TRIPS and Access to Medicines

Name: TRIPS and Access to Medicines | Pharmaceutical Patents and the Experience of Brazil
Brand: Kluwer Law International
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Pharmaceutical Patents and the Experience of Brazil

Renata Curzel(Autor*in)

Kluwer Law International (Verlag)

Erschienen am 10. Dezember 2020

384 Seiten

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Beschreibung

Although ideally a patent system for pharmaceuticals should serve to incentivize research into the development of new medicines, the COVID-19 pandemic has exposed the equal importance of drug access and affordability. This book, by focusing on the Brazilian rule which makes the grant of pharmaceutical patents dependent on the prior consent of the National Health Surveillance Agency (ANVISA), shows how the Brazilian model affords an example for other countries to follow in dealing with tensions between patent protection and the right to healthcare. Based on an empirical study in which the author examined 147 reports issued by ANVISA as a basis for its decisions, the book deals with such central questions concerning the interface of regulation and innovation in the patent system as the following: compatibility between ANVISA's prior consent mechanism and the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement; how ';evergreening' and ';trivial patents' undermine public health and access to medicines; ways of correcting abuses of patent rights and controlling quality of patents; and the discourse on health as a human right. Along with her examination of ANVISA reports, the author analyzes how Article 229-C LPI, which introduced the need of ANVISA's prior consent to the patent grant of pharmaceuticals in Brazil, has been interpreted in Brazilian case law. Interviews with Brazilian experts are also included. In its commitment to harmonizing patent rights and the right to access of affordable medicines, Brazil's patent system for pharmaceuticals stands out as a workable response to the basic problem of access to medicines in the developing world. By describing the successes and failures in the Brazilian policy of promoting drug access, this book helps policymakers in developing and emerging countries to better explore TRIPS flexibilities when dealing with similar problems, and provides practitioners in the law of the World Trade Organization, patent law, competition law, and health law with a guide to how a more equitable pharmaceutical patenting system could work in practice.

