Compulsory License and Access to Medicines: The Indian Experience to Date

Monday, September 16, 2013


Wasserstein Hall B015

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Presented in cooperation with the Harvard University South Asia Institute, Harvard Law School Law & International Development Society, Harvard UAEM (Universities Allied for Essential Medicines), and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics

V. Lakshmikumaran
Founder and Managing Partner
Lakshmikumaran & Sridharan, Attorneys

Mr. V. Lakshmikumaran is the founder and managing partner of Lakshmikumaran & Sridharan (L&S). L&S is one of India’s elite law firms, serving several Fortune 500 and top Indian companies in international trade, tax, intellectual property, and corporate matters. Chambers Asia Pacific recently declared several L&S’s practices to be in the top-tier and exclaimed that Mr. Lakshmikumaran “possesses a virtual monopoly when it comes to indirect tax litigation” in India. Besides corporate and tax matters, L&S handles high-profile intellectual property (IP) cases and has been retained by the Indian government to argue several cases on its behalf before the World Trade Organization (WTO).

Mr. Lakshmikumaran’s talk will focus on India’s compulsory licensing regime, which can be used to mandate that an IP holder license its IP right to another company or individual for a fee. In 2012, India’s government first exercised its power to issue a compulsory license, allowing a generic pharmaceutical company, Natco, to manufacture a version of the cancer-fighting drug, Nexavar, developed by Bayer, after finding, among others, the branded drug to be cost-prohibitive for India. This action is being closely watched worldwide because of the important role played by Indian companies in supplying affordable generic versions of medicines globally. In March 2013, the Indian Patent Appeals Body rejected an appeal from Bayer; the case is now before the High Court of Bombay. If upheld, the development of this regime may be a game changer for global health, opening the way for other Indian generic pharmaceutical companies to seek compulsory licenses to manufacture cheaper version of essential drugs. In fact, further applications have already been filed against Bristol-Meyers Squibb and Roche for other cancer-fighting drugs. Mr. Lakshmikumaran will discuss recent global trends in compulsory licensing, examine the Indian legal framework, and discuss the lessons of the Nexavar dispute. He will also explore the compatibility of India’s compulsory licensing regime with the WTO’s TRIPS Agreement.