In July 2011, the Medicines Patent Pool (MPP) signed a licence agreement with Gilead Sciences for several antiretrovirals. It included a covenant not to sue on products containing emtricitabine (FTC). FTC is recommended by the World Health Organization (WHO) as a component of first and second-line treatment regimens for adults and children.
In September 2017, the two parties amended the agreement to allow for an extension of the Territory for FTC to 116 countries that together are home to 90.5% of people living with HIV in low- and middle-income countries.
In September 2019, the agreement with Gilead Sciences mentioned above was amended to allow for the inclusion of Azerbaijan to the territory of now 117 countries.
|Eligibility:||All entities based in China, India and South Africa that have signed the licence with Gilead and MPP on TDF, TAF, COBI and EVG, regardless of whether they have terminated TDF or not.|
|Geographical scope for sale:||The geographical scope is 112 countries, representing 90.5% of people living with HIV in low- and middle-income countries, equivalent to the territory included in the TDF and TAF licences.|
|Sales outside the licensed territory:||The covenant not to sue only applies to the 112 countries included. Sales outside the licensed territory may be possible if not infringing on any granted patents.|
|Royalties:||No royalties on the covenant not to sue (but there may be royalties on other components of any specific combination)|
|Combinations:||The covenant not to sue covers combinations that include FTC, such as TDF/FTC, TAF/FTC and TDF/FTC/EFV|
|Patent disclosure:||The covenant not to sue discloses the list of all pending and granted patents in the 112 licensed countries at the time of signing the licence|
|Termination (or unbundling)||Licensees that have terminated TDF continue to benefit from the covenant not to sue on TDF/FTC, TAF/FTC and TDF/FTC/EFV.|