
[1] The Relationship Between the Definition of the Active Ingredient(s) in an SPC and Its Scope of Protection
[C] Enforcement of an SPC
[D] The Manufacturing Waiver
§21.04 DETERMINATION OF THE SPC TERM
[A] The Calculation of the SPC Term
[1] The Relevant Marketing Authorization for the Term of an SPC
[2] The Expiration Date of an SPC
[B] Correction of the SPC Term
[C] The Term of a Paediatric Extension
§21.05 PROCEDURE OF FILING AN SPC APPLICATION
[A] Entitlement to an SPC Application
[B] The Time Limit for Filing an SPC Application
[C] The Filing of an SPC at the National Patent Office
[D] The Documentation Required for an SPC Application
[E] The Definition of the Product in an SPC Application
[F] SPC Examination Procedure and Appeal Procedure
[G] Publication of SPC Applications and Issued SPCs
[H] Renewal Fees
[I] Applications for a Paediatric Extension
§21.06 PROCEDURE OF INVALIDATING AN SPC
[A] Grounds for the Invalidation of an SPC
[B] The Filing of an Invalidation Suit
[C] Invalidation Procedure and the Corresponding Appeal Procedure
[D] The Revocation of a Paediatric Extension
§21.07 UNFAIR COMPETITION LAW
CHAPTER 22 Luxembourg
§22.01 LEGAL BASIS
§22.02 SUBSTANTIVE REQUIREMENTS FOR OBTAINING AN SPC
[A] Types of Products That Can Be Protected
[1] Practical Considerations: What Is the Active Ingredient or Combination of Active Ingredients That Can Form the Basis for an SPC?
[2] Active Ingredient or Combination of Active Ingredients of a Medicinal Product
[3] Active Substance or Combination of Active Substances of a Plant Protection Product
[4] Fixed-Dose and Loose Combinations
[5] Limitation to Products Subjected to a Specific Marketing Authorization Procedure
[B] Basic Patent
[1] Requirement for the Product to Be 'Protected' by the Basic Patent
[a] Small Molecules
[b] Polymers
[c] Antibodies, Enzymes and Other Proteins
[d] Nucleic Acids
[2] Basic Patent Claiming the Product, i.e., the Active Ingredient(s), but Not the Corresponding Authorized Medicinal Product (or Plant Protection Product)
[3] Requirement for the Product to Constitute 'the Invention' of the Basic Patent
[4] Criteria for Choosing the Basic Patent among Various Available Patents
[C] The Marketing Authorization Forming Basis for an SPC
[1] Combinations of Active Ingredients
[a] The Marketing Authorization Refers to Fewer Active Ingredients than the SPC Application
[b] The Marketing Authorization Refers to More Active Ingredients than the SPC Application
[c] The Marketing Authorization Indicates That a Medicinal Product Containing a Single Active Ingredient Is Authorized for Use in Combination with a Further Active Ingredient
[2] The Marketing Authorization Has Not Yet Been Granted at the Time the SPC Application Is Filed
[3] The Holder of the Marketing Authorization
[4] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Medicinal Products
[5] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Plant Protection Products
[6] The Product in Question Is Contained in the Authorized Medicinal Product (or the Authorized Plant Protection Product) but Is Not Identified as an Active Ingredient in the Corresponding Marketing Authorization
[7] The Notion of the 'First' Marketing Authorization
[a] Marketing Authorization for a New Therapeutic Application of a Previously Authorized Product
[b] Marketing Authorization for a New Formulation of a Previously Authorized Product
[c] Marketing Authorization for a New Specific Salt, Ester or Other Derivative of a Previously Authorized Active Ingredient
[d] Marketing Authorization for a New Specific Enantiomer of an Active Ingredient Previously Authorized in Racemic Form
[e] The Product Has Already Been Placed on the Market Before, but Without an Authorization Granted under Directive 2001/83/EC or Directive 2001/82/EC
[f] Prior Marketing Authorization Which Refers to Fewer Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[g] Prior Marketing Authorization Which Refers to More Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[D] Preclusion of New SPCs by an Earlier SPC
[1] The 'One SPC per Product per Patent Holder' Rule
[2] Consequences of an Earlier Third-Party SPC for the Same Product
[a] Earlier SPC Granted to an Affiliated Third Party
[b] Partial Overlap Between the Holders of the Earlier SPC and the Applicants for the New SPC
[c] Earlier Third-Party SPC Has Been Licensed-In
[3] Consequences of an Own Earlier SPC for the Same Product
[a] Own Earlier SPC Application Not Yet Granted
[b] Revocation, Surrender or Lapse of the Own Earlier SPC after Grant
[c] Transfer of the Own Earlier SPC to a Third Party
[d] Acquisition of an SPC Granted to a Third Party
[4] Consequences of an Own Earlier SPC for a Different Product
[a] Required Distinction from the Product of the Own Earlier SPC
[b] Combinations of Active Ingredients
[c] New Therapeutic Applications of Previously Approved Active Ingredients
[d] SPCs for a Specific Salt, Ester or Other Derivative Where an Own Earlier SPC Has Already Been Granted for the Corresponding Active Ingredient
[e] SPCs for a Specific Enantiomer Where an Own Earlier SPC Has Already Been Granted for the Corresponding Racemate
[5] Grant of More than One SPC on the Basis of the Same Patent
§22.03 EXTENT OF PROTECTION AND ENFORCEMENT OF SPCS
[A] The Protection Conferred by an SPC
[B] The Scope of an SPC in Relation to Derivatives of an Active Ingredient
[1] The Relationship Between the Definition of the Active Ingredient(s) in an SPC and Its Scope of Protection
[C] Enforcement of an SPC
[D] The Manufacturing Waiver
§22.04 DETERMINATION OF THE SPC TERM
[A] The Calculation of the SPC Term
[1] The Relevant Marketing Authorization for the Term of an SPC
[2] The Expiration Date of an SPC
[B] Correction of the SPC Term
[C] The Term of a Paediatric Extension
§22.05 PROCEDURE OF FILING AN SPC APPLICATION
[A] Entitlement to an SPC Application
[B] The Time Limit for Filing an SPC Application
[C] The Filing of an SPC at the National Patent Office
[D] The Documentation Required for an SPC Application
[E] The Definition of the Product in an SPC Application
[F] SPC Examination Procedure and Appeal Procedure
[G] Publication of SPC Applications and Issued SPCs
[H] Renewal Fees
[I] Applications for a Paediatric Extension
§22.06 PROCEDURE OF INVALIDATING AN SPC
[A] Grounds for the Invalidation of an SPC
[B] The Filing of an Invalidation Suit
[C] Invalidation Procedure and the Corresponding Appeal Procedure
[D] The Revocation of a Paediatric Extension
§22.07 UNFAIR COMPETITION LAW
CHAPTER 23 Malta
§23.01 LEGAL BASIS
§23.02 SUBSTANTIVE REQUIREMENTS FOR OBTAINING AN SPC
[A] Types of Products That Can Be Protected
[1] Practical Considerations: What Is the Active Ingredient or Combination of Active Ingredients That Can Form the Basis for an SPC?
[2] Active Ingredient or Combination of Active Ingredients of a Medicinal Product
[3] Active Substance or Combination of Active Substances of a Plant Protection Product
[4] Fixed-Dose and Loose Combinations
[5] Limitation to Products Subjected to a Specific Marketing Authorization Procedure
[B] Basic Patent
[1] Requirement for the Product to Be 'Protected' by the Basic Patent
[a] Small Molecules
[b] Polymers
[c] Antibodies, Enzymes and Other Proteins
[d] Nucleic Acids
[2] Basic Patent Claiming the Product, i.e., the Active Ingredient(s), but Not the Corresponding Authorized Medicinal Product (or Plant Protection Product)
[3] Requirement for the Product to Constitute 'the Invention' of the Basic Patent
[4] Criteria for Choosing the Basic Patent among Various Available Patents
[C] The Marketing Authorization Forming Basis for an SPC
[1] Combinations of Active Ingredients
[a] The Marketing Authorization Refers to Fewer Active Ingredients than the SPC Application
[b] The Marketing Authorization Refers to More Active Ingredients than the SPC Application
[c] The Marketing Authorization Indicates That a Medicinal Product Containing a Single Active Ingredient Is Authorized for Use in Combination with a Further Active Ingredient
[2] The Marketing Authorization Has Not Yet Been Granted at the Time the SPC Application Is Filed
[3] The Holder of the Marketing Authorization
[4] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Medicinal Products
[5] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Plant Protection Products
[6] The Product in Question Is Contained in the Authorized Medicinal Product (or the Authorized Plant Protection Product) but Is Not Identified as an Active Ingredient in the Corresponding Marketing Authorization
[7] The Notion of the 'First' Marketing Authorization
[a] Marketing Authorization for a New Therapeutic Application of a Previously Authorized Product
[b] Marketing Authorization for a New Formulation of a Previously Authorized Product
[c] Marketing Authorization for a New Specific Salt, Ester or Other Derivative of a Previously Authorized Active Ingredient
[d] Marketing Authorization for a New Specific Enantiomer of an Active Ingredient Previously Authorized in Racemic Form
[e] The Product Has Already Been Placed on the Market Before, but Without an Authorization Granted under Directive 2001/83/EC or Directive 2001/82/EC
[f] Prior Marketing Authorization Which Refers to Fewer Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[g] Prior Marketing Authorization Which Refers to More Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[D] Preclusion of New SPCs by an Earlier SPC
[1] The 'One SPC per Product per Patent Holder' Rule
[2] Consequences of an Earlier Third-Party SPC for the Same Product
[a] Earlier SPC Granted to an Affiliated Third Party
[b] Partial Overlap Between the Holders of the Earlier SPC and the Applicants for the New SPC
[c] Earlier Third-Party SPC Has Been Licensed-In
[3] Consequences of an Own Earlier SPC for the Same Product
[a] Own Earlier SPC Application Not Yet Granted
[b] Revocation, Surrender or Lapse of the Own Earlier SPC after Grant
[c] Transfer of the Own Earlier SPC to a Third Party
[d] Acquisition of an SPC Granted to a Third Party
[4] Consequences of an Own Earlier SPC for a Different Product
[a] Required Distinction from the Product of the Own Earlier SPC
[b] Combinations of Active Ingredients
[c] New Therapeutic Applications of Previously Approved Active Ingredients
[d] SPCs for a Specific Salt, Ester or Other Derivative Where an Own Earlier SPC Has Already Been Granted for the Corresponding Active Ingredient
[e] SPCs for a Specific Enantiomer Where an Own Earlier SPC Has Already Been Granted for the Corresponding Racemate
[5] Grant of More than One SPC on the Basis of the Same Patent
§23.03 EXTENT OF PROTECTION AND ENFORCEMENT OF SPCS
[A] The Protection Conferred by an SPC
[B] The Scope of an SPC in Relation to Derivatives of an Active Ingredient
[1] The Relationship Between the Definition of the Active Ingredient(s) in an SPC and Its Scope of Protection
[C] Enforcement of an SPC
[D] The Manufacturing Waiver
§23.04 DETERMINATION OF THE SPC TERM
[A] The Calculation of the SPC Term
[1] The Relevant Marketing Authorization for the Term of an SPC
[2] The Expiration Date of an SPC
[B] Correction of the SPC Term
[C] The Term of a Paediatric Extension
§23.05 PROCEDURE OF FILING AN SPC APPLICATION
[A] Entitlement to an SPC Application
[B] The Time Limit for Filing an SPC Application
[C] The Filing of an SPC at the National Patent Office
[D] The Documentation Required for an SPC Application
[E] The Definition of the Product in an SPC Application
[F] SPC Examination Procedure and Appeal Procedure
[G] Publication of SPC Applications and Issued SPCs
[H] Renewal Fees
[I] Applications for a Paediatric Extension
§23.06 PROCEDURE OF INVALIDATING AN SPC
[A] Grounds for the Invalidation of an SPC
[B] The Filing of an Invalidation Suit
[C] Invalidation Procedure and the Corresponding Appeal Procedure
[D] The Revocation of a Paediatric Extension
§23.07 UNFAIR COMPETITION LAW
CHAPTER 24 The Netherlands
§24.01 LEGAL BASIS
§24.02 SUBSTANTIVE REQUIREMENTS FOR OBTAINING AN SPC
[A] Types of Products That Can Be Protected
[1] Practical Considerations: What Is the Active Ingredient or Combination of Active Ingredients That Can Form the Basis for an SPC?