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Inhalt

Intro
Half-Title Page
Title Page
Copyright Page
Table of Contents
List of Abbreviations
List of Tables
Acknowledgments
Chapter 1 Introduction
Chapter 2 The Case of Patents and Drugs
A Patent Protection and Drug Development
I Why Patent Protection?
1 Background Information
1.1 Introduction
1.2 Short History of Patent Protection
1.3 Rationales of Patent Protection
1.3.1 Noneconomic Justifications for the Patent System
1.3.1.1 The "Natural-Law" or "Property" Thesis
1.3.1.2 The "Reward-by-Monopoly" Thesis
1.3.2 Economic Justifications for the Patent System
1.3.2.1 The "Exchange for Secret" Thesis
1.3.2.2 The "Incentive to Invent/Innovate" Thesis
1.3.3 Do Patents Really Promote Innovation?
2 Economic Consequences of the Patent Monopoly
2.1 The So-Called Paradox of Patents
2.2 Benefits of Patent Protection
2.3 Social Costs of Patent Protection
2.4 Some Distortions of the Patent System
2.4.1 "Leveraging Monopoly Power"
2.4.2 "Strategic Patenting"
2.4.3 "Patent Thickets"
2.4.4 Disparity Between Contribution and Return
2.4.4.1 The Contribution of Having Been the First
2.4.4.2 "Enclosing the Commons"
2.5 Benefits and Costs for Developing Countries
3 The Special Case of Pharmaceutical Patents
3.1 Legal Treatment of Pharmaceutical Patents in Some Industrialized Nations
3.1.1 The United States
3.1.2 Western European Countries
3.2 Legal Treatment of Pharmaceutical Patents in Developing Countries
3.3 Importance of Patent Protection for Pharmaceutical Products
4 Justifying Patents Today
II Protecting and Promoting Public Health
1 Drugs and Public Health
2 Protecting Public Health by Regulating the Efficacy and Safety of Drugs
2.1 Short History of the Pharmacovigilance System
2.2 Principles
2.3 Drug Development Process
3 Promoting Public Health by Expanding Access to Medicines
4 Relationship Between Patent Protection and Public Health
III How Distortions of the Patent System May Affect Public Health and Access to Medicines
1 Setting the Problem in Context
2 Some Concepts
2.1 Evergreening of Patents (Secondary or Follow-On Patents)
2.2 "Patent Thickets" or "Patent Clusters"
2.3 "Trivial Patents"
3 Practices That Indicate "Evergreening" in the Pharmaceutical Field
3.1 Obtaining Multiple Patenting Regarding the Same Product
3.1.1 Swiss-Type Patent Claims
3.1.1.1 Option One and Two: Product Claims over the Drug/ and or Active Chemicals
3.1.1.2 Option Three: Use Claim over the Use of the Drug ("Use of Known Substance X for New Purpose Y")
3.1.1.3 Option Four: Use Claim over the Use of the Active Chemicals (Swiss-Type Claim)
3.1.2 Selection Patents or Selection Inventions
3.1.3 Pharmacologically Active Metabolites
3.1.4 Isomeric Forms
3.1.5 Polymorphs (Crystalline Forms)
3.1.6 Process Patents
3.1.7 Novel Therapeutic Indications in Connection with "Patent Linkage"
3.1.8 Novel Dosage Regimes
3.1.9 Combination Therapies
3.2 Abuse of the Right to Litigation
4 Consequences of the Abuse of Patent Rights
IV Ways of Correcting Abuses and Controlling Quality of Patents
1 Introduction
2 Instruments Within Patent Law
2.1 Instruments Concerning Quality of Patents
2.1.1 Patent Examination System
2.1.2 Patent Opposition System
2.2 Instruments Concerning Public or National Interest
2.2.1 Compulsory Licensing
2.2.2 Voluntary Licensing
2.2.3 Forfeiture of Patents
3 New Developments: Searching for Instruments Outside Patent Law in Order to Deal with Patent Law Problems
3.1 Compulsory Licenses of Patents Issued on the Basis of a Violation of Competition Law
3.2 Identifying Misuse of Patent Rights and Other Strategies: The EU Pharma Sector Inquiry
3.3 A Peculiar Legal Instrument: ANVISA's Prior Consent (Anuência Prévia)
4 Conclusion
B International Law, Public Health and Patents
I International Law: The Discourse on Health as a Human Right and the TRIPS Agreement
