Study on Testdata Protection in India

This book deals with the nature of obligation cast upon India under Article 39(3) of the Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement to protect testdata submitted by the pharmaceutical and agrochemical industries for market approval. It examines in detail the law relating to trade secret protection under common law and the application of these principles for protecting testdata. The development of the international norms for protection of testdata from Paris Convention to TRIPS Agreement and the different interpretations regarding the nature of obligation under TRIPS are dealt in detail. The analysis of the current Indian law regarding protection of testdata submitted under the Drugs and Cosmetics Act, 1940, Insecticides Act, 1968 along with the divergent views expressed by the Indian Pharmaceutical industries regarding nature of protection is the major focus of the book. The study highlights the inadequacies of the existing Indian law to comply with the obligations under TRIPS Agreement and proposes amendments based on the principles of trade secret protection.

Reviews

Study on Testdata Protection in India was undertaken by the Centre for Intellectual Property Rights Studies, School of Legal Studies, Cochin University of Science & Technology, Cochin, being sponsored by the Department of Commerce, Ministry of Commerce & Industry, Government of India.

The learned authors have done an immense job in the creation of the book before us. Their research work presents the five aspects in five chapters, namely Protection of Undisclosed Information - A Common Law Perspective; Protection of Testdata Under TRIPS Agreement; Protection of Testdata - Indian Scenario; Protection of Testdata in India; Pharmaceutical Industry Perspective and Conclusion. The summary chapter deals with Proposed Amendments to the Drugs and Cosmetic Act and Rules. Appendix-A deals with relevant provisions of Drugs and Cosmetic Rules; whereas Appendix-B concentrates on relevant provisions of Insecticides Rules. The Bibliography points out the pains taken by the learned authors.

We are of the opinion that the Authorities, the Institutions, the Court & the Bar can find the book useful.

- The Cuttack Law Times

This miniature book entirely deals with and delve into the nature and contents of obligation cast upon India as a member signatory of I.P. Rs. in W.T.O., to project the testdata incorporated in Art. 39(3) of T.R.I.P.S. agreement. The Art. 39(3) minutely examines and discusses the intricacies relating to trade secret protection and application of the principles.

The area that needs urgent attention is pharma and agro-industries. Developing as well as under-developed countries feared about the prevailing patent system that producers and manufacturers of life-saving drugs are costly. In some developed countries, pharmaceutical sales are from generic formulations whose patents have already expired. If generic alternatives found place in various therapeutic categories available, the people will get the life-saving drug at affordable price and the adverse effect of T.R.I.P.S. is minimised and the benefits are maximised. This book will be useful to students of law, traders in pharma and agro sectors and members of T.R.I.P.S. for information.

- The Gujarat Law Reporter

Table of Contents:

1. Introduction
Protection of Undisclosed Information
A Common Law Perspective Development of the Concept of Trade
Secret under Common Law
Justification for Trade Secret Protection
Protection of Testdata under Common Law

2. Protection of Testdata under TRIPS Agreement
Paris Convention and Undisclosed Information
Protection of Undisclosed Information under TRIPS Agreement
Protection of Testdata before TRIPS Agreement
Data Exclusivity - Conceptual Analysis
Data Exclusivity in US and EU
Negotiating History of Article  39(3) of TRIPS Agreement
Protection of Testdata under Article  39(3) - An Analysis
Unfair Competition and Testdata Protection
Data Entitled Protection
New Chemical Entity
Considerable Effort
Unfair Commercial Use
Argument Based on History of TRIPS Negotiation
Implementation of Testdata Protection under Article 39(3)

3. Protection of Testdata - Indian Scenario
Protection of Trade Secrets in India
Testdata Requirements under the Drugs and Cosmetics Act, 1940
Testdata Requirement under Insecticides Act, 1968

4. Protection of Testdata in India:Pharmaceutical Industry Perspective
Current Status of Pharmaceutical Industry
Nature of Testdata Protection
Products that Require Testdata Protection
New Chemical Entity
Considerable Effort
Uses that Require Testdata Protection
Unfair Commercial Use
Compulsory Licensing

Summary
Proposed Amendments to the Drugs and Cosmetics Act
Proposed Amendments to the Drugs and Cosmetics Rules, 1945
Appendix A: Relevant Provisions of Drugs and Cosmetics Rules, 1945
Appendix B: Relevant Provisions of Insecticides Rules, 1971

BIBLIOGRAPHY
Books
Articles