Drug patent pool organization signs nilotinib patent license with Novartis

Recently, the drug patent poolOrganization (Medicines Patent Pool,MPP)With Novartis in No.27The first World Cancer Conference was signed.Patent license agreement for anti-cancer drugs, in which selected generic drug companies in licensed countries and regions will be able to carry out nilotinib.(Nilotinib)This is a good news for patients with chronic myeloid leukemia in low-and middle-income countries and regions.

Nilotinib (trade name dasina,Tasigna) is developed by Novartis Pharmaceuticals for the treatment of chronic myeloid leukemia (Chronic myeloid leukemia,CML)The second generation of targeted small molecule drugs, that is, the first generation of targeted small molecule drugs imatinib (trade name Gleevec,Gleevec) upgraded version. Compared with the first generation drugs, nilotinib molecules are more lipophilic and can effectively treat chronic myeloid leukemia resistant to imatinib. As Novartis's star drug for the treatment of chronic myeloid leukemia at this stage, nilotinib has excellent market performance due to its good efficacy. At present, the global average annual sales of nilotinib is as high20Billions of dollars.

Figure1 Chemical structure of nilotinib

Nilotinib drugs have been used in Switzerland (2007Year07Month01Day), the United States (2007Year10Month29Day), the European Union (2007Year11Month19Japan), Japan (2009Year01Month21Day) and China (2009Year07Month14Japan) was approved for the first time, and its compound patents in many countries and regions will be issued.2023Year7However, Novartis Pharmaceuticals has also laid out a number of derivative patents, including crystal forms, pharmaceutical compositions, derivatives, formulations and uses, effectively extending the patent life of Nilotinib.10Year.

The pharmaceutical patent pool organization is an international drug purchasing agency.UNITAIDwith the supportestablished non-profit organizations, in2010It was officially established in Geneva. The drug patent pool organization negotiates with the original drug research companies to include drug patents in the drug patent pool and license them to generic drug companies in low-and middle-income countries and regions that meet the requirements, which can effectively reduce the disease groups in the licensed countries and regions. Treatment burden. The existence of the pharmaceutical patent pool organization to a certain extent avoids the situation that a single or a small number of generic drug companies in low-and middle-income countries and regions are unable to negotiate with large original drug companies due to their weak power, and has made considerable progress in promoting the development of public health. Contribution. In its early years, the Pharmaceutical Patent Pool focused on infectious diseases that threatened global public health, such as AIDS, tuberculosis and malaria. But after more than a decade of development, the Pharmaceutical Patent Pool has also begun to expand its work to non-communicable but still widespread public health threats, such as cancer.

Although the compound patent for nilotinib will be2023Year7After the expiration of the patent license agreement, less than a year after the expiration of the core compound patent, generic drug companies can more easily avoid the remaining derivative patents for production. However, as the first anti-cancer drug patent license agreement signed by the drug patent pool organization, the nilotinib license agreement is a milestone in promoting the development of public health.