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PART Ⅰ: THE PROBLEM - ACCESS AS A NECESSARY ELEMENT OF FOLLOW-ON INNOVATION?utical R&D: the increased importance of cumulative innovation and related concerns3

1. Biopharmaceduction3

1.1 Introase of research tools7

1.2 The cfining research tools7

1.2.1 Dee patent experience in biotechnology: biomedical research tools9

1.2.2 The effect of patent trends on the patent balance for research tools12

1.2.3 Thusion16

1.3 ConclATENT BALANCE AND WORKING SOLUTIONS IN THE PATENT SYSTEMsystem as a system of balancing21

PART Ⅱ: THE Patent Balance21

2. The patent rticular importance of the patent balance in the biopharmaceutical industry25

2.1 The Pe patent system and the biopharmaceutical industry25

2.2 The particular importance of the patent balance in the biopharmaceutical industry25

2.2.1 The patent system and the biopharmaceutical industry25

2.2.1.1 Biopharmaceutical innovation and patenting28

2.2.1.2 Has the importance of patents been overstated?31

2.3 Conclusion34

3. The patent system and some potential safety nets36

3.1 Introduction to the patent safety nets36

3.2 The patent safety nets37

3.2.1 Experimental use exemption39

3.2.1.1 The experimental use exemption: a viable and effective working solution?39

3.2.1.2 The US experience: a helpful paradigm?44

3.2.1.3 Conclusion on the EUE46

3.2.2 The reverse doctrine of equivalents and blocking patents48

3.2.3 Patent pools51

3.2.4 Compulsory licensing in the patent provisions54

3.2.4.1 Introduction to compulsory licensing54

(a) Definition and history54

(b) Support and opposition for CL54

(c) Grounds for granting a compulsory licence57

3.2.4.2 Analysis of the role of CL58

(a) The role of CL in balancing commensurability58

(i) CL as a mechanism to induce broad licensing58

(ii) CL for non-use59

(iii) CL for significant technological advances59

(iv) CL to address health emergencies61

(v) CL as a remedy for anti-competitive conduct63

(b) Conclusions on CL63

4. The right to health as an interpretive principle of patent law70

4.1 Introduction70

4.2 The right to health as a human right and its status in European law71

4.2.1 Introduction to the right to health71

4.2.2 Sources of the right to health74

4.2.3 Implications of the right to health76

4.2.3.1 Elements of the right to health77

4.2.3.2 Obligation to respect, protect and fulfil79

4.2.4 International Efforts to Strengthen the Right to Health80

4.3 The right to health and patent law: The fundamental nature of health concerns and the move towards a right to health as an interpretive principle in patent law82

4.3.1 The link between the right to health and patent law82

4.3.1.1 The effect of patent law on the right to health82

4.3.1.2 The effect of the right to health on patent law83

4.3.2 The right to property and IP: IP as a human right84

4.3.2.1 Striking the balance: limitations in the public interest86

4.3.3 Patenting and the right to health87

4.3.3.1 Direct effect87

4.3.3.2 The indirect effect of the right to health88

4.3.4 The right to health as an interpretive principle in patent law90

4.3.4.1 Effect on specific patent provisions91

4.3.4.2 Case-law on public health93

4.3.4.3 European cases on IP and fundamental rights analysis94

4.4 Conclusions96

PART Ⅲ: ANTITRUST AS A COMPLEMENT TO THE PATENT SYSTEM96

5. Unilateral conduct, intellectual property rights and Competition Law: a systems' interaction101

5.1 Introduction101

5.2 The practice of the courts103

5.2.1 The existence/exercise distinction103

5.3 IPRs and competition: A systems' interaction107

5.3.1 IPRs - public goods, exclusivity and information goods107

5.3.1.1 Public goods and market failure107

5.3.1.2 Patronage, procurement and property109

5.3.2 Implications for competition112

5.3.2.1 IP like other property rights for the purposes of competition112

5.3.2.2 Competition embedded in the IP system114

5.3.2.3 The transition from separate to unified fields114

5.3.2.4 How antitrust control affects incentives to innovate116

5.3.3 Recent recognition of antitrust control119

5.4 Conclusions121

6. The Duty to Deal under Art. 82 EC122

6.1 Introduction122

6.1.1 What is a refusal to deal and what is the rationale behind its prohibition?122

6.1.2 Concerns relating to a refusal to deal: Potential harm to competition123

6.2 The state of the law126

6.2.1 Cutting off existing customers: The dependence cases128

6.2.2 'Reservation of an ancillary activity' and leverage economics130

6.2.3 The indispensability requirement and the essential facilities doctrine (EFD)133

6.2.3.1 Indispensability135

6.2.3.2 Two-market requirement138

6.2.3.3 Objective justification139

6.2.4 New product innovation141

6.3 Conclusions143

Appendix The refusal to deal cases under Art. 82145

PART Ⅳ: A MORE INNOVATION SENSITIVE APPROACH TO THE INTERFACE OF COMPETITION LAW AND PATENTS?145

7. The duty to deal as applied to address technology access problems in the biopharmaceutical industry177

7.1 Conclusions on the patent system in the case of research tools177

7.1.1 The particularity of research tools: pre-commercial stage patents177

7.1.2 A gap in the patent system?179

7.1.3 The more the better? Optimal market structure for innovation179

7.2 Two possible avenues for increased access to essential research tools181

7.2.1 Patent law181

7.2.2 A role for Art. 82?185

7.2.2.1 Indispensability186

7.2.2.2 Preventing the emergence of a new product for which there is potential consumer demand187

7.2.2.3 Elimination of competition on a downstream or neighbouring market/two-market requirement187

7.2.2.4 The absence of an objective justification188

7.2.3.1 The impact of Art. 82 duty to deal with case-law on the patent system189

7.2.3.2 An innovation sensitive approach:innovation markets in Art. 82?191

7.2.3.3 Conclusions on compulsory licensing as a safety net195

7.2.4 Conclusion: A human rights approach to competition law ?196

Bibliography200

Legislation and Guidelines200

Reports and Studies204

Authors210

Index239