Zuykov and partners achieved recognition of legality of the Rospatent decision, which cancelled Eurasian patent of Pfizer

The IP Court reviewed the application of a foreign entity, Pfizer Products Inc., to invalidate the decision of Rospatent dated May 26, 2023, adopted following the consideration of the objection to the validity of Eurasian patent for invention No. 012666 in the territory of the Russian Federation.

The Eurasian Patent Office and PSK Pharma LLC were brought in to participate in the case as third parties that do not make independent claims regarding the subject of the dispute. The interests of PSK Pharma LLC were represented by Zuykov and partners.

This case concerns Eurasian patent EA No. 012666 for the group of inventions “Optical separation of (1-benzyl-4-methylpiperidin-3-yl) methylamine and its use for the preparation of pyrrolo 2,3-pyrimidine derivatives as protein kinase inhibitors ” with a filing date of 29.05.2002.

On 21.06.2022, Rospatent received an objection from PSK Pharma against the validity of this patent in the Russian Federation, motivated by the non-compliance of the patented group of inventions with the patentability conditions of "industrial applicability", "novelty" and "inventive step", as well as the presence in the invention formula of features that were absent from the application materials on the date of its filing. According to the materials clarifying the arguments of the objection, presented at the board meeting on 13.09.2022, the arguments of the objection concern independent claims 16 and 17, in respect of which the validity period of patent EA No. 012666 in the Russian Federation was extended until 29.05.2027.

Based on the results of the consideration of the objection, Rospatent came to the conclusion that the pharmaceutical compositions according to independent claims 16 - 17 of the formula of the contested patent do not meet the patentability condition of "industrial applicability", which served as the basis for satisfying the objection received on 21.06.2022, the validity of the Eurasian patent for invention No. 012666 on the territory of the Russian Federation was recognized as completely invalid.

Pfizer disagreed with the conclusions of Rospatent in its statement, pointing out that neither the objections of PSK Pharma nor the decision of Rospatent provided evidence refuting the possibility of implementing the invention, which could serve as the basis for recognizing the disputed invention as not meeting the patentability condition of “industrial applicability.”

The applicant justifies the erroneousness of Rospatent's conclusion on the non-compliance of the inventions under paragraphs 16 and 17 of the patent formula with the patentability condition of "industrial applicability" by the fact that Rospatent made this conclusion based on requirements that are absent from the Eurasian legislation. Namely, based on the fact that the application materials do not contain information on the implementation of the purpose of the invention, which should be provided on the date of filing the application and confirm the possibility of using the patented pharmaceutical composition in healthcare (biological activity and the possibility of use for the treatment of diseases listed in paragraph 16 of the patent formula). The applicant believes that paragraph 1.4.6.3 of Rules No. 22, to which Rospatent refers in the decision, is not applicable to the disputed legal relations, since it does not concern the assessment of the invention's compliance with the patentability condition of "industrial applicability".

In addition, according to the applicant, the contested decision of Rospatent on the lack of industrial applicability of the invention under the disputed patent is illegal and contradicts the principle of legal certainty, since Pfizer was also granted Eurasian patent EA No. 7251 for application No. 200301193, from which application No. 200600575 was separated, for which, in turn, the disputed patent was issued. The object of legal protection of the invention under independent claim 1 of the formula of Eurasian patent EA No. 7251 is the same substance tofacitinib , which is the basis of the pharmaceutical composition of the invention under claims 16 and 17 of the formula of the disputed patent. In other words, the applicant believes that since the invention under the original application was recognized as industrially applicable, the invention under the divided application should also be recognized as meeting this patentability condition.

Pfizer also draws attention to the fact that the consideration of the objection in terms of the remaining points was not carried out by Rospatent due to the lack of confirmation of the interest of the company PSK PHARMA, in connection with which Rospatent was obliged to partially satisfy the objection, or offer the copyright holder to submit an amended formula of the invention to recognize the disputed patent as partially invalid.

In turn, the IP Court came to the conclusion that there were no grounds for recognizing the contested non-normative legal act as invalid due to the following.

According to paragraph 1.4.6.3 of the Rules for the preparation, filing and consideration of Eurasian applications in the Eurasian Patent Office, for an invention relating to a means for the treatment, diagnosis or prevention of a disease in humans or animals, reliable information must be provided confirming its suitability for the treatment, diagnosis or prevention of the said disease.

The court found that since the pharmaceutical composition in question is based on a new compound unknown from the state of the art, then in this case, contrary to the arguments of the applicant, the provisions of paragraph 1.4.6.3 of Rules No. 22 must be taken into account. In this case, for a new compound, the method by which it was obtained must be given, and if the compound is a biologically active substance, the indicators of the quantitative characteristics of activity and toxicity, as well as the selectivity of action and other indicators must be given. With respect to the composition, paragraph 1.4.6.3 of Rules No. 22 establishes that examples must be given indicating the ingredients included in the composition, their characteristics and quantitative ratio. The method for obtaining the composition must also be described.

However, the materials of application EA No. 200600575, for which the disputed patent was issued on the filing date, as well as the description of the disputed patent, do not contain information that allows us to conclude that the compositions under the disputed patent can be used in healthcare, i.e., no information is provided that objectively confirms the implementation of the purpose of the inventions under independent claims 16-17 of the formula of the disputed patent. Also, the application materials contain only declarative information concerning general standard methods and regimens of administration, as well as expected effective doses of the agent containing compounds of the general formula, which includes tofacitinib.

Thus, contrary to the applicant’s arguments, the materials of application EA No. 200600575 do not contain information confirming the possibility of implementing the stated purpose (clause 4.3 of Rules No. 22).

The court also rejected the applicant's argument that Rospatent's conclusion on the lack of industrial applicability of the invention under the disputed patent contradicts Rospatent's decision of 24.01.2023, adopted following the consideration of the objection of PSC Pharma against the validity in the territory of the Russian Federation of Eurasian patent EA No. 7251, also owned by the applicant, since Rospatent's decision contested in this case concerns another objection of PSC Pharma against the validity in the territory of the Russian Federation of another Eurasian patent EA No. 7251. The purpose of the invention under patent EA No. 7251 is to obtain a specific compound 3-{(311,411)-4-methyl-3-[methyl- (7H-pyrrolo [2,3- c1] pyrimidin-4-yl) amino ] piperidin-1-yl}-3- oxopropionitrile ( tofacitinib ) and its pharmaceutically acceptable salts.

The applicant's arguments that the disputed patent should be partially terminated on the territory of the Russian Federation were not accepted by the panel of judges, since the validity of the disputed patent was extended on the territory of the Russian Federation until 29.05.2027 in relation to points 16 and 17 of the formula, and the term of the remaining independent points of the invention formula had expired.

Thus, contrary to the applicant’s arguments to the contrary, Rospatent came to the justified conclusion that the pharmaceutical compositions according to independent claims 16-17 of the formula of the contested patent do not meet the patentability requirement of “industrial applicability” (Article 6 of the Convention, paragraph 1 of Article 3 of the Patent Regulations).

Having assessed the evidence presented, the court came to the conclusion that the contested non-normative legal act was legal and justified. The court checked and established that the contested decision was made by an authorized body, complies with the requirements of the current legislation, does not violate the rights and legitimate interests of the applicant, and therefore the applicant's claim to recognize the contested decision of Rospatent as invalid is not subject to satisfaction.

Thus, the lawyers of Zuykov and partners in case SIP-863/2023 managed to achieve recognition of the decision previously taken by Rospatent as legal.