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On December 13, 2023, a hearing was held in the Intellectual Rights Court in case No. SIP-58/2023 on the application of Pfizer Products Inc. on invalidating the decision of Rospatent dated October 31, 2022, adopted based on the results of consideration of an objection to the grant of patent of the Russian Federation No. 2315052 for an invention. The PSK Pharma was involved in the case as a third party who does not make independent claims regarding the subject of the dispute.
Zuykov and partners represented the interests of PSK Pharma LLC in this case.
According to the case materials, the group of inventions under the contested patent was provided with legal protection in the scope of the invention formula containing 5 clauses, independent of which are clauses No. 1, No. 4 and No. 5. Rospatent in the contested decision stated that the invention does not meet the condition of patentability “industrial applicability" according to paragraph 1 of Article 4 Patent Law of the Russian Federation dated September 23, 1992 No. 3517-I and clause 19.5.1 of the Rules for the preparation, filing and consideration of an application for a patent for an invention dated June 6, 2003 (No. 82). In particular, the description of the invention under the disputed patent contains an indication of the possibility of using the compound according to independent claim 1 of the claimed formula, but it is not confirmed that if the invention is implemented, this purpose can be realized.
During the trial, the Intellectual Property Court's counsel and a chemist confirmed the fact that the challenged patent did not contain any information that would make it possible to verify that the new crystalline form of the monocitrate of the specified enantiomer of tofacitinib (as set out in claim 1 of the claims of the challenged patent) could be used for the manufacture of drugs, including solid dosage form, and does not contain any reliable data confirming the possibility of its use for the treatment or prevention of diseases mediated by protein tyrosine kinases, such as JAK3.
Under these circumstances, the court decided the claim of Pfizer Products Inc. to invalidate the decision of Rospatent dated October 31, 2022, adopted based on the results of consideration of an objection to the grant of patent of the Russian Federation No. 2315052 for an invention, to be left without satisfaction.
Thus, the decision of Rospatent was upheld, which invalidated the patent of the Russian Federation No. 2315052 for the invention “Crystalline form of monocitrate 3-{(3r,4r)-4-Methyl-3-[Methyl-(7n-Pyrrolo[2,3 -D] Pyrimidin-4-Il) Amino ]Piperidin-1-Il}-3-Oxo-Propionitrile and its application.”