UKRAINE Trends and Developments Contributed by: Oleksandr Mamunya and Nataliia Badora, Mamunya IP
The Court further refined its interpretation by addressing the relationship between research activities and registration procedures. It main- tained that, while research activities for regis- tration purposes are permitted under the Bolar exemption, this does not extend to the actual registration process itself. The Court empha- sised that filing registration documents before patent expiration constitutes a violation of patent rights that requires immediate cessation, regard- less of whether the product has actually entered the market. Organon Canada Inc. v Teva Ukraine (Case No 910/1476/22, Supreme Court decision, 8 June 2023) Building upon its previous interpretation, the Supreme Court reaffirmed its position regarding the narrow scope of the Bolar exemption. The Court emphasised that the mere act of filing an application for state registration of a pharmaceu- tical product containing a patented compound before patent expiration constitutes preparation for bringing the product into civil circulation, thereby infringing the patent owner’s rights. This interpretation by the Supreme Court contin- ues to be consistently applied by lower courts throughout 2024, creating a clear legal frame- work regarding the scope of the Bolar exemp- tion in Ukraine. The courts maintain that, while research and development activities for registra- tion purposes are protected, the actual submis- sion of registration documents must wait until patent expiration. The stringent interpretation ensures strong pat- ent protection while still allowing necessary preparatory research work for generic manu- facturers. This approach aligns with Ukraine’s obligations under international intellectual prop-
erty agreements while maintaining a balance between patent protection and facilitating timely market entry of generic medications after patent expiration. Strategic Developments The establishment of the High Court of Intellec- tual Property remains a crucial pending devel- opment in Ukraine’s IP landscape. This special- ised court represents a significant advancement in the administration of IP justice in Ukraine. The creation of a dedicated intellectual prop- erty court is expected to substantially improve access to justice through specialised expertise in handling complex IP matters. Such speciali- sation ensures more consistent and predictable jurisprudence in IP cases, faster resolution of disputes, and better quality of judicial decisions through deeper understanding of technical and legal intricacies specific to intellectual property matters. An important moment in shaping Ukraine’s IP future occurred on 26 April 2024, when the Ukrainian IP Office presented the Concept of the National Strategy for Intellectual Property Devel- opment until 2030. This comprehensive strategy outlines several crucial developments in the pat- ent sphere that will likely define the trajectory of patent litigation and protection in Ukraine. The strategy emphasises the implementation of detailed procedures regarding Supplementary Protection Certificates (SPCs), introducing com- prehensive regulations for their administration. These include specific provisions for publish- ing SPC-related information, filing applications, grounds for invalidation, and the introduction of opposition procedures against SPC grants. Additionally, the strategy introduces the legal framework for mandatory cross-licensing, rep- resenting a significant step toward balancing
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