Indian manufacture of new generic antiretrovirals: implications for global access to anti-HIV drugs

Abstract

India’s ruling on patent protection India recently rejected patent applications on two antiretrovirals (ARVs), darunavir and tenofovir, which ensures the continued generic manufacturing of these drugs at substantially reduced costs compared with proprietary formulations [1]. The ruling by India’s Patent Office (IPO) to reject the exclusive licensing of the nucleoside reverse-transcriptase inhibitor tenofovir (Gilead Sciences, CA, USA) and protease inhibitor (PI) darunavir (Tibotec Pharmaceuticals, NJ, USA) also allows other countries to import generic versions produced in India. Cipla, the Mumbai-based generic drug manufacturer, had filed cases against both companies. Even before the anticipated outcome, Gilead had already offered 13 Indian drug manufactures the licensing rights to manufacture tenofovir, but with the caveat that the Indian manufacturers purchase the active drug ingredient from Gilead and that the product be sold only to the poorest 95 countries (which does not include middle-income countries, such as China and Brazil). The patent rejection potentially opens up the market for generic drug manufactures to further drive down the cost of these two ARVs, and may have wider implications for the future development and distribution of ARVs.