Russia - Improvements in the protection of pharmaceutical inventions, Part 2: Setting-up of a patent linkage system in drug approval

The Ministry of Health of the Russian Federation has launched a bill, the aim of which is the introduction of amendments to the Drug Registration and Administration Act in part of the approval of drugs (submission no. 02/04/02-19/00088523 of February 15, 2019).

This draft law has meanwhile passed the public reading, the examination by the Anti-Corruption Commission and the body of the Regulatory Impact Assessment of the parliament. The finalized version of the text was submitted to the Russian government for review and approval. The final date for the enactment of the law is not yet known. The law shall come into force 180 days after its publication.

According to the pending text of the draft law, the following changes are planned in the Drug Act:

1. In the application for approval of a drug, the applicant must provide the following information:

- Information on existing patent rights (Russian patents and Eurasian patents in force in Russia) relating to the drug
- Information about existing trademark rights relating to this drug

2. The applicant for a marketing authorization has to provide a written confirmation that the state registration of the medicinal product will not lead to a violation of IP rights of any third person in the Russian Federation. This written confirmation will be included by the Regulatory Authority in the product dossier of the given medicament.

3. When approving a generic medicament that comprises an active ingredient which, at the approval date, is protected by a patent and is included in the "Register of patent-protected pharmaceutically active compounds" (see part 1 of this blog), the Registration Certificate will show the actual date when this marketing authorization will come into effect. This starting day of the marketing authorization is the first day following the expiry date of the aforementioned patent protection. If the applicant is in the possession of the right to use said invention on the registration date of the drug, then the marketing authorization will be valid directly from the registration date of the drug.

4. The Russian Patent Office is in charge of maintaining the above-mentioned "Register of patent-protected pharmaceutically active compounds ". The rules and regulations for the maintenance of this Register will be established by the Russian government. The information that the Regulatory Authority needs from this Register for the registration of any medicament will be made available by the Patent Office or will be read out by the Regulatory Authority directly from the online database.