Patents as an Incentive for Innovation

Name: Patents as an Incentive for Innovation
Brand: Kluwer Law International
Price: 147.99 EUR
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Rafal Sikorski(Herausgeber*in)

Kluwer Law International (Verlag)

Erschienen am 16. Februar 2021

368 Seiten

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Beschreibung

Patents as an Incentive for Innovation Edited by Rafal Sikorski & Zaneta Zemla-Pacud Patents are a reward for human inventiveness. A well-functioning patent system must provide incentives for innovation, safeguard dynamic competition and protect the public interest a balancing act fraught with difficulty in the ';connected' global world. This ground-breaking book is the first to deeply analyse how patent law today performs its function of stimulating innovation in the crucial sectors of healthcare, agriculture, artificial intelligence and communications technology. Patent specialists, practitioners and scholars from various jurisdictions thoroughly describe how patent rights can be deployed to incentivize investments in researching and developing socially critical innovations without sacrificing the public's interest in sharing the benefits that are produced. Among the emerging issues of patent rights investigated are the following: protectability and morality of according private rights over material derived from the human body; licensing on fair, reasonable and non-discriminatory (FRAND) terms; the supplementary protection certificate (SPC) manufacturing waiver; patent eligibility of artificial intelligence-related inventions; excessive enforcement of patents by patent assertion entities; enforcement of second medical use innovations; the so-called farmer's privilege, the farm-save seed exemption, and breeders' rights; international trade regulations and their influence on patent systems; human enhancement technologies and the consequences of patenting them; specifics of patent protection for biologic medicines; challenges posed by artificial intelligence for the disclosure requirement in patent law; and standard essential patent licensing, particularly in the context of the 5G standard. Perspectives taken into consideration by the authors include protectability criteria, length and scope of the granted protection, mechanisms for dealing with the friction between generalized application and specialized concerns, and rights enforcement. These aspects are analysed on the domestic, international and global levels. The COVID-19 pandemic has highlighted the urgent need to strike the right balance between innovation and access in healthcare and other technologies, a need rooted in patent law. Because the problems discussed and solutions offered in this collection of expert essays are of tremendous practical and cultural significance, the book will be of immeasurable value to practitioners, policymakers and researchers in patent law and other fields of intellectual property law.

