The Supreme Court of India has rejected the patent application filed by Novartis AG for a beta crystalline form of its cancer drug Gleevec, also known as Glivec, finding that the changed form failed “in both the tests of invention and patentability.” Novartis AG v. Union of India, Nos. 2706-2716 of 2013 (India, decided April 1, 2013).

Recognizing the significance of its ruling, the Court stated that it was “urged to strike a balance between the need to promote research and development in science and technology and to keep private monopoly (called an ‘aberration’ under our Constitutional scheme) at the minimum. Arguments were made about India’s obligation to faithfully comply with its commitments under international treaties and counter arguments were made to protect India’s status as ‘the pharmacy of the world’.” The latter reference is to the nation’s apparent role as the world’s most significant provider of inexpensive generic drugs.

The Court noted that the patent application was submitted during a transition period between two different patent law regimes, so it discussed at some length the development of patent law protections in India and certain proceedings before the World Trade Organization to explain what led to the most recent statutory amendments that were finalized in 2005. According to the Court, “To anyone going through the debate on the Bill, Parliament would appear keenly alive to national interests, human-rights considerations and the role of India as the producer and supplier of drugs to different parts of the world where impoverished humanity is critically in need of those drugs at cheap and affordable prices. Cutting across party lines, member after member from the Opposition benches highlighted the grave risk in creating private monopolies in an area like pharmaceuticals, the abuses to which product patents in pharmaceutical products were vulnerable, and the ploys used by big companies to artificially extend the period of patent to keep competitors out and keep the prices of the patented product high.” The drug at issue here was apparently referred to specifically during floor debate.

The Court then analyzed the patent application under the amended requirements for an “invention” and, in finding that the drug did not qualify, established an intellectual property benchmark in India that multinational drug makers were expected to view as a setback. A cancer-patient advocate, who argued before the Court on his organization’s behalf, reportedly observed that most drugs patented in the United States win patents for minimal discoveries, a practice referred to as “evergreening.” He said, “What is happening in the United States is that a lot of money is being wasted on new forms of old drugs. That will not happen in India.”

A U.S. trade organization representing the interests of pharmaceutical companies issued a statement, saying that the Pharmaceutical Research and Manufacturers of America (PhRMA) “is very disappointed with the Indian Supreme Court’s decision to deny a patent on Glivec. This decision marks yet another example of the deteriorating innovation environment in India. Innovation is critical in meeting unmet needs of patients and is particularly relevant in the context of changing health-care systems.” PhRMA President and CEO John Castellani further noted, “It is critically important that India promote a policy environment that supports continued research and development of new medicines for the health of patients in India and worldwide,” including patent protection. Castellani said that the industry “is committed to working closely with the Indian Government and other stakeholders to find appropriate solutions to this challenge.” See The New York Times, Reuters and PhRMA News Release, April 1, 2013.