II International Patent Law and Minimum Standards of Patent Protection Imposed by the TRIPS Agreement
1 Introductory Remarks
2 International Patent Law Before 1996
2.1 Right to National Treatment (Articles 2-3 PC)
2.2 Right of Priority (Article 4 PC)
2.3 Independence of Patents (Article 4bis PC)
3 International Patent Law and the International Trade System Before the WTO's Foundation
3.1 International Trade Law System (1947-1994)
3.1.1 Principles of GATT 1947
3.1.2 General Exceptions to the Non-discrimination Rule (Article XX GATT)
3.1.3 Treaties Other Than the GATT
3.2 The GATT Uruguay Round (1986-1994)
3.2.1 Introducing Intellectual Property Rights onto the GATT Agenda
3.2.2 TRIPS Negotiations
3.2.2.1 Controversy Concerning Transitional Periods
3.2.2.2 The Special Case of the "Mailbox" Provision (Article 70.8 TRIPS) and Its Respective "Exclusive Marketing Rights" (Article 70.9 TRIPS) as a Compromise Solution for the Rejected "Pipeline" Protection
3.2.3 The Results: The "Grand Bargain"
4 Objectives and Principles of the TRIPS Agreement
4.1 Preamble
4.2 Promotion of Technological Innovation Versus Transfer and Dissemination of Technology (Article 7 TRIPS)
4.3 Principles Invoked to Protect Public Health and Nutrition and to Deal with the Abuse of Intellectual Property Rights
5 Overview of the Provisions on Patents in the TRIPS Agreement
5.1 Availability of Patents for Any Inventions, Whether Products or Processes, in All Fields of Technology
5.2 Conditions of Patentability
5.3 Nondiscrimination (Article 27.1 TRIPS)
5.3.1 Discrimination as to the Place of the Invention
5.3.2 Discrimination as to the Field of Technology
5.3.3 Discrimination as to Whether Products Are Imported or Locally Produced
5.3.4 Exceptions to the Principle of Nondiscrimination
5.3.4.1 Transitional Periods (Article 65.4 TRIPS)
5.3.4.2 Mailbox (Article 70.8 TRIPS)
5.3.4.3 Other Exceptions
5.3.5 Significance of Article 27.1
5.4 Patent Rights Conferred by TRIPS (Article 28)
5.5 Conditions on Patent Applicants (Article 29)
5.6 Revocation/Forfeiture (Article 32)
5.7 Minimum 20 Years' Protection (Article 33)
5.8 Process Patents (Article 34)
III Flexibilities of Patent Rights under the TRIPS Agreement
1 Introductory Remarks
2 Flexibilities
2.1 Parallel Imports
2.2 Exclusion from Patentability (Article 27.2 and 27.3 TRIPS)
2.2.1 Conditional Exclusion of Patentability on the Grounds of Ordre Public, Morality or Protection of Public Health
2.2.2 Cases of Unconditional Exclusion of Patentability (Article 27.3 TRIPS)
2.2.2.1 Methods of Medical Treatment (Article 27.3.a TRIPS)
2.2.2.2 Biotechnological Clause (Article 27.3.b TRIPS)
2.2.3 Implicit Cases of Exclusion of Patentability
2.3 General Exceptions to Rights Conferred by Patents
2.4 Compulsory License (Article 31 TRIPS)
2.5 The Doha Declaration
2.5.1 Negotiating History
2.5.2 The Substantive Provisions of the Declaration on the TRIPS Agreement and Public Health (Doha Declaration)
2.5.3 Legal Status and Effects of the Doha Declaration
2.6 Special Compulsory License System (Article 31bis TRIPS)
2.7 Right to Delay Implementation (Article 65 TRIPS)
IV Post-TRIPs Demands, TRIPS-Plus Provisions and the Developing Countries' Right to Use Flexibilities
C The Brazilian Health Innovation System
I National Systems of Innovation
II Brazilian National Health System of Innovation
1 Country Overview
2 The Pharmaceutical Industry in Brazil
2.1 Historical Development
2.2 Market Overview
2.3 Research and Development
3 Pharmaceutical Production Policies
4 The Role of the Brazilian Universities
5 The Main Characteristics of the Brazilian Health Innovation System
D ANVISA'S Prior Consent and the WTO
I Relevant Interpretative Rules Contained in the TRIPS Agreement
1 Preamble
2 Nature and Scope of Obligations (Article 1 TRIPS)
3 Objectives (Article 7 TRIPS)
4 Principles (Article 8 TRIPS)
5 The Doha Declaration
II Relevant Interpretative Rules Outside the TRIPS Agreement
