NILOTINIB
En octobre 2022, Novartis AG et MPP a annoncé aujourd’hui la signature d’un accord de licence volontaire pour améliorer l’accès au nilotinib, un médicament oral à prise biquotidienne figurant sur la Liste modèle des médicaments essentiels de l’Organisation mondiale de la Santé (OMS) pour le traitement de la leucémie myéloïde chronique (LMC) chez l’adulte et l’enfant de plus d’un an.
Grâce à cet accord, les génériqueurs sélectionnés pourront mettre au point, fabriquer et commercialiser des versions génériques du nilotinib dans le territoire couvert par la licence, sous réserve que ce médicament soit approuvé par les autorités nationales de réglementation des pays concernés. Le territoire couvert inclut notamment sept pays à revenu intermédiaire, à savoir l’Égypte, le Guatemala, l’Indonésie, le Maroc, le Pakistan, les Philippines et la Tunisie, où des brevets sur le nilotinib sont en attente ou en cours de validité.
Cet accord de licence est le premier conclu par le MPP pour un traitement contre le cancer, et c’est aussi la première fois qu’une entreprise concède une licence sur un médicament anticancer breveté à travers un mécanisme de licence volontaire orienté vers la santé publique.
| 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. |
