Indian authorities have rejected patent requests from US pharmaceutical company Gilead Sciences on two life-saving HIV/AIDS drugs, Tenofovir and Darunavir, as they were considered to be in infringement with the patent law. According to the decision, the patents violated section 3(d) of the Indian patent law, which prohibits ‘evergreening’ — the practice of multinational pharmaceutical companies of making small, trivial changes to existing medicines in order to extend the period of patent monopoly on a drug, thereby preventing the entry of generic competitors into the market and keeping drug prices high.
“This is a really important day for HIV patients in developing countries. The rejection of the patents on Tenofovir opens up the market for new generic competitors to drive down the price of this key HIV/AIDS drug,” says Michelle Childs, Director of Policy at Doctors Without Borders/Médecins Sans Frontières (MSF)’s Access to Essential Medicines Campaign and continues “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, for example Brazil where the patent on Tenofovir has also been rejected. The decision regarding Darunavir is significant because the drug is one of the newest and most expensive of HIV/AIDS drugs. These decisions highlight the success and importance of Section 3(d) and opposition procedures in India’s patent law to safeguard public health. Other countries which need access to affordable essential drugs should look at India and build similar public health safeguards into their own patent law.”
Tenofovir is a key HIV/AIDS drug recommended by the World Health Organization for improved first-line treatment of HIV/AIDS. Darunavir is a new and expensive HIV/AIDS drug that is needed by patients failing on their existing treatments. Access to both medicines is currently limited by their high price.