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National Institutes of Health Donates Protease Inhibitor Patent to UNITAID Medicines Patent Pool

By Mark Harrington

Autumn 2010

On September 30, 2010 the U.S. National Institutes of Health (NIH) became the first research funder to license intellectual property rights to the Medicines Patent Pool essential to manufacturing anti-HIV protease inhibitors. The patent pool is an innovative initiative that -- by pooling patents from diverse inventors -- will allow the manufacture of low-cost, high-quality generic medications for people with HIV and other life-threatening diseases in low- and middle-income countries.

By becoming the first research funder to license medical patents to the Medicines Patent Pool, the NIH has taken a historic step toward facilitating equitable global access to medical innovations created with taxpayer funds to fight such diseases of global concern as HIV, tuberculosis, and malaria.

The NIH donated a use patent covering the HIV protease inhibitor darunavir (Prezista), which is marketed by Johnson & Johnson/Tibotec. The Medicines Patent Pool is seeking voluntary licenses from the patent holders who market additional anti-HIV drugs, including lopinavir and ritonavir from Abbott; nevirapine from Boehringer-Ingelheim; atazanavir from Bristol-Myers Squibb; tenofovir and FTC from Gilead; efavirenz and raltegravir from Merck; etravirine and darunavir from Tibotec; and 3TC, abacavir, fosamprenavir, and maraviroc from GSK's joint venture with Pfizer, ViiV.

For the past decade, activists, scientists, and political leaders have worked together to bring down the costs of anti-HIV drugs by over 99%, allowing more than 5.2 million people around the world to be able to receive lifesaving HIV therapy. The current global economic recession and the associated threats of widespread scale-back of country and donor support for health programs in low- and middle income countries makes it imperative that further innovations are pursued to reduce the costs of treatment. The UNITAID-sponsored Medicines Patent Pool is one such mechanism which can help to ensure HIV medicines become more widely available at lower cost without compromising quality. The Patent Pool works by pooling intellectual property (patents) from diverse patent holders including government agencies such as NIH and private pharmaceutical and biotechnology companies.

The patent pool is an initiative of UNITAID, the global funding mechanism established by a group of countries that agreed to levy a small transaction tax on air travel to provide support for expensive second-line HIV and tuberculosis drugs, and for pediatric formulations. The pool, by reducing the costs of HIV treatments and making it easier to manufacture high-quality generic medications, will help to reduce the yawning funding gap for global HIV treatment. UNAIDS has estimated that US$ 28 billion to US$ 50 billion would be needed globally every year from 2010 to 2015 in order to progressively reach universal access targets for HIV/AIDS by 2015.1 Though 5.2 million people with HIV are receiving HIV treatment around the world, 10 million more need treatment and are not receiving it. According to UNAIDS, the funding gap will rise to $20 billion per year by 2015.

The patent pool by itself cannot fill the treatment funding gap. However, it can drive continuous reductions in HIV drug combination costs by diversifying manufacturers; expanding the generic market; facilitating improved formulations such as pediatric dosing regimens and fixed-dose combinations to improve treatment adherence; reducing transaction costs; and increasing legal and market certainty to allow generic companies to plan for the long term and invest in high-quality, lower-cost HIV treatments.

UNITAID estimates that the patent pool has the potential to reduce HIV drug costs by between $52 million and $1.3 billion per year or a savings of $260 million to $6.3 billion over a five-year period.

TAG urges BI, BMS, Gilead, Merck, Tibotec, and ViiV to provide licenses for their anti-HIV medications to the Patent Pool in order to broaden access to lifesaving treatments around the world. TAG also recommends that the patent pool be broadened to include expensive second-line tuberculosis drugs and pediatric formulations.

  1. WHO, UNAIDS, UNICEF. Towards Universal Access: Scaling Up Priority HIV/AIDS Interventions in the Health Sector: Progress Report 2009. Geneva: WHO; 2009.




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