Gilead Sciences Licenses Drug to Indian Manufacturers Amid Patent Challenges

Gilead Sciences licensed a drug to manufacturers in India on November 14, 2026. The company filed applications covering the drug's basic compound, salt forms, formulations, and dosage schedules. These filings have been challenged by patient groups and civil society organizations, who argue the applications lack novelty and inventive steps. The drug, Lenacapavir, was previously approved by the US Food and Drug Administration as a twice-yearly injectable for HIV prevention and treatment.

The licensing agreement allows generic drugmakers to manufacture and market the drug in low and lower-middle-income countries, including India. This practice, which involves seeking secondary patents on modifications to an existing drug, is described as evergreening. Patient groups are urging the patent office to reject these secondary applications.