[2] Active Ingredient or Combination of Active Ingredients of a Medicinal Product
[3] Active Substance or Combination of Active Substances of a Plant Protection Product
[4] Fixed-Dose and Loose Combinations
[5] Limitation to Products Subjected to a Specific Marketing Authorization Procedure
[B] Basic Patent
[1] Requirement for the Product to Be 'Protected' by the Basic Patent
[a] Small Molecules
[b] Polymers
[c] Antibodies, Enzymes and Other Proteins
[d] Nucleic Acids
[2] Basic Patent Claiming the Product, i.e., the Active Ingredient(s), but Not the Corresponding Authorized Medicinal Product (or Plant Protection Product)
[3] Requirement for the Product to Constitute 'the Invention' of the Basic Patent
[4] Criteria for Choosing the Basic Patent among Various Available Patents
[C] The Marketing Authorization Forming Basis for an SPC
[1] Combinations of Active Ingredients
[a] The Marketing Authorization Refers to Fewer Active Ingredients than the SPC Application
[b] The Marketing Authorization Refers to More Active Ingredients than the SPC Application
[c] The Marketing Authorization Indicates That a Medicinal Product Containing a Single Active Ingredient Is Authorized for Use in Combination with a Further Active Ingredient
[2] The Marketing Authorization Has Not Yet Been Granted at the Time the SPC Application Is Filed
[3] The Holder of the Marketing Authorization
[4] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Medicinal Products
[5] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Plant Protection Products
[6] The Product in Question Is Contained in the Authorized Medicinal Product (or the Authorized Plant Protection Product) but Is Not Identified as an Active Ingredient in the Corresponding Marketing Authorization
[7] The Notion of the 'First' Marketing Authorization
[a] Marketing Authorization for a New Therapeutic Application of a Previously Authorized Product
[b] Marketing Authorization for a New Formulation of a Previously Authorized Product
[c] Marketing Authorization for a New Specific Salt, Ester or Other Derivative of a Previously Authorized Active Ingredient
[d] Marketing Authorization for a New Specific Enantiomer of an Active Ingredient Previously Authorized in Racemic Form
[e] The Product Has Already Been Placed on the Market Before, but Without an Authorization Granted under Directive 2001/83/EC or Directive 2001/82/EC
[f] Prior Marketing Authorization Which Refers to Fewer Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[g] Prior Marketing Authorization Which Refers to More Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[D] Preclusion of New SPCs by an Earlier SPC
[1] The 'One SPC per Product per Patent Holder' Rule
[2] Consequences of an Earlier Third-Party SPC for the Same Product
[a] Earlier SPC Granted to an Affiliated Third Party
[b] Partial Overlap Between the Holders of the Earlier SPC and the Applicants for the New SPC
[c] Earlier Third-Party SPC Has Been Licensed-In
[3] Consequences of an Own Earlier SPC for the Same Product
[a] Own Earlier SPC Application Not Yet Granted
[b] Revocation, Surrender or Lapse of the Own Earlier SPC after Grant
[c] Transfer of the Own Earlier SPC to a Third Party
[d] Acquisition of an SPC Granted to a Third Party
[4] Consequences of an Own Earlier SPC for a Different Product
[a] Required Distinction from the Product of the Own Earlier SPC
[b] Combinations of Active Ingredients
[c] New Therapeutic Applications of Previously Approved Active Ingredients
[d] SPCs for a Specific Salt, Ester or Other Derivative Where an Own Earlier SPC Has Already Been Granted for the Corresponding Active Ingredient
[e] SPCs for a Specific Enantiomer Where an Own Earlier SPC Has Already Been Granted for the Corresponding Racemate
[5] Grant of More than One SPC on the Basis of the Same Patent
§24.03 EXTENT OF PROTECTION AND ENFORCEMENT OF SPCS
[A] The Protection Conferred by an SPC
[B] The Scope of an SPC in Relation to Derivatives of an Active Ingredient
[1] The Relationship Between the Definition of the Active Ingredient(s) in an SPC and Its Scope of Protection
[C] Enforcement of an SPC
[D] The Manufacturing Waiver
§24.04 DETERMINATION OF THE SPC TERM
[A] The Calculation of the SPC Term
[1] The Relevant Marketing Authorization for the Term of an SPC
[2] The Expiration Date of an SPC
[B] Correction of the SPC Term
[C] The Term of a Paediatric Extension
§24.05 PROCEDURE OF FILING AN SPC APPLICATION
[A] Entitlement to an SPC Application
[B] The Time Limit for Filing an SPC Application
[C] The Filing of an SPC at the National Patent Office
[D] The Documentation Required for an SPC Application
[E] The Definition of the Product in an SPC Application
[F] SPC Examination Procedure and Appeal Procedure
[G] Publication of SPC Applications and Issued SPCs
[H] Renewal Fees
[I] Applications for a Paediatric Extension
§24.06 PROCEDURE OF INVALIDATING AN SPC
[A] Grounds for the Invalidation of an SPC
[B] The Filing of an Invalidation Suit
[C] Invalidation Procedure and the Corresponding Appeal Procedure
[D] The Revocation of a Paediatric Extension
§24.07 UNFAIR COMPETITION LAW
CHAPTER 25 North Macedonia
§25.01 LEGAL BASIS
§25.02 SUBSTANTIVE REQUIREMENTS FOR OBTAINING AN SPC
[A] Types of Products That Can Be Protected
[1] Practical Considerations: What Is the Active Ingredient or Combination of Active Ingredients That Can Form the Basis for an SPC?
[2] Active Ingredient or Combination of Active Ingredients of a Medicinal Product
[3] Active Substance or Combination of Active Substances of a Plant Protection Product
[4] Fixed-Dose and Loose Combinations
[5] Limitation to Products Subjected to a Specific Marketing Authorization Procedure
[B] Basic Patent
[1] Requirement for the Product to Be 'Protected' by the Basic Patent
[a] Small Molecules
[b] Polymers
[c] Antibodies, Enzymes and Other Proteins
[d] Nucleic Acids
[2] Basic Patent Claiming the Product, i.e., the Active Ingredient(s), but Not the Corresponding Authorized Medicinal Product (or Plant Protection Product)
[3] Requirement for the Product to Constitute 'the Invention' of the Basic Patent
[4] Criteria for Choosing the Basic Patent among Various Available Patents
[C] The Marketing Authorization Forming Basis for an SPC
[1] Combinations of Active Ingredients
[a] The Marketing Authorization Refers to Fewer Active Ingredients than the SPC Application
[b] The Marketing Authorization Refers to More Active Ingredients than the SPC Application
[c] The Marketing Authorization Indicates That a Medicinal Product Containing a Single Active Ingredient Is Authorized for Use in Combination with a Further Active Ingredient
[2] The Marketing Authorization Has Not Yet Been Granted at the Time the SPC Application Is Filed
[3] The Holder of the Marketing Authorization
[4] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Medicinal Products
[5] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Plant Protection Products
[6] The Product in Question Is Contained in the Authorized Medicinal Product (or the Authorized Plant Protection Product) but Is Not Identified as an Active Ingredient in the Corresponding Marketing Authorization
[7] The Notion of the 'First' Marketing Authorization
[a] Marketing Authorization for a New Therapeutic Application of a Previously Authorized Product
[b] Marketing Authorization for a New Formulation of a Previously Authorized Product
[c] Marketing Authorization for a New Specific Salt, Ester or Other Derivative of a Previously Authorized Active Ingredient
[d] Marketing Authorization for a New Specific Enantiomer of an Active Ingredient Previously Authorized in Racemic Form
[e] The Product Has Already Been Placed on the Market Before, but Without an Authorization Granted under Directive 2001/83/EC or Directive 2001/82/EC
[f] Prior Marketing Authorization Which Refers to Fewer Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[g] Prior Marketing Authorization Which Refers to More Active Ingredients Than the SPC Application (and the Later Marketing Authorization Relied upon)
[D] Preclusion of New SPCs by an Earlier SPC
[1] The 'One SPC per Product per Patent Holder' Rule
[2] Consequences of an Earlier Third-Party SPC for the Same Product
[a] Earlier SPC Granted to an Affiliated Third Party
[b] Partial Overlap Between the Holders of the Earlier SPC and the Applicants for the New SPC
[c] Earlier Third-Party SPC Has Been Licensed-In
[3] Consequences of an Own Earlier SPC for the Same Product
[a] Own Earlier SPC Application Not Yet Granted
[b] Revocation, Surrender or Lapse of the Own Earlier SPC after Grant
[c] Transfer of the Own Earlier SPC to a Third Party
[d] Acquisition of an SPC Granted to a Third Party
[4] Consequences of an Own Earlier SPC for a Different Product
[a] Required Distinction from the Product of the Own Earlier SPC
[b] Combinations of Active Ingredients
[c] New Therapeutic Applications of Previously Approved Active Ingredients
[d] SPCs for a Specific Salt, Ester or Other Derivative Where an Own Earlier SPC Has Already Been Granted for the Corresponding Active Ingredient
[e] SPCs for a Specific Enantiomer Where an Own Earlier SPC Has Already Been Granted for the Corresponding Racemate
[5] Grant of More than One SPC on the Basis of the Same Patent
§25.03 EXTENT OF PROTECTION AND ENFORCEMENT OF SPCS
[A] The Protection Conferred by an SPC
[B] The Scope of an SPC in Relation to Derivatives of an Active Ingredient
[1] The Relationship Between the Definition of the Active Ingredient(s) in an SPC and Its Scope of Protection
[C] Enforcement of an SPC
[D] The Manufacturing Waiver
§25.04 DETERMINATION OF THE SPC TERM
[A] The Calculation of the SPC Term
[1] The Relevant Marketing Authorization for the Term of an SPC
[2] The Expiration Date of an SPC
[B] Correction of the SPC Term
[C] The Term of a Paediatric Extension
§25.05 PROCEDURE OF FILING AN SPC APPLICATION
[A] Entitlement to an SPC Application
[B] The Time Limit for Filing an SPC Application
[C] The Filing of an SPC at the National Patent Office
[D] The Documentation Required for an SPC Application
[E] The Definition of the Product in an SPC Application
[F] SPC Examination Procedure and Appeal Procedure
[G] Publication of SPC Applications and Issued SPCs
[H] Renewal Fees
[I] Applications for a Paediatric Extension
§25.06 PROCEDURE OF INVALIDATING AN SPC
[A] Grounds for the Invalidation of an SPC
[B] The Filing of an Invalidation Suit
[C] Invalidation Procedure and the Corresponding Appeal Procedure
[D] The Revocation of a Paediatric Extension
§25.07 UNFAIR COMPETITION LAW
CHAPTER 26 Norway
§26.01 LEGAL BASIS
§26.02 SUBSTANTIVE REQUIREMENTS FOR OBTAINING AN SPC
[A] Types of Products That Can Be Protected
[1] Practical Considerations: What Is the Active Ingredient or Combination of Active Ingredients That Can Form the Basis for an SPC?
