Ukraine introduces Bolar exemption

04/ 06/ 2020

On June 2, 2020, Ukrainian Parliament passed draft law introducing a legal exemption from patent infringement for actions relating to the development and submission of testing data to Ukrainian regulator for obtaining of marketing authorization for medicinal products. The relevant amendments were introduced to the Law of Ukraine On Protection of Rights in Inventions and Utility Models, thus bringing to Ukraine the concept known in international practice as Bolar exemption. More specifically, the new law excludes from infringement of patent rights import to the customs territory of 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. As at the date of this legal alert, final approved text of the law is yet to become publicly available). Previously, Ukrainian legislation had no similar specific provision. Therefore, the issue of whether early working by generic companies could be considered a patent infringement was resolved at the level of case law. Though practice somewhat varied, prevailing position supported by Ukrainian courts was that the start of any preparation for market entry by a generic manufacturer could be viewed as an infringement. Patent holders were often able to obtain injunctions against the launch of generic marketing approval process, while the patent was in effect, or successfully challenge the marketing authorization if it has already been granted. New law is expected to change this trend, allowing generic companies to proceed with the marketing authorization application for a generic product before the expiry of the patent, for commercialization after its expiry. On the formal side, the law still requires execution by the President and official publication to become effective. Furthermore, as it happened before in other jurisdictions, the exact borders and mechanics of Ukrainian Bolar exemption remain to be further spelled out by practice and case law. Nevertheless, Bolar provision is already here. Therefore, we recommend pharmaceutical companies to pay close attention to this development and revisit their strategies for Ukraine in terms of product clearance, market entry and patent enforcement. For further information, please contact Asters Partner Julia Semeniy or Asters Counsel Viktoriya Podvorchanska

The relevant amendments were introduced to the Law of Ukraine “On Protection of Rights in Inventions and Utility Models”, thus bringing to Ukraine the concept known in international practice as “Bolar exemption”.

More specifically, the new law excludes from infringement of patent rights import to the customs territory of 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. As at the date of this legal alert, final approved text of the law is yet to become publicly available).

Previously, Ukrainian legislation had no similar specific provision. Therefore, the issue of whether early working by generic companies could be considered a patent infringement was resolved at the level of case law. Though practice somewhat varied, prevailing position supported by Ukrainian courts was that the start of any preparation for market entry by a generic manufacturer could be viewed as an infringement. Patent holders were often able to obtain injunctions against the launch of generic marketing approval process, while the patent was in effect, or successfully challenge the marketing authorization if it has already been granted.

New law is expected to change this trend, allowing generic companies to proceed with the marketing authorization application for a generic product before the expiry of the patent, for commercialization after its expiry.

On the formal side, the law still requires execution by the President and official publication to become effective. Furthermore, as it happened before in other jurisdictions, the exact borders and mechanics of Ukrainian Bolar exemption remain to be further spelled out by practice and case law.

Nevertheless, Bolar provision is already here. Therefore, we recommend pharmaceutical companies to pay close attention to this development and revisit their strategies for Ukraine in terms of product clearance, market entry and patent enforcement.

For further information, please contact Asters’ Partner Julia Semeniy or Asters’ Counsel Viktoriya Podvorchanska