Roche Faces More Opposition Heat!

Sankalp, a Mumbai-based non-governmental organization has filed a post-grant opposition against Roche’s Indian patent covering Hepatitis C drug Pegasys pursuant to section 25(2) of the Patents Act 1970. This is the second post-grant opposition filed against Pegasys patent, after Mumbai-based biopharmaceutical company Wockhardt filed a similar post-grant opposition two months back. Pegasys is the first drug to secure product patent protection status in India after India brought third patent amendment to extend patent protection to pharmaceutical and biopharmaceutical drug products. Pegasys patent will be valid in India until May 16, 2017. Sankalp alleges that Pegasys involves combining interferon with polyethelyene glycol (PEG) which helps the interferon to remain in the bloodstream, and also that the technology of combining interferon and other biologically active proteins with PEG had been known for years prior to Pegasys patent. They further alleged that Roche ‘invention’ is at most a ‘mere admixture’ of known substances and thus not patentable under section 3(e) of the Patents Act 1970, and is just a ‘new form of a known substance’ and not patentable under section 3(d) of the Act.