Public health groups raise concern on patent grant to promising, new HIV drug

NEW DELHI: Patient and public health groups have expressed concern on the potential grant of a patent to US biggie, Gilead Sciences on one of the most promising HIV drugs, lenacapavir, in India. The patent, if granted, could block the manufacture of key raw materials and API (active pharmaceutical ingredient) of lenacapavir, hindering access to affordable generics for patients in developing countries including India.
This comes just ahead of the Indian Patent Office taking up on Sept 19 the pre-grant application filed by the patient group, Sankalp Rehabilitation Trust. In 2021, Sankalp opposed the patent applications because the drug consists of a previously-known compound, and lacks novelty and inventive step according to India's Patent Act.
The HIV drug which costs around $44,000 for twice-yearly injections, has garnered attention for its potential in HIV prevention globally. Multiple clinical trials have demonstrated the drug’s superior efficacy to standard oral preventative medicines, known as pre-exposure prophylaxis (PrEP). According to UNAIDS, the results ``provide hope of accelerating efforts to end AIDS, but only if Gilead ensures that all people who need it can have access to this game-changing medicine.”
Worldwide there are 1.3 million infections every year, with one new HIV infection every 24 seconds.
Gilead has several patent applications in India on lenacapavir. Two of these patent applications, filed in 2020, seek patents on the choline and sodium salt of the drug, which patent experts say 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.
“Granting these patents, which would last until August 2038, could hinder access to affordable generic versions of lenacapavir " said Eldred Tellis, director Sankalp Rehabilitation Trust. "Without a steady supply of affordable lenacapavir from India, ending AIDS will remain an elusive goal’’.
Indian generic manufacturers have already developed the API and have the capacity to mass-produce long-acting injectables of lenacapavir, Leena Menghaney, India Head of Médecins Sans Frontières Access Campaign said.
KM Gopakumar of the Third World Network said “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’’.