Victory in the Pfizer Eurasian Patent Case in the Court of Cassation

Earlier, in the Intellectual Property Court, Zuykov and partners achieved recognition of the legality of the decision of Rospatent, which cancelled Pfizer's Eurasian patent for invention No. 012666. In this case, we are talking about Eurasian patent EA No. 012666 for a group of inventions "Optical separation of (1-benzyl-4-methylpiperidin-3-yl) methylamine and its use for obtaining pyrrolo 2,3-pyrimidine derivatives as protein kinase inhibitors" with a filing date of 29.05.2002.

In this case, in addition to Pfizer (the applicant) and Rospatent, the Eurasian Patent Organization and PSK Pharma LLC (the person who filed the objection) participated in the case as third parties not making independent claims regarding the subject of the dispute. The interests of PSK Pharma LLC were represented by specialists from Zuykov and partners.

Disagreeing with the decision of the IP Court dated 25.07.2024 in case No. IP Court-863/2023, Pfizer and the Eurasian Patent Organization filed cassation appeals with the Presidium of the IP Court (IPC), in which, citing the inconsistency of the conclusions contained in the decision of the court of first instance dated 25.07.2024, the established circumstances and the evidence available in the case, and the incorrect application of the rules of substantive and procedural law, they requested the decision to cancel the said judicial act and send the case for a new trial in the court of first instance.

As part of the review of the arguments of the cassation appeal, the Presidium of the IPC examined the formula, the description of the group of inventions under the disputed patent and the content of the sources of information, as well as the arguments of the persons participating in the case, and came to the conclusion that the conclusion of the court of first instance on the non-compliance of independent clauses 16 and 17 of the formula under consideration with the patentability condition of “industrial applicability” corresponds to the evidence presented in the case materials and the established circumstances.

Thus, the presidium noted that in the application materials for which the disputed patent was issued, as of the filing date, as well as in the description of the group of inventions under the disputed patent, there is no information that allows us to conclude that the compositions according to independent claims 16 and 17 of the formula under consideration can be used in healthcare, i.e. no information is provided that objectively confirms the implementation of the purpose of the inventions according to independent claims 16 and 17 of such a formula.

The Presidium of the IPC indicates that a pharmaceutical composition requires confirmation of its therapeutic efficacy, in connection with which Rospatent and the court of first instance reasonably proceeded from the fact that the activity on cells in vitro may confirm the biological activity of a substance, but the therapeutic efficacy of a pharmaceutical composition cannot be confirmed in this way. Under these circumstances, the court of first instance rightly rejected all arguments of Pfizer and the Eurasian Patent Organization regarding the administrative body's violation of the principle of legal certainty.

The Presidium of the IP Court also noted that, with regard to the non-compliance of the disputed group of inventions with the requirement of “industrial applicability,” the arguments of the applicants of the cassation appeals repeat the arguments and reasoning that were the subject of consideration by the court of first instance, and, in essence, boil down to disagreement with the results of the study carried out by the court of first instance and with the assessment of the evidence presented in the case materials, in connection with which the court rejected them.

At the same time, the Presidium of the IP Court recognized as worthy of attention the arguments of the applicants of the cassation appeals regarding the unjustified recognition of the validity of the disputed patent in the territory of the Russian Federation as completely invalid, namely:

The disputed patent No. EA 012666 was issued for a group of inventions, its formula consisted of 25 claims, only the 16th and 17th independent claims were valid at the time of filing the objection to Rospatent, the rest expired in 2022 and were not extended by the patent holder. In this regard, Rospatent recognized the interest of PSC Pharma LLC in challenging the patent only in relation to claims 16 and 17 of the formula, but made a decision to recognize the disputed patent as invalid in full, which, by virtue of clause 5 of Article 1398 of the Civil Code of the Russian Federation, entails other legal consequences for the patent holder in contrast to the termination of legal protection of the invention, due to the expiration of its validity period.

The Presidium of the IPC did not agree with this conclusion of Rospatent, pointing out that the administrative body could not go beyond the stated requirements and satisfy the objection to a greater extent than requested by the applicant.

In this regard, the Presidium of the IP Court ruled to partially satisfy the cassation appeals and to overturn the IP Court decision of July 25, 2024 in case No. SIP-863/2023 in terms of refusing to satisfy the application of Pfizer Products Inc. to invalidate the decision of Rospatent of May 26, 2023 in relation to paragraphs 1–15, 18–25 of the formula of the group of inventions under Eurasian patent No. EA 012666.

At the same time, despite the fact that the Presidium of the IPC partially satisfied the cassation appeals, this did not lead to a negative decision for PSC Pharma. The patent claims (1–15, 18–25), which were restored by the Presidium of the IPC by its resolution, ceased to be valid due to the expiration of the term (May 29, 2022). More significant is the fact that the Presidium of the IPC recognized as legal the conclusions of the court of first instance and Rospatent regarding the non-patentability of independent claims 16 and 17 of the formula of the group of inventions, for which the patent remained valid in the territory of the Russian Federation.