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10.12.2021

Russian IP professionals involved in patent litigation in the pharma field have been intensively discussing a new Ruling of the Presidium of the Intellectual Property Court, which gave new guidelines in the ways of challenging a Supplementary Protection Certificate (SPC), granted with a breach of law. But still, although the Ruling contains crucial conclusions regarding the nature of SPC, it is not clear whether the Court has resolved the topical question of the case. 

The dispute (case number SIP-461/2020) was between Russian generic company Geropharm, the Russian Patent Office (which is always a defendant in such types of cases), and Novo Nordisk AS regarding SPC, granted to extend the Russian patent 2352581 for insulin derivatives based on Tresiba and Ryzodeg marketing authorizations. Plaintiff claimed that the patent owner had not proved that the patent covered those two products and that one of the patent claims had been extended without application from the patent owner - on the initiative of Rospatent. Although all these issues are notable per se, the essence of the dispute was around the suit limitation issue. It is important to note that challenging an SPC can be done in the procedure of appealing an unlawful decision of an administrative body - Rospatent, and the appeal should be filed within three months from the date when the plaintiff discovered or should have discovered the breach of law by this unlawful decision. Therefore, all the discussion was around the moment when Plaintiff actually should have learned about the patent extension since SPC was granted in June 2014, while the suit was filed only in 2020. 

The first instance of the IP Court refused in the claim referring to the missed deadline to appeal the decision of Rospatent, while the Presidium of the IP Court, after requesting clarifications from the Constitutional Court (and, in fact, having not received them), gave a very broad construction of the law, having stated that SPC can be invalidated in the IP Court during the whole term of its validity. Although the Presidium stated, that in that very case the claims had been formulated in a way in which three months deadline mattered, and, therefore, those claims would be refused, it was clear that the Presidium was encouraging the Plaintiff to file another action - an invalidity action of SPC with the IP Court.

It seemed to be a perfect win of the colleagues, appealing SPC, but careful study of the Ruling text has shown that some doubts still exist. It is clear from the Ruling that in case SPC is granted with the breach of material law (for example, the marketing authorization is not the first one, or that the patent does not cover the pharmaceutical in question), a party can challenge it during the whole term of its validity. But the Ruling says nothing about procedural breaches (such as the wrong count of the deadline to apply for SPC). Therefore, most likely procedural breaches can not be a ground for such an invalidation action - they still should be appealed within three months deadline after the breach became known to an interested party.

To sum up, although the Ruling is a serious step forward, it still needs further development in the court practice.

by Aleksey Zalesov

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