India will ignore GILEAD patent and force generic HIV drugs?

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India will ignore GILEAD patent and force generic HIV drugs?

India will ignore GILEAD patent and force generic HIV drugs?

Summary:

Recently, The Hindu reported on India’s rejection of a patent application by Gilead Sciences for Lenacapavir, a long-acting HIV preventive drug administered twice a year.

The patent rejection has sparked widespread attention, with various organizations opposing Gilead’s application on the grounds that it could hinder the production of affordable generic versions in India, which would make HIV treatment unaffordable for many patients worldwide.

India will ignore GILEAD patent and force generic HIV drugs

Patent Dispute:

This week, India’s patent office will review objections to Gilead’s patent application for Lenacapavir. Opponents argue that granting the patent will allow Gilead to monopolize the market and obstruct global public health goals.

Lenacapavir, which has shown superior efficacy in clinical trials compared to existing oral pre-exposure prophylaxis (PrEP) drugs, has gained significant attention. However, civil organizations like Sankalp, which focus on supporting vulnerable HIV populations, argue that the compound used in Lenacapavir is not novel and does not warrant patent protection.

UNAIDS has also expressed that the widespread availability of Lenacapavir could represent a breakthrough in the fight to end AIDS. However, granting a patent until August 2038 could severely limit access to affordable generic versions of the drug, which are vital to saving lives, particularly in India.

Eldred Tellis, director of the Sankalp Rehabilitation Trust, emphasized in a statement on September 17, 2024, that “if India cannot provide a stable supply of affordable Lenacapavir, achieving the goal of ending AIDS will be difficult. The Indian patent office’s decision will directly impact the lives of HIV/AIDS patients worldwide.”

Gilead has filed several patent applications for Lenacapavir in India, including one in 2020 covering choline and sodium salts of the drug.

The Potential for Generic Drugs and Economic Feasibility:

Experts note that Indian generic drug manufacturers have already developed the active ingredient in Lenacapavir and are capable of producing the long-acting injectable version. The opposition to the patent aims to break Gilead’s monopoly and encourage competition in the generic drug market.

K.M. Gopakumar, a senior researcher at the Third World Network, stressed, “We hope the Indian patent office prioritizes public health over pharmaceutical company profits during its review.” His organization advocates for patient rights and points out that Indian patent law does not allow monopolies on old technologies, and Lenacapavir’s salt form does not represent significant technological advancement.

“A monopoly of this kind would block generic manufacturers and disrupt India’s supply of affordable medicines,” Gopakumar added.

Currently, Lenacapavir costs around $40,000 per year. However, if voluntary licenses were granted and generic manufacturers could produce the injectable form, production costs could drastically decrease. It is estimated that if demand reached one million patients, the annual cost per person could drop to $94; if demand increased to 10 million, costs could fall further to $41 per person.

These estimates include a 30% profit margin and 27% tax, ensuring production remains profitable under current cost structures. With improvements in production technology and heightened market competition, costs could decline even more.