Nilotinib included in the Medicines Patent Pool; New voluntary licensing agreement between the Medicines Patent Pool (MPP) and Novartis

The Medicines Patent Pool (MPP) and Novartis have unveiled a new voluntary licensing agreement to allow generic drugmakers in seven middle income nations to develop, manufacture, and supply generic versions of the leukaemia treatment nilotinib. This new agreement was announced on the side-lines of the World Cancer Congress.

The MPP is a United Nations-backed public health organisation engaged in increasing access to, and facilitate the development of, life-saving medicines for low- and middle-income countries (you can read more about MPP here). The MPP has signed agreements with 18 patent holders for 13 HIV antiretrovirals, one HIV technology platform, three hepatitis C direct-acting antivirals, a tuberculosis treatment, a cancer treatment, four long-acting technologies, three oral antiviral treatments for COVID-19 and 12 COVID-19 technologies.

This is the first time that the MPP has signed a license for a cancer treatment, and the first time a company is licensing a patented cancer medicine through a public health-oriented voluntary licensing mechanism. Through this agreement, selected generic manufacturers in Egypt, Guatemala, Indonesia, Morocco, Pakistan, the Philippines, and Tunisia will have the opportunity to develop, manufacture, and supply generic versions of nilotinib in the licensed territory, subject to local regulatory authorisation. Patents on the product are pending or in force in these seven selected nations.

Nilotinib is a twice-daily oral medication used to treat chronic myeloid leukaemia (CML). In 2017, the drug was added to the World Health Organization’s list of Essential Medicines for treatment in adults. Following this, Nilotinib was then added to the Essential Medicines List for Children in 2019 as second-line therapy for the treatment of CML that is resistant to imatinib.

High prices on cancer medicines have made treatment of cancer patients inaccessible in several low and middle-income countries. For this reason, in May 2022, Novartis and MPP joined the Access to Oncology Medicines (ATOM) Coalition, a global initiative led by the Union for International Cancer Control (UICC) to improve access to essential cancer medicines in low and lower-middle income countries.

The remaining period of patent protection for nilotinib is relatively short, and thus the impact of the license is in practice will be a limited one. It is, however, the first cancer medicine included in the licensing scheme, and it will hopefully constitute an important precedent followed by others. There is a hope that voluntary licensing agreements will constitute an important means of remedying the side-effects of exclusivity in the public health sector.