On 12 July, Gilead became the first commercial pharmaceutical company to sign up for the Medicines Patent Pool initiative to broaden generic manufacturing of antiretrovirals drugs for use in resource limited settings.
After many years in development, this programme was originally launched by UNITAID in November 2010 but now runs as an independent organisation. It aims to stimulate new drugs and formulations and increase access to HIV treatment by negotiating voluntary licenses on medicine patents.
The arrangement with Gilead includes tenofovir, FTC, the pharmacokinetic booster cobicistat and the integrase inhibitor elvitegravir. The agreement covers each drug individually and in appropriate combinations (as in the Gilead four-drug "Quad" formulation). This is exciting as cobicistat, elvitegravir and the Quad are products still in clinical development. Importantly it provides some hope that integrase inhibitors will potentially be available in resource-limited countries.
The agreement provides Gilead with royalities calculated at 3-5% of generic sales, with royalties waived for any new paediatric formulations, and each license is granted for a limited number of countries: 111 for tenofovir and FTC, 102 of cobicistat and 99 for elvitegravir and Quad.
Médecins Sans Frontières in a press release following this news, while welcoming the news also highlighted limitations.2
MSF press release states that the agreement limits competition "by confining manufacturing to one country (India) and includes narrow supply options for APIs needed to make the drugs. Most critically, people living with HIV in certain middle-income countries are excluded. This contrasts sharply to the first Pool license granted by the U.S. National Institutes of Health for all developing countries. If voluntary measures like the Patent Pool are unable to ensure people access to the medicines they need, countries that are left out will need to aggressively pursue non-voluntary paths such as compulsory licenses."
The Patent Pool is negotiating with at least five other companies and have publically announced that talks with Boehringer-Ingelheim and Bristol-Myers Squibb have started.3
"Of all pharmaceutical companies with HIV medicines patents, only three are currently not in negotiation with the Pool. We call on Johnson & Johnson, Merck, and Abbott to follow the lead of their colleagues and enter into negotiations with us," said Ellen 't Hoen, executive director of the Medicines Patent Pool.
The Pool received its first licence, related to darunavir, from the United States National Institutes of Health in September 2010.
Medicines Patent Pool
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