1 The WTO Dispute Settlement Understanding
2 The Vienna Convention on the Law of the Treaties
2.1 General Rule of Interpretation (Article 31 VCLT)
2.1.1 Good Faith
2.1.2 Ordinary Meaning
2.1.3 Context, Object and Purpose
2.2 Supplementary Means of Interpretation (Article 32 VCLT)
III The Meaning of Article 27.1 TRIPS and the Question of the Compatibility of Article 229-C Brazilian Patent Law With It
1 Meaning of Article 27.1 TRIPS, First Sentence
2 Meaning of Discrimination in Article 27.1 TRIPS, Second Sentence
3 Conclusion: Compatibility of Article 229-C LPI with Article 27.1 TRIPS
Chapter 3 The Case of Patents and Drugs in Brazil
A Why Was It Necessary to Create Prior Consent in Brazil?
I Development of Brazilian Patent Law
1 National Patent Law Before TRIPS
1.1 Historical Development
1.2 Legal Treatment of Pharmaceutical Patents
2 Negotiating History of the New Patent Act (1990-1996)
2.1 Câmara dos Deputados (1991-1993)
2.2 SF (1993-1996)
3 National Patent Law Post-TRIPS
3.1 The Problem of the (In) Direct Applicability (Self-Executing) of TRIPS in Brazil
3.2 The New Industrial Property Law (LPI 96)
3.2.1 What Is an "Invention" According to the New Legal Framework?
3.2.1.1 General Rule
3.2.1.2 General Exclusions from the Concept of Invention
3.2.2 General Exceptions to Patentability (Article 18 LPI)
3.2.2.1 Inventions Against Morality, Good Morals, Security, Ordre Public and Public Health
3.2.2.2 Inventions Resulting from the Transformation of the Atomic Nucleus
3.2.2.3 Living Beings
3.2.3 Provisions Particularly Relevant for Pharmaceutical Inventions
3.2.3.1 Transitional Patent Protection for Pharmaceuticals, Chemical and Alimentary Products and Processes
3.2.3.2 Compulsory Licensing (Articles 68-71 LPI)
3.2.3.3 Exceptions to Rights Conferred by a Patent
3.2.3.4 Minimum 10-Years' Term of Patent Protection after Patent Grant
3.3 Important Topics That the LPI 96 Does Not Deal With
II Patent Grant Proceedings
1 Basic Principles of Administrative Law in Brazil
2 Brazilian Judicial System
3 Ordinary Patent Proceedings
3.1 First Administrative Instance
3.2 Second Administrative Instance
3.3 No Provision for Opposition Proceedings
III The LPI 96: A "TRIPS-Plus" Patent Law
IV The Brazilian Policy on Access to Medicines
1 Public Health System (SUS)
2 The Constitutional Right to Health and the Court's Understanding of the Right to Access Medicine
3 AIDS in Brazil
3.1 History and Development of AIDS/HIV in Brazil
3.2 Brazilian National AIDS/HIV Program
4 National Medicines Policy
4.1 Reforming the Public Health Surveillance System: The Creation of the National Health Surveillance Agency (ANVISA)
4.2 Expanding Access to Medicines
4.2.1 Adoption of a List of "Essential" and "Strategic" Medicines
4.2.2 Generic Medicines
5 Controlling Prices
6 Using Compulsory Licensing on the Grounds of Public Health
6.1 Field of Coverage of Decree 3.201
6.2 Cases of National Emergency and Public Interest
6.3 Competent Authority
6.4 Proceedings
6.5 Requirements of the Compulsory License Grants Act
6.6 Threats to Grant Compulsory Licenses as Part of the Medicines Policy (1999-2007)
6.7 The Efavirenz Case: The First and So Far, Only Brazilian Compulsory License on the Grounds of Public Health
V Reasons for Creating ANVISA's Prior Consent
1 Clash Between the New Patent Policy and the National Medicines Policy
2 Discontentment with the INPI's Performance
VI Conclusion
B Contents of the Amendment to the Patent Law (Law 10.196/2001)
I Legislative History
II Content of the Reform
1 Limiting the Possibility of the LPI's Retroactivity (Article 229 LPI)
2 Introduction of Article 229 Parágrafo Único LPI (Mailbox Provision-Article 70.8 TRIPS)
3 Introduction of Article 229-A LPI
4 Introduction of Article 229-B LPI
5 Creating ANVISA's Anuência Prévia (Article 229-C LPI) and Its Purpose
6 Giving the INPI More Structure (Article 2 MP)
