
Patents as an Incentive for Innovation
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Content
- 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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