CABOTEGRAVIR A ACTION PROLONGEE (LA) COMME PROPHYLAXIE PRE-EXPOSITION (PrEP)
En juillet 2022, ViiV Healthcare et le Medicines Patent Pool ont annoncĂ© la signature dâun nouvel accord de licence volontaire pour les brevets sur le cabotĂ©gravir Ă action prolongĂ©e (LA) comme prophylaxie prĂ©-exposition (PrEP) au VIH pour faciliter lâaccĂšs au traitement dans les pays les moins avancĂ©s, Ă faible revenu, Ă revenu intermĂ©diaire de la tranche infĂ©rieure et dâAfrique subsaharienne.
Par cet accord, les fabricants de mĂ©dicaments gĂ©nĂ©riques sĂ©lectionnĂ©s auront la possibilitĂ© de dĂ©velopper, fabriquer et fournir des versions gĂ©nĂ©riques du cabotĂ©gravir Ă action prolongĂ©e en tant que prophylaxie prĂ©-exposition (PrEP), le premier mĂ©dicament prĂ©ventif Ă action prolongĂ©e contre le VIH, dans 90 pays, sous rĂ©serve de lâobtention des approbations rĂ©glementaires requises. Cet accord devrait permettre lâaccĂšs Ă grande Ă©chelle au cabotĂ©gravir gĂ©nĂ©rique Ă action prolongĂ©e comme PrEP. Cette annonce intervient sept mois seulement aprĂšs la premiĂšre approbation rĂ©glementaire du cabotĂ©gravir LA comme PrEP dans le monde par lâAgence amĂ©ricaine des produits alimentaires et mĂ©dicamenteux (US FDA).
Le MPP invite des potentiels sous-licenciĂ©s basĂ©s partout dans le monde Ă manifester leur intĂ©rĂȘt pour lâobtention dâune sous-licence afin de fabriquer et de vendre le cabotĂ©gravir injectable Ă action prolongĂ©e pour la PrEP sur le territoire dĂ©fini dans la licence :
| Eligibility for sublicences | Sublicences can be issued to any qualified entity worldwide. The number of sublicensees is up to three, with a possibility to have additional sublicensees if the evidence demonstrates a public health need for it. |
| Manufacturing | Allows manufacturing of cabotegravir anywhere in the world in the form of a tablet containing 30 mg of cabotegravir as its sole active pharmaceutical ingredient; and/or an extended-release injectable suspension form. |
| Geographical scope for sale | Allows for sale of cabotegravir in all low-income countries, lower middle-income countries, sub-Saharan African countries, least-developed countries (as defined by the UN), amounting to at least 90 countries. Sales in royalty countries (see below) are allowed only in the public market. |
| Sales outside the licensed territory | Nothing in this Agreement shall be construed to prevent the Licensee from undertaking any activity anywhere in the world where such activity is (1) outside the scope of the Patent Rights or (2) is permitted pursuant to a compulsory licence of the Patent Rights. |
| Royalties | The licence is royalty free for most countries within the Territory for both private and public market. It is royalty-bearing for 10 countries where ViiV holds patent rights (i.e. Algeria, Egypt, India, Indonesia, Kyrgyzstan, Morocco, Philippines, Tajikistan, Ukraine, Vietnam). In those royalty countries the rate is 5% of net sales of the product in the public market. As for the private market of the royalty countries, ViiV may apply a differentiated royalty rate for private market sales, if any private markets are subsequently permitted. |
| Quality assurance | Licensees must obtain World Health Organization (WHO) Pre-qualification (PQ), or approval from a Stringent Regulatory Authority (SRA). Where such approval is not yet available, provisional or emergency use authorisations available through WHO or an SRA may be obtained. |
| Data exclusivity | Data exclusivity is waived in countries of the Territory with such form of protection, thus facilitating regulatory approval of generics. |
| Patent disclosure | The licence discloses the list of PCT patent applications at the time of licence signing. |
Génériqueurs partenaires et développeurs de produits
