On August 13, 2026, the Supreme Court of Ukraine has clarified how the one-year statutory period for obtaining additional protection for pharmaceutical patents applies to legal relationships that arose before amendments introduced in 2020. The dispute arose after a company challenged the refusal of the Ukrainian National Office for Intellectual Property and Innovations to grant additional protection for a patented invention relating to a medicinal product.
The applicant asked the court to invalidate the refusal and require the relevant additional protection to be registered. The refusal was based on the amended provision entered into force on August 16, 2020. One of the significant changes reduced the relevant period from five years to one year.
The period concerns the interval between the filing of the first application for authorization to place the medicinal product on the market in any country and the filing of the corresponding application in Ukraine. The legislative change created uncertainty where the relevant period had already begun before August 16, 2020. The Supreme Court therefore addressed how the new one-year requirement should operate in transitional situations.
The Court identified several scenarios depending on when the one-year period began and ended. If the one-year period both commenced and expired before August 16, 2020, the new rule does not apply to the relevant legal relationship. If the period began before August 16, 2020, but had not expired by that date, it is extended until August 16, 2021. This gives the patent proprietor one year from the effective date of the new provision in such transitional cases.
If the relevant one-year period began after August 16, 2020, it is calculated under the amended legislation in the ordinary manner. In that situation, the calculation runs from the filing date of the first application for marketing authorization in any country to the date of the corresponding application in Ukraine. The approach is designed to prevent the retroactive application of a shortened statutory period where the period had already fully expired under the previous legal framework.
At the same time, it gives effect to the new one-year requirement in relationships that continued after the amendments entered into force. The Court noted that the lower courts had followed the instructions previously provided by the cassation court when reconsidering the case. As a result, the challenged lower-court decisions were left unchanged.
The Supreme Court also emphasized the limits of its review in cassation proceedings. It stated that it was not determining whether the claimant had complied with every other substantive or procedural condition required to obtain additional protection. The Court’s task in the proceedings was limited to the legal issue concerning application of the amended statutory period. The Supreme Court stressed that, as the highest judicial body, it acts as a court of law rather than a court of fact when exercising cassation review.
The judgment is particularly relevant to pharmaceutical patent owners whose marketing authorization timelines overlap with the 2020 legislative reform. It provides a clearer framework for assessing whether an application falls under the former or amended timing rules. The decision may also assist patent owners when reviewing older portfolios for possible additional protection rights.
Companies should nevertheless evaluate the complete set of statutory requirements rather than relying solely on compliance with the one-year rule. Documentary records concerning the first foreign authorization application and the corresponding Ukrainian filing remain particularly important. The judgment contributes to greater predictability in the application of Ukraine’s transitional rules governing additional protection for medicinal product patents.