[2] Active Ingredient or Combination of Active Ingredients of a Medicinal Product
[3] Active Substance or Combination of Active Substances of a Plant Protection Product
[4] Fixed-Dose and Loose Combinations
[5] Limitation to Products Subjected to a Specific Marketing Authorization Procedure
[B] Basic Patent
[1] Requirement for the Product to Be 'Protected' by the Basic Patent
[a] Small Molecules
[b] Polymers
[c] Antibodies, Enzymes and Other Proteins
[d] Nucleic Acids
[2] Basic Patent Claiming the Product, i.e., the Active Ingredient(s), but Not the Corresponding Authorized Medicinal Product (or Plant Protection Product)
[3] Requirement for the Product to Constitute 'the Invention' of the Basic Patent
[4] Criteria for Choosing the Basic Patent among Various Available Patents
[C] The Marketing Authorization Forming Basis for an SPC
[1] Combinations of Active Ingredients
[a] The Marketing Authorization Refers to Fewer Active Ingredients than the SPC Application
[b] The Marketing Authorization Refers to More Active Ingredients than the SPC Application
[c] The Marketing Authorization Indicates That a Medicinal Product Containing a Single Active Ingredient Is Authorized for Use in Combination with a Further Active Ingredient
[2] The Marketing Authorization Has Not Yet Been Granted at the Time the SPC Application Is Filed
[3] The Holder of the Marketing Authorization
[4] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Medicinal Products
[5] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Plant Protection Products
[6] The Product in Question Is Contained in the Authorized Medicinal Product (or the Authorized Plant Protection Product) but Is Not Identified as an Active Ingredient in the Corresponding Marketing Authorization
[7] The Notion of the 'First' Marketing Authorization
[a] Marketing Authorization for a New Therapeutic Application of a Previously Authorized Product
[b] Marketing Authorization for a New Formulation of a Previously Authorized Product
[c] Marketing Authorization for a New Specific Salt, Ester or Other Derivative of a Previously Authorized Active Ingredient
[d] Marketing Authorization for a New Specific Enantiomer of an Active Ingredient Previously Authorized in Racemic Form
[e] The Product Has Already Been Placed on the Market Before, but Without an Authorization Granted under Directive 2001/83/EC or Directive 2001/82/EC
[f] Prior Marketing Authorization Which Refers to Fewer Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[g] Prior Marketing Authorization Which Refers to More Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[D] Preclusion of New SPCs by an Earlier SPC
[1] The 'One SPC per Product per Patent Holder' Rule
[2] Consequences of an Earlier Third-Party SPC for the Same Product
[a] Earlier SPC Granted to an Affiliated Third Party
[b] Partial Overlap Between the Holders of the Earlier SPC and the Applicants for the New SPC
[c] Earlier Third-Party SPC Has Been Licensed-In
[3] Consequences of an Own Earlier SPC for the Same Product
[a] Own Earlier SPC Application Not Yet Granted
[b] Revocation, Surrender or Lapse of the Own Earlier SPC after Grant
[c] Transfer of the Own Earlier SPC to a Third Party
[d] Acquisition of an SPC Granted to a Third Party
[4] Consequences of an Own Earlier SPC for a Different Product
[a] Required Distinction from the Product of the Own Earlier SPC
[b] Combinations of Active Ingredients
[c] New Therapeutic Applications of Previously Approved Active Ingredients
[d] SPCs for a Specific Salt, Ester or Other Derivative Where an Own Earlier SPC Has Already Been Granted for the Corresponding Active Ingredient
[e] SPCs for a Specific Enantiomer Where an Own Earlier SPC Has Already Been Granted for the Corresponding Racemate
[5] Grant of More than One SPC on the Basis of the Same Patent
§26.03 EXTENT OF PROTECTION AND ENFORCEMENT OF SPCS
[A] The Protection Conferred by an SPC
[B] The Scope of an SPC in Relation to Derivatives of an Active Ingredient
[1] The Relationship Between the Definition of the Active Ingredient(s) in an SPC and Its Scope of Protection
[C] Enforcement of an SPC
[D] The Manufacturing Waiver
§26.04 DETERMINATION OF THE SPC TERM
[A] The Calculation of the SPC Term
[1] The Relevant Marketing Authorization for the Term of an SPC
[2] The Expiration Date of an SPC
[B] Correction of the SPC Term
[C] The Term of a Paediatric Extension
§26.05 PROCEDURE OF FILING AN SPC APPLICATION
[A] Entitlement to an SPC Application
[B] The Time Limit for Filing an SPC Application
[C] The Filing of an SPC at the National Patent Office
[D] The Documentation Required for an SPC Application
[E] The Definition of the Product in an SPC Application
[F] SPC Examination Procedure and Appeal Procedure
[G] Publication of SPC Applications and Issued SPCs
[H] Renewal Fees
[I] Applications for a Paediatric Extension
§26.06 PROCEDURE OF INVALIDATING AN SPC
[A] Grounds for the Invalidation of an SPC
[B] The Filing of an Invalidation Suit
[C] Invalidation Procedure and the Corresponding Appeal Procedure
[D] The Revocation of a Paediatric Extension
§26.07 UNFAIR COMPETITION LAW
CHAPTER 27 Poland
§27.01 LEGAL BASIS
§27.02 SUBSTANTIVE REQUIREMENTS FOR OBTAINING AN SPC
[A] Types of Products That Can Be Protected
[1] Practical Considerations: What Is the Active Ingredient or Combination of Active Ingredients That Can Form the Basis for an SPC?
