Patent Applications for HIV Prevention Drug Opposed in India: Vulnerable Group Seeks to Protect Generic Competition to Lower Prices of HIV Prevention Drug Lena
The Indian Patent Office is set to hear the objections of Sankalp Rehabilitation Trust against the grant of patent claims filed by US-based pharmaceutical company Gilead Sciences on the HIV drug lenacapavir (LEN). Sankalp, a civil society organisation working with populations vulnerable to HIV, opposed the patent applications in 2021 because the drug consists of a previously known compound, and should not be considered an invention according to India’s Patent Act.
LEN, administered as twice-yearly injections, has garnered attention for its potential in HIV prevention after multiple clinical trials demonstrated superior efficacy to standard oral preventative medicines, known as pre-exposure prophylaxis (PrEP). According to UNAIDS, this new HIV drug can offer hope of ending AIDS if all have access.
Gilead has several patent applications in India on LEN. Two of these patent applications, filed in 2020, seek patents on the choline and sodium salt of the drug LEN.
Sankalp Rehabilitation Trust contends that two of Gilead’s patent applications on the salt forms of LEN are not innovative. 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. If granted, these patents could impede global efforts to end AIDS.
“Granting these patents, which would last until August 2038, could hinder access to affordable generic versions of LEN. Affordable generic HIV medicines have been crucial in keeping people alive globally, including in India,” said Mr Eldred Tellis, Director of Sankalp Rehabilitation Trust. “Without a steady supply of affordable LEN 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.”
Researchers from Liverpool University have estimated that generic LEN can be produced at a fraction of Gilead’s price of $42,250 per year. With generic competition, the costs for LEN 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 LEN.
The oppositions are part of a global effort to challenge Gilead’s monopoly on LEN and open up generic competition.
“Within the Make Medicines Affordable campaign led by ITPC, HIV and vulnerable population organizations in India, Argentina, Indonesia, Thailand and Vietnam have filed nine oppositions against Gilead’s LEN patent applications–the Thai Network of People living with HIV (TNP+), Delhi Network of Positive People (DNP+), Fundación Grupo Efecto Positivo, Indonesia AIDS Coalition and the Vietnam Network of People living with HIV (VNP+),” said Othoman Mellouk, Access to Diagnostics and Medicines Lead, ITPC.
“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”, said K.M. Gopakumar, a senior researcher at the organization. “The bottom line is Indian Patents Act does not grant monopolies on old science, like salt forms of lenacapavir that do not contribute significantly to the technological pool. Such monopolies can limit the entry of generic manufacturers and impede access to affordable medicines from India.”
For more information, read the original press release.
For more news from the world of long-acting therapeutics, sign up to the CELT's LONGEVITY mailing list here for regular updates.