New Delhi, 18 September 2024 – 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.”
Background
Public health safeguards against evergreening in Indian patent law and the grounds for challenging
the lenacapavir patent applications
By joining the World Trade Organization in 1995, India became obligated to start granting pharmaceutical product patents. But in 2005, the country adopted a strict medicines patent law that while ensuring patent protection for new pharmaceutical compounds, makes it tougher to get a patent on new forms of existing medicines and allows opposition to a patent application before it is granted. The law is designed to stop drug giants from indulging in “evergreening,” a common abusive patenting practice in the pharmaceutical industry aimed at filing and obtaining separate patents relating to different aspects of the same medicine.
Gilead has applied for patents across LMICs, including key manufacturing countries like India.
Gilead has several patent applications in India on LEN. Of these two patent applications, IN202017007904 and IN202017010006, seeking patents on the choline and sodium salt of the drug LEN filed in 2020, are now under examination by the Patent Office, and a hearing on the oppositions filed will be held on 19 September 2024. LEN’s patent applications are already known for their solubility, stability, and other typical qualities for which salts are generally used.
The concept of “obviousness” is central to patentability. If obtaining a specific salt or polymorph of a compound would be obvious to someone skilled in the art—such as a person trained and experienced in disciplines relevant to the pharmaceutical sector—then it does not meet the criteria for patentability. Examiners should consider that identifying a pharmaceutically suitable salt to manufacture a medicine or its formulation from the active ingredient is part of the common knowledge of people working in those fields. Section 3(d) of the Indian Patents Act restricts the patenting of new forms of known substances, including salts, unless they demonstrate a significant enhancement in efficacy. The Indian patent office has rejected such patent applications.
In 2005, the Cancer Patient Aid Association (CPAA) successfully opposed a Novartis patent for
Gleevec (Imatinib Mesylate) on similar grounds. The Indian Patent Office rejected the patent, and the
Supreme Court upheld the rejection in 2012.
HIV drug LEN and prevention
Despite global efforts to combat HIV and AIDS, the epidemic persists with 1.3 million new infections annually. LEN, if made affordable, could significantly impact the fight against HIV, especially in countries with high infection rates. New infections continue to rise among key populations and in some middle-income countries (MICs).
Pre-exposure prophylaxis or “PrEP” is the use of an antiretroviral medication by HIV-negative people to reduce the risk of HIV acquisition. PrEP 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 LEN, 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.
Currently, lenacapavir is approved in high-income countries for treating multidrug-resistant HIV and
is priced at over $40,000 annually in the US.
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.
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 LEN also showed much-improved efficacy for preventing HIV infections compared to standard oral preventative HIV medicines, known as pre-exposure prophylaxis (PrEP).
The data from the trials will support upcoming regulatory filings so that twice-yearly LEN for PrEP can be authorised by National Drug Regulatory Authorities (NDRAs) for multiple populations and comunities around the world that need additional HIV prevention choices. Gilead is expected to begin a series of regulatory filings by the end of 2024.
Media contacts:
Leena Menghaney
Médecins Sans Frontières – Access Campaign
+919811365412
Rajnia Rodrigues
Third World Network
[email protected]
+55 21 971250691
