The Indian Patent Office is set to hear objections against patent claims filed by US-based pharmaceutical giant Gilead Sciences on the HIV prevention drug ‘lenacapavir’. Sankalp Rehabilitation Trust, a civil society organisation working with vulnerable populations, argues that the patent applications could impact access to affordable treatment in India and would hinder access to affordable generic versions of the drug.
On September 19, 2024, the Indian Patent Office will hear objections filed by Sankalp Rehabilitation Trust against Gilead’s applications, the organisation claimed.
Sankalp contends that Gilead’s claims on lenacapavir are not innovative and violate India’s patent laws, which prevent the practice of “evergreening” — extending monopolies on drugs through minor, unoriginal modifications.
At the heart of the dispute is lenacapavir, an injectable HIV drug taken twice yearly, which has demonstrated superior efficacy in preventing HIV compared to existing oral treatments. According to the United Nations (UN) agency UNAIDS, lenacapavir has the potential to play a critical role in ending AIDS, provided it is made widely accessible.
Gilead is seeking patents in India for the choline and sodium salt forms of lenacapavir. If approved, these patents would extend Gilead’s monopoly over the drug in India until 2038. Sankalp and other public health advocates argue that granting such patents would block the production of more affordable generic versions of the drug, limiting access to the drug for millions of people who need it.
“Granting these patents could hinder access to affordable lenacapavir, making it impossible for India to produce the generic version that could save lives globally,” said Eldred Tellis, director of Sankalp Rehabilitation Trust. “Access to affordable medicines is a life or death issue, and India’s patent offices have the power to decide this.”
Gilead’s price for lenacapavir in high-income countries is $42,250 annually, but researchers estimate that Indian generic manufacturers could produce the drug for as little as $100 per person per year, with further reductions possible as demand increases. Indian generic drugmakers, known for producing affordable treatments for HIV, already have the capacity to mass-produce lenacapavir, but the patent dispute could slow the process.
The opposition to Gilead’s patent applications in India is part of a larger global movement. Public health groups in countries including Argentina, Thailand, and Vietnam have filed a total of nine patent challenges against lenacapavir as part of the Make Medicines Affordable campaign.
“India has a robust legal framework designed to prevent evergreening,” said K M Gopakumar, a senior researcher at Third World Network, an organisation supporting the patent challenge. “Gilead’s applications for salt forms of lenacapavir do not represent significant technological advancements. The patents should be rejected to allow the production of affordable generics.”
In 2012, India’s Supreme Court upheld the rejection of a Novartis patent for a modified cancer drug, blocking the company from extending its monopoly and opening the door to generics. India’s strict patent laws have enabled the country to become a key supplier of low-cost HIV medicines, crucial in the global fight against the epidemic.
While advancements in treatment have dramatically improved the lives of people living with HIV, there are still 1.3 million new infections annually, according to UNAIDS. Lenacapavir’s success in clinical trials has raised hopes of significantly reducing that number, especially in vulnerable communities.
The latest phase 3 trials, known as PURPOSE 1 and PURPOSE 2, have shown promising results for lenacapavir as a pre-exposure prophylaxis (PrEP) drug. Data from the trials demonstrated 100 per cent efficacy among cisgender women and 96 per cent efficacy among transgender and nonbinary individuals, cisgender men, and other populations at risk of HIV.
The drug is currently approved in high-income countries for treating multidrug-resistant HIV, but Gilead plans to seek approval for its use in HIV prevention worldwide by the end of 2024. Public health advocates are pushing for affordable access to the drug, particularly in low- and middle-income countries like India, which are key to global HIV prevention efforts.
India’s Patent Act prohibits the granting of patents on new forms of known substances, such as salt forms of existing compounds, unless they demonstrate a significant improvement in efficacy. This safeguard, combined with India’s opposition mechanism, allows civil society groups to challenge patent applications that could hinder access to affordable medicines. Gilead’s case in India is crucial due to its implications for access to lenacapavir, a drug with the potential to curb new HIV infections globally.
First Published: Sep 17 2024 | 5:45 PM IST