Mon.-Fri.: 1000-1900

Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

On February 20, 2023, the Moscow Arbitration Court ruled in favor of the client of «A.Zalesov & Partners» Patent & Law Firm - a Russian pharmaceutical company - to refuse to recognize the decision of the Ministry of Health of the Russian Federation on registration of the client's pharmaceutical product as illegal.

The manufacturer of the reference medicinal product filed a statement on the recognition as illegal the decision of the Ministry of Health of the Russian Federation on the registration of the pharmaceutical product of our client, registered under the mutual recognition procedure in accordance with the rules of the EAEU.

The plaintiff claimed that the application for registration of the pharmaceutical product had been filed earlier than the deadline stipulated by the law on registration of pharmaceutical products, since the drug is generic.

Registration of the pharmaceutical product was submitted in accordance with the Eurasian legislation, where there is no corresponding prohibition on filing an application for registration of a generic pharmaceutical product earlier than in 4 years from the date of registration of the reference drug.

We managed to prove that in that case the Ministry of Health did not have the reason for refusal to register a pharmaceutical product on such basis, therefore, the client's registration of the medicinal product remained in force.

Managing partner of «A.Zalesov & Partners» Aleksey Zalesov and senior partner Irina Ozolina represented client’s interests in Court.

Please follow the link to find out more about the case.

Latest news