Russia - Improvements in the Protection of Pharmaceutical Inventions, Part 1: Setting-up of a Register for patent-protected pharmaceutically active compounds
The Ministry of Economic Development of the Russian Federation recently launched a bill, the aim of which is to create a “Register for patent-protected pharmaceutically active compounds” (Submission no. 01/05/12-21/00123076 of December 2, 2021).
This draft law has passed the public reading and the examination by the Anti-Corruption Commission. The final date for the enactment of the law is not yet known. The law shall come into force 1 year after its publication.
The Prime Minister of the Russian Federation, W.M. Mishustin, did already beforehand instruct the Russian Patent Office to start with the creation of this Register. A prototype of the Register was presented on June 30, 2021. By order of the Prime Minister, the work on the Register should be accomplished on February 1, 2022, and the Register should be ready for work from then on.
According to the pending text of the draft law, the following information shall be included in the Register:
- information on the active pharmaceutical ingredient (INN or chemical name, structural formula)
- information on the patent (number, country code (RU, EA), type of patent (invention patent, SPC), duration, status)
- claims protecting the active substance
- details of the patent owner
- information on issued licenses etc.
- granted marketing authorizations (incl. trade names of the approved preparations)
- details of the holders of the marketing authorizations.
The introduction of data into the Register and changes in the register will take place upon request of the corresponding patentee, or by transmission of the relevant information from state authorities. Compulsory licenses issued by the government or ruled by the courts will also be shown in the Register.
The corresponding entry in the Register should be deleted upon request of the patentee or after the patent protection has expired (expiry of patent term, nullification, non-payment of annuities etc.).
Only patents that protect a compound as such, i.e. compound patents, shall be included in the Register. Explicitly excluded from introduction in the Register are patents that are directed to a certain new form of a known chemical compound (salts, solvates, hydrates, polymorphs, derivatives, etc.), as well as the use of a compound for a defined purpose, or methods of treatment or diagnosis using this compound.