BICTÉGRAVIR (BIC)

En septembre 2017, le Medicines Patent Pool a signé un accord de licence avec Gilead Sciences pour le bictégravir (BIC), bénéficiant à 116 pays qui accueillent ensemble 89.8% des personnes vivant avec le VIH dans les pays à revenu faible et intermédiaire. La licence BIC a développé la collaboration du MPP avec Gilead en élargissant la licence précédente pour la production de ténofovir alafénamide (TAF) fumarate de ténofovir disoproxil (TDF), d’emtricitabine (FTC), de cobicistat (COBI) et d’élvitégravir (EVG).

Caractéristiques clés
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 BIC in 116 countries representing 89.8% 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 five (5) percent of net sales of finished product.  There are no royalties for the sale of the active pharmaceutical ingredient or paediatric formulations
Quality assurance Licensees to manufacture in accordance with WHO Pre-qualification standards, standards of the European Medicines Agency, or USFDA tentative approval standards. Licensees to apply for WHO-Prequalification in the event BIC is included in the WHO Guidelines or in the expression of interest for WHO pre-qualification of medicines
Combinations Sublicensees have the right to combine BIC with other ARVs and to develop suitable 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 he licence discloses the list of all pending and granted patents in the 116 licensed countries
Technology transfer All Indian and South-African sub-licensees 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

 
Voir la licence concernée

Liste des pays
Afghanistan, Afrique du Sud, Angola, Anguilla, Antigua-et-Barbuda, Arménie, Aruba, Bahamas, Bangladesh, Barbade, Belize, Benin, Bhoutan, Biélorussie, Bolivie, Botswana, Burkina Faso, Burundi, Cambodge, Cameroun, Cap Vert, Comores, Côte d’Ivoire, Cuba, Djibouti, Dominique, El Salvador, Equateur, Erythrée, Ethiopie, Fidji, Gabon, Gambie, Georgie, Ghana, Grenade, Guatemala, Guinée, Guinée Equatoriale, Guinée-Bissau, Guyana, Haiti, Honduras, Ile Maurice, Iles Salomon, Iles Turks-et-Caicos, Iles Vierges britanniques, Inde, Indonésie, Jamaïque, Kazakhstan, Kenya, Kirghizistan, Kiribati, Laos, Lesotho, Liberia, Madagascar, Malaisie, Malawi, Maldives, Mali, Mauritanie, Moldavie, Moldova, Mongolie, Montserrat, Mozambique, Myanmar, Namibie, Nauru, Nepal, Nicaragua, Niger, Nigeria, Ouganda, Ouzbékistan, Pakistan, Palaos, Papouasie Nouvelle Guinée, Philippines, République Centrafricaine, République Démocratique du Congo, République Dominicaine, République du Congo, Rwanda, Saint-Christophe-et-Niévès, Saint-Vincent-et-les-Grenadines, Sainte Lucie, Salvador, Samoa, Sao Tomé-et-Principe, Senegal, Seychelles, Sierra Leone, Somalie, Soudan, Sri Lanka, Sud Soudan, Suriname, Swaziland, Syrie, Tadjikistan Tanzanie, Tajikistan, Tanzania, Tchad, Thailand, Thaïlande, Timor oriental, Timor-Leste, Togo, Tonga, Trinité-et-Tobago, Turkmenistan, Tuvalu, Uganda, Ukraine, Vanuatu, Vietnam, Yemen, Zambia, Zambie, Zimbabwe
Ce site web utilise des cookies pour vous assurer une expérience utilisateur optimale. En savoir plus