IP Court Presidium Clarifies Industrial Applicability of Pharmaceutical Compositions

In its ruling dated 09.12.2024 in case No. SIP-863/2023, the Presidium of the Intellectual Property Court (IP Court) addressed a dispute over the validity of a Eurasian patent for a group of inventions related to pharmaceutical compositions.

An objection was filed with Rospatent against the patent’s validity in Russia, targeting two independent claims of the formula with extended protection, citing non-compliance with the “industrial applicability” criterion. Rospatent declared the patent entirely invalid, despite the objection covering only part of the formula. The first instance court upheld this, though the Presidium only partially agreed - with key clarifications.

Namely, proving industrial applicability of a pharmaceutical composition requires evidence of its therapeutic efficacy. The patent holder must provide data showing the composition’s suitability for treatment, diagnosis, or prevention of diseases, including examples of ingredients, their characteristics, and production methods (Rule 1.4.6.3 of the Eurasian Rules). Here, the patent description offered only declarative statements, none in vitro test results were provided, but even if had been provided, they would have been insufficient, according to the court, because in vitro data confirm the compound's biological activity but not the composition's therapeutic efficacy. In vitro tests cannot account for factors like absorption or metabolism in a living organism, critical to efficacy.

The patent holder argued that the composition, based on a novel chemical compound, should fall under less stringent rules (para. 2 of Rule 1.4.6.3), but the Presidium rejected this, as the disputed claims pertained solely to compositions, not the compound itself. A Eurasian Patent Organization representative supported this view but offered no evidence of uniform interpretation under the Convention.

Additionally, the Presidium found that Rospatent overstepped the objection’s scope by invalidating the entire patent, not just the contested claims. This violates Articles 45 of the Russian Constitution and 11 of the Civil Code: a decision must align with the objection’s request and cannot exceed it without the patent holder’s consent to amend the formula. Invalidity retroactively annuls the exclusive right from the filing date.

Details: court ruling.