On 1 July 2026, the Presidium of the Russian Supreme Court approved Review of Case Law No. 2 (2026). Item 23 addresses case No. A40−264 483/2024, Supreme Court Ruling No. 305-ES25−15 716, concerning the launch of an Axitinib generic before expiry of patent protection for the reference medicine.

The Supreme Court confirmed that placing a generic drug on the market before patent expiry and without the patent owner’s consent may constitute unfair competition under Article 14.5 of the Russian Competition Law. Importantly, it is not necessary to prove direct competition between the infringer and the patent holder itself. It is sufficient that the unauthorized use of the patent harms the patent holder’s economic interests, including where the patent holder monetizes the product through official distributors.

The ruling is highly relevant for the pharmaceutical market. Generic companies should not treat marketing authorization or their own manufacturing know-how as a substitute for patent clearance before launch. For originators and local distribution partners, the case confirms that FAS proceedings may serve as an additional route for enforcing patent exclusivity in Russia.