Novartis, Sun Pharma Gleevec patent battle moves to U.S.

Novartis ($NVS) has struggled unsuccessfully for years for intellectual property rights in India over cancer drug Glivec. Now, it will have to fight for patent protection in the U.S. as well. Indian drugmaker Sun Pharma has sued the Swiss drug giant, demanding rights to launch a copycat version of the leukemia medicine, marketed as Gleevec in the U.S., before its patent expires., citing an industry source, says Sun has sued Novartis in the District Court of New Jersey in search of a declaratory judgment that would allow the Mumbai-based company to sell its generic in advance of Novartis' patent expiration. According to the Rediff source, Sun Pharma claims Novartis missed its 45-day opportunity to file an infringement suit after being informed of Sun's Abbreviated New Drug Application.

Gleevec contributed $4.7 billion to Novartis' sales in 2012, Rediff reports, and the company is sticking up for itself. "Patents are vital to the ability of innovative companies like Novartis to invest in high-risk research to advance breakthrough treatments for patients without treatment options or hope. We have confidence in the integrity of the Gleevec patent and will vigorously defend our intellectual property rights," the company said in response to a query from Business Standard

After a hard-fought battle, Novartis ultimately lost out to Sun in India over its Glivec patent, one of many such IP cases that has made some Big Pharma players think twice about investing in India's burgeoning market despite its growth potential. Roche ($RHHBY) lost patent protection last November for its hep C treatment Pegasys, while Bayer was forced to license its cancer drug Nexavar to Indian company Natco, which then launched a cheaper version. Pfizer ($PFE) also saw its patent for cancer med Sutent revoked, but earlier this month India's Intellectual Property Appellate Board decided to reconsider, citing an affidavit that mistakenly went unreviewed in its decision.

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