A Critique of 'Report on Steps to Be Taken by Government of India in the Context of Data Protection Provisions of Article 39.3 of TRIPS Agreement' [Satwant Reddy Report] - With a Focus on Agrochemicals

Abstract

The Department of Chemicals and Petrochemicals, Government of India was entrusted with the task of recommending appropriate steps to be taken in the context of Article 39.3 of the TRIPS Agreement and the report was submitted in May 2007 (hereinafter: the Committee report), recommending that applications for approval of ‘me too’ agrochemical products should not be granted for a period of 3 years after the approval of a new product for the first time in India thereby allowing the first registrant for an agrochemical to enjoy a period of monopoly. However a similar period of exclusivity was not recommended for pharmaceuticals.

The recommendations for the 3 year period of exclusivity (now enhanced to 5 years by the Standing Committee on Agriculture) have been incorporated in The Pesticides Management Bill, 2008, which is currently pending consideration of Parliament. On the other side, the EU, which is currently negotiating a Free Trade Agreement with India, is reportedly pressing the case for extending similar exclusivity.

This critique is primarily an analysis of the reasoning in the Committee report from a legal perspective, particularly its interpretation of Article 39.3 of the TRIPS Agreement. As its recommendation of data exclusivity for agrochemicals has been acted upon through administrative instructions and is also pending consideration in a proposed legislation, this critique is largely restricted to this recommendation on agrochemicals, and does not deal with pharmaceuticals, except in the passing.

Keywords: Data Exclusivity, Test Data Protection, EU-India FTA, Article 39.3, TRIPS Agreement, Pharmaceutical, Agrochemical

JEL Classification: K20, K33