Patent challenge to hepatitis-C medicines
New Delhi: Patients' rights advocates in India on Tuesday filed two oppositions in the Indian patent office, challenging patent claims by the US pharmaceutical company Gilead Sciences for its medicines sofosbuvir and velpatasvir, used to treat hepatitis-C infections.
The oppositions filed by the Delhi Network of Positive People (DNP+) challenge Gilead's patent applications for the tablet formulations of the fixed dose combination of sofosbuvir and velpatasvir and a new form of velpatasvir.
The opposition is based on provisions in India's patent laws that can deny or restrict patents on products that lack novelty, inventive steps and enhanced therapeutic efficacy, the DNP+ claimed in a media release.
The DNP+ said Gilead had launched sofosbuvir/velpatasvir in the US in 2016 at over $74,000 for a 12-week regimen. Velpatasvir is a key medicine used in combination with sofosbuvir in the oral treatment of all six major genotypes of the hepatitis-C virus, it said.
"Access to affordable generic sources of this medicine and its combination with sofosbuvir are critical for all countries with a high burden of people living with hepatitis-C," the network said.
India's generic drug-makers can manufacture the medicines if the patents are denied.
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