[2] Active Ingredient or Combination of Active Ingredients of a Medicinal Product
[3] Active Substance or Combination of Active Substances of a Plant Protection Product
[4] Fixed-Dose and Loose Combinations
[5] Limitation to Products Subjected to a Specific Marketing Authorization Procedure
[B] Basic Patent
[1] Requirement for the Product to Be 'Protected' by the Basic Patent
[a] Small Molecules
[b] Polymers
[c] Antibodies, Enzymes and Other Proteins
[d] Nucleic Acids
[2] Basic Patent Claiming the Product, i.e., the Active Ingredient(s), but Not the Corresponding Authorized Medicinal Product (or Plant Protection Product)
[3] Requirement for the Product to Constitute 'the Invention' of the Basic Patent
[4] Criteria for Choosing the Basic Patent among Various Available Patents
[C] The Marketing Authorization Forming Basis for an SPC
[1] Combinations of Active Ingredients
[a] The Marketing Authorization Refers to Fewer Active Ingredients than the SPC Application
[b] The Marketing Authorization Refers to More Active Ingredients than the SPC Application
[c] The Marketing Authorization Indicates That a Medicinal Product Containing a Single Active Ingredient Is Authorized for Use in Combination with a Further Active Ingredient
[2] The Marketing Authorization Has Not Yet Been Granted at the Time the SPC Application Is Filed
[3] The Holder of the Marketing Authorization
[4] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Medicinal Products
[5] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Plant Protection Products
[6] The Product in Question Is Contained in the Authorized Medicinal Product (or the Authorized Plant Protection Product) but Is Not Identified as an Active Ingredient in the Corresponding Marketing Authorization
[7] The Notion of the 'First' Marketing Authorization
[a] Marketing Authorization for a New Therapeutic Application of a Previously Authorized Product
[b] Marketing Authorization for a New Formulation of a Previously Authorized Product
[c] Marketing Authorization for a New Specific Salt, Ester or Other Derivative of a Previously Authorized Active Ingredient
[d] Marketing Authorization for a New Specific Enantiomer of an Active Ingredient Previously Authorized in Racemic Form
[e] The Product Has Already Been Placed on the Market Before, but Without an Authorization Granted under Directive 2001/83/EC or Directive 2001/82/EC
[f] Prior Marketing Authorization Which Refers to Fewer Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[g] Prior Marketing Authorization Which Refers to More Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[D] Preclusion of New SPCs by an Earlier SPC
[1] The 'One SPC per Product per Patent Holder' Rule
[2] Consequences of an Earlier Third-Party SPC for the Same Product
[a] Earlier SPC Granted to an Affiliated Third Party
[b] Partial Overlap Between the Holders of the Earlier SPC and the Applicants for the New SPC
[c] Earlier Third-Party SPC Has Been Licensed-In
[3] Consequences of an Own Earlier SPC for the Same Product
[a] Own Earlier SPC Application Not Yet Granted
[b] Revocation, Surrender or Lapse of the Own Earlier SPC after Grant
[c] Transfer of the Own Earlier SPC to a Third Party
[d] Acquisition of an SPC Granted to a Third Party
[4] Consequences of an Own Earlier SPC for a Different Product
[a] Required Distinction from the Product of the Own Earlier SPC
[b] Combinations of Active Ingredients
[c] New Therapeutic Applications of Previously Approved Active Ingredients
[d] SPCs for a Specific Salt, Ester or Other Derivative Where an Own Earlier SPC Has Already Been Granted for the Corresponding Active Ingredient
[e] SPCs for a Specific Enantiomer Where an Own Earlier SPC Has Already Been Granted for the Corresponding Racemate
[5] Grant of More than One SPC on the Basis of the Same Patent
§27.03 EXTENT OF PROTECTION AND ENFORCEMENT OF SPCS
[A] The Protection Conferred by an SPC
[B] The Scope of an SPC in Relation to Derivatives of an Active Ingredient
[1] The Relationship Between the Definition of the Active Ingredient(s) in an SPC and Its Scope of Protection
[C] Enforcement of an SPC
[D] The Manufacturing Waiver
§27.04 DETERMINATION OF THE SPC TERM
[A] The Calculation of the SPC Term
[1] The Relevant Marketing Authorization for the Term of an SPC
[2] The Expiration Date of an SPC
[B] Correction of the SPC Term
[C] The Term of a Paediatric Extension
§27.05 PROCEDURE OF FILING AN SPC APPLICATION
[A] Entitlement to an SPC Application
[B] The Time Limit for Filing an SPC Application
[C] The Filing of an SPC at the National Patent Office
[D] The Documentation Required for an SPC Application
[E] The Definition of the Product in an SPC Application
[F] SPC Examination Procedure and Appeal Procedure
[G] Publication of SPC Applications and Issued SPCs
[H] Renewal Fees
[I] Applications for a Paediatric Extension
§27.06 PROCEDURE OF INVALIDATING AN SPC
[A] Grounds for the Invalidation of an SPC
[B] The Filing of an Invalidation Suit
[C] Invalidation Procedure and the Corresponding Appeal Procedure
[D] The Revocation of a Paediatric Extension
§27.07 UNFAIR COMPETITION LAW
CHAPTER 28 Portugal
§28.01 LEGAL BASIS
§28.02 SUBSTANTIVE REQUIREMENTS FOR OBTAINING AN SPC
[A] Types of Products That Can Be Protected
[1] Practical Considerations: What Is the Active Ingredient or Combination of Active Ingredients That Can Form the Basis for an SPC?
[2] Active Ingredient or Combination of Active Ingredients of a Medicinal Product
[3] Active Substance or Combination of Active Substances of a Plant Protection Product
[4] Fixed-Dose and Loose Combinations
[5] Limitation to Products Subjected to a Specific Marketing Authorization Procedure
[B] Basic Patent
[1] Requirement for the Product to Be 'Protected' by the Basic Patent
[a] Small Molecules
[b] Polymers
[c] Antibodies, Enzymes and Other Proteins
[d] Nucleic Acids
[2] Basic Patent Claiming the Product, i.e., the Active Ingredient(s), but Not the Corresponding Authorized Medicinal Product (or Plant Protection Product)
[3] Requirement for the Product to Constitute 'the Invention' of the Basic Patent
[4] Criteria for Choosing the Basic Patent among Various Available Patents
[C] The Marketing Authorization Forming Basis for an SPC
[1] Combinations of Active Ingredients
[a] The Marketing Authorization Refers to Fewer Active Ingredients than the SPC Application
[b] The Marketing Authorization Refers to More Active Ingredients than the SPC Application
[c] The Marketing Authorization Indicates That a Medicinal Product Containing a Single Active Ingredient Is Authorized for Use in Combination with a Further Active Ingredient
[2] The Marketing Authorization Has Not Yet Been Granted at the Time the SPC Application Is Filed
[3] The Holder of the Marketing Authorization
[4] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Medicinal Products
[5] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Plant Protection Products
[6] The Product in Question Is Contained in the Authorized Medicinal Product (or the Authorized Plant Protection Product) but Is Not Identified as an Active Ingredient in the Corresponding Marketing Authorization
[7] The Notion of the 'First' Marketing Authorization
[a] Marketing Authorization for a New Therapeutic Application of a Previously Authorized Product
[b] Marketing Authorization for a New Formulation of a Previously Authorized Product
[c] Marketing Authorization for a New Specific Salt, Ester or Other Derivative of a Previously Authorized Active Ingredient
[d] Marketing Authorization for a New Specific Enantiomer of an Active Ingredient Previously Authorized in Racemic Form
[e] The Product Has Already Been Placed on the Market Before, but Without an Authorization Granted under Directive 2001/83/EC or Directive 2001/82/EC
[f] Prior Marketing Authorization Which Refers to Fewer Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[g] Prior Marketing Authorization Which Refers to More Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[D] Preclusion of New SPCs by an Earlier SPC
[1] The 'One SPC per Product per Patent Holder' Rule
[2] Consequences of an Earlier Third-Party SPC for the Same Product
[a] Earlier SPC Granted to an Affiliated Third Party
[b] Partial Overlap Between the Holders of the Earlier SPC and the Applicants for the New SPC
[c] Earlier Third-Party SPC Has Been Licensed-In
[3] Consequences of an Own Earlier SPC for the Same Product
[a] Own Earlier SPC Application Not Yet Granted
[b] Revocation, Surrender or Lapse of the Own Earlier SPC after Grant
[c] Transfer of the Own Earlier SPC to a Third Party
[d] Acquisition of an SPC Granted to a Third Party
[4] Consequences of an Own Earlier SPC for a Different Product
[a] Required Distinction from the Product of the Own Earlier SPC
[b] Combinations of Active Ingredients
[c] New Therapeutic Applications of Previously Approved Active Ingredients
[d] SPCs for a Specific Salt, Ester or Other Derivative Where an Own Earlier SPC Has Already Been Granted for the Corresponding Active Ingredient
[e] SPCs for a Specific Enantiomer Where an Own Earlier SPC Has Already Been Granted for the Corresponding Racemate
[5] Grant of More than One SPC on the Basis of the Same Patent
§28.03 EXTENT OF PROTECTION AND ENFORCEMENT OF SPCS
[A] The Protection Conferred by an SPC
[B] The Scope of an SPC in Relation to Derivatives of an Active Ingredient
[1] The Relationship Between the Definition of the Active Ingredient(s) in an SPC and Its Scope of Protection
[C] Enforcement of an SPC
[D] The Manufacturing Waiver
§28.04 DETERMINATION OF THE SPC TERM
[A] The Calculation of the SPC Term
[1] The Relevant Marketing Authorization for the Term of an SPC
[2] The Expiration Date of an SPC
[B] Correction of the SPC Term
[C] The Term of a Paediatric Extension
§28.05 PROCEDURE OF FILING AN SPC APPLICATION
[A] Entitlement to an SPC Application
[B] The Time Limit for Filing an SPC Application
[C] The Filing of an SPC at the National Patent Office
[D] The Documentation Required for an SPC Application
[E] The Definition of the Product in an SPC Application
[F] SPC Examination Procedure and Appeal Procedure
[G] Publication of SPC Applications and Issued SPCs
[H] Renewal Fees
[I] Applications for a Paediatric Extension
§28.06 PROCEDURE OF INVALIDATING AN SPC
[A] Grounds for the Invalidation of an SPC
[B] The Filing of an Invalidation Suit
[C] Invalidation Procedure and the Corresponding Appeal Procedure
[D] The Revocation of a Paediatric Extension
§28.07 UNFAIR COMPETITION LAW
CHAPTER 29 Romania
§29.01 LEGAL BASIS
§29.02 SUBSTANTIVE REQUIREMENTS FOR OBTAINING AN SPC
[A] Types of Products That Can Be Protected
[1] Practical Considerations: What Is the Active Ingredient or Combination of Active Ingredients That Can Form the Basis for an SPC?