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Inhalt

Intro
Half-Title Page
Title Page
Copyright Page
Editors
Contributors
Summary of Contents
Table of Contents
Foreword: The Complex Terrain of Intellectual Property Governance
Introduction
Part I Patents and the Health Sector
Chapter 1 TRIPS and Post-TRIPS Trade Agreements and Their Impact on Innovation
1 Introduction
2 Trade as a Lever for More Extensive Protection Beyond the TRIPS Baseline
3 Post-TRIPS Flexibilities in Patent Law
3.1. Parallel Importing and TRIPS
3.2. The EU Manufacturing Waiver
4 Mounting Evidence That Multilateralism Is Preferable to FTAS for Innovation
Chapter 2 In Between Breakthrough and Incremental Innovation: Rethinking Pharmaceuticals' Eligibility for IP Protection
1 Introduction
2 Specifics of Pharmaceutical Innovation
2.1 Pharmaceutical Innovation in the EU Regulatory Legislation
2.2 Rationales for Incentivizing Primary and Secondary Innovation
3 Patents
4 Supplementary Protection Certificates
4.1 Purposes of the SPC System
4.2 SPC Eligibility
5 Regulatory Exclusivities
5.1 Pharmaceutical Regulatory Framework in the EU
5.2 Data and Market Protection for Reference Medicinal Products
5.3 Orphan Exclusivity
5.4 Paediatric Rewards
5.5 Paediatric Data and Market Exclusivity
6 Conclusions
Chapter 3 Human Enhancement and Patent Law
1 Introduction
2 The Concept of HE and HET
3 Patentability of HET
4 Should HET Be Considered an 'Ordinary' Invention?
5 Conclusions
Chapter 4 Do We Need Patent Protection for Biopharmaceuticals?
1 Introduction
2 Why Do Biopharmaceuticals Need to Be Legally Separated from Chemical (Small Molecule) Medicinal Products?
3 Categories of Biopharmaceuticals
4 Why Do We Need Patent Protection for Biopharmaceuticals?
5 Conclusions
Chapter 5 Changing Approach to the Regulatory Testing Exemption in Patent Law: The European Union Perspective
1 Introduction
2 Rationale for the Regulatory Testing Exemption: How Does It Impact Innovation?
3 The Regulatory Testing Exemption in the EU: An Overview
3.1 Article 10(6) of the Directive 2001/83/EC
3.2 An Overview of the EU Bolar Exemption under the Current National Legislations
3.3 An Overview of National Case Law
4 Key Tendencies in the Approach to the Regulatory Testing Exemption in the EU
4.1 The Regulatory Review Exemption Is Not Only Limited to the Abridged or Hybrid Procedure
4.2 Extending the Regulatory Review Exemption to Registering Medicinal Products Abroad
4.3 The Regulatory Testing Exemption Covers Third-Party Actions under the 'Practical Requirements'
4.4 The Regulatory Testing Exemption Includes Storage
5. Final Remarks
Chapter 6 Rethinking SPC Protection: Manufacturing Waiver as an Incentive for the Generic Sector or a Disincentive to Innovators?
1 Introduction
2 Towards Extending Patent Protection by SPC and Limiting It by Manufacturing Waiver
3 Derogation from Exclusivity: A Characteristic of the Manufacturing Waiver
4 Derogation from Exclusivity or Exemption from Conferred Rights?
5 Reviewing Arguments: A Chance of Increasing Competitiveness or Risk of Affecting Innovation?
Part II Patents and Plants
Chapter 7 Rethinking IP Protection for Plants? Revisiting the Exclusivity-Access Balance Through the Type-Token Ontology
1 Introduction
2 Plant Breeding Techniques
3 IP Protection Regimes
3.1 Plant Breeder's Rights
3.1.1 Eligible Subject Matter: Plant Varieties
3.1.2 Substantive Protection Criteria
3.1.3 Scope of Rights
3.2 Patents
3.2.1 Eligible Subject Matter: Plants
3.2.2 Substantive Protection Criteria
3.2.3 Scope of Rights
4 Looking at the Exclusivity/Access Balance Through the Type/Token Lens
4.1 Plant Breeder's Rights Law
4.2 Patent Law
5 Re-assessing the Exclusivity/Access Balance
6 Concluding Thoughts
Chapter 8 Non-patent Legal Factors of Marketability in Plant Biotechnology in Europe
1 Introduction
2 The Goal of Patent Protection
3 Patent Protection of Plants in Europe
4 Plant Patents in Europe
4.1 Method
4.2 Results
5 GMO Legislation in the EU
5.1 Overview of the GMO Legislation
5.2 New Plant Breeding Techniques and the Legal Status of Their Products
6 Conclusions
Chapter 9 The Farm-Saved Seed under the Community Plant Variety Rights System in the Light of the "Recommendation Relating to Article 15(2)" of the UPOV Act of 1991 and Article 39(1)(a) TFEU
1 Introduction
1.1 The Community Plant Variety Rights System Within the UPOV System
1.2 The FSS, a Controversial Exception
2 The "Recommendation Relating to Article 15(2)" of the UPOV Act of 1991
3 The FSS under the CPVR system
3.1 "[S]afeguarding Agricultural Production" as the Grounds of the FSS under the CPVR System
3.2 "[S]afeguarding Agricultural Production" as a Limitation of the FSS under the CPVR System
4 The Grounds of the FSS under the CPVR System: Between the "Recommendation Relating to Article 15(2)" of the UPOV Act of 1991 and Article 39(1)(a) TFEU
4.1 The Grounds of the FSS in the CPVR System and the "Recommendation Relating to Article 15(2)" of the UPOV Act of 1991
4.2 The Grounds of the FSS in the CPVR System as an Implementation in the Secondary EU Law of Article 39(1)(a) TFEU
4.3 A Comprehensive Interpretation of the FSS under the CPVR System
5 Further Considerations on the FSS under the CPVR System
5.1 Extension of the Scope of the FSS under the CPVR System Beyond the Limits Set by the "Recommendation Relating to Article 15(2)" and the Logic of the EU Law
