India’s patent office is set to hear on Thursday opposition by health activists to patent applications filed by Gilead Sciences, a US biopharmaceutical company, on an anti-HIV medicine called lenacapavir.
The Mumbai-based non-government entity called Sankalp Rehabilitation Trust, which works with HIV-positive people, had opposed the patent applications in 2021, claiming that the medicine contains a known compound and should not be considered an invention under Indian patent rules.
Multiple clinical trials have suggested that lenacapavir — a twice-yearly injection — has superior efficacy over standard oral preventive medicines, known as pre-exposure prophylaxis. In June this year, Gilead had announced the results from the interim
analysis of a trial indicating that lenacapavir demonstrated 100 per cent efficacy for
the use of HIV prevention in cisgender women.
Sankalp Rehabilitation Trust said on Tuesday that a decision by India’s patent office to grant the patents to Gilead would effectively hinder access to affordable generic versions of lenacapavir until August 2038.
“Affordable generic anti-HIV medicines have been crucial in keeping people alive worldwide, including in India,” said Eldred Tellis, the director of the Sankalp Rehabilitation Trust. “Without a steady supply of lenacapavir from India, ending AIDS will remain an elusive goal.”
The patents, if granted by the Indian patent office, would not only block generic manufacture of less expensive versions of lenacapavir but would also prevent Indian companies from manufacturing and exporting raw materials for lenacapavir, said Leena Menghaney, a public health lawyer with Medicins Sans Frontieres, an international humanitarian agency that purchases generic drugs from India.
Researchers at the Liverpool University in the UK have estimated that generic versions of lenacapavir could be produced at a fraction of Gilead’s price of $ 42,250, Sankalp Rehabilitation Trust has said in a media release on Tuesday. The estimated cost of generic versions of lenacapavir under competition would be $100 per year that could be further reduced to $40 per year as demand increases, the Trust said.
