“This is fantastic news that will save countless lives in the developing world – we can now continue to access these two very effective ARVs at an affordable price,” James Kamau, coordinator of the Kenya Treatment Access Movement, told IRIN/PlusNews. Many developing countries had held off ordering generic tenofovir from Indian companies in case the patent applications were approved.
India’s patent office rejected applications filed by US-based manufacturer Gilead Sciences Inc for tenofovir, and Tibotec Pharmaceuticals Inc, a subsidiary of pharmaceutical giant Johnson & Johnson, for darunavir.
Cipla, the Indian generic drug maker, and several civil society groups argued that the patent applications did not meet the criteria in section 3(d) of India’s Patents Act, which include proving the “enhanced efficacy” of new uses or new forms of existing products.
Indian law recognised few patent restraints before the country joined the World Trade Organisation (WTO) in 2005, allowing it to develop one of the world’s largest generic drug manufacturing industries.
India is now bound by the WTO’s Trade Related Aspects of Intellectual Property Rights (TRIPS), which strengthens the intellectual property rights of pharmaceutical firms, and it has had to revise its patent laws to align them with WTO standards.
More Indian manufacturers will also be able to produce the generics, leading to further competition and lower costs. In June, Brazil also rejected a patent application by Gilead for tenofovir.
The UN World Health Organization recommends tenofovir for use in first- and second-line drug regimens in resource-poor settings, while darunavir is considered an important second-line treatment option.
“The rejection of the patents on tenofovir opens up the market for new generic competitors to drive down the price of this key AIDS drug,” said Michelle Childs, of the international medical charity, MÃ©decins Sans FrontiÃ¨res. “The decision regarding darunavir is significant because the drug is one of the newest and most expensive of HIV/AIDS drugs.”
Not out of the woods yet
Yet activists warn that the battle is not yet won; Gilead has similar patent applications pending in India, and Novartis, a large Swiss pharmaceutical manufacturer, is going to the Indian Supreme Court to challenge the interpretation and application of “efficacy” by Indian courts and the patent office.
A previous attempt by Novartis to challenge Section 3(d) of India’s Patents Act, 1970, was rejected by the Madras High Court in August 2007.
“India has led the way in provision of affordable medicines to people in the developing world; we encourage them to keep putting their foot down and standing up to big pharmaceutical companies,” said Leonard Okello, a Ugandan AIDS activist and former head of the international HIV team at the anti-poverty NGO, ActionAid.
This feature is used with permission from IRIN/PlusNews – www.plusnews.org