PFIZER INC. challenged in the Russian IP Court the decision of Rospatent to refuse to satisfy the objection to the decision to refuse to grant a RU patent for the group of inventions «Crystalline form of lorlatinib free base hydrate» under application No. 2020113141.
On August 01, 2023, IP Court ruled in favor of the company and declared the decision of Rospatent invalid as not complying with the norms of paragraph 2 of Article 1350 of the Civil Code of the Russian Federation, sending the case for reconsideration.
Rospatent filed a cassation appeal with the Presidium of the IP Court with a request to cancel the decision of the Court of first instance and send the case for a new trial to the court of first instance.
The Presidium of the Russian IP Court considered it necessary to find out the professional opinion of scientists with a sufficient level of competence in the field of patent law by sending them court requests containing the following question: by what rules and taking into account what circumstances should the compliance with the «inventive step» patentability term of a new crystalline form of a substance be determined in a situation where it is known that such a substance (polymorph) has several crystalline forms?
According to the Managing Partner of «A.Zalesov & Partners» Patent & Law Firm Aleksey Zalesov, the mere creation of a new polymorphic form of a known substance, the study of its features and the demonstration of differences in its features in a patent application do not provide inventive step, while those described in the application do not provide an effect (technical result) that is unexpected for a specialist, allowing the use of this new form in a way that the known forms could not be used.
The expert believes that in order to recognize a new polymorphic form of a known chemical substance (compound) as an invention that meets the «inventive step» patentability term, the following series of conditions must be met:
1) the polymorphic form must be aimed at solving a specific technical problem, and not be created «as such»;
2) the effect (technical result) obtained when using a new polymorphic form should not be obvious to a specialist in comparison with the known forms of this compound;
3) the change in properties must be qualitatively new and unexpected for a specialist in comparison with known forms, i.e. should allow it to be used in ways that known forms could not be used.
The Presidium of the IP Court in its decision agreed, in particular, with this position and came to the conclusion that there were no grounds for satisfying the cassation appeal, leaving the decision of the IP Court in force.