New amendments to Russian regulations pave way for generic drugs

4 minute read
05 July 2021

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 creates even more ambiguity when it comes to defining and assessing the technical effect. The inventive step assessment will be even more subjective and its result unpredictable.

Further, the improvement of existing drugs is – in some cases – even more important than the creation of the original one. Society benefits from continuing research on existing drugs, since this leads to:

  • an increase in safety;
  • an increase in therapeutic efficacy;
  • a reduction in the risk of side effects;
  • the improvement of administrative routes;
  • the improvement of shelf life; and
  • the simplification of transportation, among other things.

On one hand, the amendments could lead to further infringement of IP rights, which will negatively affect the investment climate in this sector in Russia.

On the other hand, it will have a negative impact on activity in Russia's innovative pharmaceutical companies. The majority of these do not create original medicines due to the high cost and length of the creation process and their main activity is to develop new forms of well-known medicines, including salts, hydrates and polymorphs. These new amendments may significantly complicate or make impossible the patenting of such inventions.

Going forward, in order to minimise the risk of rejection of a patent application, it is advisable to specify clearly and support the technical effect of the invention in the description and be ready to provide post filing data supporting the technical effect.

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