COMPULSORY LICENSING FOR PHARMACEUTICAL PATENTS: EXAMINING THE CONSISTENCY OF THE LOCAL WORKING REQUIREMENTS UNDER SECTION 84 OF THE INDIAN PATENT ACT WITH THE TRIPS AGREEMENT AS A MODEL FOR GHANA

Abstract

PhD thesisCompulsory licensing would offer Ghana a practical means to mitigate the high costs and shortages of medicines resulting from the failure of patentees to work their patented medicines locally. Article 5(A) of the Paris Convention as incorporated into Article 2 of TRIPS is consistent with Section 84 of the Indian Patents Act allows for the granting of compulsory licences to remedy failure to work. Where national laws permit, Article 31 of TRIPS allows the use of compulsory licences on any grounds subject to certain conditions. Although, the Doha Declaration on TRIPS and Public Health confirmed this position, there are contradictory opinions that the non-discrimination principle under Article 27(1) of TRIPS prohibits the granting of compulsory licences for failure to work. To the extent that Article 2 of TRIPS incorporates Article 5(A) of the Paris Convention provision, which is consistent with Section 84, the question that arises is whether Section 84 is consistent with TRIPS. Therefore, the aim of this thesis is to draw on applicable sources of law in an attempt to examine the consistency of Section 84 with TRIPS. This work is based on the hypothesis that Section 84, which allows the granting of a compulsory licence provided that the patented invention has not been worked in the territory of India, is consistent with TRIPS and would therefore provide a suitable model for Ghana. This argument is enhanced by the fact that in 2012 India invoked Section 84 in granting a compulsory licence to Natco and to date the consistency of this decision with TRIPS remains unchallenged within the World Trade Organisation Dispute Settlement system. The overriding implication is that if India got away with this decision, then it is probable that Ghana could implement a model similar to Section 84 to obtain affordable medicines without any legal challenge