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Patents as an Incentive for Innovation [Kietas viršelis]

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  • Formatas: Hardback, 368 pages
  • Išleidimo metai: 16-Feb-2021
  • Leidėjas: Kluwer Law International
  • ISBN-10: 9403524138
  • ISBN-13: 9789403524139
Kitos knygos pagal šią temą:
  • Formatas: Hardback, 368 pages
  • Išleidimo metai: 16-Feb-2021
  • Leidėjas: Kluwer Law International
  • ISBN-10: 9403524138
  • ISBN-13: 9789403524139
Kitos knygos pagal šią temą:
Patents as an Incentive for Innovation analyses in depth how patent law today performs its function of stimulating innovation in the vital sectors of healthcare, agriculture, artificial intelligence and communications technology. Patents are a reward forhuman inventiveness. An effective 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.
Editors v
Contributors vii
Foreword: The Complex Terrain of Intellectual Property Governance xxv
Rochelle Cooper Dreyfuss
Introduction 1(6)
Rafal Sikorski
Zaneta Zemla-Pacud
PART I Patents and the Health Sector
7(136)
Chapter 1 TRIPS and Post-TRIPS Trade Agreements and Their Impact on Innovation
9(22)
Susy Frankel
1 Introduction
9(6)
2 Trade as a Lever for More Extensive Protection Beyond the TRIPS Baseline
15(7)
3 Post-TRIPS Flexibilities in Patent Law
22(7)
3.1 Parallel Importing and TRIPS
22(3)
3.2 The EU Manufacturing Waiver
25(4)
4 Mounting Evidence That Multilateralism Is Preferable to FT AS for Innovation
29(2)
Chapter 2 In Between Breakthrough and Incremental Innovation: Rethinking Pharmaceuticals' Eligibility for IP Protection
31(30)
Zaneta Zemla-Pacud
1 Introduction
31(2)
2 Specifics of Pharmaceutical Innovation
33(4)
2.1 Pharmaceutical Innovation in the EU Regulatory Legislation
33(1)
2.2 Rationales for Incentivizing Primary and Secondary Innovation
34(3)
3 Patents
37(3)
4 Supplementary Protection Certificates
40(7)
4.1 Purposes of the SPC System
40(2)
4.2 SPC Eligibility
42(5)
5 Regulatory Exclusivities
47(9)
5.1 Pharmaceutical Regulatory Framework in the EU
47(1)
5.2 Data and Market Protection for Reference Medicinal Products
48(3)
5.3 Orphan Exclusivity
51(4)
5.4 Paediatric Rewards
55(1)
5.5 Paediatric Data and Market Exclusivity
56(1)
6 Conclusions
56(5)
Chapter 3 Human Enhancement and Patent Law
61(24)
Helena Zakowska-Henzler
1 Introduction
61(3)
2 The Concept of HE and HET
64(4)
3 Patentability of HET
68(10)
4 Should HET Be Considered an `Ordinary' Invention?
78(4)
5 Conclusions
82(3)
Chapter 4 Do We Need Patent Protection for Biopharmaceuticals?
85(14)
Marek Swierczyriski
1 Introduction
85(4)
2 Why Do Biopharmaceuticals Need to Be Legally Separated from Chemical (Small Molecule) Medicinal Products?
89(1)
3 Categories of Biopharmaceuticals
90(3)
4 Why Do We Need Patent Protection for Biopharmaceuticals?
93(4)
5 Conclusions
97(2)
Chapter 5 Changing Approach to the Regulatory Testing Exemption in Patent Law: The European Union Perspective
99(24)
Agnieszka Sztoldman
1 Introduction
99(3)
2 Rationale for the Regulatory Testing Exemption: How Does It Impact Innovation?
102(2)
3 The Regulatory Testing Exemption in the EU: An Overview
104(5)
3.1 Article 10(6) of the Directive 2001/83/EC
104(1)
3.2 An Overview of the EU Bolar Exemption under the Current National Legislations
105(3)
3.3 An Overview of National Case Law
108(1)
4 Key Tendencies in the Approach to the Regulatory Testing Exemption in the EU
109(12)
4.1 The Regulatory Review Exemption Is Not Only Limited to the Abridged or Hybrid Procedure
109(4)
4.2 Extending the Regulatory Review Exemption to Registering Medicinal Products Abroad
113(2)
4.3 The Regulatory Testing Exemption Covers Third-Party Actions under the `Practical Requirements'
115(5)
4.4 The Regulatory Testing Exemption Includes Storage
120(1)
5 Final Remarks
121(2)
Chapter 6 Rethinking SPC Protection: Manufacturing Waiver as an Incentive for the Generic Sector or a Disincentive to Innovators?
