First patent goes into the medicines patent pool - drug companies must now follow suit

Geneva/New York – The U.S. National Institutes of Health announced today it will license a patent on the HIV medicine darunavir 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, according to international humanitarian medical organisation Médecins Sans Frontières (Doctors Without Borders, or MSF).

“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 ARV 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.”

This particular NIH patent will not free the way for generic versions of darunavir, because additional patents are held by Tibotec (owned by US firm Johnson & Johnson).

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

“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.”

Significantly, the licence terms offered by the NIH include middle-income countries. Many of these 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.

“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 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.