New Amendments To Russian Regulations Pave Way For Generic Drugs

• Published date: 07 July 2021
• Subject Matter: Intellectual Property, Food, Drugs, Healthcare, Life Sciences, Patent, Food and Drugs Law
• Law Firm: Gowling WLG
• Author: Mr Ruben Dzhermakyan

This article was originally published by IAM Media.

Two new amendments to existing regulations have come into force, which could have a significant impact on the Russian pharmaceutical sector. The initiative behind these was the belief that original drug manufacturers pursue a patent renewal strategy by filing applications and obtaining patents for various forms and derivatives of known compounds, which in turn prevent the eventual production of corresponding generic drugs.

These amendments aim to address complications in assessing the inventive step condition in various forms of existing drug, especially with regard to the non-obviousness of the technical effect that they achieve. However, these measures also raise concerns among medical producers about a more rapid path for the production of generic drugs by other producers.

Technical effect

The first amendment relates to the technical effect achieved by inventions and the second covers the data required to confirm this technical effect. These cover the following:

• An invention based on the creation of a chemical compound which is a form of a known chemical compound (ie, an isomer stereoisomer, enantiomer, amorphous or crystalline form) or its derivatives (ie, a salt, solvate, hydrate, complex compound or ether) does not involve an inventive step, if such a compound does not exhibit new properties (in comparison with the known compound) in a qualitative or quantitative terms, not explicitly following from the prior art.
• If the invention relates to a chemical compound that is a form of a known chemical compound (ie, an isomer, stereoisomer enantiomer, amorphous or crystalline form) or its derivative (ie, a salt, solvate, hydrate, complex compound or ether), then data is provided about its new properties (in comparison with the known compound) in qualitative or quantitative terms, not following explicitly from the prior art, as well as data that reliably confirms these new properties.

However, this...