Intellectual Property Protection for Plant Related Innovation: Fit for Future?

Acknowledgments
Definitions
Contents
Abbreviations
Part I: Introduction: Plant Innovations
Chapter 1: Plant Breeding and Intellectual Property: A Controversial Topic
1.1 Why Plant Breeding?
1.2 Natural vs. Man-Made Plants
1.3 A Brief History of Plant Breeding
1.4 Plant Biotechnology
1.5 The Plant Breeding Industry Today
1.6 The Future of Plant Breeding and Agriculture
1.7 The Potential of New Breeding Technologies
References
Part II: The Current Legal Framework for IP on Plant Innovations (Lex lata)
Chapter 2: Overview: Intellectual Property for Plant Innovations
2.1 The International Legal Framework for Plant Innovations
References
Chapter 3: The Sui Generis System of Plant Breeders Rights
3.1 The UPOV System
3.2 Prerequisites for Protection: Distinctness, Uniformity, Stability (DUS)
3.3 Rights and Limitations
3.4 National Differences
3.5 Seed Market Authorization
3.6 The Sui Generis System of Plant Patents
References
Chapter 4: The Patent System for Plant Related Inventions
4.1 Early Patents on Plants
4.2 The Exclusion from Patentability for Plants Under the TRIPS Agreement
4.3 The Exclusion from Patentability for Essentially Biological Processes and Resulting Products
4.4 Prerequisites for Patent Protection of Plant Related Inventions
4.5 Rights and Limitations of Patents for Plant Related Inventions
4.6 National Differences: An Overview
References
Chapter 5: Legislation Related to (Plant) Genetic Resources
5.1 Convention on Biological Diversity and Nagoya Protocol
5.2 International Treaty for Plant Genetic Resources for Food and Agriculture
5.3 Declaration of Source and Origin in IP Applications
References
Chapter 6: Alternative IP Systems for Plant Innovations
6.1 Trade Secrets
6.2 Copyright
6.3 Tangible Copy-Protection Technology
6.4 Market Authorization Rights and Regulatory Data Exclusivity
6.5 Agreements and Bag Tags
References
Chapter 7: Analysis of the Status Quo: Current Benefits of IPRs for Plants
7.1 Use and Benefits of the Plant Breeders Right System
7.2 Use and Benefits of the Patents System for Plant Related Innovations
7.3 Use and Benefits of the ITPGRFA
References
Chapter 8: Analysis of the Status Quo: Current Issues in Plant Breeders Rights
8.1 Novelty of Parent Lines in Case of Commercialization of Their Hybrids
8.2 Distinctness, Uniformity and Stability (DUS) Testing
8.2.1 DUS Testing: Climate Change and Other Phenotype-Influencing Factors
8.2.2 DUS Testing: Molecular Markers and Genetic Distance
8.2.3 DUS Testing: Access to Material
8.2.4 DUS Testing: Impact of GM Regulations
8.3 Issues Related to Essential Derived Varieties (EDV)
8.3.1 EDV: The Definition
8.3.2 EDV: Procedural Aspects
8.3.3 EDV: Use of Digital Sequence Information
8.3.4 Summary: EDV Concept
