Novartis Loses Landmark India Patent Case on Cancer Drug Glivec

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Published April 01, 2013

| FOXBusiness

Novartis (NVS) lost a years-long patent battle in India’s highest court on Monday in a decision that health activists say will ensure that impoverished patients continue to receive affordable health care.

The Swiss pharmaceutical giant, however, claims the Supreme Court’s denial of an updated version of Glivec “discourages future innovation in India.”

While the original version of Novartis’ blockbuster cancer treatment was never approved in the world’s second-largest country by population, it has been approved in nearly 40 countries including China and Russia.

“We strongly believe that original innovation should be recognized in patents to encourage investment in medical innovation especially for unmet medical needs," said Ranjit Shahani, vice chairman of Novartis India.

Novartis first applied for patent protection of Glivec in 1998 as a treatment for chronic myeloid leukemia. However, India’s patent office ruled against the patent two years later, arguing the effects of the drug’s active ingredient were known prior to Glivec’s development and thus did not warrant intellectual property protection in India.

Having that exclusivity allows a company to charge more for a treatment and disallows cheaper generics from popping up and stealing market share. As U.S. drug companies lose patent exclusivity of blockbuster drugs as part of a wave of expirations, their bottom lines have been affected, leaving them scrambling to develop new treatments for their pipeline.

Novartis has long claimed Glivec is different because the ingredient transforms the chemical compound to a “beta crystal form,” enabling it to treat cancer more effectively than its predecessors.

The company, which says it has provided more than $1.7 billion worth of Glivec to Indian patients free of charge since it began making donations in 2002, told The Wall Street Journal that the ruling will force it to re-examine the introduction of new drugs there in the future.

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