2019-11-21-1-
21 November 2019GenericsRory O'Neill

LSPN Europe: new challenges for drug patent owners in Russia

Russian drug patent owners are being forced to come up with novel solutions to combat generic manufacturers trying to clear the way for competitor medicines.

This was the view of Natalia Gulyaeva, partner at  Hogan Lovells in Moscow who specialises in the pharmaceutical patent industry, speaking at Life Sciences Patent Network Europe in London today, November 21.

Gulyaeva cited a 2016 case in which  Novartis struck a blow for R&D-based pharmaceutical companies in Russia when it pioneered the ‘threat of patent infringement’ strategy.

Novartis successfully argued that a generic manufacturer’s marketing authorisation, obtained more than five years before Novartis’ patent for the original drug expired, was “worthless”, Gulyaeva said.

This was because the generic MA posed a ‘threat of patent infringement’, which has become a new tool in the armoury of pharmaceutical patent owners in Russia looking to block generics coming to market.

In the wake of this case, Gulyaeva said, generic producers have started testing new strategies in court, posing new problems for rival drug companies.

One of the most common arguments, she said, was that generic companies were basing their cheaper products off their own patents, which are “often just slightly different” to those of their rivals.

According to Gulyaeva, this argument was based on a misinterpretation of a 2007 ruling of the High Commercial Court, which she said was in fact only applicable to cases where disputed patent claims were “identical”.

The Moscow Region Commercial Court has since clarified that the 2007 ruling is not applicable in the case of generics patents with only minor differences from the patent covering the original drug.

Gulyaeva welcomed the recent creation of a new online-database of pending market authorisations, which she said had been “very helpful” for practitioners in spotting potential patent infringements.

Earlier this week, LSIPR reported that the  Russian government had approved a law enabling compulsory drug licensing.

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