Register of active substances possessing pharmacological activity protected by patent for invention

2021

Mishustin instructed to create a register of pharmacologically active active substances

At the end of October 2021, the Prime Minister instructed to create a register of pharmacologically active active substances. Such a task, which must be completed before February 1, 2022, is assigned to the Ministry of Economic Development, the Ministry of Industry and Trade, the Ministry of Health, the Ministry of Finance, the Ministry of Finance, Rospatent and the Federal Antimonopoly Service.

In particular, the Ministry of Health was instructed to conduct the necessary analysis and submit proposals to the government to develop a program for the development of this segment of the market.

Mishustin instructed to create a register of pharmacologically active active substances

The bill on the creation of the Register of Pharmacologically Active Substances Protected by Patents for Inventions in September 2021 was prepared by the Ministry of Economic Development of the Russian Federation. It is assumed that basic patents protecting substances as such will be included in the register. At the legislative level, the registry will certify that the patent for the invention protects a particular active substance, as well as reflect who owns the patent rights to the invention. Accounting will be based on the international generic name assigned by WHO to each new drug. Copyright holders will be able to use information from the registry in courts to protect rights and to impose interim measures on manufacturers that violate patent rights.

Rospatent will maintain the Register. According to the head of the department, Grigory Ivlev, the register will serve the interests of both high-tech pharmaceutical companies and generics manufacturers, making it difficult for unscrupulous activity and at the same time contributing to the timely and legal entry of generics into the market.

The scope of the registry will be determined by the needs of users: it is expected that it will be used in the field of public procurement, as well as in the protection of rights in court. The creation of the Register is a logical step in the development of regulation in the field of health care, "he said.[1]

Demonstration of the prototype Registry

On June 30, 2021, in Rospatent, in an online format, a demonstration of the prototype of the Register of Active Substances Possessing Pharmacological Activity Protected by the Patent for the Invention took place.

The event was attended by representatives of the Eurasian Economic Commission, the Eurasian Patent Office, national patent departments and other authorized bodies of the EAEU member states, state authorities of the Russian Federation. The event also aroused great interest among Russian and foreign pharmaceutical companies.

Representatives of Rospatent and FIPS spoke about the current state of the issue of creating the Register, showed on concrete examples the work of the prototype.

"Ensuring access to the Register of all interested persons, market participants, state and regulatory bodies will improve the system of state registration of medicines. The Rospatent, together with interested federal executive authorities and participants in the pharmaceutical market, worked out the principles for the formation of the Register, determined the list of information included in it, as well as the procedure for their presentation and synchronization, the procedure for providing the relevant state service and challenging entries in the Register. Now, in order to consolidate them, it is necessary to adopt an appropriate normative legal act, "said Grigory Ivliev, head of Rospatent.

The register is developed by Rospatent in accordance with the instructions of the Chairman of the Government of the Russian Federation Mikhail Mishustin. It is created in order to provide interested persons with reliable information about the patent protection of medicines and to prevent unfair practices associated with the entry into the market of analogue drugs (generics) before the expiration of the patent for the original drug.

The demonstration of the work of the Register was carried out taking into account the results of the consideration of the relevant issue at the meeting of the ECE Council on March 5, 2021.

"The pharmaceutical industry has long been talking about the need to address intellectual property rights violations. The register is an important element in the accounting of patent rights and the effective resolution of disputes between pharmaceutical companies, which also facilitates the solution of problems facing market regulators. We are grateful to Rospatent for the fact that the request of the industry was heard. At this stage, it is critical to launch the Register this year both at the national level and at the level of the Eurasian Economic Union in order to make the single market more transparent and stimulate investment activity, "said Irina Panarina, co-chairman of the Business Russia Committee for the Development of the Pharmaceutical Industry.

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