7 Introducing the Regulatory Exception ("Early Working")
III Repercussions
IV Conclusion
C The Implementation of ANVISA's Prior Consent Procedure
I Historical Development
1 The First Period (2001-2003): Confusing Times
2 The Second Period (2003-2012): Rivalry's Times Between ANVISA and the INPI
II The GTI's Suggestions to Solve the Conflict Between the INPI and ANVISA
III Reaction of ANVISA
IV Controversy on the Applicability of Article 229-C in the Brazilian Jurisprudence
1 Report of Judgments
1.1 Valganciclovir (Valcyte) Case
1.2 Docetaxel Case
1.3 Penciclovir Case
1.4 Leishmaniasis Case
1.5 Isobutylgaba Case
1.6 Gleevec Case
1.7 Gilead Case
2 Evaluation
D ANVISA's Examination: What Does It Check and According to Which Criteria?
I The Empirical Study
1 Method and Content
2 Cases Decided under the Old Workflow
2.1 Criteria Used by ANVISA
2.1.1 Correction of Translation and Formal Mistakes
2.1.2 State of the Art, Lack of Novelty
2.1.3 Therapeutic and Surgical Methods
2.1.4 State of the Art, Lack of Inventive Step
2.1.5 Lack of Sufficient Description of the Invention/Scope of the Invention Too Broad
2.1.6 Selection Inventions (Lack of Inventive Step and Novelty)
2.1.7 Second Medical Indication
2.1.8 Living Beings
2.1.9 Former Patent Law
2.1.10 Formal Procedural Criteria of the Patent Law
2.1.11 Prior Consent Given after Hearing the Applicant
2.2 Standard of ANVISA's Technical Reports
2.3 Interpreting the Findings
3 Cases Decided under the GTI's Workflow
3.1 Criteria Used by ANVISA to Deny Prior Consent
3.1.1 "Risk to Health"
3.1.2 Invention Considered to Be of Interest to Medicines Policies
3.1.2.1 Lack of Novelty
3.1.2.2 Lack of an Inventive Step
3.1.2.3 Therapeutic Method
3.1.2.4 Living Beings
3.1.2.5 Insufficient or Imprecise Description
3.1.2.6 Claim Too Broad
3.1.2.7 Presentation of Information
3.2 Standard of ANVISA's Examination under the GTI's Workflow
3.3 Interpreting the Findings
II How Often Has ANVISA Denied Prior Consent?
1 From 2001 to 2010
2 From June 2012 to July 2016
III How Effectively Has ANVISA Influenced the Granting of Patents for Medicines and Has Improved Access to Medicines?
1 Period under the Old Workflow (1999-2012)
2 Period under the GTI's Workflow (June 2012-July 2016)
3 Concluding Remarks
IV Managing the Dispute Between ANVISA and the INPI
1 Why Was There a Lack of Cooperation Between ANVISA and the INPI for Such a Long Period?
2 The 2017 Solution: ANVISA's Veto Power Comes to an End
Chapter 4 Integrating Pharmacological Superior Expertise in the Patent Examination for Public Health Policies Interests
A Critique of the 2017 Solution
B How Article 229-C LPI Has Been Interpreted
I Patent Community's View: ANVISA as Controller of the Granting of Pipeline Patents
II ANVISA's Interpretation of Article 229-C LPI: Acting as an Ordinary Patent Division
III ANVISA as an Instance of "Public Health" Within the Meaning of Article 18, I LPI (2017 Solution)
C The Author's Viewpoint
I Examination of the Patentability's Requirements as the Chore of ANVISA's Prior Consent
II What Does Differ ANVISA's Report from the INPI's and What Is the Use of It?
1 Finding the Right Balance Between Innovation Policy and Health Policy
2 Pharmacological Expert Knowledge
3 INPI Versus ANVISA: A Conflict Within the Patent Community?
3.1 The Conception of "Epistemic Community" and "Legal Epistemic Community"
3.2 The Conflict INPI Versus ANVISA as a Conflict Between Two Different Patent Communities
3.3 Consequences
4 The Regulatory Function of Patents
III Conclusion: ANVISA's Prior Consent as a "Raising the Bar" Reform to the Patentability of Pharmaceutical Inventions in Benefit of Access Rights
Chapter 5 Lessons for the Future
Bibliography
Table of Cases
Personal Interviews
List of Cited ANVISA's Reports on Prior Consent Within Patent Proceedings at the INPI
Index

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