Russia. Patent Protection Period for Original Pharmaceuticals in Russia May Be Reduced

The Ministry of Healthcare developed amendments to the Federal Law “On Circulation of Pharmaceuticals” intended at reduction of the patent protection period for original pharmaceuticals. The Draft has already passed by the interdepartmental review and was submitted to the Russian Government for consideration.

Producers of generics (analogues of the original drugs) could be allowed to file an application for registering a pharmaceutical in 4 years after the market access of the original drug, and biosimilars’ (a drug, which is similar to the original drug in terms of safety, quality and efficiency) producers – in 3 years.

Amendments may allow the pharmaceuticals companies get an earlier access to the data on trials results for the original drugs, which, in view of the Ministry of the Healthcare could accelerate the market access for generics and biosimilars in Russia.

Source: remedium