New Delhi: Patent applications filed in India by a US pharmaceutical giant for an antiretroviral drug—meant to prevent Human Immunodeficiency Virus (HIV) infection—are facing stiff opposition from a number of Indian civil society organisations working to expand patients’ access to life-saving medicines.
They have claimed that these patents, if granted, could impede global efforts to end Acquired Immunodeficiency Syndrome (AIDS), the most advanced stage of HIV infection, and hinder access to affordable generic versions of the medicine in India and several other countries.
The drug, lenacapavir, recently showed 100 percent efficacy in preventing HIV infection. Developed by California-based pharmaceutical firm Gilead Sciences, lenacapavir was approved in the European Union (EU) and the US in 2022 for drug-resistant AIDS, and is available under the brand name Sunlenca. It is administered as a twice-yearly injection.
Lenacapavir has garnered attention for its potential in HIV infection prevention, as shown by multiple clinical trials demonstrating superior efficacy of the drug compared to standard oral preventative medicines.
In June this year, findings from the PURPOSE 1 study—trial conducted by Gilead Sciences between August 2021 and June 2024 on women in South Africa and Uganda to evaluate the efficacy and safety of lenacapavir for HIV infection—hit global headlines after showing that the drug is cent percent effective in African women as a pre-exposure prophylaxis (PrEP), which refers to a medicine used to prevent HIV infection.
Gilead Sciences has applied for patents on lenacapavir across low- and middle-income countries, including India. The firm has filed five patent applications in India, two of which seek patents on the choline and sodium salt forms of lenacapavir.
These applications are being examined by the Indian Patent Office, which is set to hear objections Friday against the potential grant of patent to lenacapavir in India, raised by Mumbai-based non-governmental organisation Sankalp Rehabilitation Trust, and other organisations working with people vulnerable to and suffering from AIDS.
The agency is currently examining five patent applications for lenacapavir.
A patent on a drug is a kind of intellectual property right (IPR) that grants a pharmaceutical company exclusive rights to the medicine for a specified period of time, and is intended to stop other manufacturers from producing its generic versions and lowering the prices.
However, organisations have raised concerns on the potential grant of patents, citing multiple reasons.
“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,” Eldred Tellis, director of Sankalp Rehabilitation Trust, said in a statement Tuesday.
“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 stressed.
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Is lenacapavir a new hope against HIV?
Lenacapavir is a capsid inhibitor, a new class of medicine which works by interfering with the protein shell that protects the virus’s genetic material and enzymes needed for replication.
According to the Joint United Nations Programme on HIV/AIDS (UNAIDS), lenacapavir offers hope to end AIDS if all have access to the drug.
Currently, lenacapavir is approved in high-income countries for treating multidrug-resistant HIV infections and is priced at over $40,000 annually in the US.
AIDS activists claim that lenacapavir, if made affordable, could significantly impact the fight against HIV infections, especially in countries with high infection rates.
Last week, Gilead Sciences announced interim results from PURPOSE 2 trials—conducted in multiple countries, including the US, Mexico, Argentina, Brazil and South Africa, between late 2023 and September 2024, to evaluate the efficacy of lenacapavir as a PrEP in cisgender men, transgender men and women, and non-binary individuals who have intercourse with partners assigned male at birth.
The findings revealed that the drug showed 96 percent efficacy in preventing new HIV infections in the participants.
Therefore, data from phase 3 clinical trials (PURPOSE 1 and PURPOSE 2) has shown that lenacapavir can be highly effective as a PrEP among vulnerable populations.
However, despite global efforts to combat HIV infection, the disease persists, with an estimated 1.3 million new infections worldwide in 2023.
In India, too, the disease has been showing an uptick, particularly in select states. As many as 68,451 new HIV infections were registered in the country last year.
It is estimated that six to seven generic drugmakers from India supply nearly two-thirds of the world’s antiretroviral drugs—considered a lifeline for patients with HIV infection, including AIDS.
According to a study published 3 September in the Journal of Antimicrobial Chemotherapy, researchers from Liverpool University have estimated that generic lenacapavir can be produced at a fraction of Gilead’s price of $42,250 (Rs 35.38 lakh) per year.
Considering generic competition, the cost of lenacapavir is estimated to be initially $100 per person per year, with further reductions to $40 per year as demand increases, said Leena Menghaney, an activist from Médecins Sans Frontières (Doctors Without Borders) access campaign in India, during a virtual press briefing organised by Indian patient groups Tuesday.
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, Indian civil society organisations opposing the grant of patents said in the statement.
ThePrint has reached Gilead Sciences over email. This report will be updated if and when a response is received.
Ground for patent opposition
After joining the World Trade Organization (WTO) in 1995, India became obligated to start granting patents to pharmaceutical products.
However, the Patents (Amendment) Act of 2005 in India makes it tougher to get a patent on new forms of existing medicines and allows for opposition to a patent application before the patent 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 for different variants of the same medicine.
However, on several occasions in the past, Gilead Sciences has made crucial patented drugs accessible to poorer countries.
One such instance was during the Covid-19 pandemic, when the firm provided voluntary licences to several Indian companies to produce remdesivir—an Ebola drug that had initially shown huge promise to treat Covid-19—in order to bring down the drug’s cost in low- and middle-income countries.
Voluntary licensing allows for the production of generic versions of a patented drug, typically in the event of a public health emergency.
In a statement released 12 September, Gilead Sciences said that if approved, lenacapavir can be made available to multiple populations across the world who are in dire need of additional methods to prevent HIV infection. The firm added that it is likely to begin a series of regulatory filings for the drug by the end of the year.
(Edited by Radifah Kabir)
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