On the back of our recent post concerning the grant of compulsory licences for HIV/AIDS and Hepatitis B medicines in Indonesia, the Indian Patent Appellate Board has now revoked Roche’s patent for its hepatitis C drug, Pegasys, on the ground that it was not sufficiently inventive and “increased efficacy” required by India’s Patent law was not proved. The decision is significant as the Appellate Board held that an NGO had standing to challenge the validity of the previously granted patent.
Roche was granted its patent in relation to Pegasys in 2006 after India amended its patent laws to bring the regime in line with India’s obligations under the TRIPS Agreement. A post-grant opposition was subsequently filed by Sankalp Rehabilitation Trust (“Sankalp”) in 2007. Sankalp is an NGO that provides care and support for street-based drug users and seeks to prevent the spread of HIV/AIDS in Mumbai.
Under the Indian Patents Act 1970, section 25(2) provides that a post-grant opposition can only be brought by a “person interested” (as opposed to pre-grant oppositions, which can be brought by “any person”). Roche submitted that Sankalp was not a “person interested” as required by the Act and thus could not bring the opposition. This was rejected by the Appellate Board, which found that Sankalp, a society which works for the community of Hepatitis C sufferers in need of the patented medicine, had a sufficient interest to commence the opposition proceedings. The court indicated that it would construe the standing requirement broadly, noting that “public interest is a persistent presence in intellectual property law and will not melt into thin air, nor dissolve”. The Appellate Board cautioned that it was as much against the public interest to allow unworthy patents to be on the Register as it is to prevent third parties having no interest from attacking a deserving patent.
This decision clarifies the ability of community groups and NGOs with a sufficient interest in the relevant patient groups to challenge granted patents in India. It will be interesting to see whether any such organisations commence fresh challenges to granted pharmaceutical patents in India. Roche may appeal the decision.