[2] Active Ingredient or Combination of Active Ingredients of a Medicinal Product
[3] Active Substance or Combination of Active Substances of a Plant Protection Product
[4] Fixed-Dose and Loose Combinations
[5] Limitation to Products Subjected to a Specific Marketing Authorization Procedure
[B] Basic Patent
[1] Requirement for the Product to Be 'Protected' by the Basic Patent
[a] Small Molecules
[b] Polymers
[c] Antibodies, Enzymes and Other Proteins
[d] Nucleic Acids
[2] Basic Patent Claiming the Product, i.e., the Active Ingredient(s), but Not the Corresponding Authorized Medicinal Product (or Plant Protection Product)
[3] Requirement for the Product to Constitute 'the Invention' of the Basic Patent
[4] Criteria for Choosing the Basic Patent among Various Available Patents
[C] The Marketing Authorization Forming Basis for an SPC
[1] Combinations of Active Ingredients
[a] The Marketing Authorization Refers to Fewer Active Ingredients than the SPC Application
[b] The Marketing Authorization Refers to More Active Ingredients than the SPC Application
[c] The Marketing Authorization Indicates That a Medicinal Product Containing a Single Active Ingredient Is Authorized for Use in Combination with a Further Active Ingredient
[2] The Marketing Authorization Has Not Yet Been Granted at the Time the SPC Application Is Filed
[3] The Holder of the Marketing Authorization
[4] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Medicinal Products
[5] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Plant Protection Products
[6] The Product in Question Is Contained in the Authorized Medicinal Product (or the Authorized Plant Protection Product) but Is Not Identified as an Active Ingredient in the Corresponding Marketing Authorization
[7] The Notion of the 'First' Marketing Authorization
[a] Marketing Authorization for a New Therapeutic Application of a Previously Authorized Product
[b] Marketing Authorization for a New Formulation of a Previously Authorized Product
[c] Marketing Authorization for a New Specific Salt, Ester or Other Derivative of a Previously Authorized Active Ingredient
[d] Marketing Authorization for a New Specific Enantiomer of an Active Ingredient Previously Authorized in Racemic Form
[e] The Product Has Already Been Placed on the Market Before, but Without an Authorization Granted under Directive 2001/83/EC or Directive 2001/82/EC
[f] Prior Marketing Authorization Which Refers to Fewer Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[g] Prior Marketing Authorization Which Refers to More Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[D] Preclusion of New SPCs by an Earlier SPC
[1] The 'One SPC per Product per Patent Holder' Rule
[2] Consequences of an Earlier Third-Party SPC for the Same Product
[a] Earlier SPC Granted to an Affiliated Third Party
[b] Partial Overlap Between the Holders of the Earlier SPC and the Applicants for the New SPC
[c] Earlier Third-Party SPC Has Been Licensed-In
[3] Consequences of an Own Earlier SPC for the Same Product
[a] Own Earlier SPC Application Not Yet Granted
[b] Revocation, Surrender or Lapse of the Own Earlier SPC after Grant
[c] Transfer of the Own Earlier SPC to a Third Party
[d] Acquisition of an SPC Granted to a Third Party
[4] Consequences of an Own Earlier SPC for a Different Product
[a] Required Distinction from the Product of the Own Earlier SPC
[b] Combinations of Active Ingredients
[c] New Therapeutic Applications of Previously Approved Active Ingredients
[d] SPCs for a Specific Salt, Ester or Other Derivative Where an Own Earlier SPC Has Already Been Granted for the Corresponding Active Ingredient
[e] SPCs for a Specific Enantiomer Where an Own Earlier SPC Has Already Been Granted for the Corresponding Racemate
[5] Grant of More than One SPC on the Basis of the Same Patent
§29.03 EXTENT OF PROTECTION AND ENFORCEMENT OF SPCS
[A] The Protection Conferred by an SPC
[B] The Scope of an SPC in Relation to Derivatives of an Active Ingredient
[1] The Relationship Between the Definition of the Active Ingredient(s) in an SPC and Its Scope of Protection
[C] Enforcement of an SPC
[D] The Manufacturing Waiver
§29.04 DETERMINATION OF THE SPC TERM
[A] The Calculation of the SPC Term
[1] The Relevant Marketing Authorization for the Term of an SPC
[2] The Expiration Date of an SPC
[B] Correction of the SPC Term
[C] The Term of a Paediatric Extension
§29.05 PROCEDURE OF FILING AN SPC APPLICATION
[A] Entitlement to an SPC Application
[B] The Time Limit for Filing an SPC Application
[C] The Filing of an SPC at the National Patent Office
[D] The Documentation Required for an SPC Application
[E] The Definition of the Product in an SPC Application
[F] SPC Examination Procedure and Appeal Procedure
[G] Publication of SPC Applications and Issued SPCs
[H] Renewal Fees
[I] Applications for a Paediatric Extension
§29.06 PROCEDURE OF INVALIDATING AN SPC
[A] Grounds for the Invalidation of an SPC
[B] The Filing of an Invalidation Suit
[C] Invalidation Procedure and the Corresponding Appeal Procedure
[D] The Revocation of a Paediatric Extension
§29.07 UNFAIR COMPETITION LAW
CHAPTER 30 Serbia
§30.01 LEGAL BASIS
§30.02 SUBSTANTIVE REQUIREMENTS FOR OBTAINING AN SPC
[A] Types of Products That Can Be Protected
[1] Practical Considerations: What Is the Active Ingredient or Combination of Active Ingredients That Can Form the Basis for an SPC?
[2] Active Ingredient or Combination of Active Ingredients of a Medicinal Product
[3] Active Substance or Combination of Active Substances of a Plant Protection Product
[4] Fixed-Dose and Loose Combinations
[5] Limitation to Products Subjected to a Specific Marketing Authorization Procedure
[B] Basic Patent
[1] Requirement for the Product to Be 'Protected' by the Basic Patent
[a] Small Molecules
[b] Polymers
[c] Antibodies, Enzymes and Other Proteins
[d] Nucleic Acids
[2] Basic Patent Claiming the Product, i.e., the Active Ingredient(s), but Not the Corresponding Authorized Medicinal Product (or Plant Protection Product)
[3] Requirement for the Product to Constitute 'the Invention' of the Basic Patent
[4] Criteria for Choosing the Basic Patent among Various Available Patents
[C] The Marketing Authorization Forming Basis for an SPC
[1] Combinations of Active Ingredients
[a] The Marketing Authorization Refers to Fewer Active Ingredients than the SPC Application
[b] The Marketing Authorization Refers to More Active Ingredients than the SPC Application
[c] The Marketing Authorization Indicates That a Medicinal Product Containing a Single Active Ingredient Is Authorized for Use in Combination with a Further Active Ingredient
[2] The Marketing Authorization Has Not Yet Been Granted at the Time the SPC Application Is Filed
[3] The Holder of the Marketing Authorization
[4] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Medicinal Products
[5] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Plant Protection Products
[6] The Product in Question Is Contained in the Authorized Medicinal Product (or the Authorized Plant Protection Product) but Is Not Identified as an Active Ingredient in the Corresponding Marketing Authorization
[7] The Notion of the 'First' Marketing Authorization
[a] Marketing Authorization for a New Therapeutic Application of a Previously Authorized Product
[b] Marketing Authorization for a New Formulation of a Previously Authorized Product
[c] Marketing Authorization for a New Specific Salt, Ester or Other Derivative of a Previously Authorized Active Ingredient
[d] Marketing Authorization for a New Specific Enantiomer of an Active Ingredient Previously Authorized in Racemic Form
[e] The Product Has Already Been Placed on the Market Before, but Without an Authorization Granted under Directive 2001/83/EC or Directive 2001/82/EC
[f] Prior Marketing Authorization Which Refers to Fewer Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[g] Prior Marketing Authorization Which Refers to More Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[D] Preclusion of New SPCs by an Earlier SPC
[1] The 'One SPC per Product per Patent Holder' Rule
[2] Consequences of an Earlier Third-Party SPC for the Same Product
[a] Earlier SPC Granted to an Affiliated Third Party
[b] Partial Overlap Between the Holders of the Earlier SPC and the Applicants for the New SPC
[c] Earlier Third-Party SPC Has Been Licensed-In
[3] Consequences of an Own Earlier SPC for the Same Product
[a] Own Earlier SPC Application Not Yet Granted
[b] Revocation, Surrender or Lapse of the Own Earlier SPC after Grant
[c] Transfer of the Own Earlier SPC to a Third Party
[d] Acquisition of an SPC Granted to a Third Party
[4] Consequences of an Own Earlier SPC for a Different Product
[a] Required Distinction from the Product of the Own Earlier SPC
[b] Combinations of Active Ingredients
[c] New Therapeutic Applications of Previously Approved Active Ingredients
[d] SPCs for a Specific Salt, Ester or Other Derivative Where an Own Earlier SPC Has Already Been Granted for the Corresponding Active Ingredient
[e] SPCs for a Specific Enantiomer Where an Own Earlier SPC Has Already Been Granted for the Corresponding Racemate
[5] Grant of More than One SPC on the Basis of the Same Patent
§30.03 EXTENT OF PROTECTION AND ENFORCEMENT OF SPCS
[A] The Protection Conferred by an SPC
[B] The Scope of an SPC in Relation to Derivatives of an Active Ingredient
[1] The Relationship Between the Definition of the Active Ingredient(s) in an SPC and Its Scope of Protection
[C] Enforcement of an SPC
[D] The Manufacturing Waiver
§30.04 DETERMINATION OF THE SPC TERM
[A] The Calculation of the SPC Term
[1] The Relevant Marketing Authorization for the Term of an SPC
[2] The Expiration Date of an SPC
[B] Correction of the SPC Term
[C] The Term of a Paediatric Extension
§30.05 PROCEDURE OF FILING AN SPC APPLICATION
[A] Entitlement to an SPC Application
[B] The Time Limit for Filing an SPC Application
[C] The Filing of an SPC at the National Patent Office
[D] The Documentation Required for an SPC Application
[E] The Definition of the Product in an SPC Application
[F] SPC Examination Procedure and Appeal Procedure
[G] Publication of SPC Applications and Issued SPCs
[H] Renewal Fees
[I] Applications for a Paediatric Extension
§30.06 PROCEDURE OF INVALIDATING AN SPC
[A] Grounds for the Invalidation of an SPC
[B] The Filing of an Invalidation Suit
[C] Invalidation Procedure and the Corresponding Appeal Procedure
[D] The Revocation of a Paediatric Extension
§30.07 UNFAIR COMPETITION LAW
CHAPTER 31 Slovakia
§31.01 LEGAL BASIS
§31.02 SUBSTANTIVE REQUIREMENTS FOR OBTAINING AN SPC
[A] Types of Products That Can Be Protected
[1] Practical Considerations: What Is the Active Ingredient or Combination of Active Ingredients That Can Form the Basis for an SPC?
