The US-based Initiative for Medicines, Access & Knowledge (I-MAK) and the Delhi Network of Positive People (DNP+) have filed an appeal with the Delhi High Court challenging the Delhi Patent Office's decision to accord patent to US pharma company Gilead Sciences' blockbuster hepatitis C (HCV) drug sofosbuvir.

In their appeal, these health groups have pleaded that the Indian patent office's latest decision is contrary to the public interest, fails to assess the full scientific and legal evidence presented and ignores key Indian patent law and judicial precedents. Gilead has claimed existing public knowledge as its own and its patent on sofosbuvir, the base compound in its Hep C drug Sovaldi, is 'unmerited', these groups said.

In direct contradiction to its earlier order dated January 13, 2015, the Delhi Patent Office on May 9, 2016 had granted Gilead Sciences the patent for sofosbuvir (brand name Sovaldi) in India. An application for the same patent was first rejected in January 2015 for lacking inventiveness and novelty. On May 9, however, the patent office dismissed all pre-grant oppositions and stated that it found “claimed compounds are novel, inventive and patentable under Patents Act”. The pre-grant oppositions were filed by Sankalp Rehabilitiation Trust along with those filed by DNP+, I-MAK and three Indian generic companies--- Optimus, BDR Pharma and India Cares.

According to Tahir Amin, co-director of I-MAK, “The facts of the case are undeniable as sofosbuvir, the base compound in Gilead's hepatitis C drugs, was developed with previously published techniques that have been used repeatedly in other antiviral drugs”. The groups also added that the patent office rejected Gilead's patent last year, ruling that the main compound in sofosbuvir was a 'molecule with minor changes' and has the 'same use in treatment of HCV infection and flavivirus injection' compared with an earlier compound.

Gilead had earlier defended its patent, reportedly stating that its licensing agreements with Indian drug makers would continue to enable the production of high-quality, low-cost generics of Sovaldi here. Recognition of Intellectual Property (IP) is central to investment in pharma research and development, the company had reportedly said, adding that it was Gilead's goal to enable access to these medicines for as many people as possible as quickly as possible. At the same time, organisations opposing the patent grant argue that Indian companies with voluntary licenses from Gilead are now prohibited from selling more affordable versions of sofosbuvir to many middle-income countries.