Restriction Impossible to be Registered: Lidings Team Defends Interests of Major Russian Pharmaceutical Manufacturer in Patent Dispute Over Registration of Generic

Lidings Intellectual Property team has helped a major Russian pharmaceutical manufacturer, Groteks, to terminate unlawful interim relief in a patent infringement dispute.

In January 2022, a Grotek’s competitor, a Russian pharmaceutical company Polysan, brought a claim for the protection of patent rights against Groteks. The claimant also submitted an application on interim relief seeking to suspend the issuance of a marketing authorization for a generic drug manufactured by Groteks. Breaking away from consistent practice, the Commercial Court of Saint Petersburg and the Leningrad Region granted interim relief, creating a threat of substantial damages for our client.

Lidings Partner and Head of Intellectual Property Boris Malakhov, representing Groteks, comments on the case:

The interim relief issued in the case demonstrates the formation of a rather misguided practice never before occurring in the court system. In intellectual property disputes, interim relief is granted in limited cases and requires meeting a serious burden of proof. In this case, the court failed to reliably establish the use of the claimant’s patent and still granted an injunction on registering a generic with the Ministry of Health.

Lidings team elaborated a procedural strategy that secured the result favorable for the client: thus, the Intellectual Property Court reversed the interim measures ruling and denied interim measures without referring the case for retrial. 

The decision not only sets a legal precedent, but is a landmark case for the entire industry. If the practice of such interim relief had been endorsed by the Intellectual Property Court, the balance of interests existing in the pharmaceutical market could have been disturbed. The tactic developed by the Lidings team helped to defend the position that interim measures in patent disputes should not prejudice the decision on the merits of the dispute and belittle procedural guarantees of the parties.

Pursuant to the rules of the Russian Civil Code, registration of a drug, in and of itself, and running clinical trials is not an infringement, hence the ruling on interim relief was contradictory and was the first one of its kind in practice. We are glad that all our arguments, namely, the lack of proof, disruption of the balance of interests of the parties, and court practice in other cases have been taken into account by the Intellectual Property Court in favor of our client.

The case has been widely publicized in the mass media. For details refer to reports by Pharmvestnik and Delovoy Peterburg

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Lidings has extensive experience in Life Sciences sector providing leading pharmaceutical and healthcare sector companies with comprehensive legal advice and representation in respect of regulatory issues, routine commercial activities, tax and antitrust matters, intellectual property, personal data protection, resolution of disputes and bankruptcy assistance 

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