5.2 Undue Influence of the List of Species in Article 14(2) of the Basic Regulation on National Lists of Species under the FSS
5.3 The Evolution of the CAP and the FSS under the CPVR System
6 Conclusions
Part III Patents and Artificial Intelligence
Chapter 10 AI Patents: Is There a Need to Rethink Patent Law?
1 Introduction
2 AI Patents: Determining Invention and Its Patent Eligibility
3 AI Patents and Innovation
4 AI Patents and Public Interest
5 Conclusions
Chapter 11 Transparency in the Patent System: Artificial Intelligence and the Disclosure Requirement
1 Introduction
2 The Disclosure Requirement in Patent Law
2.1 Historical Background
2.2 Current Role and Function
2.3 Fixing the Disclosure Requirement
3 Artificial Intelligence
3.1 AI and Magic
3.2 Explainable AI
3.3 Reproducibility
4 Looming Challenges
4.1 AI-Created Invention, Disclosed
4.2 Inventive AI as the Invention, Disclosed
4.3 Inventive AI/Working Requires AI, Disclosed, but Unexplainable
4.4 Working Requires AI, Concrete Use of AI Undisclosed
4.5 Working Requires AI, Invention Not Reproducible
5 Possible Remedies
6 Conclusions
Chapter 12 Artificial Intelligence, Novelty and Inventive Step: What Is the Impact of AI on Patent Law?
1 Introduction
2 What Is Artificial Intelligence?
2.1 Types of AI
2.1.1 Machine Learning and Deep Learning
2.1.2 Evolutionary/Genetic Algorithms
2.1.3 Artificial Neural Networks
2.2 Summary
3 Three Use Cases of AI and Patent Law
3.1 Pharmaceuticals
3.2 Product Design and Development
3.3 Prior Art Search
4 The Law on Novelty and Inventive Step
4.1 Novelty
4.2 Inventive Step
4.3 Applying the Law to AI in General
4.4 Applying the Law to the Use Cases
5 Conclusions and Considerations
Part IV Patents and ICT Sector
Chapter 13 Over-Enforcement Practices by Patent Assertion Entities in Europe: The Practice of National Courts
1 Growing Concerns Regarding Over-Enforcement Practices by PAEs in Europe
2 Identification of the Practices Adopted by PAEs
3 The Response of National Courts to Over-Enforcement Practices of PAEs in Europe
3.1 Methodology
3.2 Safeguards and Sanctions Imposed by National Courts
3.2.1 Taking Advantage of Being an NPE
3.2.2 Choice of Targeted Company
3.2.3 Choice of Asserted Patents
3.2.4 Frivolous Litigation
3.2.5 Vague Demand Letters
3.2.6 Threat of Injunction
3.2.6.1 Preliminary Injunction
3.2.6.2 Permanent Injunction
3.2.7 Patent Hold Up
4 Conclusion
4.1 Mechanisms in Place
4.2 Potential Drawbacks
Chapter 14 Standard Essential Patents: Between Open Access and Rewarding Innovation
1 Introduction
2 The Legal Framework of the FRAND Declaration
2.1 FRAND Declarations for Standardization
2.2 The Direct Contractual Effect of the FRAND Declaration
2.3 The Effect of the FRAND Declaration under EU Competition Law
2.4 Result: Two Ways to a FRAND License
3 The FRAND Defense under Huawei v. ZTE in Germany
3.1 Limited Guidance from the CJEU
3.2 The Sisvel v. Haier Case in the Federal Court of Justice
3.2.1 The Decision of the Düsseldorf Higher Regional Court in Sisvel v. Haier
3.2.2 Sisvel v. Haier Before the Federal Court of Justice
3.2.3 Parallel Case Between Sisvel and ZTE
3.3 Case Law of the Düsseldorf Higher Regional Court and Regional Court
3.3.1 Düsseldorf Higher Regional Court-Unwired Planet v. Huawei
3.3.2 Düsseldorf Regional Court-MPEG LA v. Huawei and MPEG LA v. ZTE
3.4 The Case Law of the Karlsruhe Higher Regional Court and Mannheim Regional Court
3.4.1 Mannheim Regional Court and Karlsruhe Higher Regional Court-Pioneer v. Acer
3.4.2 Mannheim Regional Court-Philips v. Archos
3.4.3 Mannheim Regional Court-Philips v. Asus and IP Bridge v. HTC
3.4.4 Karlsruhe Higher Regional Court-Philips v. Wiko
4 Summary of the Current Practice in FRAND Cases in Germany
4.1 Transparency Requirement for FRAND Offers
4.2 Royalty Review, Not Royalty Setting
4.3 FRAND Defines a Range
4.4 Formalities of the FRAND Negotiation
4.5 Open Issues
5 Final Conclusion
Chapter 15 Should Standard Essential Patents Be Licensed to Makers of Components or Manufacturers of Final Products? A View from Competition Law Perspective
1 Introduction
2 Licensing SEPs to Manufacturers of Components Versus Licensing SEPs to Manufacturers of Final Products: Industry Perspectives
2.1 Qualcomm's 'No License, No Chips' Licensing Model
2.2 Licensing in the Automotive Industry
2.3 Industry Responses to Component Level Licensing
3 Approaches Towards Refusal to License Component Makers in Selected Jurisdictions
3.1 Recent Developments in the US
3.1.1 FTC v. Qualcomm
3.1.1.1 Duty to Deal
3.1.1.2 Qualcomm's Royalties as an Artificial Surcharge
3.1.1.3 Qualcomm's 'No License, No Chips' Policy
3.1.1.4 Critique of the Court of Appeals' Decision
3.1.2 DOJ Business Review Letter Concerning Avanci Patent Pool
3.2 Developments in the EU
3.2.1 Nokia v. Daimler (Mannheim Regional Court)
3.2.2 Nokia v. Daimler (Dusseldorf Regional Court)
3.2.3 Huawei v. Nokia (Dusseldorf Regional Court)
3.2.4 Licensing Between SEP Holders and Component Makers
4 Future Developments: Possible Solutions - Conclusions
4.1 Future Developments
4.2 Licensing Makers of Final Products Does Not Always Raise Competition Concerns
4.3 Setting-up a Dedicated Licensing Company
4.4 Room for Competition Law in Enforcing FRAND Commitments

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