[2] Active Ingredient or Combination of Active Ingredients of a Medicinal Product
[3] Active Substance or Combination of Active Substances of a Plant Protection Product
[4] Fixed-Dose and Loose Combinations
[5] Limitation to Products Subjected to a Specific Marketing Authorization Procedure
[B] Basic Patent
[1] Requirement for the Product to Be 'Protected' by the Basic Patent
[a] Small Molecules
[b] Polymers
[c] Antibodies, Enzymes and Other Proteins
[d] Nucleic Acids
[2] Basic Patent Claiming the Product, i.e., the Active Ingredient(s), but Not the Corresponding Authorized Medicinal Product (or Plant Protection Product)
[3] Requirement for the Product to Constitute 'the Invention' of the Basic Patent
[4] Criteria for Choosing the Basic Patent among Various Available Patents
[C] The Marketing Authorization Forming Basis for an SPC
[1] Combinations of Active Ingredients
[a] The Marketing Authorization Refers to Fewer Active Ingredients than the SPC Application
[b] The Marketing Authorization Refers to More Active Ingredients than the SPC Application
[c] The Marketing Authorization Indicates That a Medicinal Product Containing a Single Active Ingredient Is Authorized for Use in Combination with a Further Active Ingredient
[2] The Marketing Authorization Has Not Yet Been Granted at the Time the SPC Application Is Filed
[3] The Holder of the Marketing Authorization
[4] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Medicinal Products
[5] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Plant Protection Products
[6] The Product in Question Is Contained in the Authorized Medicinal Product (or the Authorized Plant Protection Product) but Is Not Identified as an Active Ingredient in the Corresponding Marketing Authorization
[7] The Notion of the 'First' Marketing Authorization
[a] Marketing Authorization for a New Therapeutic Application of a Previously Authorized Product
[b] Marketing Authorization for a New Formulation of a Previously Authorized Product
[c] Marketing Authorization for a New Specific Salt, Ester or Other Derivative of a Previously Authorized Active Ingredient
[d] Marketing Authorization for a New Specific Enantiomer of an Active Ingredient Previously Authorized in Racemic Form
[e] The Product Has Already Been Placed on the Market Before, but Without an Authorization Granted under Directive 2001/83/EC or Directive 2001/82/EC
[f] Prior Marketing Authorization Which Refers to Fewer Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[g] Prior Marketing Authorization Which Refers to More Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[D] Preclusion of New SPCs by an Earlier SPC
[1] The 'One SPC per Product per Patent Holder' Rule
[2] Consequences of an Earlier Third-Party SPC for the Same Product
[a] Earlier SPC Granted to an Affiliated Third Party
[b] Partial Overlap Between the Holders of the Earlier SPC and the Applicants for the New SPC
[c] Earlier Third-Party SPC Has Been Licensed-In
[3] Consequences of an Own Earlier SPC for the Same Product
[a] Own Earlier SPC Application Not Yet Granted
[b] Revocation, Surrender or Lapse of the Own Earlier SPC after Grant
[c] Transfer of the Own Earlier SPC to a Third Party
[d] Acquisition of an SPC Granted to a Third Party
[4] Consequences of an Own Earlier SPC for a Different Product
[a] Required Distinction from the Product of the Own Earlier SPC
[b] Combinations of Active Ingredients
[c] New Therapeutic Applications of Previously Approved Active Ingredients
[d] SPCs for a Specific Salt, Ester or Other Derivative Where an Own Earlier SPC Has Already Been Granted for the Corresponding Active Ingredient
[e] SPCs for a Specific Enantiomer Where an Own Earlier SPC Has Already Been Granted for the Corresponding Racemate
[5] Grant of More than One SPC on the Basis of the Same Patent
§31.03 EXTENT OF PROTECTION AND ENFORCEMENT OF SPCS
[A] The Protection Conferred by an SPC
[B] The Scope of an SPC in Relation to Derivatives of an Active Ingredient
[1] The Relationship Between the Definition of the Active Ingredient(s) in an SPC and Its Scope of Protection
[C] Enforcement of an SPC
[D] The Manufacturing Waiver
§31.04 DETERMINATION OF THE SPC TERM
[A] The Calculation of the SPC Term
[1] The Relevant Marketing Authorization for the Term of an SPC
[2] The Expiration Date of an SPC
[B] Correction of the SPC Term
[C] The Term of a Paediatric Extension
§31.05 PROCEDURE OF FILING AN SPC APPLICATION
[A] Entitlement to an SPC Application
[B] The Time Limit for Filing an SPC Application
[C] The Filing of an SPC at the National Patent Office
[D] The Documentation Required for an SPC Application
[E] The Definition of the Product in an SPC Application
[F] SPC Examination Procedure and Appeal Procedure
[G] Publication of SPC Applications and Issued SPCs
[H] Renewal Fees
[I] Applications for a Paediatric Extension
§31.06 PROCEDURE OF INVALIDATING AN SPC
[A] Grounds for the Invalidation of an SPC
[B] The Filing of an Invalidation Suit
[C] Invalidation Procedure and the Corresponding Appeal Procedure
[D] The Revocation of a Paediatric Extension
§31.07 UNFAIR COMPETITION LAW
CHAPTER 32 Slovenia
§32.01 LEGAL BASIS
§32.02 SUBSTANTIVE REQUIREMENTS FOR OBTAINING AN SPC
[A] Types of Products That Can Be Protected
[1] Practical Considerations: What Is the Active Ingredient or Combination of Active Ingredients That Can Form the Basis for an SPC?
[2] Active Ingredient or Combination of Active Ingredients of a Medicinal Product
[3] Active Substance or Combination of Active Substances of a Plant Protection Product
[4] Fixed-Dose and Loose Combinations
[5] Limitation to Products Subjected to a Specific Marketing Authorization Procedure
[B] Basic Patent
[1] Requirement for the Product to Be 'Protected' by the Basic Patent
[a] Small Molecules
[b] Polymers
[c] Antibodies, Enzymes and Other Proteins
[d] Nucleic Acids
[2] Basic Patent Claiming the Product, i.e., the Active Ingredient(s), but Not the Corresponding Authorized Medicinal Product (or Plant Protection Product)
[3] Requirement for the Product to Constitute 'the Invention' of the Basic Patent
[4] Criteria for Choosing the Basic Patent among Various Available Patents
[C] The Marketing Authorization Forming Basis for an SPC
[1] Combinations of Active Ingredients
[a] The Marketing Authorization Refers to Fewer Active Ingredients than the SPC Application
[b] The Marketing Authorization Refers to More Active Ingredients than the SPC Application
[c] The Marketing Authorization Indicates That a Medicinal Product Containing a Single Active Ingredient Is Authorized for Use in Combination with a Further Active Ingredient
[2] The Marketing Authorization Has Not Yet Been Granted at the Time the SPC Application Is Filed
[3] The Holder of the Marketing Authorization
[4] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Medicinal Products
[5] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Plant Protection Products
[6] The Product in Question Is Contained in the Authorized Medicinal Product (or the Authorized Plant Protection Product) but Is Not Identified as an Active Ingredient in the Corresponding Marketing Authorization
[7] The Notion of the 'First' Marketing Authorization
[a] Marketing Authorization for a New Therapeutic Application of a Previously Authorized Product
[b] Marketing Authorization for a New Formulation of a Previously Authorized Product
[c] Marketing Authorization for a New Specific Salt, Ester or Other Derivative of a Previously Authorized Active Ingredient
[d] Marketing Authorization for a New Specific Enantiomer of an Active Ingredient Previously Authorized in Racemic Form
[e] The Product Has Already Been Placed on the Market Before, but Without an Authorization Granted under Directive 2001/83/EC or Directive 2001/82/EC
[f] Prior Marketing Authorization Which Refers to Fewer Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[g] Prior Marketing Authorization Which Refers to More Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[D] Preclusion of New SPCs by an Earlier SPC
[1] The 'One SPC per Product per Patent Holder' Rule
[2] Consequences of an Earlier Third-Party SPC for the Same Product
[a] Earlier SPC Granted to an Affiliated Third Party
[b] Partial Overlap Between the Holders of the Earlier SPC and the Applicants for the New SPC
[c] Earlier Third-Party SPC Has Been Licensed-In
[3] Consequences of an Own Earlier SPC for the Same Product
[a] Own Earlier SPC Application Not Yet Granted
[b] Revocation, Surrender or Lapse of the Own Earlier SPC after Grant
[c] Transfer of the Own Earlier SPC to a Third Party
[d] Acquisition of an SPC Granted to a Third Party
[4] Consequences of an Own Earlier SPC for a Different Product
[a] Required Distinction from the Product of the Own Earlier SPC
[b] Combinations of Active Ingredients
[c] New Therapeutic Applications of Previously Approved Active Ingredients
[d] SPCs for a Specific Salt, Ester or Other Derivative Where an Own Earlier SPC Has Already Been Granted for the Corresponding Active Ingredient
[e] SPCs for a Specific Enantiomer Where an Own Earlier SPC Has Already Been Granted for the Corresponding Racemate
[5] Grant of More than One SPC on the Basis of the Same Patent
§32.03 EXTENT OF PROTECTION AND ENFORCEMENT OF SPCS
[A] The Protection Conferred by an SPC
[B] The Scope of an SPC in Relation to Derivatives of an Active Ingredient
[1] The Relationship Between the Definition of the Active Ingredient(s) in an SPC and Its Scope of Protection
[C] Enforcement of an SPC
[D] The Manufacturing Waiver
§32.04 DETERMINATION OF THE SPC TERM
[A] The Calculation of the SPC Term
[1] The Relevant Marketing Authorization for the Term of an SPC
[2] The Expiration Date of an SPC
[B] Correction of the SPC Term
[C] The Term of a Paediatric Extension
§32.05 PROCEDURE OF FILING AN SPC APPLICATION
[A] Entitlement to an SPC Application
[B] The Time Limit for Filing an SPC Application
[C] The Filing of an SPC at the National Patent Office
[D] The Documentation Required for an SPC Application
[E] The Definition of the Product in an SPC Application
[F] SPC Examination Procedure and Appeal Procedure
[G] Publication of SPC Applications and Issued SPCs
[H] Renewal Fees
[I] Applications for a Paediatric Extension
§32.06 PROCEDURE OF INVALIDATING AN SPC
[A] Grounds for the Invalidation of an SPC
[B] The Filing of an Invalidation Suit
[C] Invalidation Procedure and the Corresponding Appeal Procedure
[D] The Revocation of a Paediatric Extension
§32.07 UNFAIR COMPETITION LAW
CHAPTER 33 Spain
§33.01 LEGAL BASIS
§33.02 SUBSTANTIVE REQUIREMENTS FOR OBTAINING AN SPC
[A] Types of Products That Can Be Protected
[1] Practical Considerations: What Is the Active Ingredient or Combination of Active Ingredients That Can Form the Basis for an SPC?
