IP Court ruled to issue supplemental patent for RYALTRIS® nasal spray despite Rospatent refusal

In a recent decision of June 6, 2023, the IP Court overturned the Rospatent Refusal to extend the term of patent RU2687551 for RYALTRIS® nasal spray in the territory of the Russian Federation

The decision of Rospatent of July 21, 2022 to refuse extension of the patent term has been based on the conclusion that the set of claims proposed for the supplemental patent does not characterize a product relating to RYALTRIS® nasal spray (Marketing Approval LP – 006768), since the amount of one of the excipients (Na CMC) in the claims is recited as a range, but not as a specific value, as in the approved product. This was considered to be an obstacle for the patent term extension, since according to the Russian legislation, after issuance of a marketing approval for a pharmaceutical, a patent term can be extended with a supplemental patent issued with the claims adapted to cover exactly the composition of the drug approved for use.

The patent owner, Glenmark Specialty S.A., a subsidiary of the global research-based pharmaceutical company Glenmark Pharma, disagreed with the Rospatent decision and appealed to the IP Court.

A team of experienced PATENTICA representatives, Ms. Ekaterina Petrova, MSc. Biotech., patent attorney, and Mr. Alexander Tymofeev, lawyer, prepared and submitted before the IP Court an appeal supporting that the proposed set of claims totally covers RYALTRIS® nasal spray. The IP Court has appointed a court expert, specialist in the art,  who conducted detailed comparison analysis of the features recited in the independent claim with the composition of the nasal spray RYALTRIS®  disclosed in the instruction for medical use, and came to the same conclusion that all of the features of the independent claim proposed by the applicant fully coincide with the characteristics of the drug RYALTRIS®. Thanks to the professional expertise and convincing arguments prepared by PATENTICA representatives, whose opinion has been supported by the court expert evidence, and in view of Art. 1363(2) of the Civil Code, the IP Court has come to a justifiable conclusion that the term of patent RU2687551 relating to RYALTRIS® nasal spray shall be extended in the territory of the Russian Federation (IP Court decision СИП-954/2022 of June 6, 2023, https://kad.arbitr.ru/Card?number=%D0%A1%D0%98%D0%9F-954/2022).