UKRAINE Trends and Developments Contributed by: Oleksandr Mamunya and Nataliia Badora, Mamunya IP
The decision carries particular significance in the context of Ukraine’s European integration aspi- rations. As noted by leading intellectual property practitioners involved in the case, the decision affirms Ukraine’s commitment to respecting and effectively protecting intellectual property rights, a crucial consideration as the country progresses toward EU membership. The Court’s emphasis on the rule of law principle, particu- larly in addressing legislative gaps, showcases the maturation of Ukraine’s intellectual property jurisprudence. This precedent-setting case has broad implica- tions for patent holders in Ukraine, particularly in the pharmaceutical sector. It establishes clear judicial guidance on handling transitional periods in patent protection mechanisms and reinforces the importance of maintaining consistency with international obligations, even when faced with legislative ambiguities. The Supreme Court’s Interpretation of the Bolar Exemption The implementation of the Bolar provision in Ukraine represents a significant development in pharmaceutical patent law, initiated through the 2020 Law of Ukraine “On Amendments to Certain Laws of Ukraine on the Elimination of Artificial Bureaucratic Barriers and Corruption Factors in Healthcare”. This legislative change aimed to align Ukrainian law with international practices regarding generic drug development and market entry. The amendments to the Law on Inventions introduced provisions specifying that research activities and the use of patented inventions for preparing and submitting information for drug registration would not constitute patent infringe- ment. This modification represented a crucial step toward facilitating generic drug develop-
ment, including allowing the importation of com- ponents for evaluating the feasibility of generic drug development while the original drug’s pat- ent remains active. The Supreme Court’s jurisprudence has played a crucial role in defining the scope and limitations of the Bolar provision in Ukraine. Merck Sharp & Dohme Corp. v KRKA (Case No 910/10855/20, Supreme Court deci- sion, 1 December 2022) In this landmark case, the Supreme Court estab- lished fundamental principles regarding the scope of the Bolar exemption in Ukraine. The Court held that, while Article 31(5) of the Law on Inventions permits certain activities without pat- ent infringement, these exemptions are strictly limited to: • importing goods containing the patented invention for research purposes; and • using the patented invention in research con- ducted specifically for preparing and submit- ting information for drug registration. Significantly, the Court emphasised that the submission of registration documents and the actual state registration of pharmaceutical prod- ucts are not included in the list of non-infringing actions. The Court explicitly stated that Ukrain- ian law does not provide for the possibility of submitting applications for drug registration and obtaining marketing authorisation before patent expiration. Merck Sharp & Dohme Corp. v Farmak (Case No 910/17860/21, Supreme Court deci- sion, 8 December 2022)
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