[2] Active Ingredient or Combination of Active Ingredients of a Medicinal Product
[3] Active Substance or Combination of Active Substances of a Plant Protection Product
[4] Fixed-Dose and Loose Combinations
[5] Limitation to Products Subjected to a Specific Marketing Authorization Procedure
[B] Basic Patent
[1] Requirement for the Product to Be 'Protected' by the Basic Patent
[a] Small Molecules
[b] Polymers
[c] Antibodies, Enzymes and Other Proteins
[d] Nucleic Acids
[2] Basic Patent Claiming the Product, i.e., the Active Ingredient(s), but Not the Corresponding Authorized Medicinal Product (or Plant Protection Product)
[3] Requirement for the Product to Constitute 'the Invention' of the Basic Patent
[4] Criteria for Choosing the Basic Patent among Various Available Patents
[C] The Marketing Authorization Forming Basis for an SPC
[1] Combinations of Active Ingredients
[a] The Marketing Authorization Refers to Fewer Active Ingredients than the SPC Application
[b] The Marketing Authorization Refers to More Active Ingredients than the SPC Application
[c] The Marketing Authorization Indicates That a Medicinal Product Containing a Single Active Ingredient Is Authorized for Use in Combination with a Further Active Ingredient
[2] The Marketing Authorization Has Not Yet Been Granted at the Time the SPC Application Is Filed
[3] The Holder of the Marketing Authorization
[4] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Medicinal Products
[5] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Plant Protection Products
[6] The Product in Question Is Contained in the Authorized Medicinal Product (or the Authorized Plant Protection Product) but Is Not Identified as an Active Ingredient in the Corresponding Marketing Authorization
[7] The Notion of the 'First' Marketing Authorization
[a] Marketing Authorization for a New Therapeutic Application of a Previously Authorized Product
[b] Marketing Authorization for a New Formulation of a Previously Authorized Product
[c] Marketing Authorization for a New Specific Salt, Ester or Other Derivative of a Previously Authorized Active Ingredient
[d] Marketing Authorization for a New Specific Enantiomer of an Active Ingredient Previously Authorized in Racemic Form
[e] The Product Has Already Been Placed on the Market Before, but Without an Authorization Granted under Directive 2001/83/EC or Directive 2001/82/EC
[f] Prior Marketing Authorization Which Refers to Fewer Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[g] Prior Marketing Authorization Which Refers to More Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[D] Preclusion of New SPCs by an Earlier SPC
[1] The 'One SPC per Product per Patent Holder' Rule
[2] Consequences of an Earlier Third-Party SPC for the Same Product
[a] Earlier SPC Granted to an Affiliated Third Party
[b] Partial Overlap Between the Holders of the Earlier SPC and the Applicants for the New SPC
[c] Earlier Third-Party SPC Has Been Licensed-In
[3] Consequences of an Own Earlier SPC for the Same Product
[a] Own Earlier SPC Application Not Yet Granted
[b] Revocation, Surrender or Lapse of the Own Earlier SPC after Grant
[c] Transfer of the Own Earlier SPC to a Third Party
[d] Acquisition of an SPC Granted to a Third Party
[4] Consequences of an Own Earlier SPC for a Different Product
[a] Required Distinction from the Product of the Own Earlier SPC
[b] Combinations of Active Ingredients
[c] New Therapeutic Applications of Previously Approved Active Ingredients
[d] SPCs for a Specific Salt, Ester or Other Derivative Where an Own Earlier SPC Has Already Been Granted for the Corresponding Active Ingredient
[e] SPCs for a Specific Enantiomer Where an Own Earlier SPC Has Already Been Granted for the Corresponding Racemate
[5] Grant of More than One SPC on the Basis of the Same Patent
§33.03 EXTENT OF PROTECTION AND ENFORCEMENT OF SPCS
[A] The Protection Conferred by an SPC
[B] The Scope of an SPC in Relation to Derivatives of an Active Ingredient
[1] The Relationship Between the Definition of the Active Ingredient(s) in an SPC and Its Scope of Protection
[C] Enforcement of an SPC
[D] The Manufacturing Waiver
§33.04 DETERMINATION OF THE SPC TERM
[A] The Calculation of the SPC Term
[1] The Relevant Marketing Authorization for the Term of an SPC
[2] The Expiration Date of an SPC
[B] Correction of the SPC Term
[C] The Term of a Paediatric Extension
§33.05 PROCEDURE OF FILING AN SPC APPLICATION
[A] Entitlement to an SPC Application
[B] The Time Limit for Filing an SPC Application
[C] The Filing of an SPC at the National Patent Office
[D] The Documentation Required for an SPC Application
[E] The Definition of the Product in an SPC Application
[F] SPC Examination Procedure and Appeal Procedure
[G] Publication of SPC Applications and Issued SPCs
[H] Renewal Fees
[I] Applications for a Paediatric Extension
§33.06 PROCEDURE OF INVALIDATING AN SPC
[A] Grounds for the Invalidation of an SPC
[B] The Filing of an Invalidation Suit
[C] Invalidation Procedure and the Corresponding Appeal Procedure
[D] The Revocation of a Paediatric Extension
§33.07 UNFAIR COMPETITION LAW
CHAPTER 34 Sweden
§34.01 LEGAL BASIS
§34.02 SUBSTANTIVE REQUIREMENTS FOR OBTAINING AN SPC
[A] Types of Products That Can Be Protected
[1] Practical Considerations: What Is the Active Ingredient or Combination of Active Ingredients That Can Form the Basis for an SPC?
[2] Active Ingredient or Combination of Active Ingredients of a Medicinal Product
[3] Active Substance or Combination of Active Substances of a Plant Protection Product
[4] Fixed-Dose and Loose Combinations
[5] Limitation to Products Subjected to a Specific Marketing Authorization Procedure
[B] Basic Patent
[1] Requirement for the Product to Be 'Protected' by the Basic Patent
[a] Small Molecules
[b] Polymers
[c] Antibodies, Enzymes and Other Proteins
[d] Nucleic Acids
[2] Basic Patent Claiming the Product, i.e., the Active Ingredient(s), but Not the Corresponding Authorized Medicinal Product (or Plant Protection Product)
[3] Requirement for the Product to Constitute 'the Invention' of the Basic Patent
[4] Criteria for Choosing the Basic Patent among Various Available Patents
[C] The Marketing Authorization Forming Basis for an SPC
[1] Combinations of Active Ingredients
[a] The Marketing Authorization Refers to Fewer Active Ingredients than the SPC Application
[b] The Marketing Authorization Refers to More Active Ingredients than the SPC Application
[c] The Marketing Authorization Indicates That a Medicinal Product Containing a Single Active Ingredient Is Authorized for Use in Combination with a Further Active Ingredient
[2] The Marketing Authorization Has Not Yet Been Granted at the Time the SPC Application Is Filed
[3] The Holder of the Marketing Authorization
[4] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Medicinal Products
[5] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Plant Protection Products
[6] The Product in Question Is Contained in the Authorized Medicinal Product (or the Authorized Plant Protection Product) but Is Not Identified as an Active Ingredient in the Corresponding Marketing Authorization
[7] The Notion of the 'First' Marketing Authorization
[a] Marketing Authorization for a New Therapeutic Application of a Previously Authorized Product
[b] Marketing Authorization for a New Formulation of a Previously Authorized Product
[c] Marketing Authorization for a New Specific Salt, Ester or Other Derivative of a Previously Authorized Active Ingredient
[d] Marketing Authorization for a New Specific Enantiomer of an Active Ingredient Previously Authorized in Racemic Form
[e] The Product Has Already Been Placed on the Market Before, but Without an Authorization Granted under Directive 2001/83/EC or Directive 2001/82/EC
[f] Prior Marketing Authorization Which Refers to Fewer Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[g] Prior Marketing Authorization Which Refers to More Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[D] Preclusion of New SPCs by an Earlier SPC
[1] The 'One SPC per Product per Patent Holder' Rule
[2] Consequences of an Earlier Third-Party SPC for the Same Product
[a] Earlier SPC Granted to an Affiliated Third Party
[b] Partial Overlap Between the Holders of the Earlier SPC and the Applicants for the New SPC
[c] Earlier Third-Party SPC Has Been Licensed-In
[3] Consequences of an Own Earlier SPC for the Same Product
[a] Own Earlier SPC Application Not Yet Granted
[b] Revocation, Surrender or Lapse of the Own Earlier SPC after Grant
[c] Transfer of the Own Earlier SPC to a Third Party
[d] Acquisition of an SPC Granted to a Third Party
[4] Consequences of an Own Earlier SPC for a Different Product
[a] Required Distinction from the Product of the Own Earlier SPC
[b] Combinations of Active Ingredients
[c] New Therapeutic Applications of Previously Approved Active Ingredients
[d] SPCs for a Specific Salt, Ester or Other Derivative Where an Own Earlier SPC Has Already Been Granted for the Corresponding Active Ingredient
[e] SPCs for a Specific Enantiomer Where an Own Earlier SPC Has Already Been Granted for the Corresponding Racemate
[5] Grant of More than One SPC on the Basis of the Same Patent
§34.03 EXTENT OF PROTECTION AND ENFORCEMENT OF SPCS
[A] The Protection Conferred by an SPC
[B] The Scope of an SPC in Relation to Derivatives of an Active Ingredient
[1] The Relationship Between the Definition of the Active Ingredient(s) in an SPC and Its Scope of Protection
[C] Enforcement of an SPC
[D] The Manufacturing Waiver
§34.04 DETERMINATION OF THE SPC TERM
[A] The Calculation of the SPC Term
[1] The Relevant Marketing Authorization for the Term of an SPC
[2] The Expiration Date of an SPC
[B] Correction of the SPC Term
[C] The Term of a Paediatric Extension
§34.05 PROCEDURE OF FILING AN SPC APPLICATION
[A] Entitlement to an SPC Application
[B] The Time Limit for Filing an SPC Application
[C] The Filing of an SPC at the National Patent Office
[D] The Documentation Required for an SPC Application
[E] The Definition of the Product in an SPC Application
[F] SPC Examination Procedure and Appeal Procedure
[G] Publication of SPC Applications and Issued SPCs
[H] Renewal Fees
[I] Applications for a Paediatric Extension
§34.06 PROCEDURE OF INVALIDATING AN SPC
[A] Grounds for the Invalidation of an SPC
[B] The Filing of an Invalidation Suit
[C] Invalidation Procedure and the Corresponding Appeal Procedure
[D] The Revocation of a Paediatric Extension
§34.07 UNFAIR COMPETITION LAW
CHAPTER 35 Switzerland
§35.01 LEGAL BASIS
§35.02 SUBSTANTIVE REQUIREMENTS FOR OBTAINING AN SPC
[A] Types of Products That Can Be Protected
[1] Practical Considerations: What Is the Active Ingredient or Combination of Active Ingredients That Can Form the Basis for an SPC?
