Zuykov and partners proved the correctness of the decision of Rospatent to invalidate the Pfizer patent in the cassation instance

The Presidium of the IP Court considered the cassation appeal of Pfizer Products Inc. on the decision of the IP Court dated 10.10.2024 in case No SIP-58/2023 on the invalidation of the decision of Rospatent dated 31.10.2022, adopted based on the results of consideration of the opposition against the grant of the patent of the Russian Federation No 2315052 for a group of inventions "Crystalline form of monocitrate 3-{(3R,4R)-4 methyl-3-[methyl-(7n-pyrrolo[2,3-d]pyrimidine-4-yl)amino]piperidin-1 yl}-3-oxo-propionitrile and its use".

PSK Pharma LLC was involved in the case as a third party that did not make independent claims regarding the subject of the dispute. The interests of PSK Pharma were represented by Zuykov and partners.

Earlier, by the decision of the IP Court dated 19.12.2023, the claim was dismissed, but by the decision of the Presidium of the IP Court dated 30.05.2024, the case was sent for a new trial to the court of first instance. However, during the reconsideration of the case, the decision of the IP Court dated 10.10.2024 again dismissed the claim. In this regard, Pfizer Products Inc. appealed to the Presidium of the IP Court with a cassation appeal.

Details of the decision of the Presidium of the IP Court in the case No SIP-58/2023

As we reported earlier, in the decision of Rospatent dated 31.10.2022, challenged in the Intellectual Property Court, it was established that since the subject matter of patenting does not meet the patentability condition "industrial applicability", the patent of the Russian Federation No 2315052 is subject to invalidation.

When reconsidering the case in the court of first instance, taking into account the comments of the Presidium of the IP Court, the panel of judges concluded that when extending the patent, the applicant presented and formalized the extension of the disputed patent as not just a substance related to the form, but as a drug, i.e., intended for treatment. All documents submitted by the applicant relate to the characteristics of the disputed invention as a medicinal product. Therefore, the reference in this case to the fact that the purpose of the invention protected by the disputed patent is exclusively to obtain a new crystalline form of the substance was qualified by the IP Court as contradictory procedural conduct refuting the presumption of good faith of the person participating in the case, and applied the principle of estoppel.

Taking into account that the disputed patent does not contain information about the results of clinical studies of the invention as a medicinal product with the prescription of "treatment", which was not disputed by the company, the court of first instance concluded that the decision taken by Rospatent was legal.

In the cassation appeal, the company insisted that the patent owner acted in good faith when renewing the disputed patent, did not allow contradictory behavior in establishing the purpose of a group of inventions, for the purposes of testing industrial applicability in the present case and when extending the term of the patent. The company also pointed out that the establishment of the purpose of the invention is not included in the subject of proof when extending the term of the patent, since the invention under the disputed patent is the crystalline form of the compound, which in itself does not have pharmacological activity and, accordingly, the purpose of the invention is to improve the physical properties of the crystalline form for the possibility of preparing medicines, and not to treat diseases.

Based on the results of the consideration of the cassation appeal of Pfizer, the Presidium of the IP Court came to the following conclusions.

In pursuance of the mandatory instructions of the court of cassation, in a new trial of the case, the court of first instance compared the legal position of the company regarding the purpose of the disputed inventions characterizing the crystalline form and its application, in the present case and in the case No SIP-1031/2020.

Taking into account the circumstances of a particular case, the Presidium of the IP Court agreed with the conclusion of the court of first instance that the company's conduct in terms of determining the purpose of inventions characterizing the crystalline form and its application under paragraphs 1 and 4 of the claims in question is contradictory in the present case and in the case No SIP-1031/2020. This served as the basis for the application of the principle of estoppel in the form of depriving the company of the opportunity to challenge the purpose of inventions in the present case In view of the earlier claim that the purpose of these inventions is to treat certain types of diseases.

Rejecting the company's arguments that the subject of proof in case No IPC-1031/2020 did not include determining the purpose of inventions for the renewal of a patent for them, the Presidium of the IP Court confirmed the correctness of this judgment, but pointed out that in the case of the principle of estoppel, only the actual actions of the party are relevant.

The Presidium of the IP Court also noted that the legal position on the correlation between the dispute on the extension of the term of a patent and the dispute on the compliance of the invention with the patentability criterion "industrial applicability" is not universal: in this case, the specific procedural position of a particular person expressed during the consideration of each of the disputes is important.

Taking into account that within the framework of case No SIP-1031/2020, Pfizer, for the purposes of extending the patent, insisted that the purpose of the inventions characterizing the crystalline form and its application coincides with the purpose of the drug "Iaquinus" (the purpose of which, in turn, is the treatment of the above diseases), then when checking the invention for compliance with the patentability criterion "industrial applicability", Pfizer is no longer entitled to assert, that the purpose of the invention is different.

Thus, the Presidium of the IP Court upheld the decision of the Intellectual Property Court dated 10.10.2024 in the case No IPC-58/2023, and the cassation appeal of Pfizer Products Inc. was dismissed.