Zuykov and partners defended Rospatent's decision to invalidate Pfizer's patent once again

On October 10, 2024, the Intellectual Property Court considered case No. SIP-58/2023 on the application of Pfizer Products Inc. to invalidate the decision of Rospatent dated October 31, 2022, adopted following the consideration of the objection to the issuance of Russian patent No. 2315052 for the group of inventions "Crystalline form of 3-{(3R,4R)-4-methyl-3-[methyl-(7n-pyrrolo[2,3-d]pyrimidin4-yl) amino ]piperidin-1-yl}-3-oxo-propionitrile monocitrate and its use."

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

The previous IP Court decision on case No. SIP-58/2023 (dated 12/19/2023) can be found on our website. Subsequently, by the resolution of the IP Court Presidium dated 05/30/2024, the decision of the IP Court dated 12/19/2023 on case No. SIP-58/2023 was canceled, and the case was sent for a new consideration to the IP Court as a court of first instance.

However, upon reconsideration, the court of first instance, taking into account the instructions of the court of cassation, ruled that the demands of Pfizer Products Inc. to invalidate the decision of Rospatent dated October 31, 2022, adopted following the consideration of the objection to the issuance of Russian patent No. 2315052 for a group of inventions, be left unsatisfied.

Case details

By the Resolution of the Presidium of the IP Court dated 30.05.2024, the decision of the IP Court dated 19.12.2023 in case No. IPPC-58/2023 was canceled and sent for a new consideration to the IP Court as a court of first instance. The Presidium of the IP Court pointed out that the court of first instance did not properly resolve the issue of designation of each invention from the group of inventions under the disputed patent, and therefore the verification of compliance of this invention with the patentability condition "industrial applicability" cannot be recognized as having been properly carried out.

The Presidium of the IP Court pointed out that, when reconsidering the case when resolving this dispute, the court of first instance may also examine the company's position on the purpose of the disputed invention, if it was expressed when extending the validity period of the disputed patent, taking into account the provisions of paragraph 2 of Article 1363 of the Civil Code of the Russian Federation, which establishes the possibility of extending the validity period of a patent for an invention related to medicine (case No. SIP-1031/2020). If the court of first instance finds that in one case the company recognized the purpose of the disputed invention as the treatment of diseases, and in the present case indicates a different purpose of the same invention, then such behavior of the applicant may be qualified as bad faith, and the court has the right to apply the principle of estoppel when resolving this dispute.

The principle of estoppel follows from the general principles of civil legislation and is a special case of the manifestation of the principle of good faith, according to which, when establishing, exercising, and protecting civil rights and when fulfilling civil obligations, participants in civil legal relations must act in good faith; no one has the right to derive an advantage from their illegal or unfair behavior (clauses 3 and 4 of Article 1 of the Civil Code of the Russian Federation). The principle of estoppel can be qualified as a prohibition to refer to circumstances previously recognized by a party as indisputable based on its actions or assurances.

In the applicant's written explanations submitted during the new consideration of the case, the applicant reiterated that the invention under the disputed patent relates to a newly obtained crystalline form, which consists in obtaining a compound in a form suitable for the manufacture of tablets, and not in the treatment of diseases, as erroneously established by Rospatent and the court of first instance in the decision of 19.12.2023. The applicant also argued that he had not violated the principle of estoppel when establishing the purpose of the invention to check industrial applicability in the present case and when extending the invention's validity period (group of inventions) under Russian patent No. 2315052.

Having examined the disputed patent taking into account the comments of the Presidium of the IP Court, the panel of judges concluded that the key issue of this case is the determination of the purpose of the disputed invention in the form in which it was formulated by the patent holder. The identified purpose of the disputed invention allows us to check the compliance of the disputed invention with the patentability criterion of "industrial applicability", since the purpose of "treatment", unlike the purpose of "form", requires the provision of the results of clinical trials in vivo. The company did not dispute the absence in the disputed patent of information on the results of clinical trials of the disputed invention as a medicinal product with the purpose of "treatment". In this regard, not only the content of the patent was subject to the establishment, but also the previously expressed positions of the same applicant about the same invention, including those made in the framework of case No. SIP-1031/2020, as well as his previous behavior about the disputed patent. In other words, the applicant's good faith was subject to investigation.

The IP Court examined the legal positions expressed in this case and case No. SIP-1031/2020, as well as the documents submitted by Rospatent in this case, with which the right holder accompanied the extension of the disputed patent. The panel of judges came to the conclusion that, when extending, the applicant presented and formalized the extension of the disputed patent as not simply related to the form of the substance, but as a medicinal product, 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, the IP Court qualified as contradictory procedural behavior, refuting the presumption of good faith of the person participating in the case.

Pfizer's theses on the difference between the purpose of the medicinal product and the group of inventions (paragraphs 1, 2, 4 of the formula) under the disputed patent, as well as the fact that the extension was carried out not with respect to the group of inventions that constituted the drug, but with respect to the invention that is in some way related to the drug. Thus, taking into account the application of the principle of estoppel, the panel of judges agreed with the conclusion of Rospatent that the purpose of the group of inventions under the disputed patent is the treatment of certain types of diseases. Consequently, since the disputed patent does not contain the relevant data on the results of clinical trials, Rospatent's conclusion that the patented object does not meet the patentability condition of "industrial applicability" is justified.

Thus, following the consideration of the case, the IP Court rejected the application of Pfizer Products Inc., and the decision of Rospatent was upheld. The court's decision is available at the link.