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India rejects Pfizer’s patent application for cancer drug

The Patent Controller has rejected the international pharmaceutical company’s application for lack of inventive step, reports The Business Standard

Monday’s holding is the second time that the Patent Office has ruled against Pfizer’s patent for its Sutent (sunitinib) anti-cancer drug. Last October, the Patent Controller made a similar finding after domestic generic manufacturer Cipla filed a post-grant opposition to the patent (patent number IN209251). An appeal to the Supreme Court reinstated the patent with orders for the Controller to rehear the matter.

Pfizer had also filed for an injunction with the Delhi High Court to stop Cipla’s sale of its generic version, which costs roughly one-fourth of Pfizer’s Rs196,000 ($3600) price for a 45-day treatment. The Delhi High Court stayed its hearings pending the Patent Controller’s ruling.

A spokesperson for Pfizer says that the company plans to appeal, and that it “remain(s) concerned about the environment for innovation and investment in India”.

Cipla was represented by Singh and Singh.

Pfizer has faced multiple challenges to its Sutent patent. In 2008, it successfully withstood an application by Natco for a compulsory licence on the grounds that there was a public health crisis in Nepal.

Natco later became the first company to receive a compulsory licence in India after it received one last March for Bayer’s Nexavar (sorafenib), a drug for treating kidney cancer.

For more on this case and what it means for pharmaceutical patents in India, come to Managing IP's India IP and Innovation Forum in New Delhi on March 7.

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