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Patents and Public Health / Article 31 bis of the TRIPS Agreement
Patents and Public Health / Article 31 bis of the TRIPS Agreement
Contents
Chapter
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Page
2–16
Titelei/Inhaltsverzeichnis
2–16
Details
17–18
Chapter 1 Introduction
17–18
Details
19–25
Chapter 2 Patents and society
19–25
Details
26–28
Chapter 3 The legalising policy thoughts in the Public Health Declaration
26–28
Details
29–41
Chapter 4 The circumstances leading up to the Public Health Declaration
29–41
29–30
A. Introduction
29–30
Details
30–41
B. The events preceding the Public Health Declaration
30–41
30–34
I. The GATT system and the Uruguay Round
30–34
Details
34–41
II. The implementation of the TRIPS Agreement
34–41
Details
42–155
Chapter 5 An analysis of the TRIPS Agreement
42–155
42–47
A. Nature and scope of the TRIPS Agreement
42–47
Details
47–69
B. The object and purpose of the TRIPS Agreement
47–69
47–51
I. An analysis of the preamble
47–51
Details
51–53
II. An analysis of Article 7 TRIPS
51–53
Details
53–56
III. An analysis of Article 8.1 TRIPS
53–56
Details
56–58
IV. An analysis of Article 8.2 TRIPS Agreement
56–58
Details
58–60
V. The influence of the international customary rule of interpretation on the object and purpose provisions
58–60
Details
60–65
VI. The role of ‘flexibility’ in the object and purposes of the TRIPS Agreement
60–65
Details
1. The flexibilities found in the object and purposes provisions
Details
2. The role of the object and purpose provisions in flexibilities found in other TRIPS provision
Details
3. The relevance given to the role of flexibility in the object and purpose provisions by the Member States
Details
65–68
VII. The role of health in the object and purpose of the TRIPS Agreement
65–68
Details
68–69
VIII. Other influences on the object and purpose of the TRIPS Agreement
68–69
Details
69–154
C. The material provisions of the TRIPS Agreement
69–154
69–85
I. The subject matter of patents
69–85
Details
1. Article 27.1 of the TRIPS Agreement
Details
2. Article 27.2 of the TRIPS Agreement
Details
a) Commercial exploitation
Details
b) Necessity
Details
c) Discrimination and differentiation
Details
d) Implementation restrictions relating to the Article 27.2 exclusion
Details
3. Conclusion
Details
85–86
II. Rights conferred to the patent holder
85–86
Details
86–145
III. The withdrawal and limitation of rights conferred
86–145
Details
1. Revocation
Details
2. Limited exceptions
Details
3. Compulsory licenses
Details
a) General
Details
aa) The compulsory license system
Details
bb) Grounds for compulsory licenses
Details
cc) Discrimination
Details
dd) Causality approach
Details
ee) The relationship between Article 31 of the TRIPS Agreement and Article 5A(4) of the Paris Convention
Details
ff) Commercial use of compulsory licenses
Details
b) Article 31 (a)
Details
c) Article 31 (b), first sentence
Details
d) Article 31 (b), second sentence
Details
aa) Extreme urgencies and national emergencies
Details
bb) Public non-commercial use
Details
e) Article 31 (c)
Details
aa) Scope
Details
bb) Duration
Details
f) Article 31 (d)
Details
g) Article 31 (e)
Details
h) Article 31 (f)
Details
i) Article 31 (g)
Details
j) Article 31 (h)
Details
k) Article 31 (i and j)
Details
l) Article 31 (k)
Details
m) Conclusion
Details
145–149
IV. Disclosure
145–149
Details
149–154
V. Exhaustion
149–154
Details
154–155
D. Conclusion
154–155
Details
156–185
Chapter 6 The Public Health Declaration
156–185
156–161
A. The scope of the Public Health Declaration
156–161
156–159
I. Clarification of the relationship between the TRIPS Agreement and public health
156–159
Details
159–160
II. Countries without domestic productions facilities
159–160
Details
160–161
III. The postponed implementation of certain TRIPS-obligations
160–161
