Novartis signs Voluntary License Agreement with the Medicine Patent Pool for Nilotinib

Novartis signs Voluntary License Agreement with the Medicine Patent Pool for Nilotinib

Pankhuri Malik is an Osgoode LLM Graduate, IPilogue Writer and IP Innovation Clinic Fellow.

In a landmark development, Novartis has signed a Voluntary Licensing Agreement with the Medicine Patent Pool (MPP) for its nilotinib drug, used in treating Chronic Myeloid Leukemia (CML) in adults and children as young as a year old. Nilotinib is the first cancer treatment drug and the first drug for the treatment of non-communicable diseases to be voluntarily licensed in a public health initiative.

The MPP is a public health organisation funded by Unitaid and backed by the United Nations. The MPP  aims to facilitate access to life-saving medicine in low- and middle-income countries. So far, the MPP has signed agreements with 18 patent holders, including MSD and Pfizer, for treatments for tuberculosis, COVID-19, Hepatitis C and HIV.

Nilotinib is a second-generation tyrosine kinase inhibitor offered to patients resistant or intolerant to imatinib. It is administered as an oral medication twice a day. The World Health Organization first added it to its list of Essential Medicines in 2017.

The announcement coincided with the World Cancer Congress’s announcement that nilotinib is now free for development, manufacture and supply in seven countries including Egypt, Guatemala, Indonesia, Morocco, Pakistan, Philippines and Tunisia, subject to local regulatory approvals. MPP’s Executive Director Charles Gore acknowledged that while the remaining term for nilotinib's patent is not significant, with the patent expiring in the US on July 4, 2023, this move is a precedent for MPP’s expansion into drugs for non-communicable diseases. In terms of revenue, nilotinib accounted for $2.1 billion for Novartis last year.

This move comes in the wake of Novartis and MPP joining the Access to Oncology Medicines Coalition (ATOM) in May 2022. ATOM is a global initiative led by the Union for International Cancer Control (UICC) to improve access to cancer treatment in low- and middle-income countries. The World Trade Organisations’ Agreement on the Trade Related Aspects of Intellectual Property Rights already provides waiver from patent obligations to the least developed countries. Further, the phase-out period for the waiver has been extended till January of 2034. Patent protection is only one of many factors that hamper this access.

Since the remaining term of the patent is less than a year, the footprint of this license probably will not be significant. Though, with conversation around Big Pharma’s chokehold on the healthcare industry increasing, this may prove to be a bargaining chip for further discussion on licensing of life-saving medicine in low- and middle-income countries.