KEI comments on Tibotec voluntary licenses of a new HIV-AIDS product

Today, Tibotec, a subsidiary of Johnson & Johnson, announced it has signed voluntary licensing agreements with several Indian and South African generic companies to allow generic competition on a new HIV-AIDS treatment, the investigational non-nucleoside reverse transcriptase inhibitor rilpivirine hydrochloride (TMC278) (rilpivirine hydrochloride), to certain developing countries. The Tibotec press release is available here. The release specifically mentions three firms: Hetero Drugs Limited, Matrix Laboratories Limited (a Mylan company) of India and Aspen Pharmacare of South Africa.

KEI has not seen the terms of the licenses granted, but notes from the press release that the license is significantly limited in terms of geographical scope. The press release announces that “the generic pharmaceutical manufacturers in India will have rights to market the product in sub-Saharan Africa (SSA), Least Developed Countries (LDCs) and India” and that Aspen “will have rights to market the product in SSA including South Africa”. This excludes all countries in Latin America outside of Haiti, all of North Africa, and many other countries in Asia. For example, countries in Asia excluded from the announcement would include such countries as Thailand, Malaysia, the Philippines, Indonesia, and Pakistan, to mention a few.

Some speculate the Tibotec announcement is part of a larger effort to undermine the recently established Medicines Patent Pool. The Medicines Patent Pool is a UNITAID-supported mechanism to accelerate the availability of HIV-AIDS medicines by obtaining open licenses to patents for AIDS medicines in developing countries. The Tibotec announcement focuses on a small number of firms that have in the past collaborated with Tibotec, Gilead or GSK on voluntary licensing. It notably excludes CIPLA and other firms that are seen as more independent.

After months of informal conversations, on December 1, 2010 during the World Aids Day, the Medicines Patent Pool sent a letter to Johnson & Johnson/ Tibotec asking to formally start negotiations for Tibotec to voluntary joint the Medicines Patent Pool. On December 15, civil society from around the world sent a follow up letter to Tibotec asking for the negotiations to be conducted with transparency and to include all developing countries.

The Global Fund to Fight AIDS, Tuberculosis and Malaria, the UK government and many others have asked for companies to joint the Medicines Patent Pool without delay. In September 2010, the White House announced that the US Government would be the first to share patents with Medicines Patent Pool and last week, during the Executive Board of the World Health Organization, the US government made a strong intervention in support of the Medicines Patent Pool and generic competition to lower the price of HIV-AIDS medicines in developing countries.

The Medicines Patent Pool asked Tibotec to provide a response before January 31, 2011. The response that Tibotec has provided today January 27, 2011, a few days before the deadline expires, suggests Tibotec will reject the initial Medicines Patent Pool offer.

Under the announced agreement, the generic manufacturers will be allowed to manufacture TMC278 as a single agent medicine and a fixed-dose combination using TMC278 with tenofovir disoproxil fumarate and lamivudine. The Tibotec press release mentions that the licenses are pending the product “approval for use with other antiretroviral agents in the treatment of treatment-naïve HIV-1 infected adults”. The Press Release also mentions that Tibotec and Gilead are collaborating to develop a new fixed-dose combination containing Tibotec’s TMC278 and Gilead’s Truvada® (emtricitabine and tenofovir disoproxil fumarate). Today, we also learned that the FDA has refused the approval for TMC278 & Truvada fixed-dose combination.