[2] Active Ingredient or Combination of Active Ingredients of a Medicinal Product
[3] Active Substance or Combination of Active Substances of a Plant Protection Product
[4] Fixed-Dose and Loose Combinations
[5] Limitation to Products Subjected to a Specific Marketing Authorization Procedure
[B] Basic Patent
[1] Requirement for the Product to Be 'Protected' by the Basic Patent
[a] Small Molecules
[b] Polymers
[c] Antibodies, Enzymes and Other Proteins
[d] Nucleic Acids
[2] Basic Patent Claiming the Product, i.e., the Active Ingredient(s), but Not the Corresponding Authorized Medicinal Product (or Plant Protection Product)
[3] Requirement for the Product to Constitute 'the Invention' of the Basic Patent
[4] Criteria for Choosing the Basic Patent among Various Available Patents
[C] The Marketing Authorization Forming Basis for an SPC
[1] Combinations of Active Ingredients
[a] The Marketing Authorization Refers to Fewer Active Ingredients than the SPC Application
[b] The Marketing Authorization Refers to More Active Ingredients than the SPC Application
[c] The Marketing Authorization Indicates That a Medicinal Product Containing a Single Active Ingredient Is Authorized for Use in Combination with a Further Active Ingredient
[2] The Marketing Authorization Has Not Yet Been Granted at the Time the SPC Application Is Filed
[3] The Holder of the Marketing Authorization
[4] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Medicinal Products
[5] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Plant Protection Products
[6] The Product in Question Is Contained in the Authorized Medicinal Product (or the Authorized Plant Protection Product) but Is Not Identified as an Active Ingredient in the Corresponding Marketing Authorization
[7] The Notion of the 'First' Marketing Authorization
[a] Marketing Authorization for a New Therapeutic Application of a Previously Authorized Product
[b] Marketing Authorization for a New Formulation of a Previously Authorized Product
[c] Marketing Authorization for a New Specific Salt, Ester or Other Derivative of a Previously Authorized Active Ingredient
[d] Marketing Authorization for a New Specific Enantiomer of an Active Ingredient Previously Authorized in Racemic Form
[e] The Product Has Already Been Placed on the Market Before, but Without an Authorization Granted under Directive 2001/83/EC or Directive 2001/82/EC
[f] Prior Marketing Authorization Which Refers to Fewer Active Ingredients than The SPC Application (and the Later Marketing Authorization Relied upon)
[g] Prior Marketing Authorization Which Refers to More Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[D] Preclusion of New SPCs by an Earlier SPC
[1] The 'One SPC per Product per Patent Holder' Rule
[2] Consequences of an Earlier Third-Party SPC for the Same Product
[a] Earlier SPC Granted to an Affiliated Third Party
[b] Partial Overlap Between the Holders of the Earlier SPC and the Applicants for the New SPC
[c] Earlier Third-Party SPC Has Been Licensed-In
[3] Consequences of an Own Earlier SPC for the Same Product
[a] Own Earlier SPC Application Not Yet Granted
[b] Revocation, Surrender or Lapse of the Own Earlier SPC after Grant
[c] Transfer of the Own Earlier SPC to a Third Party
[d] Acquisition of an SPC Granted to a Third Party
[4] Consequences of an Own Earlier SPC for a Different Product
[a] Required Distinction from the Product of the Own Earlier SPC
[b] Combinations of Active Ingredients
[c] New Therapeutic Applications of Previously Approved Active Ingredients
[d] SPCs for a Specific Salt, Ester or Other Derivative Where an Own Earlier SPC Has Already Been Granted for the Corresponding Active Ingredient
[e] SPCs for a Specific Enantiomer Where an Own Earlier SPC Has Already Been Granted for the Corresponding Racemate
[5] Grant of More than One SPC on the Basis of the Same Patent
§35.03 EXTENT OF PROTECTION AND ENFORCEMENT OF SPCS
[A] The Protection Conferred by an SPC
[B] The Scope of an SPC in Relation to Derivatives of an Active Ingredient
[1] The Relationship Between the Definition of the Active Ingredient(s) in an SPC and Its Scope of Protection
[C] Enforcement of an SPC
[D] The Manufacturing Waiver
§35.04 DETERMINATION OF THE SPC TERM
[A] The Calculation of the SPC Term
[1] The Relevant Marketing Authorization for the Term of an SPC
[2] The Expiration Date of an SPC
[B] Correction of the SPC Term
[C] The Term of a Paediatric Extension
§35.05 PROCEDURE OF FILING AN SPC APPLICATION
[A] Entitlement to an SPC Application
[B] The Time Limit for Filing an SPC Application
[C] The Filing of an SPC at the National Patent Office
[D] The Documentation Required for an SPC Application
[E] The Definition of the Product in an SPC Application
[F] SPC Examination Procedure and Appeal Procedure
[G] Publication of SPC Applications and Issued SPCs
[H] Renewal Fees
[I] Applications for a Paediatric Extension
§35.06 PROCEDURE OF INVALIDATING AN SPC
[A] Grounds for the Invalidation of an SPC
[B] The Filing of an Invalidation Suit
[C] Invalidation Procedure and the Corresponding Appeal Procedure
[D] The Revocation of a Paediatric Extension
§35.07 UNFAIR COMPETITION LAW
CHAPTER 36 United Kingdom
§36.01 LEGAL BASIS
§36.02 SUBSTANTIVE REQUIREMENTS FOR OBTAINING AN SPC
[A] Types of Products That Can Be Protected
[1] Practical Considerations: What Is the Active Ingredient or Combination of Active Ingredients That Can Form the Basis for an SPC?
[2] Active Ingredient or Combination of Active Ingredients of a Medicinal Product
[3] Active Substance or Combination of Active Substances of a Plant Protection Product
[4] Fixed-Dose and Loose Combinations
[5] Limitation to Products Subjected to a Specific Marketing Authorization Procedure
[B] Basic Patent
[1] Requirement for the Product to Be 'Protected' by the Basic Patent
[a] Small Molecules
[b] Polymers
[c] Antibodies, Enzymes and Other Proteins
[d] Nucleic Acids
[2] Basic Patent Claiming the Product, i.e., the Active Ingredient(s), but Not the Corresponding Authorized Medicinal Product (or Plant Protection Product)
[3] Requirement for the Product to Constitute 'the Invention' of the Basic Patent
[4] Criteria for Choosing the Basic Patent among Various Available Patents
[C] The Marketing Authorization Forming Basis for an SPC
[1] Combinations of Active Ingredients
[a] The Marketing Authorization Refers to Fewer Active Ingredients than the SPC Application
[b] The Marketing Authorization Refers to More Active Ingredients than the SPC Application
[c] The Marketing Authorization Indicates That a Medicinal Product Containing a Single Active Ingredient Is Authorized for Use in Combination with a Further Active Ingredient
[2] The Marketing Authorization Has Not Yet Been Granted at the Time the SPC Application Is Filed
[3] The Holder of the Marketing Authorization
[4] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Medicinal Products
[5] The Marketing Authorizations Which Can Be Relied upon for SPC Applications for Plant Protection Products
[6] The Product in Question Is Contained in the Authorized Medicinal Product (or the Authorized Plant Protection Product) but Is Not Identified as an Active Ingredient in the Corresponding Marketing Authorization
[7] The Notion of the 'First' Marketing Authorization
[a] Marketing Authorization for a New Therapeutic Application of a Previously Authorized Product
[b] Marketing Authorization for a New Formulation of a Previously Authorized Product
[c] Marketing Authorization for a New Specific Salt, Ester or Other Derivative of a Previously Authorized Active Ingredient
[d] Marketing Authorization for a New Specific Enantiomer of an Active Ingredient Previously Authorized in Racemic Form
[e] The Product Has Already Been Placed on the Market Before, but Without an Authorization Granted under Directive 2001/83/EC or Directive 2001/82/EC
[f] Prior Marketing Authorization Which Refers to Fewer Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[g] Prior Marketing Authorization Which Refers to More Active Ingredients than the SPC Application (and the Later Marketing Authorization Relied upon)
[D] Preclusion of New SPCs by an Earlier SPC
[1] The 'One SPC per Product per Patent Holder' Rule
[2] Consequences of an Earlier Third-Party SPC for the Same Product
[a] Earlier SPC Granted to an Affiliated Third Party
[b] Partial Overlap Between the Holders of the Earlier SPC and the Applicants for the New SPC
[c] Earlier Third-Party SPC Has Been Licensed-In
[3] Consequences of an Own Earlier SPC for the Same Product
[a] Own Earlier SPC Application Not Yet Granted
[b] Revocation, Surrender or Lapse of the Own Earlier SPC after Grant
[c] Transfer of the Own Earlier SPC to a Third Party
[d] Acquisition of an SPC Granted to a Third Party
[4] Consequences of an Own Earlier SPC for a Different Product
[a] Required Distinction from the Product of the Own Earlier SPC
[b] Combinations of Active Ingredients
[c] New Therapeutic Applications of Previously Approved Active Ingredients
[d] SPCs for a Specific Salt, Ester or Other Derivative Where an Own Earlier SPC Has Already Been Granted for the Corresponding Active Ingredient
[e] SPCs for a Specific Enantiomer Where an Own Earlier SPC Has Already Been Granted for the Corresponding Racemate
[5] Grant of More than One SPC on the Basis of the Same Patent
§36.03 EXTENT OF PROTECTION AND ENFORCEMENT OF SPCS
[A] The Protection Conferred by an SPC
[B] The Scope of an SPC in Relation to Derivatives of an Active Ingredient
[1] The Relationship Between the Definition of the Active Ingredient(s) in an SPC and Its Scope of Protection
[C] Enforcement of an SPC
[D] The Manufacturing Waiver
§36.04 DETERMINATION OF THE SPC TERM
[A] The Calculation of the SPC Term
[1] The Relevant Marketing Authorization for the Term of an SPC
[2] The Expiration Date of an SPC
[B] Correction of the SPC Term
[C] The Term of a Paediatric Extension
§36.05 PROCEDURE OF FILING AN SPC APPLICATION
[A] Entitlement to an SPC Application
[B] The Time Limit for Filing an SPC Application
[C] The Filing of an SPC at the National Patent Office
[D] The Documentation Required for an SPC Application
[E] The Definition of the Product in an SPC Application
[F] SPC Examination Procedure and Appeal Procedure
[G] Publication of SPC Applications and Issued SPCs
[H] Renewal Fees
[I] Applications for a Paediatric Extension
§36.06 PROCEDURE OF INVALIDATING AN SPC
[A] Grounds for the Invalidation of an SPC
[B] The Filing of an Invalidation Suit
[C] Invalidation Procedure and the Corresponding Appeal Procedure
[D] The Revocation of a Paediatric Extension
§36.07 UNFAIR COMPETITION LAW
Appendices
Appendix I Legal Text of Regulation (EC) 469/2009 on SPCs for Medicinal Products
Appendix II Legal Text of Regulation (EC) 1610/96 on SPCs for Plant Protection Products
Appendix III Excerpt of Regulation (EC) 1901/2006 on Medicinal Products for Paediatric Use
Appendix IV The Specific Mechanism for Parallel Imports of Pharmaceuticals from the New EU Member States
Appendix V Excerpt of the EEA Agreement - Annex XVII (Intellectual Property)
Table of Cases

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