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.

• The Cuttack Law Times :

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 Gujarat Law Reporter :

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.

                   - 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 

                   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

                   Protection of Trade Secrets in India 25
                   Testdata Requirements under the Drugs
                   and Cosmetics Act, 1940 26
                   Testdata Requirement under Insecticides Act, 1968 36

                   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

                   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

                   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