NIH Entry Into Medicines Patent Pool is a Welcome First Step

Drug Companies Must Now Follow Suit

Geneva/New York – September 30, 2010 – The U.S. National Institutes of Health (NIH) announced today it will license a patent for an HIV medicine to the Medicines Patent Pool, a mechanism designed to boost access to more affordable AIDS drugs in the developing world. The move acts as a wake-up call to pharmaceutical companies to put patents on key AIDS medicines into the pool, said the international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF).

A patent pool for medicines has the potential to increase access to patented medicines for people living with HIV in the developing world, by creating a structure for patent holders to share their HIV drug patents and receive royalties in return. Drug companies can then access these patents to produce more affordable versions of the patented medicines. Companies are financially rewarded, and patients benefit from access to more affordable medicines.

The NIH patent applies to darunavir, a drug listed in World Health Organization guidelines as a potential third-line treatment for patients experiencing failure with second-line medicines. However, this particular NIH patent submission will not clear the way for generic versions of darunavir because additional patents are held by Tibotec, owned by US firm Johnson & Johnson, undermining wider access to the drug.

“This demonstrates serious political backing for the Medicines Patent Pool to benefit all developing countries, and the fact that the NIH has also agreed to review its entire antiretroviral medicines portfolio with the intention of putting other patents in the Pool is very promising,” said Dr. Tido von Schoen-Angerer, director of MSF’s Campaign for Access to Essential Medicines. “But this single patent isn’t enough to allow a cheaper version of the medicine to be produced.  We need to build on this - the onus is on the drug companies that own patents on this and other key AIDS medicines to put their patents in the Pool.”

The lack of access to newer AIDS medicines is a crisis today for patients in the developing world. MSF currently treats over 160,000 people living with HIV/AIDS, largely thanks to the availability of affordable generic versions of antiretroviral drugs.  

Significantly, the licence terms offered by the NIH include middle-income countries. Many middle-income countries have large numbers of people on HIV treatment, but are not eligible for the price discounts offered by drug companies, making access to patented medicines extremely difficult.

“HIV requires lifelong treatment, and patients will eventually need to move on to newer medicines as they inevitably develop resistance – but these are much more expensive,” said Dr. Peter Saranchuk, HIV doctor for MSF in South Africa. “Generic production of many of these drugs is blocked by intellectual property barriers. The Patent Pool could help overcome these hurdles, but only if the licences cover all developing countries.”

“The only benchmark we should use to judge the Patent Pool is the impact it has on patients’ lives,” said von Schoen-Angerer. “If companies are genuine about wanting to boost access to newer medicines, then they must license the patents that are actually blocking generic production and will make a real difference to people’s lives.  The clock is ticking for patients, so countries should also consider compulsory license measures, as is their right under international law. This will be even more important if companies refuse to support an effective Patent Pool.”

The US Government’s support of the Medicines Patent Pool is significant, not least because it establishes the principle that publically-funded research like the NIH’s should be for the public benefit.  The US Government now needs to recognise that more needs to be done, and also increase funding available for AIDS through PEPFAR and the Global Fund.   

MSF has developed a list of the key AIDS medicines that should be put in the Pool.  These include darunavir (patent held by Tibotec/Johnson & Johnson), atazanavir (Bristol-Myers Squibb), ritonavir (Abbott), raltegravir (Merck), etravirine (Tibotec/Johnson & Johnson), tenofovir (Gilead), and a number of other antiretrovirals.