The draft law “On amendments to Federal Law “On drugs circulation” had been already amended with a provision on the creation of a unified Register of pharmacologically active substances in 2019.
As of the date, the Federal Service for Intellectual Property has developed and created a prototype of the Register of Pharmacologically Active Substances, protected by patents for invention. At the briefing on the results of the Rospatent College in 2020 Grigory Ivliev, the head of Rospatent, stated that the launch of the Registry is scheduled for 2021.
Rospatent will be responsible for maintaining the Registry. After submitting documents for entering information on a patent for an active substance, Rospatent shall check the documents, compare the active substance characteristics in the patent and the registration certificate, then issue an expert opinion and, if the characteristics coincide, add the information to the Registry.
The registry will contain the following information:
- INN (chemical and/or grouping name);
- Structural formula or amino acid sequence;
- The patent details and its status;
- The patentholder details;
- Issued licenses.
The purpose of the Russian registry is to receive the information on existing patent rights to active substances promptly. Thus, the Registry information may be used in public procurements of drugs. This way it will help to establish the right to use the invention. Furthermore, usage of the Registry will speed up the consideration of the court case. The registry information will also enable to issue a registration certificate for a generic with a deferred start date – upon the patent expires.
The Registry will limit the entry of generics on the market before the expiry of a patent for the original drug and reduce the number of violations of the originator’s exclusive rights. At the same time, the functioning of the Registry will not prevent the initiation of preparatory actions, which will allow starting a release of a generic immediately after the patent expiration.
It is worth mentioning that in March 2021 a similar registry of the Eurasian Patent Office (EAPO) began to operate (see our review). Additionally, it includes information about patents on biological medication, as well as methods of their production and use.