People living with HIV in India are up in arms against the US pharmaceutical corporation Gilead Sciences for its recent additional patent claims for the hepatitis C medicines sofosbuvir and velpatasvir, a move that would make the drugs out of the reach of the affected community.
The Delhi Network of Positive People (DNP+) on Tuesday filed two patent oppositions before the Indian patent office, challenging the US company’s move. The group alleged that the patent would make the medicines out of their reach as it would allow the company to continue charging exorbitant prices from governments in many middle- and high-income countries.
Paul Lhungdim from Delhi Network of Positive People said that “Just like Gilead attempted to patent different forms and combinations of the key HIV drug tenofovir many years back, the corporation is again using evergreening tactics to block affordable options of hep C drugs that other countries can import in the future.
“With these patent challenges, we hope to prevent Gilead from obtaining unmerited patent rights on sofosbuvir and velpatasvir, which would allow them to continue charging exorbitant prices from governments in many middle- and high-income countries,” he added.
These oppositions challenge Gilead’s patent applications for the tablet formulation of the fixed-dose combination of sofosbuvir/velpatasvir and the polymorph form of velpatasvir.
Velpatasvir, a direct acting antiviral (DAA), is one of the key medicines used in combination with sofosbuvir for the oral treatment of people with all six major genotypes of hepatitis C virus.
Its effectiveness as a pan-genotypic medicine makes it a key drug in the fight against hepatitis C. Access to affordable generic sources of this medicine, and its combination with sofosbuvir, are therefore critical for all countries with a high burden of people living with hepatitis C.
The grounds for these two patent oppositions are based on provisions in the Indian Patents Act that prevent patent evergreening, which restricts the patentability of a host of secondary patents, i.e., new forms of known substances, new property or new use of known substances, use of known processes without showing any enhanced therapeutic efficacy, and admixtures without synergistic effect, said Paul Lhungdim, an HIV activist.
Through these patent oppositions, DNP+ aims to prevent such unmerited patent applications from being granted and encourage open competition on the combination of sofosbuvir and velpatasvir after the basic compound patents have expired or are revoked in countries excluded from Gilead’s license agreements.