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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 concerns 3

1. Biopharmaceduction 3

1.1 Introase of research tools 7

1.2 The cfining research tools 7

1.2.1 Dee patent experience in biotechnology: biomedical research tools 9

1.2.2 The effect of patent trends on the patent balance for research tools 12

1.2.3 Thusion 16

1.3 ConclATENT BALANCE AND WORKING SOLUTIONS IN THE PATENT SYSTEMsystem as a system of balancing 21

PART Ⅱ: THE Patent Balance 21

2. The patent rticular importance of the patent balance in the biopharmaceutical industry 25

2.1 The Pe patent system and the biopharmaceutical industry 25

2.2 The particular importance of the patent balance in the biopharmaceutical industry 25

2.2.1 The patent system and the biopharmaceutical industry 25

2.2.1.1 Biopharmaceutical innovation and patenting 28

2.2.1.2 Has the importance of patents been overstated? 31

2.3 Conclusion 34

3. The patent system and some potential safety nets 36

3.1 Introduction to the patent safety nets 36

3.2 The patent safety nets 37

3.2.1 Experimental use exemption 39

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 EUE 46

3.2.2 The reverse doctrine of equivalents and blocking patents 48

3.2.3 Patent pools 51

3.2.4 Compulsory licensing in the patent provisions 54

3.2.4.1 Introduction to compulsory licensing 54

(a) Definition and history 54

(b) Support and opposition for CL 54

(c) Grounds for granting a compulsory licence 57

3.2.4.2 Analysis of the role of CL 58

(a) The role of CL in balancing commensurability 58

(i) CL as a mechanism to induce broad licensing 58

(ii) CL for non-use 59

(iii) CL for significant technological advances 59

(iv) CL to address health emergencies 61

(v) CL as a remedy for anti-competitive conduct 63

(b) Conclusions on CL 63

4. The right to health as an interpretive principle of patent law 70

4.1 Introduction 70

4.2 The right to health as a human right and its status in European law 71

4.2.1 Introduction to the right to health 71

4.2.2 Sources of the right to health 74

4.2.3 Implications of the right to health 76

4.2.3.1 Elements of the right to health 77

4.2.3.2 Obligation to respect, protect and fulfil 79

4.2.4 International Efforts to Strengthen the Right to Health 80

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 law 82

4.3.1 The link between the right to health and patent law 82

4.3.1.1 The effect of patent law on the right to health 82

4.3.1.2 The effect of the right to health on patent law 83

4.3.2 The right to property and IP: IP as a human right 84

4.3.2.1 Striking the balance: limitations in the public interest 86

4.3.3 Patenting and the right to health 87

4.3.3.1 Direct effect 87

4.3.3.2 The indirect effect of the right to health 88

4.3.4 The right to health as an interpretive principle in patent law 90

4.3.4.1 Effect on specific patent provisions 91

4.3.4.2 Case-law on public health 93

4.3.4.3 European cases on IP and fundamental rights analysis 94

4.4 Conclusions 96

PART Ⅲ: ANTITRUST AS A COMPLEMENT TO THE PATENT SYSTEM 96

5. Unilateral conduct, intellectual property rights and Competition Law: a systems' interaction 101

5.1 Introduction 101

5.2 The practice of the courts 103

5.2.1 The existence/exercise distinction 103

5.3 IPRs and competition: A systems' interaction 107

5.3.1 IPRs - public goods, exclusivity and information goods 107

5.3.1.1 Public goods and market failure 107

5.3.1.2 Patronage, procurement and property 109

5.3.2 Implications for competition 112

5.3.2.1 IP like other property rights for the purposes of competition 112

5.3.2.2 Competition embedded in the IP system 114

5.3.2.3 The transition from separate to unified fields 114

5.3.2.4 How antitrust control affects incentives to innovate 116

5.3.3 Recent recognition of antitrust control 119

5.4 Conclusions 121

6. The Duty to Deal under Art. 82 EC 122

6.1 Introduction 122

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 competition 123

6.2 The state of the law 126

6.2.1 Cutting off existing customers: The dependence cases 128

6.2.2 'Reservation of an ancillary activity' and leverage economics 130

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

6.2.3.1 Indispensability 135

6.2.3.2 Two-market requirement 138

6.2.3.3 Objective justification 139

6.2.4 New product innovation 141

6.3 Conclusions 143

Appendix The refusal to deal cases under Art. 82 145

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 industry 177

7.1 Conclusions on the patent system in the case of research tools 177

7.1.1 The particularity of research tools: pre-commercial stage patents 177

7.1.2 A gap in the patent system? 179

7.1.3 The more the better? Optimal market structure for innovation 179

7.2 Two possible avenues for increased access to essential research tools 181

7.2.1 Patent law 181

7.2.2 A role for Art. 82? 185

7.2.2.1 Indispensability 186

7.2.2.2 Preventing the emergence of a new product for which there is potential consumer demand 187

7.2.2.3 Elimination of competition on a downstream or neighbouring market/two-market requirement 187

7.2.2.4 The absence of an objective justification 188

7.2.3.1 The impact of Art. 82 duty to deal with case-law on the patent system 189

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 net 195

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

Bibliography 200

Legislation and Guidelines 200

Reports and Studies 204

Authors 210

Index 239