The NATCO Decision: Bringing into the Indian Patent Practice the TRIPs Flexibility of Compulsory Licensing
11 Pages Posted: 2 Jun 2012 Last revised: 10 Jun 2012
Date Written: April 20, 2012
Compulsory License (CL) under the Patent system is an involuntary contract between a willing buyer and an unwilling seller imposed and enforced by the State. The WTO states that compulsory licensing is when a government allows someone else to produce the patented product or process without the consent of the patent owner. It is one of the flexibilities on patent protection included in the WTO’s agreement on intellectual property — the TRIPS.
The current system of compulsory licensing for patents in India, contained in Chapter XVI of the Patents Act, 1970 (S.82 to S.94) was introduced by the Patents (Amendment) Act of 2002, slightly amended by the Patents (Amendment) Act of 2005, and was designed to be TRIPS-compliant. The 2005 amendment is of predominance since it introduced the product patent regime for pharmaceuticals for the first time in India and consequently increased the patent scope with concerns of compulsory licensing assuming greater significance. The compulsory licensing provisions under the Indian Patent regime, until now, have largely been a subject of legal and academic debates, open to numerous interpretations owing to the non-grant of a single compulsory license for a pharmaceutical product despite several attempts thereof.
The recent 2012 judgment of NATCO Pharma Ltd. v. Bayer Corporation by the Controller of Patents, Mumbai is one of the first of its kind in the history of Patents Act, 1970, wherein the provisions of Section 84 have been invoked by the Applicant for seeking the grant of a compulsory license. It has laid down the very foundation stone of the jurisprudence of compulsory licensing in patents with respect to pharmaceutical products in India and has principally clarified the legislative intent behind various key provisions governing compulsory licensing under the Indian Patents Act, 1970 read together with the TRIPs Agreement providing guidance to any further construal in this direction.
The objective of this paper is to examine the compliance of the Nexaver compulsory license grant with the TRIPS requirements and in view of the same to assess the consistency of the Indian compulsory licensing regime with the TRIPs obligations.
Keywords: NATCO, TRIPS, Compulsory Licensing, Patents, Section 84, Flexibility
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