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Delhi HC adjourns hearing on patent challenge to US pharma giant Gilead's controversial hepatitis C drug, sofosbuvir to Nov 22

Ramesh Shankar, Mumbai
Saturday, September 17, 2016, 08:00 Hrs  [IST]

The Delhi High Court (HC) has adjourned hearing on patent challenge to US Pharmaceutical major Gilead's controversial hepatitis C drug, sofosbuvir. The first hearing on this much talked about case was expected to take place on September 13. However, Patent Controller and Union of India asked for postponement of the case as they needed more time to submit their response to the petition.

The judge has given a week’s time to Patent Controller and Union of India to make their submission. However, next date given for hearing is now for November 22.

The writ petition was filed before the Delhi High Court by the US-based Initiative for Medicines, Access & Knowledge (I-MAK) and the Delhi Network of Positive People (DNP+), challenging the grant of patent to blockbuster hepatitis C drug, sofosbuvir. The patent to sofosbuvir was granted to Gilead on May 9, 2016 by the Delhi Patent Office, in direct contradiction to its earlier order dated January 13, 2015.

The sofosbuvir saga dates back to January 13, 2015 when an application for the patent to sofosbuvir (brand name Sovaldi) was first rejected by the Delhi Patent Office for lacking inventiveness and novelty. However, on May 9, the patent office granted patent to Gilead on sofosbuvir, dismissing 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--- which were rejected by the Deputy Patent Controller of the Delhi Patent Office, Dr Rajesh Dixit following hearings held from February 23 to 25, 2016. In the patent challenge, they argued that sofosbuvir was 'old science', and did not meet the standard needed for patenting in India.

Criticising the Delhi Patent Office's decision to accord patent to sofosbuvir, I-MAK and DNP+ filed an appeal with the Delhi High Court. 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.


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