Russia prepares legislation changes to combat ‘ever greening’ patents

| By | Drug Patents, Rospatent

The Russian Federal Service for Intellectual Property (Rospatent) published a document on amendments to the Rules for drawing up, filing and reviewing documents that are the basis for committing legally significant actions for the state registration of inventions and their forms and Requirements to the documents for an application for grant of a patent for an invention approved by Order of the Ministry of Economic Development of the Russian Federation of 25 May 2016 No. 316.

In the practice of patenting inventions in pharmaceutics, there are inventions that can be categorized as ‘ever greening patents’ if, by this definition, the presumably the same pharmaceutical compositions are understood, but characterized by other features not known from the art.

Such pharmaceutical compositions differ from those known by one or more features, for example, such as:

  • measured or calculated parameters characterizing one or more properties of this composition, for example, a viscosity or pharmacokinetic profile parameter that may be objectively inherent in this known composition, but not known from the art by virtue of maintaining the confidentiality of clinical trial files;
  • conditions, doses or treatment regimens of a known composition in a method of treatment or diagnosis that may also be contained in a clinical trials file and maintained in a confidentiality mode.

The essence of the changes introduced is to limit the use of such features when characterizing the pharmaceutical composition in the claims.

The above characteristics according to the changes are not taken into account when assessing patentability for compliance with the condition of patentability “novelty” or “inventive level”. The proposed approach will help avoiding the “double” patenting of already known compositions or their application.