8.4 Farm-Saved-Seed, Farmer´s Rights, and Private & Non-commercial Use
8.5 The Breeders Exemption
8.5.1 Impact of Effective Protection Time
8.5.2 Impact of an Expanded EDV Concept on the Breeders Exemption
8.5.3 The Need to Use Legally Obtained Material
8.5.4 Summary: Breeders Exemption
8.6 Extension to Harvested Material and Direct Products
8.7 The Authorization of the Breeder: Licensing and Compulsory Licensing
8.8 Enforcement of PBRs
8.9 Seed Marketing Authorization
8.10 Current Issues Related to Plant Patents
References
Chapter 9: Analysis of the Status Quo: Current Issues in Patents on Plants
9.1 The Scope of Exclusion from Patentability for Plants
9.2 Novelty and the Exemption for Products-of-Nature
9.3 US Variety Patents
9.4 Plant Biotechnology Patents
9.4.1 Hypothetical Patent Filing
9.4.2 Claims on DNA Sequences with ``Percent Identity´´ Extensions
9.4.3 Claims on Sequences with Only Functional Language
9.4.4 Patent Lifecycle Management and Ever-Greening
9.5 Essentially Biological Processes and Their Products Under the EPC
9.5.1 Rule 28 (2) EPC and the Impact of the G 3/19 ``Pepper´´ Decision
9.5.2 Rule 28 (2) EPC and the Impact of National Patent Laws
9.5.3 The Clarity Requirement of Article 84 EPO: ``Obtainable´´ v. ``Obtained´´
9.5.4 The Issue of Non-Budapest Treaty Deposits
9.5.5 Summary: Patents on Native Traits
9.6 Farm-Saved-Seed Under Patent Law
9.7 Research & Breeder´s Exemption Under Patent Law
9.8 Access to Material in Patent Deposits
9.9 Scope of Protection and Enforceability
9.9.1 Biotech Traits
9.9.2 Native Traits
9.9.3 Variety Patents
9.9.4 Emerging Issue: Scope of Process Claims
9.10 Exhaustion
9.11 Compulsory Licensing and Cross Licensing
9.12 Emerging Issue: Generic GM Traits
9.13 Costs, Time, and Quality of Examination
References
Chapter 10: Other Issues
10.1 Issues Related to Plant Genetic Resource Legislation
10.1.1 The Lack of Access
10.1.2 The Lack of Monetary Benefit Sharing
10.1.3 The Emerging Issue of Digital Sequence Information (DSI)
10.1.4 The Inability to Compromise
10.1.5 The Ultimate Dilemma: After All a Change for Subscription Models?
10.2 Trade Secrets & Prior Use Rights
References
Chapter 11: Issues: Summary and Conclusion
Chapter 12: Current Solutions for Issues in Plant IPR Systems
12.1 Legislative Solutions
12.2 Case Law
12.3 Private Sector Solutions
12.3.1 Voluntary Patent Transparency: The PINTO Database
12.3.2 Patent Pools
12.3.3 Patent Clearinghouses
12.3.3.1 The BiOS Initiative
12.3.3.2 International Licensing Platform: Vegetables (ILP)
12.3.3.3 Licensing Platform: Field Crops
12.3.4 E-Licensing and Licensing Pledges
12.3.5 Open-Source Models
12.3.6 Discussion of Current Private Sector Solutions
12.3.6.1 Antitrust Considerations
12.3.6.2 Current Private Sector Solutions: Fit for Future?
References
Part III: The Need for Legislative Change and Related Options (Lex ferenda)
