On October 02, 2023, the Presidium of the Russian IP Court adopted a very important resolution that changes the long-standing, however, erroneous approach of Rospatent to the rules for filing divisional applications.
The dispute on the correctness of establishing priority under the divisional application in relation to the patent for dapagliflozin (a medication for the treatment of type II diabetes) arose for a reason. In 2008, a patent was issued in Russia for the dapagliflozin substance based on an application with a priority date of 2002. Before a patent was granted, a divisional application was filed from the application, another from it, and another from that, for a total of four consecutive applications. The patent, issued in 2008, was not renewed and expired in 2023, and by 2021, many generic companies had already registered generic medications and were preparing to enter the market after the expiration of the first patent. But as a result of a series of divisions, unexpectedly for everyone, in 2021, one more patent for dapagliflozin (for the same substance) was issued under one of the divisional applications. It is worth noting that Rospatent, when issuing this patent, indicated that the applicant already has one patent for the same thing, issued in 2008, but invited the applicant to abandon this patent (terminate its validity), after which, referring to Article 1383 of the Civil Code of the Russian Federation issued a patent for the same substance, but in 2021. The exclusive right to it was immediately extended - an additional patent was obtained, valid until mid-2028.
Since neither divisional applications nor information about their filing are published, the extension of a patent that was supposed to expire in 2023 was a complete surprise to the pharmaceutical market. The validity of the patent and/or the legality of the extension was disputed by such companies as Akrikhin, Geropharm, Severnaya Zvezda, Kanonpharma and a number of other companies.
In 2021, among the first, «A.Zalesov & Partners» team, on behalf of «KRKA, d.d., Novo mesto», filed two invalidation actions regarding grant of patents under two separate applications - patent No. 2643764 (for a method for the production of dapagliflozin) and patent No. 2746132. Both objections were based on the fact that priority for a divisional application is established by the priority date of the initial application only if a patent has not been issued for the initial application at the time of filing the divisional application. Both applications were filed after the grant of the patent for the initial application in 2008, so KRKA, d.d., Novo mesto considered that priority could not be established by the filing date of the initial application (2002), therefore, it should be established by the date of filing of the new applications with Rospatent and then both inventions do not meet the «novelty» patentability term, since the publication of the initial application will be part of the prior art.
Rospatent and the Court of first instance did not agree with this approach, considering that there can be many initial applications: for each divisional application there will be «its own» initial one - the one from which the application was divided. But the Presidium of the IP Court agreed that there can be only one initial application, and, citing both the norms of the Civil Code and the Paris Convention, overturned the decision of the Court of first instance, the decision of Rospatent and obliged Rospatent to reconsider the objection to the grant of a patent of the Russian Federation No. 2643764 (case No. SIP-570/2022). The Presidium of the Intellectual Rights Court came to a similar conclusion in the second case, which was considered by the Presidium on October 16, 2023 (case No. SIP-552/2022).
KRKA, d.d., Novo mesto was represented in this dispute by the partners of «A.Zalesov & Partners» Aleksey Zalesov, Maria Makhlina, Irina Ozolina, as well as a team of associates, including Darya Kushnarenko.