Last year brought a lot of legislative changes with which we will have to work in 2021. As part of the block of lectures "Legislative novels 2021. Effective construction of the lawyer's work" partner of Doubinsky and Osharova Victoria Sopilnyak gave a lecture at Legal High School on a new concept for Ukrainian legislation - "Bolar Exemption" in practice: issues to be solved for the effective functioning of the new mechanism".
During the lecture, Victoria reminded that in 2020 the patent legislation of Ukraine has undergone significant changes. In particular, the Law of Ukraine On Protection of Rights to Inventions and Utility Models was amended. Due to these changes the import of goods into the customs territory of Ukraine according to the established procedure produced for use in research and use of inventions provided for the purpose of preparation and application of information for registration of a medicinal product is not a violation of the rights to an invention.
According to the speaker, such changes in the Ukrainian patent legislation can be considered the "Bolar Exemption". The concept of this notion is that at the legislative level of different countries there are restrictions of the patent rights of the patent owner. Such restrictions are aimed at encouraging and stimulating launch of the generic medicinal product on the market.
At the same time, the question arises whether it is possible today under Ukrainian laws to apply for registration of a generic medicinal product before the patent expire? Will such an application be deemed to have been filed under the Bolar Exemption or will it be an infringement of patent rights?
Victoria's position on this issue is that the adopted amendments to the Law of Ukraine On Protection of Rights to Inventions and Utility Models did not give the legislative basis for generic companies to file applications for registration before expiration of a patent.
More details: https://lhs.net.ua/ua-faktychno-v-ramkakh-patentnoho.../