Lidings’ Intellectual Property practice team succeeded in obtaining cancellation of registration of a drug in a dispute against the holder of the marketing authorisation (MA) due to the fact that during the process of registration of a generic drug product the Ministry of Health of Russia received false information from the holder of the MA.
In particular, on 21.11.2024 the Ninth Court of Appeal published a decision in the case A40-28914/2024, which recognised the fact of providing false information as part of the drug dossier and obliged the Russian Ministry of Health to cancel the relevant registration.
In this dispute, the Lidings team, representing the interests of Kopran Research Laboratories Limited, an Indian pharmaceutical company, managed to prove that the competitor had submitted a false letter of consent to use the closed part of the master file for the pharmaceutical substance as part of the drug dossier.
The said document is a part of the drug dossier and its proper execution is one of the conditions for registration (clause 1.5.3 of Appendix No. 1 of the Rules for Registration and Expertise of Medicinal Products for Medical Use).
In the course of the court's consideration of the case, we managed to request the materials of the opponent's drug dossier, documented and normatively substantiated the unreliability of some of the information in the drug dossier.
The relevant conclusion, among other things, was confirmed by documents obtained at the request of law enforcement authority, which was reflected in the reasoning part of the court decision.
The court's decision sets a precedent in the Russian pharmaceutical market: for the first time in Russian court practice, the Eurasian registration of a medicinal product was cancelled due to false information submitted during the registration process.
The dispute has attracted widespread public attention (link, link), and the court's conclusions may potentially influence the procedural aspects of similar disputes.
Boris Malakhov, Partner at Lidings, represented the client in this dispute.