ATAZANAVIR (ATV)
En décembre 2013, le Medicines Patent Pool (MPP) a annoncé un accord avec la société biopharmaceutique Bristol-Myers Squibb (BMS) pour accroître l’accès à un médicament clé contre le VIH, l’atazanavir (ATV), qui fait partie du traitement de deuxième intention préféré par l’Organisation mondiale de la Santé (OMS) pour adulte et enfant.
En juillet 2017, le MPP a signé une extension de son accord de licence pour y inclure 12 pays supplémentaires : l’Algérie, les îles Cook, l’Égypte, la Guinée équatoriale, l’Indonésie, la Malaisie, le Maroc, Nioué, les Philippines, la Tunisie, l’Ukraine et le Vietnam.
La licence permet la fabrication générique d’ATV pour sa vente dans au moins 122 pays, qui abritent ensemble 89 % des personnes vivant avec le VIH dans les pays à revenu faible et intermédiaire.
| 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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