The US-based Gilead Sciences’ long-acting injectable HIV drug lenacapavir is at the centre of a patent opposition case scheduled to come up this week at the Indian Patent Office (IPO). Civil society group Sankalp Rehabilitation Trust had opposed Gilead’s patent application on the grounds that it was a known compound.
The twice-a-year injectable has generated much interest internationally, as recent trial results showed its superior efficacy as a preventive - fueling hope that it signals the endgame on AIDS. However, its pricing at over $40,000, per person, per year, poses a challenge, say health activists, calling for “pool procurement” and local participation from Indian drugmakers to make the product.
Sankalp had opposed the patent applications in 2021, saying it was not an invention according to India’s Patent Act. A response is awaited from Gilead to queries from businessline on this opposition case.
Lenacapavir has been in the headlines recently as multiple clinical trials demonstrated superior efficacy, as compared to standard oral preventative medicines or pre-exposure prophylaxis (PrEP).
Gilead has multiple patent applications in India on lenacapavir, health activists said, speaking to the media on the upcoming patent challenge. Two of these patent applications, filed in 2020, seek patents on the choline and sodium salt of lenacapavir.
Not Innovative
Sankalp contends that two of Gilead’s patent applications on the salt forms of lenacapavir are not innovative. The Indian patent law prohibits “evergreening” - where drugmakers seek to extend the patent life on products (beyond 20 years) through minor tweaks, unless it showed greater efficacy.
In March 2023, the IPO had rejected a similar patent application on the salt form of bedaquiline, used to treat drug-resistant tuberculosis. Prathibha Sivasubramanian, senior researcher at Third World Network, said the IPO had rejected such patent applications in the past, as well. In 2005, the Cancer Patient Aid Association had successfully opposed a Novartis patent on blood cancer drug Glivec (Imatinib Mesylate) on similar grounds. This was upheld by the Supreme Court in 2012.
Eldred Tellis, Director of Sankalp, said granting these patents would extend its monopoly to 2038 and hinder access to affordable versions of Lenacapavir, for people in India and in other parts of the world. “Decisions made by Indian patent offices are a matter of life or death for people living with HIV/AIDS worldwide,” he said.
Researchers from Liverpool University have estimated that generic lenacapavir can be produced at a fraction of Gilead’s price, the activists said. Leena Menghaney, Global IP Advisor and India Head of Médecins Sans Frontières (MSF) Access Campaign, said, researchers have shown that generic competition can bring the price of lenacapavir to $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, she said. She called for a public health approach of “pool procurement” rather than India-specific pricing or voluntary licensing, which she said, keeps several countries out of the deal.
The oppositions are part of a global effort to challenge Gilead’s monopoly on lenacapavir and bring in generic competition, the activists said. “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 lenacapavir 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 (a group of HIV treatment activists).