Legal scene set for Russian drugmaker to get compulsory license on Sutent

The issuing of a compulsory license for the production of a patent-protected drug in Russia may take place shortly, due to the recent victory of several legal disputes with US pharma giant Pfizer (NYSE: PFE) by local drugmaker Nativa, reports The Pharma Letter’s local correspondent.

A subject of recent judicial proceedings between the companies became a component of an antitumor drug Sutent (sunitinib), the analogue of which is produced by Nativa. The dispute initially began in September 2017. At that time Pfizer demanded in the Moscow Arbitration Court that Nativa cease the production and sale of the drug sunitinib-nativ, since its active ingredient is protected by Pfizer’s patent on sunitinib.

As a result of hearings, the court found that the production of the generic is impossible without the use of only one of the constituent parts of sunitinib. Such a decision resulted in the filling of a counter-application from Nativa for the issue of a compulsory license to use the patent of this component. The Russian company in its application also provided guarantees for the payment of royalties to Pfizer.