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