Medicines Patent Pool Signs Deal With Indian Generics Producer

The Medicines Patent Pool, which negotiates voluntary licences for lower pharmaceutical prices, today announced the signing of an agreement with generics producer Aurobindo Pharma Limited to manufacture antiretroviral medicines. The Patent Pool has recently come under criticism from AIDS activists concerned about its July licence agreement with drug company Gilead, and it remains to be seen if this action will address their concerns.

The Medicines Patent Pool said in a release that the agreement “will enable Aurobindo to manufacture products licensed to the Pool by Gilead Sciences in July: emtricitabine (FTC), cobicistat (COBI), elvitegravir (EVG), and the fixed-dose combination of these medicines known as the Quad (a combination of FTC, COBI, EVG, and tenofovir). COBI, EVG and the Quad are new products in development. Their uptake by generic manufacturers will help close the gap between the arrival of new medical technology in developed country markets and its often delayed arrival in developing countries.”

In particular, it said, Aurobindo took advantage of a “key provision negotiated by the Pool so it can sell tenofovir to a larger number of countries and without paying royalties.” The Pool negotiated for its licences with Gilead to be “unbundled,” allowing a generic manufacturer to take up licences on a product-by-product basis. Aurobindo took licences on the other medicines but not tenofovir, for which there is no patent in India. This should make it possible for Aurobindo to sell tenofovir to a larger number of countries than before, the Patent Pool said in a release.

“The Pool’s patent status database indicates that there are several significant middle-income countries that were excluded from the Gilead licence that may now be able to purchase tenofovir from Aurobindo,” Patent Pool spokesperson Kaitlin Mara said in an ip-health listserv posting.

Those countries include: Argentina, Brazil, Chile, Colombia, Malaysia, Peru, Philippines, Ukraine, and Uruguay, she said, adding: “In addition, there are several middle income countries on which we do not have definitive patent data but on which there are potentially no TDF patents, including Egypt, Jordan, Morocco, Panama, and Russia.”

Meanwhile, a newly launched petition against the MPP-Gilead agreement is being led by the International Treatment Preparedness Coalition, and is based on their assessment that the deal with Gilead represents a “setback” for people living with HIV, and that the process is not sufficiently transparent.

The petition is here. It calls for a renegotiation of the voluntary licence agreement, and a moratorium on agreements by the Patent Pool with Indian generics producers until a model can be created. The petition followed a 2 October meeting between activists and the MPP, and has dozens of signatures of individuals and groups.

Defenders of the Patent Pool’s Gilead agreement view it as having likely been the best possible at the time, and having moved the status quo further to the side of patients.

Denis Broun, executive director of UNITAID, which helped create the Patent Pool in 2010, said: “Competition from generic producers has been one of the most powerful tools to reduce drug prices. This agreement shows that generic manufacturers believe in the Patent Pool, and this is good news for people living with HIV across the developing world who will be able to access affordable, quality medicines.”

Another generics producer, MedChem, also entered into agreement with the Patent Pool, the release said.