NILOTINIB
In October 2022, MPP and Novartis AG signed a voluntary licensing agreement to increase access to nilotinib, a twice daily oral medication used to treat chronic myeloid leukaemia (CML), part of the World Health Organization Model List of Essential Medicines (WHO EML) for treatment in adults and children of at least one year of age.
Through this agreement, selected generic manufacturers will have the opportunity to develop, manufacture and supply generic versions of nilotinib in the licensed territory, subject to local regulatory authorisation. In particular, the licence includes seven middle-income countries, namely Egypt, Guatemala, Indonesia, Morocco, Pakistan, the Philippines and Tunisia, where patents on the product are pending or in force.
This is the first licence that MPP has signed for a cancer treatment, and the first time a company is licensing a patented cancer medicine through a public health-oriented voluntary licensing mechanism.
| 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. |
GENERIC PARTNERS AND PRODUCT DEVELOPERS
