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LimeGreenIP News

Hogan Lovells Moscow Life Sciences team secures major win in a precedent patent case for Novartis against a generic producer in Russia

Led by partner Natalia Gulyaeva, the Hogan Lovells Moscow team represented Novartis in a precedent case for pharma business proving that one can obtain an injunction using patent rights against a generic in Russia before the generic starts sales.

It is well known that, in the past, permanent injunctions were granted by Russian courts in patent disputes only upon actual commercialization of the infringing generic product.

Given this, when, in this Novartis case, a generic producer started taking certain steps for obtaining a marketing authorization for its generic product seven years before Novartis’ patent expiration, the Hogan Lovells team chose to base the case on a concept of threat of patent infringement, without waiting for  generic sales to happen.

The Russian court of first instance confirmed that the chain of consecutive actions by the generic producer (including conducting bioequivalence study, obtaining marketing authorization for pharmaceutical substance, obtaining marketing authorization for pharmaceutical product and state registration of wholesale price) proved the threat of patent infringement and justified a permanent injunction in this case.

On 21 December 2017 the Russian court of appeal confirmed the position of the court of first instance and the permanent injunction came into force.

This case proves the ability of Russian court system to demonstrate international standards for injunctive relief in pharma patent litigation and confirms that successful patent enforcement is possible in Russia.