ISSN (Print) - 0012-9976 | ISSN (Online) - 2349-8846

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Compulsory Licence for Diabetes Drug

Legality of Lee Pharma’s Application

This article examines the legality of the Indian pharmaceutical company Lee Pharma's application for compulsory licence for Saxagliptin (Onglyza and Kombiglyze), an anti-diabetes drug, the patent for which is held by the Swedish multinational company AstraZeneca. What are the merits of the prima facie view taken by the controller of patents and the possibility of Lee Pharma getting the licence under the Indian patents law?

Balancing the need to protect the patent rights of multinational pharmaceutical companies, with the need to ensure access to essential medicines is one of the most pressing challenges in India after the introduction of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Against this backdrop, Lee Pharma, a Hyderabad-based domestic pharmaceutical company, submitted an application (on 29 June 2015) for compulsory licence for Saxagliptin (Onglyza and Kombiglyze). The patents for this diabetes drug is held by the Swedish MNC AstraZeneca (Lee Pharma 2015). The Controller of Patents (henceforth the controller) in its notice of 12 August 2015 to Lee Pharma said that a prima facie case has not been made out for the order of compulsory licence (Controller of Patents 2015). Lee Pharma has requested the controller for a hearing in the matter.

Lee Pharma’s move is the third instance for a compulsory licence application in India after the TRIPS.1 Before the Hyderabad-based pharma company made its application, Natco Pharma applied successfully for a compulsory licence application for Bayer’s Nexavar while BDR’s application for Bristol–Myers Squibb’s (BMS) Dasatinib was rejected.

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