Medicines Patent Pool Boosts HIV Drug Prospects With First Licence

The Medicines Patent Pool and pharmaceutical company Gilead Sciences today announced a breakthrough licence agreement to allow for the production of key HIV medicines at lower cost and in an easier-to-use formulation, making them more accessible to developing countries. The agreement also opens up the use of treatments for Hepatitis B for the first time.

“Today marks a milestone in managing patents for public health,” Medicines Patent Pool Executive Director Ellen ‘t Hoen said in a release. “People in developing countries often have to wait for years before they can access new health technologies. Today’s agreement changed that.”

In particular, ‘t Hoen said, the licensing of elvitegravir, cobicistat and “the Quad” [a combination of four medicines] while they are still in clinical development should significantly accelerate availability. The licence will allow generic versions of patented drugs to enter markets shortly after they become available in wealthy countries, according to the Pool.

The Medicines Patent Pool release, FAQ and copy of the licence are available here.

The licence can be considered a significant accomplishment for the patent pool, which arose from innovative drug financing mechanism UNITAID last year. The licence also stands out in that it preserves the right to flexibilities to patent law under international trade law, including the use of compulsory licensing, while also providing an option for the company to pull out if it wishes.

The company gets the benefit of possible new applications of its patented drugs, and the good will that comes with a project aimed at the world’s poor. It will receive royalties of 5 percent of generic sales, with royalties waived for any new paediatric formulations, the Pool said.

“We believe the Pool is an innovative mechanism to increase access to patented medicines in a way that works for the pharmaceutical industry and people living with HIV,” Gregg Alton, executive vice president for Corporate and Medical Affairs at Gilead, said in the release.

The agreement covers all patents related to five products: tenofovir (TDF), emtricitibine (FTC), elvitegravir (EVG), cobicistat (COBI), and the Quad, which is a fixed-dose combination [aka several medicines combined into one pill] containing TDF-FTC-EVG-COBI.

In some of these drugs, the products are still in the pipeline, while others are near the end of their patent life, according to the Medicines Patent Pool patent database.

The licences will allow for the supply of tenofovir and emtricitabine in 111 countries, cobicistat in 102 countries, and for elvitegravir and the Quad in 99 countries. But the licences do not include all developing countries, the Pool said.

The geographic scope of the licences covers the majority of people in low and middle income countries living with HIV, according to Medicines Patent Pool spokesperson Kaitlin Mara.