COBICISTAT (COBI)
En juillet 2011, le Medicines Patent Pool (MPP) a signé un accord de licence avec Gilead Sciences pour la production du cobicistat (COBI) et des combinaisons contenant du cobicistat.
En septembre 2017, les deux organisations ont amendé l’accord afin d’étendre sa portée géographique au Bélarus, à la Malaisie, à l’Ukraine et aux Philippines. Le territoire nouvellement étendu représente 90.5% des personnes vivant avec le VIH dans les pays à revenu faible et intermédiaire.
En septembre 2019, l’accord a été amendé afin de permettre l’inclusion de l’Azerbaïdjan dans le territoire de maintenant 117 pays couvrant les licences pour 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 |
Termination letters
Anhui Biochem termination letter for TAF, TDF, EVG, BIC, COBI
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
Génériqueurs partenaires et développeurs de produits
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