Protection of Regulatory Data Under Article 39.3 of Trips: The Indian Context

Abstract

The appropriate standard of protection for regulatory data (pharmaceutical and agro-chemical) under Article 39.3 of TRIPS is the subject of considerable controversy. This paper finds that the minimum standard mandated by Article 39.3 is neither one of data exclusivity (as argued by the US and EU) nor one of 'permissive reliance' (as argued by Professor Carlos Correa and others).

Rather the term 'unfair commercial use' in Article 39.3 in effect envisages a 'compensatory liability' model, whereby regulatory data that complies with the pre-requisites of Article 39.3 (i.e. it relates to pharmaceutical or agricultural new chemical entities, is undisclosed and its origination involves considerable effort) cannot be used by any person, including a regulatory authority that uses such information to approve another product, without some compensation being paid to the originator of such data. The paper discusses some examples of such compensatory liability models.

The paper also finds that Indian law does not currently comply with Article 39.3.

Keywords: regulatory data protection, data exclusivity, pharmaceuticals, drugs, Article 39.3, TRIPS, Indian law, compensatory liability model, compulsory licensing

JEL Classification: O34, K33