GLECAPREVIR/PIBRENTASVIR (G/P)
En novembre 2018, le Medicines Patent Pool (MPP) a signé un accord de licence non soumis à redevance pour le glécaprévir/pibrentasvir (G/P), un traitement recommandé par l’Organisation mondiale de la Santé (OMS) pour les personnes atteintes d’hépatite C chronique (VHC).
Cette licence permettra à des fabricants de médicaments de qualité garantie de produire et de vendre à prix abordable des médicaments génériques contenant du G/P dans 96 pays à revenu faible et intermédiaire, intensifiant ainsi le traitement de la maladie en ouvrant l’accès aux médicaments pangénotypiques les plus efficaces.
Principales caractéristiques
| Eligibility for sublicences | Non exclusive sublicences can be issued to any qualified entity in the Territory and in India. |
| Manufacturing | Allows for the manufacturing of the fixed-dose combination of G/P anywhere in the territory and in India. |
| Geographical scope for sale | Allow sales in 96 countries accounting for 47.5% of the HCV burden worldwide. |
| Sales outside the licensed territory | Sales outside the Territory are permitted if no granted patent is being infringed. This includes cases in which a compulsory licence is issued. |
| Non-Territory Purchasers | NGOs, UN-related orgs, other not-for-profits, and funding mechanisms such as PEPFAR, Unitaid, USAID, Global Fund, and others based outside the Territory are eligible to procure generic G/P for use in countries within the Territory. |
| Royalties | The licence is royalty-free. |
| Quality assurance | Sublicensees must meet WHO pre-qualification standards or the standards of any stringent regulatory authority as defined by the WHO, or, where such approvals are not yet available, must gain temporary approval by WHO Expert Review Panel. |
| Data exclusivity | AbbVie agrees to provide waivers of data exclusivity in countries with such form of protection, thus facilitating regulatory approval of generics. Sublicensees agree not to seek further regulatory exclusivity. |
| Patent disclosure | The licence discloses the list of pending and granted patents in the Territory and in India at the time of licence execution. |
| Registration assistance | AbbVie will provide, upon MPP request, a copy of clinical data and all non-commercial and non-manufacturing documents to facilitate product registration. |
| Patent challenges | No restrictions on sublicensee patent challenges. |
Afghanistan, Angola, Antigua-et-Barbuda, Bangladesh, Belize, Bénin, Bhoutan, Bolivie (État plurinational de), Botswana, Burkina Faso, Burundi, Cambodge, Cameroun, Cabo Verde, République centrafricaine, Tchad, Comores, Congo, Îles Cook, Côte d'Ivoire, Congo, la République démocratique de, Djibouti, Dominique, Égypte, Guinée équatoriale, Érythrée, Eswatini, Éthiopie, Fidji, Gabon, Gambie, Géorgie, Ghana, Grenade, Guinée, Guinée-Bissau, Guyane, Haïti, Indonésie, Jordanie, Kenya, Kiribati, Lao, République démocratique populaire, Lesotho, Libéria, Libye, Madagascar, Malawi, Maldives, Mali, Îles Marshall, Mauritanie, Maurice, Micronésie (États fédérés de), Maroc, Mozambique, Myanmar, Namibie, Nauru, Népal, Niger, Nigéria, Niue, Pakistan, Palaos, Papouasie-Nouvelle-Guinée, Philippines, Rwanda, Saint-Kitts-et-Nevis, Sainte-Lucie, Saint-Vincent-et-les Grenadines, Samoa, Sao Tomé-et-Principe, Sénégal, Seychelles, Sierra Leone, Îles Salomon, Somalie, Afrique du Sud, Soudan du Sud, Sri Lanka, Soudan, Suriname, Tanzanie, République-Unie de, Timor-Leste, Togo, Tunisie, Turkménistan, Tuvalu, Ouganda, Vanuatu, Viet Nam, État de Palestine, Yémen, Zambie, Zimbabwe
Génériqueurs partenaires et développeurs de produits
