Novartis battle for cancer drug patent protection in India

Hannah Blake

pharmaphorum

Swiss pharmaceutical company Novartis AG goes to India’s Supreme Court this week, to seek patent protection for its cancer drug, Gilvec. Lawyers will make their final arguments in an intellectual property hearing, which could result in a change in India’s healthcare landscape.

The legal battle began six years ago, after India rejected Novartis’ application for a patent, as they believe Gilvec (imatinib) is not a new compound, but a modified version of an existing compound, which goes against India’s patent law. The drug was approved in the United States in 2001 and is sold under the trade name, Gleevec.

If Novartis were to win this battle, while it would not affect the company financially, the decision would affect India’s generic pharma market, which currently supplies affordable versions to 1.2 billion people. In March, Bayer AG’s cancer drug, Nexavar (sorafenib), was stripped of its patent on the grounds that its expensive cost put it out of the reach of ordinary people.

The hearing is expected to last several weeks, with a verdict a month or two later. The outcome of this high-stake patent battle will determine how much protection foreign companies can get from India competitors that make lower-cost, generic versions of their products.