NIH announces it will share IP rights to some AIDS drugs in UNITAID Patent Pool

Oct 4 2010

The NIH announced Thursday "it will share intellectual property rights on some AIDS drugs in a patent pool designed to make treatments more widely available to the poor," Reuters reports. The move makes the NIH the "the first research institution to join an HIV medicines patent pool launched by UNITAID, a health financing system funded by a tax on airline tickets which was co-founded by Brazil, Britain, Chile, France, and Norway in 2006," the news service adds (Kelland, 9/30).

UNITAID's Medicines Patent Pool "aims to create a common space for patent-holders to license their technology for use by generic manufacturers in exchange for royalties," IRIN/PlusNews writes in an article that examines how the decision could benefit people living with HIV/AIDS in low- and middle-income countries. "Proponents of the pool argue that not only does it have the potential to reduce the price of existing [antiretrovirals] ARVs, but it could also stimulate the development of urgently needed new medicines and formulations such as paediatric ARVs and fixed-dose combinations," the news service writes (10/1).

"The patents licensed [Thursday] relate to the protease inhibitor class of HIV medicines, which is primarily used to treat drug-resistant HIV infection," according to a joint press release issued by NIH, UNITAID and Medicines Patent Pool. "The NIH Office of Technology Transfer has previously granted non-exclusive licenses to these patents, including to Tibotec (a subsidiary of Johnson & Johnson) for darunavir." The release adds other details on the agreement, including that the license "stipulates that this technology is to be available for the benefit of all low- and middle-income countries, as defined by the World Bank ... is royalty-free," and "on its own will not provide rights to produce or sell any specific existing medicine."

The release continues: "Other patent holders would also need to share their patents with the Pool in order to clear the legal path for production of affordable, generic HIV medicines. The Pool is inviting all leaders of companies and institutions that hold patents on HIV medicines to make their patents available" (9/30).

The protease inhibitor darunavir "is recommended for use in combination with another ARV, but the cost of darunavir alone for one patient for one year is US$1,095, according to the medical NGO, Medecins Sans Frontieres; in comparison, generic first-line combinations cost as little as $90 per patient per year," IRIN/PlusNews reports (10/1).

"This license underlines the U.S. government's commitment to the Medicines Patent Pool and its goal to increase the availability of HIV medicines in developing countries," NIH Director Francis Collins said, according to a joint press release. "We are now discussing licensing to the Medicines Patent Pool other patents that could have a positive impact on the treatment of HIV/AIDS," he added.

"The licence is an important first step that shows the U.S. is committed to bringing down the cost of ARVs, but pharmaceutical companies must move forward quickly and share their licences using the same positive terms of license as the NIH," Asia Russell of Health GAP said, according to IRIN. The article also includes comments by Ellen 't Hoen, head of the Medicines Patent Pool, who describes the ongoing talks between UNITAID and drug manufacturers about the patent pool (10/1).

Reuters adds: "A UNITAID official told Reuters in July several major drugmakers, including Merck, Tibotec and Gilead, were in advanced talks on joining the AIDS drug pool. … But others - including GlaxoSmithKline and Pfizer's HIV/AIDS drug joint venture, ViiV Healthcare - have said they would rather agree their own licensing deals with generic makers in developing countries" (9/30).

"While few pharmaceutical companies have openly criticised the patent pool, many have preferred to launch their in-house programmes to develop and improve the affordability of drugs for the poor," the Financial Times writes. "They are particularly reluctant to license their rights via the patent pool in middle-income countries, the markets in which their generic rivals argue are essential in order to make low-cost production viable," the newspaper continues.

The article describes the growing concern among health advocates over the rising costs of patented HIV/AIDS medications, "as older and cheaper drugs become less effective." The Financial Times adds, "New trade rules have enforced stricter patent standards in India - traditionally the home of low-cost generic manufacturers of HIV drugs - while the economic slowdown has threatened funding for an expansion in treatment" (Jack, 10/1).