Details
161–163
B. The legal status of the Public Health Declaration
161–163
Details
163–185
C. The effect of the Public Health Declaration on the TRIPS Agreement
163–185
163–169
I. The scope and purpose
163–169
Details
1. The customary rules of interpretation
Details
2. The Public Health Declaration and Articles 7 and 8 of the TRIPS Agreement
Details
3. The Public Health Declaration and the right to health
Details
4. Conclusion
Details
169–178
II. The material obligations
169–178
Details
1. Exhaustion
Details
2. Compulsory licenses
Details
a) The flexibilities in paragraph 5 of the Public Health Declaration
Details
b) Paragraph 5(b) of the Public Health Declaration
Details
c) Paragraph 5(c) of the Public Health Declaration
Details
d) Subsequent developments
Details
e) Conclusion
Details
178–185
III. The extension of the transitional period for LDCs
178–185
Details
1. Paragraph 7 of the Public Health Declaration
Details
2. The TRIPS Council decision extending the transition period
Details
3. The General Council waiver of Article 70.9
Details
185–185
IV. Member States without domestic pharmaceutical production facilities
185–185
Details
186–222
Chapter 7 The solution to the paragraph 6 dilemma
186–222
186–190
A. The identification of the paragraph 6 issues
186–190
186–187
I. The scope of paragraph 6
186–187
Details
187–188
II. Manufacturing capacity
187–188
Details
188–188
III. Insufficient or no capacities
188–188
Details
188–189
IV. Pharmaceutical sector
188–189
Details
189–189
V. Effective use of the compulsory license system
189–189
Details
189–190
VI. Potential paragraph 6 solutions
189–190
Details
190–218
B. The 30 August 2003 decision
190–218
190–197
I. The legal effect of the Decision and the Chairman’s Statement
190–197
Details
1. The waivers in the Decision
Details
2. The Decision’s moratorium
Details
3. The Chairman’s Statement
Details
197–198
II. The scope of the Decision
197–198
Details
198–217
III. The legal implications of the Decision
198–217
Details
1. The pharmaceutical product
Details
2. Eligible countries
Details
a) The exporting Member State
Details
b) The importing Member State
Details
c) Conclusion
Details
3. Safeguards
Details
a) Safeguards inherent to the system
Details
b) General safeguards
Details
4. Transfer of technology
Details
217–218
IV. Procedure for the adoption of a final solution
217–218
Details
218–222
C. Article 31 bis of the TRIPS Agreement
218–222
Details
223–247
Chapter 8 The realisation opportunities afforded by the Public Health Declaration
223–247
223–228
A. Norway
223–228
Details
228–234
B. Canada
228–234
Details
234–236
C. The Netherlands
234–236
Details
236–238
D. India
236–238
Details
238–242
C. EC
238–242
Details
242–247
F. Related measures taken to reflect the Public Health Declaration
242–247
242–242
I. International and multilateral policies and measures
242–242
Details
242–245
II. Bilateral policies and measures
242–245
Details
245–247
III. National policies and measures
245–247
Details
247–247
G. Conclusion
247–247
Details
248–250
Chapter 9 Definitive consequences of the Public Health Declaration
248–250
Details
251–261
Bibliography
251–261
Details
262–267
Cited treaties, legislation and similar legal documents
262–267
Details
268–271
Cited cases
268–271
Details
272–274
Annex I: Public Health Declaration
272–274
Details
275–281
Annex II: 30 August 2003 Decision
275–281
Details
282–290
Annex III: The Article 31 bis Amendment
282–290
Details
291–292
Annex IV: Examples of royalty rates in compulsory licensing & related cases
291–292
Details
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Patents and Public Health , page 218 - 222
Article 31 bis of the TRIPS Agreement
Autoren
Andrew Law
DOI
doi.org/10.5771/9783845212654-218
ISBN print: 978-3-8329-4078-2
ISBN online: 978-3-8452-1265-4
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