Updated on 5 November 2012
Trouble for Roche - IPAB revokes patent for pegylated interferon alfa-2a (Pegasys)
New Delhi: India's Intellectual Property Appellate Board (IPAB) has revoked a patent granted in India to F Hoffmann-La Roche (Roche) for pegylated interferon alfa-2a (Pegasys). Pegasys is a medication for hepatitis C, and is also the first ever product patent that was granted following the adoption of the TRIPS regime in 2006.
This comes close on the heels of another patent being revoked, that of Pfizer for its drug Sunitib. The patent, which was contested by Cipla, was revoked only last month by the IPAB, as it lacked an inventive step. Over the past year, the Indian patent system have seen many decisions such as the grant of the first-ever compulsory license in India for Bayer's anti-cancer drug Nexavar.
Talking about the impact of this judgement, Mr Anand Grover, senior counsel and director, Lawyers Collective HIV/AIDS Unit, said that, "This victory will facilitate early entry of generics, which is likely to lower the prices. If this happens, millions suffering from hepatitis C, both globally and in India, will benefit."
Patients with chronic hepatitis C, who need a six-month course of treatment of Roche's pegylated interferon alfa2a, have to purchase it at a cost of approximately $8,752.38 (Rs4,36,000 ), which is also available at a discounted price of $6,313.28 (Rs3,14,496). This has to be taken in combination with ribavarin, which alone costs $946.70 (INR 47,160). Earlier in 2009, the patent office rejected the post-grant oppositions filed by Sankalp and an Indian company and upheld the validity of Roche's patent. Sankalp then filed an appeal before the IPAB challenging this decision, thus finally succeeding in the getting the patent revoked.
Another important decision made by the IPAB, which could have far reaching consequences, was the ruling that a patients' group can challenge the validity of granted patents. Earlier Roche had challenged Sankalp's standing to file the post-grant opposition as well as the appeal, arguing that because Sankalp was not a business competitor or a researcher in the sector, it could not have challenged its patent at all.