By the resolution of the Moscow District Arbitration Court dated September 19, 2023, regarding case No. A40-202954/2022, the requirements of the cassation appeal filed in defense of the interests of a Russian pharmaceutical company - the client of «A.Zalesov & Partners» Patent & Law Firm - were satisfied.
The manufacturer of the reference medicinal product filed an invalidation action against the decision of the Ministry of Health of the Russian Federation to register our client’s medicinal product, registered under the mutual recognition procedure in accordance with the rules of the EAEU. The requirements were based on the fact that the application for registration of the client’s medicinal product was submitted earlier than the deadline provided for by the Russian law on the circulation of medicinal products, since the medication is generic.
Registration of the client's medicinal product was carried out in accordance with the rules of Eurasian legislation, where there is no corresponding prohibition on filing an application for registration of generic medicinal products earlier than in 4 years from the date of registration of the reference medication.
Previously, the Moscow Arbitration Court, as well as the court of first instance, had already refused to satisfy the requirements of the manufacturer of the reference medicinal product; the registration of our client’s medicinal product remained in force.
The Court of appeal canceled the decision of the Moscow Arbitration Court and considered the decision of the Ministry of Health of the Russian Federation to register the client’s drug illegal.
As a result of the consideration of the case in the cassation court, the court agreed with our arguments, canceled the decision of the court of appeal, and upheld the decision of the first instance court. The cassation court indicated that the provisions governing the procedure for registering medicinal products under the mutual recognition procedure do not contain such a basis for refusing registration. The Court also noted that in this case, the norms of national legislation can only be applied if there is a special indication in the rules of the Eurasian legislation.
The client was represented in the Court by Managing Partner Aleksey Zalesov and Associate Julia Kolomytseva.