IPAB sets aside Sutent patent rejection

India’s Intellectual Property Appellate Board (IPAB) has set aside a decision revoking a Pfizer-licensed patent directed to cancer drug Sutent.

Pharmaceutical company Pfizer markets Sutent (sunitinib), a drug used to treat kidney cancer, the patent for which was granted to now-defunct drug company Sugen in 2007.

Indian drug-maker Cipla opposed the patent in 2008, and the country’s patent office revoked it in September 2012 on the grounds of obviousness.

Pfizer later appealed to Delhi’s High Court, which granted an injunction blocking Cipla from selling generic versions of Sutent. Cipla appealed to India’s Supreme Court, and after the case went back to the patent office, the controller general affirmed the rejection of the Sutent patent in February this year. The injunction against Cipla was lifted.

On appeal by Pfizer, the IPAB has now set aside the patent office’s ruling and asked it to re-assess the case because the opposition board’s recommendations, which the patent controller relied on to revoke the patent, did not consider an affidavit filed by Pfizer.

Until only recently, patent controllers have been required to hand the opposition board’s recommendations to both parties, allowing them to work out whether the board had reviewed all of their documents.

During the appeal process in this case, Pfizer realised that one of its affidavits was not considered by the board, and argued that the document is important for resurrecting its patent covering Sutent.

“According to Pfizer, this is a critical affadivit,” said Ranjna Dutt, partner at Indian law firm Remfry & Sagar.

She added: “The IPAB has suggested that the members of the opposition board should preferably be different from the ones who passed the earlier recommendations, but has been categorical in directing that the same controller cannot decide the opposition,” she said.

Mohan Dewan, principal at law firm R.K Dewan & Co in Mumbai, said he expects the patent office to re-hear the case in about three months. A final ruling, he said, should be handed down in October this year.

“I do not believe the judgment will be different,” he said. “This is not a sensationalist turnaround.”

But Dutt said it was hard to predict what will happen in the case: “It all depends on how the new examiner will review all the documents. There could be more discussion on the inventive step aspects.”

Neither Pfizer nor Cipla responded to a request for comment.