Chapter 13: Emerging Challenges
13.1 Plant IP Complexity: Towards a Gordian Knot?
13.1.1 The Patent Landscape for CRISPR-CAS Technologies
13.1.2 The Patent Landscape for NBT-Derived Products
13.1.3 The Impact of Shorter Innovation Cycles
13.1.4 A Glance in the Crystal Ball: The Future Complexity of Plant Related Patents
13.1.5 The Consequences of the Future Patent Complexity
13.2 Patent Office Overload and Who Should Win: Best Innovation vs. Best Attorney?
13.3 Dematerialization of Genetic Resources and Innovation
13.4 Open Innovation and Cooperation
13.5 Climate Change & Food Security
13.6 The Dilemma of Increased Globalization in Times of Eroding Multilateralism
13.7 Summary and Conclusion I: Fit for Future?
References
Chapter 14: Potential Solutions for the Future Challenges
14.1 General Considerations
14.1.1 Legislative Intent
14.1.2 The Correlation of IP Strength (``Openness´´) and Innovation Flow
14.1.3 The Legislators´ Dilemma
14.2 Options and Scenarios
References
Chapter 15: Option 1: Do Nothing and Rely on Market Forces
15.1 Stakeholder Solution 1: Evolving the ILP
15.2 Stakeholder Solution 2: Voluntary Patent Transparency
15.3 Option 1 ``Do Nothing´´: Conclusion
References
Chapter 16: Option 2: Legislative Adjustments to the Patents and PBR System
16.1 Expand Legal Certainty and Freedom-to-Breed
16.2 Compulsory Cross-Licensing
16.3 Mandatory Transparency
16.4 Licensing Policies
16.5 Option 2 Legislative Adjustments: Conclusion
References
Chapter 17: Option 3: Abandoning Patents
17.1 The Changed Need for Patents in the Era of NBTs
17.2 Challenges to Implement Patent Abandonment for Plant Innovations
17.3 Conclusion
References
Chapter 18: Option 4: Redesigning the IP Systems
18.1 Unified Protection System (Metzger/Zech)
18.2 Plant Germplasm Integrated System (Rapela)
References
Chapter 19: A New Holistic System for Plant Innovations: UPOV 2030
19.1 A Multilateral System with a Uniform Right
19.2 The Sole IPR for Plant Related Innovations
19.3 Types of Protection
19.3.1 Protection Type A: New Plant Varieties
19.3.2 Protection Type B: Man-Made Traits with Specified Sequences
19.3.3 Protection Type C: Native Traits or Traits Without Specified Sequences
19.3.4 Protection Type D: New Plant-Derived Products
19.3.5 Protection Type E: Innovative Processes for Making and Using Plants
19.3.6 Claims
19.3.7 Description
19.3.8 Combinations of Different Protection Type
19.3.9 Complex Traits
19.4 Registration, Examination, and Invalidation Process
19.4.1 Filing Process
19.4.2 Registration & Examination Process
19.4.3 Improvements and Selection Inventions
19.4.4 Publication
19.4.5 Invalidation
19.4.6 Mandatory Deposit
19.4.7 Unique Identifier (Denomination Name)
19.4.8 Mandatory Transparency and Marking Requirement
19.4.9 Claiming Priority and Conversions
19.5 Scope and Term of Protection
19.5.1 The Core: Commercial Use of a Protected Embodiment
19.5.2 Extension 1: Harvested Goods and Direct Products
19.5.3 Extension 2: Essential Derivation and Equivalents
19.5.4 Multiple Dependencies: Uncoupling Dependency and Protection Scope
19.5.5 Term of Protection
19.6 Rights
19.6.1 Exclusive Right
19.6.2 Inclusive Rights: Liability Regime for Breeders and Farmers
19.6.2.1 Prior Registration Requirement
19.6.2.2 Establishing FRAND Terms
19.6.3 Enforcement of Rights and Defenses
19.7 Limitations and Exemptions
19.7.1 Research Exemption
19.7.2 Exemption for Breeding and Product Development
19.7.3 Private and Non-commercial Use
19.7.4 Farm-Saved-Seed as Commercial Activity
19.7.5 De minimis Exception
19.7.6 Compulsory Licensing and Cross-Licensing
19.8 Rights to Plant Genetic Resources and Related Benefit Sharing
19.9 Integration of Regulatory Legislation
19.9.1 Seeds Regulatory and Seed Market Authorization
19.9.2 GM Plant Regulatory Framework
19.9.3 Regulatory Framework for NBT-Derived Seed
19.10 Implementation of the Holistic System
19.10.1 Implementation: The Transition Period
19.10.2 Implementation: Co-existence with the Patent and PBR Systems
19.10.3 Implementation: Creating a Pull-in Effect
19.10.4 Implementation: Incentives for Fairness and Honesty
19.10.5 Implementation: Transparency
19.10.6 Implementation: Balancing Innovation Incentive and Technology Access
19.10.7 Implementation: Governance of a Multilateral System
References
Chapter 20: Assessment of the Different Options Under the Different Scenarios for the Future
Part IV: Summary and Conclusions
Chapter 21: A Changing World for Plant Intellectual Property
Chapter 22: Conclusion I: The What-An Open, Holistic IP System for Plant Innovation
Chapter 23: Conclusion II: The How-Towards Implementation of the Holistic IP System
Reference