The Delhi Patent Office's decision to accord patent to Gilead Sciences, a US-based multinational pharmaceutical company, for blockbuster hepatitis C (HCV) drug sofosbuvir in India has come in for severe criticism from the civil society organizations in the country as they fear that the decision will have far-reaching implications for access to affordable HCV treatment.

In direct contradiction to its earlier order dated January 13, 2015, the Delhi Patent Office on May 9, 2016 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--- 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.

“This comes as a huge disappointment to us. We know there was a lot of pressure to grant the patent considering Gilead had already signed licensing deals with Indian companies but we hoped to knock off the patent,” said Eldred Tellis from Sankalp Rehabilitation Trust.

“Prima facie the order lacks legal reasoning but we need to examine it closely to chart out a future course of action. We will explore all options” said Anand Grover, Senior Counsel and Director, Lawyers Collective who appeared for Sankalp Rehabilitation Trust. “There are other patent applications pending on forms of sofosbuvir so it is important for us to stay on course and fight them out”, he added.

Sofosbuvir is priced excessively high in most high-income countries, around US$ 84,000 for a 12 week course of treatment in the US and US$ 76,000 in France putting considerable strain on national health budgets and forcing rationing of treatment to those who are most sick. In India, the same treatment costs around Rs. 20,000 under the generic versions of sofosbuvir.