Stepping up efforts to ensure the access to affordable and effective treatment for people living with Hepatitis C (HCV) in India and the rest of the world, another pre-grant opposition to Gilead’s patent application on Sofosbuvir in India has been filed. This time, the opposition was filed at the Delhi Patent Office by Sankalp Rehabilitation Trust, represented by Lawyers Collective.
This is the fourth pre-grant opposition to be filed against Sofosbuvir’s base patent application. Oppositions filed by I-Mak together with the Delhi Network of Positive People (DNP+), NATCO Pharma Ltd and BDR Pharmaceuticals International Limited are also pending disposal.
Earlier on January 13, 2015, the Delhi Patent Office had rejected Gilead’s patent application on the ground that it did not meet the requirements of Section 3 (d) of the Indian patent law. On challenge before the Delhi High Court, however, it seems likely that the matter will be remanded to the Patent Controller to be heard along with the pending oppositions.
“We have studied the patent application closely and are convinced that it has no merit” says Anand Grover, director, Lawyers Collective. “It fails to satisfy any grounds required to meet the threshold of what is patentable under India’s patent law. Not only is it not new or inventive, it also does not comply with the requirements of Section 3 (d),” he adds.
Globally, there are around 180 million people living with HCV, 12 million of whom live in India alone. A large number of these people will require treatment to prevent liver-related illness which, if left untreated, can be fatal. Sofosbuvir, a once-a-day oral pill, is poised to revolutionise treatment for people living with HCV with cure rates of up to 95 per cent as compared to 65-70 per cent with weekly-injections of Pegylated Interferon, the standard current treatment. Gilead has priced the drug at $84,000 per treatment course in the US. Gilead made $5.7 million on the sales of Sofosbuvir in the first half of 2014 alone.
Without waiting for a patent on Sofosbuvir in India, Gilead went ahead and signed voluntary licences on Sofosbuvir and its combinations with several Indian generic companies back in September 2014. The licences are restrictive not only in the scope of their geographical coverage but also in terms of Gilead’s control over the ability of the licences to buy and sell the active pharmaceutical ingredient, a crucial raw material used in the preparation of medicines. Under the licences, generic versions of Sofosbuvir could cost anywhere between $300 to $900 per treatment.
“We know that even $300 per treatment is too expensive for the average person in India, let alone the poor. Open, unrestricted competition by Indian generic companies was responsible for drastic price reductions in ARV prices which allowed scaling-up of treatment to millions. If people living with HCV across the world have any hope to access affordable treatment it is vital that Gilead not be allowed to manipulate competition to further their profit motives. Treatment should be available for all.” says Eldred Tellis, Director, Sankalp Rehabilitation Trust.
“It is unfortunate that generic companies in India, who once played David to MNC’s Goliath have now chosen to go down this road. As civil society, we will continue to use pro-public health provisions to further access to medicines,” adds Grover.
Earlier this month Gilead was granted marketing approval for Sofosbuvir in India in a record time of four months and 10 days. “While we welcome the government’s swift regulatory approval to bring this much needed medicine to India, this alone will not help wide access to life-saving medicines. Our focus is now on fighting against any patent protection to Gilead” adds Tellis.