123(20)
Justyna Ozegalska-Trybalska
1 Introduction
123(2)
2 Towards Extending Patent Protection by SPC and Limiting It by Manufacturing Waiver
125(2)
3 Derogation from Exclusivity: A Characteristic of the Manufacturing Waiver
127(5)
4 Derogation from Exclusivity or Exemption from Conferred Rights?
132(3)
5 Reviewing Arguments: A Chance of Increasing Competitiveness or Risk of Affecting Innovation?
135(8)
PART II Patents and Plants
143(66)
Chapter 7 Rethinking IP Protection for Plants? Revisiting the Exclusivity-Access Balance Through the Type-Token Ontology
145(16)
Geertrui Van Overwalle
1 Introduction
145(1)
2 Plant Breeding Techniques
146(2)
3 IP Protection Regimes
148(6)
3.1 Plant Breeder's Rights
148(1)
3.1.1 Eligible Subject Matter: Plant Varieties
149(1)
3.1.2 Substantive Protection Criteria
149(1)
3.1.3 Scope of Rights
150(1)
3.2 Patents
151(1)
3.2.1 Eligible Subject Matter: Plants
151(3)
3.2.2 Substantive Protection Criteria
154(1)
3.2.3 Scope of Rights
154(1)
4 Looking at the Exclusivity/Access Balance Through the Type/Token Lens
154(4)
4.1 Plant Breeder's Rights Law
155(2)
4.2 Patent Law
157(1)
5 Re-assessing the Exclusivity/Access Balance
158(1)
6 Concluding Thoughts
159(2)
Chapter 8 Non-patent Legal Factors of Marketability in Plant Biotechnology in Europe
161(20)
Tomasz Zimny
1 Introduction
161(2)
2 The Goal of Patent Protection
163(1)
3 Patent Protection of Plants in Europe
164(4)
4 Plant Patents in Europe
168(2)
4.1 Method
168(1)
4.2 Results
169(1)
5 GMO Legislation in the EU
170(8)
5.1 Overview of the GMO Legislation
170(3)
5.2 New Plant Breeding Techniques and the Legal Status of Their Products
173(5)
6 Conclusions
178(3)
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
181(28)
Juan Antonio Vives-Valles
1 Introduction
182(4)
1.1 The Community Plant Variety Rights System Within the UPOV System
182(1)
1.2 The FSS, a Controversial Exception
183(3)
2 The "Recommendation Relating to Article 15(2)" of the UPOV Act of 1991
186(1)
3 The FSS under the CPVR system
187(4)
3.1 "[ Safeguarding Agricultural Production" as the Grounds of the FSS under the CPVR System
187(3)
3.2 "[ Safeguarding Agricultural Production" as a Limitation of the FSS under the CPVR System
190(1)
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
191(10)
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
191(2)
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
193(1)
4.3 A Comprehensive Interpretation of the FSS under the CPVR System
194(7)
5 Further Considerations on the FSS under the CPVR System
201(5)
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
201(3)
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
204(1)
5.3 The Evolution of the CAP and the FSS under the CPVR System
205(1)
6 Conclusions
206(3)
PART III Patents and Artificial Intelligence
209(58)
Chapter 10 AI Patents: Is There a Need to Rethink Patent Law?
211(24)
Iga Balos
1 Introduction
211(3)
2 AI Patents: Determining Invention and Its Patent Eligibility
214(8)
3 AI Patents and Innovation
222(7)
4 AI Patents and Public Interest
229(1)
5 Conclusions
230(5)
Chapter 11 Transparency in the Patent System: Artificial Intelligence and the Disclosure Requirement
235(18)
Alfred Fruh
1 Introduction
235(1)
2 The Disclosure Requirement in Patent Law
236(7)
2.1 Historical Background
237(2)
2.2 Current Role and Function
239(2)
2.3 Fixing the Disclosure Requirement
241(2)
3 Artificial Intelligence
243(3)
3.1 AI and Magic
244(1)
3.2 Explainable AI
245(1)
3.3 Reproducibility
245(1)
4 Looming Challenges
246(4)
4.1 Al-Created Invention, Disclosed
247(1)
4.2 Inventive AI as the Invention, Disclosed
247(1)
4.3 Inventive Al/Working Requires AI, Disclosed, but Unexplainable
248(1)
4.4 Working Requires AI, Concrete Use of AI Undisclosed
248(1)
4.5 Working Requires AI, Invention Not Reproducible
249(1)
5 Possible Remedies
250(1)
6 Conclusions
251(2)
Chapter 12 Artificial Intelligence, Novelty and Inventive Step: What Is the Impact of AI on Patent Law?
253(14)
Peter R. Slowinski
1 Introduction
253(2)
