Vol. 35, No. 6
HIV/AIDS: New medicines patent pool
On September 30, the National Institutes of Health (NIH) became the first patent-holder to share its intellectual property with the Medicines Patent Pool. This recent initiative was established with the support of UNITAID, an innovative global health financing mechanism (funded by a levy on airline tickets) co-founded by Brazil, Chile, France, Norway and the United Kingdom at the United Nations General Assembly in 2006.
The Medicines Patent Pool works to increase access to affordable and adapted HIV medicines in developing countries. Although patent pools have proven useful in many areas, such as agriculture and information technology, the Medicines Patent Pool is the first for HIV medicines.
As governments pull back from fully funding the Global Fund, the development of affordable, generic versions of newer, safer AIDS medicines and medicines to treat infants and children with HIV and AIDS is critical.
By streamlining licensing processes for the production of generic versions of patented HIV medicines, the Pool serves as a one-stop shop that will speed up the pace at which newer medicines reach patients, and will help bring prices down by encouraging competition among multiple producers.
The patents licensed to the Medicines Patent Pool relate to the protease inhibitor class of HIV medicines, which is primarily used to treat drug-resistant HIV infection. 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 patents resulted from research undertaken by the NIH National Cancer Institute and the University of Illinois at Chicago.
Patents on the licensed technology are pending or have been granted in the U.S., Canada, Australia, Japan and 19 high-income member states of the European Patent Office.
The license that NIH has given the Pool stipulates that this technology is to be available for the benefit of all low- and middle-income countries, as defined by the World Bank. The license is royalty-free. On its own, the license will not provide rights to produce or sell any specific existing medicine. 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.
The Interfaith Center on Corporate Responsibility (ICCR), Oxfam and Doctors Without Borders are among the organizations that applauded NIH's step into the Patent Pool, and are encouraging pharmaceutical companies to follow suit.
For nearly a decade, ICCR members have engaged global pharmaceutical companies as shareholders to expand access to medicines for poor and underserved communities. Through dialogues with companies including Abbott, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Johnson & Johnson, Merck and Pfizer, and through the filing of shareholder resolutions, members challenge companies to address vital issues, including voluntary licensees, public-private partnerships and alternative models for research and development.
The Patent Pool has the potential to move the drug industry to the next stage of addressing HIV, which includes developing new fixed-dose combinations and pediatric formulations. The Pool will be successful if it has a positive impact on patients' lives, and for this the collaboration of pharmaceutical companies is essential.
Several companies including Gilead, Merck and Johnson & Johnson have expressed their support for the Patent Pool, and it is hoped that they will participate, now that NIH has joined. Other companies, such as Abbott and Bristol-Myers Squibb have not demonstrated interest and will need a greater nudge from their investors and other stakeholders.Ecumenical Advocacy Alliance (EAA) writes: "2010 is the year by which world governments promised to provide universal access to HIV prevention, treatment, care and support to all who needed it. As the year draws to a close, we know that this goal will not be achieved despite recent laudable progress in increasing access to treatment. Thus, World AIDS Day 2010 [December 1] provides a timely opportunity to reflect upon the reality of the HIV pandemic today and to pray for renewed passion, wisdom and action to uphold the human dignity and rights of all people living or at risk of being infected with HIV."