Titulaire de licence: Novartis

Date: Octobre 2022

En octobre 2022, Novartis AG et MPP a annoncĂ© aujourd’hui la signature d’un accord de licence volontaire pour amĂ©liorer l’accĂšs au nilotinib, un mĂ©dicament oral Ă  prise biquotidienne figurant sur la Liste modĂšle des mĂ©dicaments essentiels de l’Organisation mondiale de la SantĂ© (OMS) pour le traitement de la leucĂ©mie myĂ©loĂŻde chronique (LMC) chez l’adulte et l’enfant de plus d’un an.

GrĂące Ă  cet accord, les gĂ©nĂ©riqueurs sĂ©lectionnĂ©s pourront mettre au point, fabriquer et commercialiser des versions gĂ©nĂ©riques du nilotinib dans le territoire couvert par la licence, sous rĂ©serve que ce mĂ©dicament soit approuvĂ© par les autoritĂ©s nationales de rĂ©glementation des pays concernĂ©s. Le territoire couvert inclut notamment sept pays Ă  revenu intermĂ©diaire, Ă  savoir l’Égypte, le Guatemala, l’IndonĂ©sie, le Maroc, le Pakistan, les Philippines et la Tunisie, oĂč des brevets sur le nilotinib sont en attente ou en cours de validitĂ©.

Cet accord de licence est le premier conclu par le MPP pour un traitement contre le cancer, et c’est aussi la premiĂšre fois qu’une entreprise concĂšde une licence sur un mĂ©dicament anticancer brevetĂ© Ă  travers un mĂ©canisme de licence volontaire orientĂ© vers la santĂ© publique.

Principales caractéristiques
Scope of Grant of Licence The agreement grants MPP a non-exclusive licence over Novartis’s patents with the ability to grant non-exclusive, royalty-bearing sublicences to eligible manufacturers purposes of supplying the product into the defined territories.
Territory There are two territories defined in the licence: the initial Territory of 44 countries, which essentially is in effect until the expiry of the compound patent in India in July 2023, and the Patent Territory, which comprises a list of seven middle-income countries (MICs) – Egypt, Guatemala, Indonesia, Morocco, Pakistan, the Philippines, and Tunisia, in which Novartis has its secondary patents granted or filed.
Patents There are also two patent exhibits included in the licence – one listing the Indian compound patent as the manufacturing patent, and the other listing the secondary patents in the seven countries listed above.
Field of Use The Field of Use in the agreement is any use that is consistent with the label approved by relevant regulatory authority in the country of sale for the use of such Product.
Manufacturing The licence allows manufacturing in India and in 7 patent countries (Egypt, Guatemala, Indonesia, Morocco, Pakistan, the Philippines, and Tunisia) till July 2023 and after that date manufacturing under the licence will be possible anywhere in the world where there are no patents on nilotinib, including in India.
Royalties Royalties are set at 5% of net sales, due only for the sales in Patent Territory, and payable to ATOM for further investment in accordance with the ATOM mission.
Compatibility with TRIPS flexibilities The licence contains language that provides that nothing in the agreement shall be interpreted as preventing activities by the sublicensees that would not infringe upon Novartis’s Patents granted and in force in a particular country.
DĂ©claration
RĂ©solution du Conseil de fondation
Rapport du Groupe d'experts consultatifs
Liste des pays
Bangladesh, Belize, BĂ©nin, Bhoutan, Bolivie (État plurinational de), Burundi, Cambodge, Cameroun, Congo, la RĂ©publique dĂ©mocratique de, Éthiopie, Ghana, GuinĂ©e, HaĂŻti, Honduras, Kenya, Kosovo, Lao, RĂ©publique dĂ©mocratique populaire, Madagascar, Malawi, Mongolie, Mozambique, NĂ©pal, Nicaragua, Papouasie-Nouvelle-GuinĂ©e, Rwanda, SĂ©nĂ©gal, Tanzanie, RĂ©publique-Unie de, Togo, Ouganda, Zambie, Angola, CĂŽte d'Ivoire, Égypte, El Salvador, GĂ©orgie, Guatemala, IndonĂ©sie, Maroc, Pakistan, Philippines, Sri Lanka, Tadjikistan, Tunisie, OuzbĂ©kistan