AstraZeneca vs. KRKA: Supreme Court of Russia’s Decision Impact on Divisional Filing Strategy at RUPTO

On June 4, 2024, the Supreme Court of Russia ruled in favor of AstraZeneca (patentee) against KRKA (opponent) regarding the validity of AstraZeneca’s patent RU2746132 for «Forxiga» (INN: dapagliflozin), which is used to treat heart failure and chronic kidney disease in type 2 diabetic patients. This patent was extended by RUPTO based on «Forxiga’s» first marketing authorization, and remains valid until May 15, 2028.

This decision is obviously significant for AstraZeneca, which is currently involved in lawsuits against several generic manufacturers in Russia. Moreover, it holds substantial importance for the validity of approximately 600 other drug-related enforceable Russian patents granted on divisional applications.

By reversing the earlier IP Court decision, the Supreme Court thereby confirmed the legal correctness of RUPTO’s approach to acknowledging the priority dates of consecutive patent applications based on the first original parent application.

As a result, the divisional filing strategy at RUPTO remains as usual, maintaining a more convenient and innovator-friendly approach compared to potential alternative, which might have been appeared otherwise.