Dispute over Patentability of Ruxolitinib Salts Resolved in Favor of Originator

In its Ruling, the Intellectual Property Rights Court (IP Court) concluded the cassation proceedings brought by AxelPharm regarding the invalidation of a Eurasian patent. The Court set forth a number of legal positions concerning the assessment of industrial applicability for inventions directed to an active pharmaceutical ingredient (API), which are useful for drafting and prosecuting applications for similar inventions.

Facts: AxelPharm sought to invalidate, in Russia, Eurasian Patent No. 019784 owned by Incyte Corporation (USA), a license to which has been granted to Novartis. The patent covers three salts of ruxolitinib – a Janus kinase inhibitor (Jakavi). The Rospatent's decision was challenged before the IP Court specifically with regard to compliance with the patentability requirement "industrial applicability."

Outcome: The court of first instance and, subsequently, the cassation court denied AxelPharm’s claims, leaving the patent in force in Russia.

Key legal positions:

1. Although the patent covers three salts, the Court held that experimental confirmation of biological activity for each of the salts is not required to establish industrial applicability. The Court explained that the inhibitory activity is determined by the biological activity of the ruxolitinib base itself, and that dissociation of ions occurs in a living organism; therefore, activity data for one salt suffice for extrapolation to the others. This position was based on the opinion of a court-appointed specialist.
2. Similarly, the absence in the description of experimental examples confirming the technical effect (in this case, providing further APIs having a specific purpose) for each alternative embodiment presented in an independent claim does not constitute a violation of the norms of the Eurasian patent system, because consideration is not limited to experimental data alone.
3. AxelPharm argued that data on salt stability and solubility should also be provided in the patent. The Court rejected this argument, noting that such parameters are necessary only where the technical effect is directly linked to an improvement in those properties. Moreover, it was the opponent who had to demonstrate that the salts were insoluble and/or unstable.
4. AxelPharm argued that experimental confirmation of the biological activity of pharmaceutical compositions would render them unpatentable. The Court stated that the activity of the pharmaceutical compositions is determined by the activity of the API, which had been confirmed.
5. The Court acknowledged the possibility of simplified confirmation of applicability for methods of treating diseases, holding that the patent confirmed the biological activity of the salts, and that the prior art disclosed the correlation between the API’s activity and the possibility of treating the diseases listed in the claims. In such case, the opponent bore the burden of proving the impossibility of treatment.
6. Furthermore, although one of the arguments related to the requirement of sufficient disclosure, the Court held that when verifying the ability to obtain salts of a known compound, it is not necessary to re‑disclose the general structure of the compound and detailed analytical data (NMR, etc.). The Court took into account prior art documents disclosing such data for the ruxolitinib base and considered the data provided on the salts (description of the preparation method, crystallinity data, melting point) as sufficient disclosure. In such case, the burden of proving that the compounds cannot be obtained by the means and methods described in the patent lies with the opponent.

Significance: In this case, the Court demonstrated a favourable approach, in particular, toward "secondary" patenting of biologically active compounds, thereby more clearly defining the limits of the robustness of such patents depending on the scope of the specification and the prior art.