A Study On Compulsory Licensing For Pharmaceutical Patents Under Section 84 Of The Patents Act, 1970
R. Afrin Jakhan, LLB (Hons.), Chettinad Academy of Research and Education
ABSTRACT
Patents are supposed to encourage innovation. They try to balance the broad goals of scientific progress with private economic interests, giving inventors exclusive rights to their creations. But honestly, there hasn’t been serious research on how well Section 84 works after the TRIPS agreement, especially when you think about what “reasonable affordability” really means under India’s current drug pricing rules. This paper takes a close doctrinal look at the law digging into statutes, major court cases like Bayer vs. Natco, and real-world data on who can actually access medication to help fill that gap. In the end, the study makes the case for a careful recalibration of licensing triggers, guaranteeing the public’s continued access to life- saving medications while upholding the fundamental principles of patent protection as a motivator for innovation. On March 9, 2012, the Controller General of Patents, acting under Section 84(1) of the Indian Patents Act, 1970, granted Natco Pharma the country’s first and so far, only compulsory licence to produce and market Sorafenib Tosylate, a patented cancer medication sold by Bayer AG under the brand name “Nexavar”. Although two further applications have been mandatory licenses have been issued after this historic decision. Section 92A (1) of the Patents Act, 1970, which enables the production and export of patented pharmaceutical items to nations with insufficient manufacturing capacity to fulfil their public health requirements, is another unique compulsory licensing system that India has implemented. Multinational pharmaceutical companies operating in India and seeking patent protection must develop a clear understanding of the country’s licensing framework and reevaluate their commercial strategies in light of these developments and the significant economic ramifications of compulsory licensing.
Keywords: Compulsory Licensing, Patent Protection, Section 84 (Indian Patents Act), Reasonable Affordability, Access to Medicines, Bayer v. Natco, TRIPS Agreement.
