Healthy Skepticism Library item: 11130

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Publication type: news

Daniel R.
Novartis: India High Court denies a Glivec-related challenge
MarketWatch 2007 Aug 6
http://www.marketwatch.com/News/Story/Story.aspx?guid=%7b28DBBD2F-95A0-434B-B73A-E2066046C3D7%7d&siteid=yhoo&dist=yhoo

Full text:

Novartis Ltd., the Basel drugmaker, said India’s high court in Chennai denied its challenge to a section of the country’s patent law. Under that section of Indian law, Novartis in 2006 had been denied a patent for Glivec, which treats chronic myelogenous leukemia and gastrointestinal stromal tumors. A spokeswoman for Novartis said that the law requires that to receive patent protection, a drug must be a “new chemical entity.” Glivec, however, is based on incremental innovation in drug science, and the section of India law that Novartis is challenging denies patent protection to such drugs, the Novartis spokeswoman said. Novartis argues that in denying such protection, India is out of compliance with the rules of the World Trade Organization, which it joined in 2005. India’s High Court deferred the question of whether the law is out of compliance with the WTO to that agency’s forum. And the question of patent protection for Glivec will now be decided by a new agency in India, the Intellectual Property Appellate Board. Novartis is also asking the High Court to appoint a new technical member to that board because the current one headed the country’s patent office when the Glivec patent application was rejected. Under a patient-assistance program, Novartis said it provides the drug free to some 99% of the 7,500 patients who take it in India.