In July 2011, the Medicines Patent Pool (MPP) signed a licence agreement with Gilead Sciences for the production of cobicistat (COBI), and combinations containing cobicistat.
In September 2017, the two parties amended the agreement to allow for an extension of the territory for COBI to Belarus, Malaysia, Ukraine and Philippines. Together, the extended territory is home to 90.5% of people living with HIV in low- and middle-income countries.
In September 2019, the agreement was amended to allow for the inclusion of Azerbaijan to the territory of now 117 countries for BIC, COBI, TAF and TDF.
|Eligibility for sublicences:||Sublicences can be issued to entities based in China, India and South Africa.|
|Manufacturing:||Allows manufacturing of active pharmaceutical ingredient and finished formulations in India, China and South Africa.|
|Geographical scope for sale:||Allows for sale of cobicistat in 117 countries representing 90.5% of people living with HIV in low- and middle-income countries|
|Sales outside the licensed territory:||Sublicensees may supply outside the licensed territory if a country issues a compulsory licence|
|Royalties:||The royalty rate is 5% of net sales of finished product. There are no royalties for the sale of the active pharmaceutical ingredient or paediatric formulations|
|Quality assurance:||Licensees must obtain approval from WHO Pre-qualification, the US Food and Drug Administration or the European Medicines Agency|
|Combinations:||Sublicensees have the right to combine COBI with other ARVs and to develop new fixed-dose combinations|
|Data exclusivity:||Data exclusivity is waived in countries with such form of protection, thus facilitating regulatory approval of generics|
|Patent disclosure:||The licence discloses the list of all pending and granted patents in the 116 licensed countries, as of September 2017|
|Technology transfer:||All Indian and South Africa sublicensees benefit from a one-time technology transfer|
|Additional flexibilities for licensees:||Licensees have the right to terminate the agreement at any time on a product-by-product basis and can challenge any of the licensed patents|
Aurobindo termination letter for COBI, EVG
Desano termination letter for TDF, EVG, COBI
Langhua Pharmaceutical termination letter for TDF, EVG, COBI, BIC
Laurus Labs termination letter for TDF, COBI, EVG
Micro Labs termination letter for COBI, TDF, EVG
Dr. Reddy’s termination letter for TDF, COBI, EVG