On June 2, 2020, the Ukrainian Parliament passed a draft law introducing a legal exemption for patent infringement for actions relating to the development and submission of testing data to a Ukrainian regulator/authority for obtaining marketing authorization for medicinal products. These amendments were introduced to the Ukrainian Intellectual Property law entitled, “On Protection of Rights in Inventions and Utility Models”. As a result, Ukraine law now contains a “Bolar exemption”. More specifically, the new law excludes from infringement the importation into “…Ukraine, in accordance with the procedure established by law, of goods manufactured using the invention for the purpose of, and/or using the invention in, studies carried out with a view to prepare and submit information for marketing approval of a medicinal product (based on the draft law presented for consideration of Ukrainian Parliament” (Please note that as of the date of this post that the final approved text of the law is not yet publicly available).
Previously, Ukrainian legislation and law did not contain a Bolar type exemption. Therefore, the issue of whether the early working (e.g., clinical studies, importation of samples and/or the submission of application for marketing approval) of a patented invention by a generic company could be considered a patent infringement was decided based on existing case law. Although the practice varied somewhat, the prevailing position of the Ukrainian courts was that the start of any preparation by a generic manufacturer to obtain market entry constituted patent infringement. Specifically, patent holders were often able to obtain injunctions during the term of a patent (a) when a generic company submitted an application for marketing approval to a Ukrainian regulator/authority (thus blocking or delaying the application at an early stage); or (b) once a marketing authorization was granted. Despite this, the new law is expected to change this trend, thereby allowing generic companies to apply for marketing approval for a generic product before the expiration of a patent for purposes of commercialization after expiry.
From a formal perspective, the law requires execution by the (Ukraine) President as well as official publication to become effective. Additionally, as has happened previously in other jurisdictions, the breadth and specifics of the Ukrainian Bolar exemption will be further developed by future practice and case law.
Please continue to watch BRICS & Beyond for updates on the Bolar exemption in Ukraine.
This post was written by Lisa Mueller and Viktoriya Podvorchanska of Asters Law.