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Civil society organisations opposing the patent applications of US-based pharma major Gilead Sciences for the HIV drug lenacapavir have said that generic competition is needed to make the long acting HIV medicine affordable to the middle-income countries.
The Indian Patent Office is scheduled to hear the objections of Sankalp Rehabilitation Trust against the grant of patent claims filed by Gilead Sciences, on September 19, 2024. According to UNAIDS, this new HIV drug can offer hope of ending AIDS if all have access.
Lenacapavir, 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).
Gilead has at least five patent applications filed at the Indian Patent Office and two of these applications, filed in 2020, seek patents on the choline and sodium salt of the drug.
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, said Eldred Tellis, director of Sankalp Rehabilitation Trust, while addressing a press conference.
“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 Tellis. The oppositions are part of a global effort to challenge Gilead’s monopoly on the drug and open up generic competition.
"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," he added.
Patentability criteria in India is high and salts and crystals are not considered as technical advances that are patentable, said Prathibha Sivasubramanian, Third World Network. The Section 3(D) of the Patent Act also acts against evergreening of the patents, she averred.
The drug is currently priced at over $40,000 per person per year in US, would not be affordable to the Indian population and considering the potential of the medicine to save lives, it should be made available in the country at an affordable cost, said Leena Menghaney, Medicines Sans Frontier (MSF).
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.
Despite global efforts to combat HIV and AIDS, the epidemic persists with 1.3 million new infections annually. If granted, these patents could impede global efforts to end AIDS, she said.
Pre-exposure prophylaxis or “PrEP”, which is the use of antiretroviral medication by HIV-negative people to reduce the risk of HIV acquisition, can contribute to preventing people from acquiring HIV, offering further opportunities to provide expanded access to HIV prevention services and reducing new infections.
According to UNAIDS, long-acting technologies like pre-exposure prophylaxis (PrEP) will play a major role in preventing new infections in the coming years. The long-acting HIV medicine lenacapavir, if approved for PrEP, could be life-changing for people at risk of getting HIV and could reverse the epidemic if it is made affordable in the countries with the highest rate of new infections.
The data from phase 3 clinical trials (the PURPOSE 1 and PURPOSE 2 trials) has shown the safety and efficacy of lenacapavir, a twice-yearly injectable for HIV pre-exposure prophylaxis (PrEP) in stopping HIV acquisition among vulnerable populations, added the organisations.
The Purpose 1 trial data released in July 2024 included cisgender adult and adolescent women demonstrating 100% efficacy in trial data published in July 2024 and released at the International AIDS Conference.
The Purpose 2 trial released last week includes cisgender men, transgender men, transgender women, and gender nonbinary individuals in Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the United States who have sex with partners assigned male at birth and demonstrated 96%efficacy in reducing the risk of HIV infection.
Twice-yearly injections of lenacapavir also showed much-improved efficacy for preventing HIV infections compared to standard oral preventative HIV medicines, they added.
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