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The Indian Supreme Court will hear arguments in Novartis v Union of India on November 29.  The case centers around section 3(D) of India’s patents act, which prohibits the patenting of a “new form of a known substance which does not result in the enhancement of the known efficacy of that substance.”  In 2006, Novartis was denied a patent on the anti-cancer drug imatinib mesylate on the grounds that it was a new form of an existing drug.  The company unsuccessfully challenged the Constitutionality of Section 3(D), and it lost an appeal of denial of its the patent application.  Novartis is now asking the Supreme Court to define of “efficacy” in a way that would include increases in bioavailabiliy, rather than the more stringent definition of “therapeutic effect in healing a disease,” which was applied by the Madras High Court.

Médecins Sans Frontières warned in a statement that “If Novartis succeeds, India may end up granting far more patents than required under international trade rules or envisioned by India’s lawmakers, with huge ramifications on generic production and the availability of affordable medicines for people across the developing world.”

Sources:

• India Patents (Amendment) Act, 2005, from WIPO Lex Database
• Ramesh Shankar for Pharmabiz.com. “Supreme Court to hear Novartis case on Section-3(d) of Indian patent law on Nov 29.” November 25, 2011.
• Leena Menghaney, Médecins Sans Frontières. “India under pressure to give up on generic production – FTA negotiations and Novartis case – next three months critical.” November 28, 2011.