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IP Court interpreted some aspects of data exclusivity

On December 17, 2015 the Intellectual Property Court (hereinafter – “the IP Court”) adopted the Ruling in case No. A40-188378/2014.

We have already highlighted the mentioned case in our recent alert, as long as we consider that it may become decisive for the industry. Actually some of the courts’ findings could impact such pharmaceutical aspects as data exclusivity, generic registration procedure, etc.

The said dispute arose between Swiss Novartis Pharma AG (producer of the original drug “Gilenia” for treatment of multiple sclerosis) and Russian Biointegrator LLC (producer of the generic “Nescler”) on alleged violation of data exclusivity.

On August 14, 2015 the Ninth Appeal Arbitrazh Court established that the data exclusivity clause shall protect originators against only those generics applied for state registration after August 22, 2012. Since Biointegrator LLC de facto had filed the application for “Nescler” registration on December 2, 2013, it was found responsible for the breach of data exclusivity.

The IP Court has supported the above appeal court’s finding that data exclusivity shall apply against “Nescler” state registration. However the Panel of Judges has declared against its broad interpretation under which data exclusivity shall cover the whole clinical trial and pretrial data, whether published or not. The IP Court has stipulated that the data exclusivity regime could not apply to information published in the specialized printed editions and shall cover only those clinical trial data provided to the Ministry of Health within the registration procedure.

By excluding information published in the specialized printed editions from the data exclusivity scope, The IP Court’s position has in fact substantially diminished legal protection of originators against unauthorized generics. We consider that such interpretation of data exclusivity corresponds neither to the provisions of Law “On circulation of drugs”1, nor to the commitments of Russia adopted within the World Trade Organization2.

The IP Court has also found that “Gilenia” registration dossier materials were not in fact submitted by Novartis Pharma AG to the courts of the first or appeal instances. Therefore, the courts had no opportunity to determine the exact scope of clinical trial data protected by the data exclusivity clause. Based on Novartis Pharma AG’s failure to prove it, Biointegrator LLC has not been found liable.

Considering that the IP Court as a cassation instance is de jure deprived of the right to revise evidence (art. 286, 287 of Russian Commercial Procedural Code), such findings may constitute a procedural violation by the IP Court.

Finally, the mere competence of the IP Court over the case is disputable, considering the legal and factual grounds of the case.

Taking into account certain legal and factual inconsistences arisen out in the process of dispute consideration, we expect that tense legal struggle between the Swiss originator and the Russian generic may continue in the Supreme Court.


1Clause 1 of Article 26 of Federal Law “On circulation of drugs” as amended on December 02, 2013 (Nescler registration application).
2Clause 1295-1296 of the Report prepared by the Working Party on the accession of the Russian Federation to the World Trade Organization. // URL: http://static.consultant.ru/obj/file/doc/docladrg_rf_vto.pdf.

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