Médecins Sans Frontières (MSF), a leading medical NGO operating in various countries, has said that patenting tenofovir in India would set dangerous precedent for global access to newer essential drugs.
If Gilead Sciences were granted the patent in India, availability of the generic version, already in the market since 2005, could be prevented until 2018, and any existing production would be in jeopardy. In addition, future generic production of fixed-dose combination pills containing tenofovir would also be blocked. Such combination drugs have had a major impact in helping scale up global AIDS treatment by simplifying it, said MSF.
"Granting this patent would set a dangerous precedent. Limiting production of tenofovir and that of other newer essential drugs to a single company keeps prices high because generic competition is blocked," noted Ellen 't Hoen, Director for Policy and Advocacy at MSF's Campaign for Access to Essential Medicines, in a press release.
Access to tenofovir in resource-poor settings is extremely limited. While Gilead, the patent-holder in most developed countries, has announced that it will offer the drug at a discount to 97 developing countries, the company has been extremely slow in making the drug available in these countries. In MSF's HIV treatment project in Khayelitsha, South Africa, where nearly 4,000 patients receive antiretroviral drugs, the difficulty in accessing tenofovir has resulted in only 40 patients with only the most urgent needs receiving the drug.
Tenofovir (tenofovir disoproxil fumarate -TDF) is commonly prescribed as part of first-line antiretroviral treatment in the US and Europe. It is increasingly needed in resource-poor settings, both for patients starting treatment for the first time, because it leads to fewer side effects than other commonly used drugs, and for those patients who have been on therapy for several years. The latest World Health Organization (WHO) antiretroviral treatment guidelines recognize the importance of tenofovir for resource-limited settings, recommending its use in first and second-line regimens. But at the same time as tenofovir's importance is being underlined, access to it may be severely restricted, noted MSF.
As reported, a pre-grant opposition was filed by The Indian Network for People Living with HIV/AIDS, represented by the Alternative Law Forum, Bangalore at the Delhi patent office against the application by Gilead Sciences for the key AIDS drug tenofovir, two days ago. People living with HIV/AIDS in India opposed the patent application on the grounds that the drug consists of a previously known compound, and should not be considered an invention according to India's Patent Act. The petitioners argue that forming a salt (fumaric acid) out of an existing compound (tenofovir disoproxil), is a common practice within the pharmaceutical industry, and should not be considered patentable under Indian law. Cipla, which manufactures the generic version of this drug, is also planning to oppose the patent application.
MSF has been providing antiretroviral treatment to people living with HIV/AIDS since 2000. Over 60,000 patients currently receive ARVs through MSF worldwide.