Objections on Gilead’s HIV drug patent claims to be heard

The Indian Patent Office will on Thursday hear objections against the grant of patent claims filed by US-based pharmaceutical firm Gilead Sciences on their HIV drug lenacapavir, said people familiar with the matter.
Sankalp Rehabilitation Trust, a civil society organisation working with populations vulnerable to HIV, opposed the patent applications in 2021 because the drug, they said, consists of a previously known compound, and should not be considered an invention according to India’s Patent Act.
Gilead has several patent applications in India on lenacapavir. Two of these patent applications, filed in 2020, seek patents on the choline and sodium salt of the drug lenacapavir.
Lenacapavir, administered as a twice-yearly injection, has garnered attention for its potential to prevent HIV infections after multiple clinical trials demonstrated superior efficacy to standard oral preventative medicines, known as pre-exposure prophylaxis (PrEP). According to UNAIDS, the United Nations’ joint programme for HIV-AIDS control, the drug could offer hope of ending AIDS if all people have access.
Two of Gilead’s patent applications on the salt forms of lenacapavir are not innovative, said Sankalp.
“Granting these patents, which would last until August 2038, could hinder access to affordable generic versions of lenacapavir. Affordable generic HIV medicines have been crucial in keeping people alive globally, including in India”, said Eldred Tellis, director, Sankalp Rehabilitation Trust, in a statement.
Indian patent law prohibits “evergreening,” a practice by which pharmaceutical corporations seek patents on routine modifications to extend their drug monopolies beyond the standard 20-year period.
In March 2023, the Indian Patent Office rejected a similar patent application for the salt form of bedaquiline, an essential drug for drug-resistant tuberculosis. According to the activists working for the cause, if granted, these patents could impede global efforts to end AIDS.
“Without a steady supply of affordable lenacapavir from India, ending AIDS will remain an elusive goal. Decisions made by Indian patent offices are a matter of life or death for people living with HIV/AIDS worldwide,” said Tellis.
According to the Trust’s statement, researchers from Liverpool University estimated that generic lenacapavir can be produced at a fraction of Gilead’s price of $42,250 per year. With generic competition, the costs for lenacapavir are estimated to be initially $100 per person per year, with further reductions to $40 per year as demand increases.
“Indian generic manufacturers have already developed the active pharmaceutical ingredient (API) and have the capacity to file for quality assurance and mass-produce long-acting injectables of lenacapavir. The oppositions are part of a global effort to challenge Gilead’s monopoly on lenacapavir and open up generic competition,” read the statement further.
KM Gopakumar, a senior researcher at the Third World Network, said, “Third World Network, an organization that supports patient groups in challenging abusive patent practices in low- and middle-income countries, calls on the Indian Patent Office to prioritize public health over pharma profiteering in its examination process.”
Meanwhile, in another patent suit, Panacea Biotec on Tuesday announced it reached a settlement agreement with Sanofi Healthcare India over patent infringement litigation for a fully liquid hexavalent vaccine, EasySix.
EasySix is the first innovative fully liquid hexavalent vaccine from India which is protected by patents in several countries including India.
“Under the terms of settlement agreement, Sanofi has inter-alia, agreed that at present Sanofi would not directly or indirectly commercially launch its fully liquid hexavalent vaccine Shan6 in India… Panacea Biotec has also agreed to forego its claim for damages and rendition of accounts in the proceedings against Sanofi as prayed for in the suit,” said Panacea Biotec in a statement.