Breakthrough HIV drug sees 18 patent filings, may delay affordable generics

An unusually high 18 patent applications filed in India for lenacapavir, a breakthrough HIV therapy, have raised concerns that these could prolong market exclusivity, delay affordable generics, keep prices high and restrict patient access. Contesting the move, patient groups and civil society have filed opposition with the regulatory authorities, arguing the applications lack novelty and inventive steps. Lenacapavir, a long-acting injectable, administered twice yearly for both HIV prevention and treatment, a medicine designated as essential by WHO. Last year, US FDA approved Gilead Sciences' lenacapavir as the first and only twice-yearly injectable pre-exposure prophylaxis to reduce sexually acquired HIV. Gilead has filed at least 18 patent pleas till date in India, covering different aspects of it, including the base compound, salt forms, formulations, dosing regimens, compositions, and methods of use. "The pattern of filings reflects a systematic strategy to create layered patent protection around a single medicine, with the effect of deterring generic entry and prolonged monopoly control beyond the standard 20-year patent term. Such practices, also referred to as "evergreening", whereby multiple secondary patents covering minor variations in forms, formulations, or used or pursued to extend exclusivity," KM Gopakumar, senior researcher and legal advisor at TWN told TOI.

In a letter to the department for promotion of industry and internal trade, patient groups demanded that the patent office must rigorously examine and reject the company's secondary patent applications. Dr Reddy's is one of six generic manufacturers which has signed voluntary licenses with Gilead to manufacture and commercialise lenacapavir across 120 low and lower middle income countries, including India. The generic injection is projected to cost approximately $40 per person annually. So, apart from the voluntary licence holders, no other generics can manufacture and market the drug. Further, the patents, if granted, are set to expire in 2042, 28 years after the first application was filed. "Granting these patents would legitimise Gilead's evergreening strategy," Prathibha Sivasubramanian of Working Group on Access to Medicines and Treatments, told TOI.