{
  "id": 19857625,
  "title": "Breakthrough HIV drug sees 18 patent filings, may delay affordable generics",
  "url": "https://urgent.news/2026/11/13/breakthrough-hiv-drug-sees-18-patent-filings-may-delay-affordable",
  "topic": "health",
  "section": "Health & Medicine",
  "published": "2026-11-13T20:05:11.000Z",
  "source": {
    "name": "Times of India",
    "slug": "times-of-india",
    "url": "https://timesofindia.indiatimes.com/india/breakthrough-hiv-drug-sees-18-patent-filings-may-delay-affordable-generics/articleshow/135815841.cms"
  },
  "original_language": "en",
  "account": "In India, a staggering 18 patent applications have been filed for lenacapavir, a cutting-edge HIV therapy developed by Gilead Sciences. This surge in patent filings has sparked apprehension that these applications could extend the drug's market exclusivity, hinder the availability of affordable generics, sustain high prices, and impede patient access. Patient advocacy groups and civil society organizations have submitted objections to regulatory authorities, arguing that the applications lack novelty and inventive steps. Lenacapavir, an injectable medication administered biannually for both HIV prevention and treatment, was recently approved by the US FDA as the first and sole twice-yearly injectable pre-exposure prophylaxis to lower HIV transmission. Since its approval, Gilead has filed at least 18 patent applications in India, covering various aspects of the drug, including the active ingredient, salt variations, formulations, dosing regimens, compositions, and methods of administration. The filing pattern suggests a deliberate strategy aimed at establishing extensive patent protection around a single medication, hindering generic entry and prolonging monopoly control beyond the typical 20-year patent period. This tactic, known as evergreening, involves filing multiple secondary patents for minor variations in formulations, doses, or uses to extend exclusivity. KM Gopakumar, a senior researcher and legal advisor at the Trade and Development Network, commented on the matter. Patient groups have written to the department promoting industry and internal trade, urging the patent office to thoroughly review and reject the additional patent applications. Currently, six generic manufacturers have entered into voluntary agreements with Gilead to produce and distribute lenacapavir in over 120 low- and lower-middle-income countries, including India. The generic version is expected to cost around $40 per person per year. However, only the licensed generic producers can manufacture and sell the drug, excluding other manufacturers. Moreover, if the patents are granted, they are projected to expire in 2042, 28 years after the initial application was submitted. Granting these patents would validate Gilead's evergreening strategy, according to Prathibha Sivasubramanian of the Working Group on Access to Medicines and Treatments.",
  "summary": null,
  "key_points": [
    "18 patent applications filed for lenacapavir in India.",
    "Patient groups object to patent applications, citing lack of novelty.",
    "Patents may delay affordable generics, extend market exclusivity."
  ],
  "editors_take": null,
  "illustration": null,
  "coverage": {
    "outlets": 1,
    "also_reported_by": []
  },
  "ai_generated": true,
  "disclaimer": "Summaries, key points and the editor’s take are written by software from other outlets’ reporting and may contain errors — always check the linked original."
}