Introduction 1
1. Protection of Undisclosed Information
- A Common Law Perspective 3
Development of the Concept of Trade
Secret under Common Law 3
Justification for Trade Secret Protection 4
Protection of Testdata under Common Law 6
2. Protection of Testdata under TRIPS Agreement
Paris Convention and Undisclosed Information 9
Protection of Undisclosed Information under TRIPS Agreement 11
Protection of Testdata before TRIPS Agreement 12
Data Exclusivity - Conceptual Analysis 13
Data Exclusivity in US and EU 14
Negotiating History of Article 39(3)
of TRIPS Agreement 15
Protection of Testdata under Article 39(3)
- An Analysis 16
Unfair Competition and Testdata Protection 17
Data Entitled Protection 17
New Chemical Entity 18
Considerable Effort 19
Unfair Commercial Use 20
Argument Based on History of
TRIPS Negotiation 22
Implementation of Testdata Protection under
Article 39(3) 23
3. Protection of Testdata - Indian Scenario
Protection of Trade Secrets in India 25
Testdata Requirements under the Drugs
and Cosmetics Act, 1940 26
Testdata Requirement under Insecticides Act, 1968 36
4. Protection of Testdata in India:Pharmaceutical Industry Perspective
Current Status of Pharmaceutical Industry 40
Nature of Testdata Protection 41
Products that Require Testdata Protection 42
New Chemical Entity 43
Considerable Effort 43
Uses that Require Testdata Protection 43
Unfair Commercial Use 44
Compulsory Licensing 45
4. Protection of Testdata in India:Pharmaceutical Industry Perspective
Current Status of Pharmaceutical Industry 40
Proposed Amendments to the
Drugs and Cosmetics Act 47
Proposed Amendments to the Drugs
and Cosmetics Rules, 1945 48
Summary
Proposed Amendments to the Drugs
and Cosmetics Act 53
Proposed Amendments to the Drugs
and Cosmetics Rules, 1945 54
Appendix A: Relevant Provisions of Drugs
and Cosmetics Rules, 1945 56
Appendix B: Relevant Provisions of
Insecticides Rules, 1971 74
BIBLIOGRAPHY 77
Books 77
Articles 77