2 What Is Artificial Intelligence?
255(3)
2.1 Types of AI
255(1)
2.1.1 Machine Learning and Deep Learning
255(1)
2.1.2 Evolutionary/Genetic Algorithms
256(1)
2.1.3 Artificial Neural Networks
257(1)
2.2 Summary
258(1)
3 Three Use Cases of AI and Patent Law
258(4)
3.1 Pharmaceuticals
258(1)
3.2 Product Design and Development
259(2)
3.3 Prior Art Search
261(1)
4 The Law on Novelty and Inventive Step
262(4)
4.1 Novelty
262(1)
4.2 Inventive Step
263(1)
4.3 Applying the Law to AI in General
264(1)
4.4 Applying the Law to the Use Cases
264(2)
5 Conclusions and Considerations
266(1)
PART IV Patents and ICT Sector
267
Chapter 13 Over-Enforcement Practices by Patent Assertion Entities in Europe: The Practice of National Courts
269(1)
Amandine Leonard
1 Growing Concerns Regarding Over-Enforcement Practices by PAEs in Europe
270(25)
2 Identification of the Practices Adopted by PAEs
272(3)
3 The Response of National Courts to Over-Enforcement Practices of PAEs in Europe
275(15)
3.1 Methodology
275(1)
3.2 Safeguards and Sanctions Imposed by National Courts
276(1)
3.2.1 Taking Advantage of Being an NPE
276(4)
3.2.2 Choice of Targeted Company
280(1)
3.2.3 Choice of Asserted Patents
281(2)
3.2.4 Frivolous Litigation
283(2)
3.2.5 Vague Demand Letters
285(1)
3.2.6 Threat of Injunction
286(1)
3.2.6.1 Preliminary Injunction
287(1)
3.2.6.2 Permanent Injunction
288(1)
3.2.7 Patent Hold Up
289(1)
4 Conclusion
290(5)
4.1 Mechanisms in Place
290(2)
4.2 Potential Drawbacks
292(3)
Chapter 14 Standard Essential Patents: Between Open Access and Rewarding Innovation
295(22)
Dietrich Kamlah
1 Introduction
295(1)
2 The Legal Framework of the FRAND Declaration
296(4)
2.1 FRAND Declarations for Standardization
296(1)
2.2 The Direct Contractual Effect of the FRAND Declaration
297(1)
2.3 The Effect of the FRAND Declaration under EU Competition Law
297(2)
2.4 Result: Two Ways to a FRAND License
299(1)
3 The FRAND Defense under Huawei v. ZTE in Germany
300(12)
3.1 Limited Guidance from the CJEU
300(1)
3.2 The Sisvel v. Haier Case in the Federal Court of Justice
301(1)
3.2.1 The Decision of the Dusseldorf Higher Regional Court in Sisvel v. Haier
301(2)
3.2.2 Sisvel v. Haier Before the Federal Court of Justice
303(2)
3.2.3 Parallel Case Between Sisvel and ZTE
305(1)
3.3 Case Law of the Diisseldorf Higher Regional Court and Regional Court
305(1)
3.3.1 Diisseldorf Higher Regional Court--Unwired Planet v. Huawei
305(2)
3.3.2 Diisseldorf Regional Court--MPEG LA v. Huawei and MPEG LA v. ZTE
307(2)
3.4 The Case Law of the Karlsruhe Higher Regional Court and Mannheim Regional Court
309(1)
3.4.1 Mannheim Regional Court and Karlsruhe Higher Regional Court--Pioneer v. Acer
309(1)
3.4.2 Mannheim Regional Court--Philips v. Archos
310(1)
3.4.3 Mannheim Regional Court--Philips v. Asus and IP Bridge v.HTC
311(1)
3.4.4 Karlsruhe Higher Regional Court--Philips v. Wiko
312(1)
4 Summary of the Current Practice in FRAND Cases in Germany
312(4)
4.1 Transparency Requirement for FRAND Offers
313(1)
4.2 Royalty Review, Not Royalty Setting
313(1)
4.3 FRAND Defines a Range
314(1)
4.4 Formalities of the FRAND Negotiation
314(1)
4.5 Open Issues
315(1)
5 Final Conclusion
316(1)
Chapter 15 Should Standard Essential Patents Be Licensed to Makers of Components or Manufacturers of Final Products? A View from Competition Law Perspective
317
Rafal Sikorski
1 Introduction
317(3)
2 Licensing SEPs to Manufacturers of Components Versus Licensing SEPs to Manufacturers of Final Products: Industry Perspectives
320(4)
2.1 Qualcomm's `No License, No Chips' Licensing Model
320(2)
2.2 Licensing in the Automotive Industry
322(1)
2.3 Industry Responses to Component Level Licensing
323(1)
3 Approaches Towards Refusal to License Component Makers in Selected Jurisdictions
324(11)
3.1 Recent Developments in the US
325(1)
3.1.1 FTC v. Quakomm
325(1)
3.1.1.1 Duty to Deal
325(2)
3.1.1.2 Qualcomm's Royalties as an Artificial Surcharge
327(1)
3.1.1.3 Qualcomm's `No License, No Chips' Policy
328(1)
3.1.1.4 Critique of the Court of Appeals' Decision
329(2)
3.1.2 DOJ Business Review Letter Concerning Avanci Patent Pool
331(1)
3.2 Developments in the EU
332(1)
3.2.1 Nokia v. Daimler (Mannheim Regional Court)
333(1)
3.2.2 Nokia v. Daimler (Dusseldorf Regional Court)
333(1)
3.2.3 Huawei v. Nokia (Dusseldorf Regional Court)
334(1)
3.2.4 Licensing Between SEP Holders and Component Makers
334(1)
4 Future Developments: Possible Solutions - Conclusions
335
4.1 Future Developments
335(1)
4.2 Licensing Makers of Final Products Does Not Always Raise Competition Concerns
335(1)
4.3 Setting-up a Dedicated Licensing Company
336(1)
4.4 Room for Competition Law in Enforcing FRAND Commitments
336