MIKHAILYUK SOROKOLAT & PARTNERS

Patent and Trademark Attorneys

Introduction of Bolar Provision into Ukrainian legislation



June 11, 2020

The Ukrainian Parliament has adopted the Draft Law incorporating the so-called Bolar provision into the Law of Ukraine "On Protection of Rights to Inventions and Utility Models".

Availability of Bolar provision in patent legislation is of vital importance for generic companies as it provides for an exemption to the rights conferred by patents for performing research and tests and for receiving marketing authorization in advance of the patent expiration.

Until now, the Ukrainian legislation has not stipulated the Bolar provision as such. Under the Ukrainian legislation, there were following exemptions for patent infringement, which could be considered as somewhat similar to the Bolar provision:

a) use of a patented invention for scientific purposes or for carrying out an experiment;

b) use of a patented invention without commercial purposes.

Nonetheless, according to the previous court practice in the prevailing majority of cases, the Ukrainian courts considered importation of the patented medicinal products, even for trials and research, as well as registration of medicinal products as an infringement of the patent holder's rights. Based on court decisions the patent holders could suspend the registration procedure during patent validity term or cancel existing marketing authorization if already obtained.

The adopted Draft Law introduces into the Ukrainian Law "On Protection of Rights to Inventions and Utility Models" the following exemptions for patent infringement:

- importation of medicinal products produced using the invention/utility model into the customs territory of Ukraine for studies;

- studies carried out for preparing and submitting the information for obtaining marketing authorization.

The Draft Law also implements new provision to the Law of Ukraine "On Medicines". It states that reference to the registration information of the original medicinal product and using it by the same applicant in the registration materials submitted for registration of another medicinal product containing the same active substance, shall not be considered as disclosure and unfair commercial use of such information.

Thus, the approved amendments shall allow the generic companies to receive marketing authorization for generic medicinal products during the validity of the patent on the original product to launch them into the Ukrainian market right after the corresponding patent expires. In view of the above, it may be reasonable for generic companies to review their previously approved strategies in respect of the Ukrainian market.

The Draft Law was adopted on June 2, 2020, and forwarded for the President’s signature on June 10, 2020. It shall enter into force immediately upon being signed by the President and published by the Parliament.