Compulsory Licensing Provision under TRIPS: A Study of Roche vs Natco Case in India vis-à-vis the Applicability of the Principle of Audi Alteram Partem

Abstract

In keeping with the relatively new waiver of the requirement of domestic production under Article 31(f) of TRIPS, the Indian Patents Act 1970 was amended allowing for compulsory license in certain exceptional circumstances. Unlike in other sections relating to compulsory licensing in the Indian Patent Act, there is no reference to a patentee being extended the "opportunity of being heard". This appears surprising since it is the generic version of patentee's patented drug which is intended to be manufactured and exported to other countries by a third party. Despite this exclusion, the Indian Controller in the relatively recent Roche vs Natco compulsory licensing case upheld the merit of one of the basic tenets of common law, i.e. no one's interest should be prejudiced without such person being provided with an opportunity of presenting his or her case. In fact, the Controller held that, besides it being fair that the party whose interest is at stake be heard, the submissions of such parties could be of extreme value in arriving at a decision regarding the terms and conditions of grant of a compulsory license. This article enquires whether giving a plain or literal interpretation to a relatively unambiguous statute is all that is expected from an adjudicating authority, or whether it is equally important for such authority to give effect to the cardinal principle of audi alteram partem as far as a patentee when such interpretation could yield results liable to be construed ultra vires the primary intention of the amended provision.