India revokes patent on Roche's Pegasys

November 02, 2012

India revokes patent on Roche’s Pegasys

Last Updated:November 02, 2012 10:43

India’s Intellectual Property Appellate Board (IPAB) revoked a patent Friday on Roche’s hepatitis C drug Pegasys (peginterferon alfa-2a) on the grounds that it didn’t demonstrate inventiveness. The patent had been issued in 2006 and was the first to be granted under reforms introduced in the country a year earlier.

The original patent was challenged by patient group Sankalp Rehabilitation Trust in 2007 on the grounds that the pegylation process was known. Both Sankalp Rehabilitation Trust’s post-grant opposition challenge and another made by Wockhardt were rejected by the Indian Patent Office, although the patient group appealed the decision.

In its ruling, the IPAB determined that “in the end, the invention is held to be obvious. The appeal is allowed and the grant of Patent No.198952 is set aside.” The IPAB added that the technology involved in producing the drug could be easily replicated by anyone skilled in the process.

Pegasys costs around 360 000 rupees ($6700) for six months of treatment. Eldred Tellis, director of Sankalp Rehabilitation Trust, said “we hope that the absence of [a] patent barrier will spur generic competition to bring down the price of this much-needed drug.”

This is the second patent setback that Roche has faced in India recently, after the Delhi High Court in September dismissed a patent infringement lawsuit filed by the company against Cipla over a generic version of Tarceva (erlotinib).