ATAZANAVIR (ATV)
En dĂ©cembre 2013, le Medicines Patent Pool (MPP) a annoncĂ© un accord avec la sociĂ©tĂ© biopharmaceutique Bristol-Myers Squibb (BMS) pour accroĂźtre l’accĂšs Ă un mĂ©dicament clĂ© contre le VIH, l’atazanavir (ATV), qui fait partie du traitement de deuxiĂšme intention prĂ©fĂ©rĂ© par l’Organisation mondiale de la SantĂ© (OMS) pour adulte et enfant.
En juillet 2017, le MPP a signĂ© une extension de son accord de licence pour y inclure 12 pays supplĂ©mentaires : lâAlgĂ©rie, les Ăźles Cook, lâĂgypte, la GuinĂ©e Ă©quatoriale, lâIndonĂ©sie, la Malaisie, le Maroc, NiouĂ©, les Philippines, la Tunisie, lâUkraine et le Vietnam.
La licence permet la fabrication gĂ©nĂ©rique d’ATV pour sa vente dans au moins 122 pays, qui abritent ensemble 89 % des personnes vivant avec le VIH dans les pays Ă revenu faible et intermĂ©diaire.
| Eligibility for sublicences | Sublicences can be issued to qualified entities worldwide. |
| Manufacturing | Allows for the manufacturing of generic active pharmaceutical ingredient and finished formulations of ATV anywhere in the world. |
| Geographical scope for sale | Allows for sale in at least 122 countries where 89% of people with HIV in low- and middle-income countries live. |
| Sales outside the licensed territory | Enables manufacturers that do not rely on BMS technology to sell outside the 122 countries if no granted patent is being infringed. This includes cases in which a compulsory licence is issued. |
| Royalties | Three percent royalty for adult formulations in countries where granted patents on ATV are in force. Royalties to be collected by MPP and channeled back to a community-based HIV organization in the country paying the royalty. Royalties not payable for paediatric formulations or for sales of adult formulations in Sub-Saharan Africa and India. |
| Quality assurance | Licensees must obtain approval from WHO Pre-qualification, or a Stringent Regulatory Authority. Where such approval is not yet available, temporary approval from a WHO Expert Review Panel may be obtained. |
| Combinations | Sublicensees have the right to combine ATV 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 pending and granted patents worldwide at the time of licence signing. |
| Technology transfer | A technology transfer package is provided to all the sub-licensees, but there is no obligation to use the technology. |
Amendements
Génériqueurs partenaires et développeurs de produits
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