Novartis lawsuit (re India patent law & access to medicine)
|In 1997, Novartis, the main producer of a drug used for treating blood cancer, filed a patent application in India. Novartis argued this new form of the drug was significantly different to be considered an invention. The court rejected Novartis's argument and found the company failed to prove improved therapeutic efficacy of the new version.|
Worldwide, Novartis is the main producer of Glivec, a drug used for treating blood cancer. The company has sought a patent that would give it the exclusive right to produce Glivec, stopping production by the generic drugs industry in India.
In 1997, when India did not allow protection for pharmaceutical products, Novartis filed a patent application in the Chennai Patent Controller’s office for what Novartis claimed was a new form of Glivec. The application was kept on hold until 2005 when India amended its patent system. In January 2006, the Patent Controller rejected the application, stating that the Patents Act does not allow protection for products that are a modified version of an existing drug, and that in this case the new version lacked novelty. In May 2006, Novartis challenged this decision in the Chennai High Court.
In August 2007, the Chennai High Court transferred the case to the newly-created Patent Office in the Intellectual Property Appellate Board. In June 2009, the Appellate Board disagreed with the Patent Controller and found that Glivec was new and involved an inventive step. However, it still denied patent protection because it said Novartis did not demonstrate that the new product was more effective than the previous one, as laid required by the Patents Act.
Novartis petitioned the Supreme Court to review the Intellectual Property Appellate Board’s decision. The company argued that Glivec had satisfied key criteria including novelty, and hence it should be considered an “invention” under the Patents Act. In April 2013 the Supreme Court upheld the Appellate Board’s decision and its finding that Novartis failed to prove improved therapeutic efficacy of the new version.
- “To patent or not to patent? the case of Novartis’ cancer drug Glivec in India”, Ravinder Gabble, Dalla Lana School of Public Health, Univ. Toronto, & Jillian Clare Kohler, Associate Professor & Director Global Health, Leslie Dan Faculty of Pharmacy, & Munk School of Global Affairs, Univ. Toronto, in Global Health, 6 Jan 2014
- “5 Take-Home Points From India’s Historic Novartis Patent Case”, Arvind Subramanian, Senior Fellow at Peterson Institute for International Economics & Senior Fellow at Center for Global Development, in Asian Scientist, 29 Apr 2013
- “Why Novartis case will help innovation”, Achal Prabhala, Sudhir Krishnaswamy, Azim Premji Univ., & Dr. B.R. Ambedkar, Visiting Professor of Indian Constitutional Law at Columbia Law School, in The Hindu, 15 Apr 2013
- “India’s Patently Wise Decision” Joseph E. Stiglitz, Nobel laureate in economics, Columbia Univ., & Arjun Jayadev, Univ. of Massachusetts, in Project Syndicate, 8 Apr 2013
- “Indian Supreme Court Delivers Verdict in Novartis Case”, NGO Pulse (So. Africa), 2 Apr 2013
- “Landmark verdict gives big boost to cancer patients”, J. Venkatesan, Hindu, 1 Apr 2013
Novartis: “Supreme Court denial of Glivec patent clarifies limited intellectual property protection and discourages future innovation in India”, 1 Apr 2013
Supreme Court of India: “Novartis AG v. Union of India & Others”, Judgment, 1 Apr 2013