India’s patent office yesterday rejected patent applications for tenofovir and darunavir, leaving the way open for any Indian company to manufacture the drugs, and to export tenofovir to Brazil, where the government has also rejected the patent
The move could increase price competition among companies manufacturing tenofovir as more manufacturers enter the market.
The decision may also permit more companies to manufacture the protease inhibitor darunavir, although the product is likely to remain more expensive than atazanavir, the cheapest protease inhibitor currently available through an Indian generic manufacturer, due to the greater complexity of the drug.
The Indian patents were rejected as a result of pre-grant oppositions filed by Indian generic manufacturers, by Indian people with HIV networks and Associação Brasileira Interdisciplinar de AIDS (ABIA), a Brazilian non-governmental organization.
In an unrelated move the World Trade Organization ruled on Monday that Brazil is entitled to over-ride US intellectual property to compensate against US subsidies to cotton growers. Brazil had argued that the US subsidy was unfair, since it allowed US farmers an unfair advantage in global markets.
According to The Financial Times, legislation is already being drafted by the Brazilian government that would allow US pharmaceutical patents to be over-ridden. The indication that Brazil is willing to play hardball on US pharmaceutical patents is a sign of the growing strength and assertiveness of Brazil as an agricultural exporter; within a decade Brazil is expected to eclipse the US as the global powerhouse of agriculture, substantially shifting the balance of power in international trade.
Brazil has already over-ridden Merck’s patent on efavirenz, and last September rejected Gilead’s patent on tenofovir, following the failure of negotiations on price reductions.
A major implication of the tenofovir patent rejection in India is that more Indian companies will be free to enter the market to produce tenofovir, and to export to countries like Brazil. Current voluntary license agreements that allow Indian companies to make generic versions of tenofovir forbid exports to countries where tenofovir is patented, even if that patent is in dispute. The new regime could allow major exports to Brazil, where over 31,000 people were already receiving treatment with the drug in 2008. High volume exports have the potential to drive down tenofovir prices even further as companies achieve economies of scale in production.
“Gilead now needs to remove any remaining contractual provisions that stop some generic companies from supplying tenofovir to other countries where there is no patent, said Michelle Childs, Director of Policy at MSF’s Access to Essential Medicines Campaign in a press statement.
Gilead has already submitted two further patent applications for tenofovir in India.