India revokes patent for Pfizer’s Sutent

Mumbai: The Indian patent office has revoked Pfizer Inc.'s local patent for its cancer drug Sutent, delivering yet another setback to multinational drug companies over the contentious issue of intellectual property (IP) rights.

Revoking the patent in an order signed on 24 September, but made public on Thursday, Nilanjana Mukherjee, assistant controller of patents and designs at the Patent Office, Delhi, said, "I conclude that the invention that is claimed in the patent (No. 209251 granted on application No. IN/PCT/2002/00785/DEL) does not involve any inventive step...and hence not patentable under section 2 (1) j of the Patents Act, 1970 (Indian Patent Act)."

Mukherjee headed the post-grant opposition board formed to hear a case filed by generic drug makerCipla Ltd challenging the local patent for Sutent, a liver and kidney cancer drug sold by Pfizer worldwide.

The oncology drug, known as Sunitinib Malate in generic terms, was developed by US drug makersSugen Inc. and Pharmacia and Upjohn Co. and licensed to Pfizer for marketing it globally. It was granted a patent in India in 2007 and Cipla opposed the patent grant the following year.

Other local drug makers including Natco Pharma Ltd too opposed the patent.

Sutent costs about Rs.1.96 lakh for a 45-day treatment, though Pfizer offers it with discounts to some under its patient access programme. Cipla has priced its copy of the drug, branded Sunitib, lower by almost one-tenth.

The patent revocation takes away the likely threat of a patent infringement case against Cipla, and paves the way for more local firms to enter the market with this drug.

This is the second major victory for Cipla. In September, the Delhi high court dismissed a patent infringement case against it by Swiss drug maker F. Hoffmann-La Roche Ltd.

Reacting to the development, a Pfizer spokesperson said on Thursday the company will appeal against the ruling before the Intellectual Property Appellate Board.

"We believe the decision undermines intellectual property rights in India and we will vigorously defend our basic Sutent patent," Jazz Tobaccowalla, managing director, Pfizer India, said in a statement.

"Through patient assistance programmes such as SPAP (Sutent Patient Assistance Programme), and working closely with our stakeholders, Pfizer will continue to improve the availability of innovative medicines to patients across socio-economic levels," he added.

Cipla's lawyer S. Majumdar, who argued the post-grant opposition matter, said, "Lack of inventiveness in the patent claim of Sutent was the main objection that we raised in the opposition and the patentee could not deny this with the support of scientific evidences before the opposition board."

Cipla joint managing director S. Radhakrishnan declined to comment on the development, saying he was yet to get complete details of the order.

"The controller held that the invention claimed in the impugned patent under opposition is obvious," Rajiv Kumar Choudhari, a patent lawyer, wrote about the development on his blog Spicy IP on Thursday. "And the only logical conclusion that can be arrived at from the above comparison of the compounds of the patent vis-a-vis the compounds of the prior art, is that the claimed compound has not been shown to involve an inventive step."

Natco Pharma, which won the country's first compulsory licence for making and selling a generic version of German drug maker Bayer AG's patented cancer drug Nexavar earlier this year, had in 2009 applied for a compulsory licence for making and exporting a copy of Sutent.

Though Natco wanted to export the cheaper version of the cancer drug to Nepal and a few other less-developed countries, it had to withdraw the application as it could not get necessary documents from the importing countries to support the export requirements.

Cipla's shares closed 3.86% lower at Rs.366.40 per piece on Thursday on BSE, while the benchmark Sensex rose 1% to 19,058.15 points.