Gilead's 18 Lenacapavir Patent Applications in India Raise Concerns Over Delayed HIV Drug Generics

Patient groups have challenged the applications before the concerned authorities, alleging that several of the claims lack novelty and inventive steps. They have urged the Indian Patent Office to conduct a stringent examination of the applications and prevent the grant of patents that could unnecessarily extend the drug’s monopoly.

Lenacapavir is a long-acting injectable medicine administered twice a year for HIV prevention and treatment. The World Health Organization (WHO) has also recognised the medicine as essential. In 2025,the US Food and Drug Administration (FDA) approved Gilead Sciences’ lenacapavir as the first and only twice-yearly injectable pre-exposure prophylaxis (PrEP) option for reducing the risk of sexually acquired HIV.

Gilead Sciences has reportedly submitted at least 18 patent applications in India covering various aspects of lenacapavir, including its active compound, salt forms, formulations, dosage schedules, compositions and therapeutic applications.

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According to KM Gopakumar, senior researcher and legal advisor at Third World Network (TWN),the multiple patent filings could represent a strategy to establish overlapping intellectual property protection around a single medicine. He raised concerns that such secondary patents could discourage generic manufacturers from entering the market and extend commercial exclusivity beyond the standard 20-year patent period. This practice is commonly described as evergreening, where additional patents are sought for modifications or variations of an existing medicine.

In a representation submitted to the Department for Promotion of Industry and Internal Trade (DPIIT),patient organisations and civil society groups called for strict scrutiny of the applications. They urged the authorities to reject secondary patent claims that fail to satisfy the legal requirements for patentability.

ETPharma reports that Dr. Reddy’s Laboratories is among six generic pharmaceutical companies that have entered into voluntary licensing agreements with Gilead Sciences to manufacture and commercialise lenacapavir in 120 low-income and lower-middle-income countries, including India. The generic injectable formulation is expected to be priced at approximately $40 per person annually.

However, the licensing arrangement restricts generic manufacturing and marketing to the authorised licensees, excluding other manufacturers from independently entering the market while the applicable patent protections remain in force.

The patent applications, if granted, could remain effective until 2042,raising concerns that affordable generic alternatives may face delays and potentially limiting wider access to this important HIV prevention and treatment option.