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Bolar Provision in Ukraine: Update Required

The so-called Bolar provision is generally understood as the rule allowing generic and biosimilar manufacturers to get prepared for launching a drug by the time the relevant patent expires, thereby offering broader options to patients as early as possible.

Recent amendments to Ukrainian law

The first attempt to introduce Bolar into Ukrainian Patent Law was taken in 2020. However, the new provisions were limited and only expressly allowed the following use of a patented invention by a person other than the patent owner or licensee: importation of products manufactured with the use of invention and/or use of the invention for studies held with the purpose to prepare and submit clinical information to apply for a marketing authorization.

In addition, the law allowed the following, but only with respect to inventions covered by the supplemental protection certificate (SPC):

• manufacture a product (drug) using the invention with the purpose of exportation to third countries or other activities necessary to manufacture the product (drug) with said purpose
• manufacture a product (drug) using the invention no earlier than six months prior to the expiration of SPC and storing it with the purpose of putting on the market after the SPC expires, as well as other use of the invention if necessary for the aforesaid manufacture and storage.

Thus, although the underlying discussions concerned broader exemption to enable manufacturers of generic products to get regulatory approvals while the relevant patent is still in force, the actual language was apparently different. So, the current Ukrainian exemption, although often called ‘Bolar’, is much more limited.

Courts treated the novel literally and narrowly. Therefore, they continued blocking consideration of applications for and grant of marketing authorizations concerning generic drugs during the term of patent protection per the request of patent owner, exactly as it was happening before, either via interim injunction or permanent prohibition.

The reasoning behind the relevant judgements is that issuance of marketing authorization to a generic drug before patent expiry would allow importation of the drug and marketing it in Ukraine, which would lead to distribution of the drug among a wide circle of persons, therefore making unavailable efficient protection of patent rights.

Wartime implications

The situation took another turn during the wartime. To allow applicants and right holders to not lose their intellectual property rights due to war-inflicted inability or difficulty to continue with prosecution, maintenance or renewals on timely basis, a new law was adopted by the Ukrainian Parliament. It is called the Law “On Protection of Interests in the Sphere of Intellectual Property during Martial Law Introduced due to Military Aggression of Russian Federation against Ukraine”, but is also known as the ‘Timeframes Law‘ since it provided for the suspension of various timeframes concerning prosecution of applications and the protection of IP rights.

Importantly, the Timeframes Law provides that tangible intellectual rights expiring during martial law shall remain effective until the day following termination or cancellation of martial law. Then, it would be possible to renew such rights in the order provided by law.

The approach based on this provision is that the patents which would otherwise expire during martial law, including final expiration with no further renewal or extension available, will remain effective while the martial law is in force. It is supported by case law (e.g. Merck vs. Rompharm, case No. 910/5743/23). Thus, the holders of such patents would remain in a position to prevent generic manufacturers from getting their marketing authorizations and launching their products in Ukraine.

In July 2023, the Ukrainian IP Office issued a guidance saying that prolongation of patent or SPC’s validity may only be available within the statutorily provided timeframes, which is 20 years from the application filing date for a patent, and for SPC up to 5 years, depending on when the marketing authorization was issued. However, the guidance is not binding, and to change the situation amendments to the Timeframes Law will be required.

What’s next?

As there is further discussion that Ukraine needs to implement a full-scale Bolar exemption, the Ukrainian IP Office came up with the relevant draft law. Specifically, the draft provides for the exemption that covers, in addition to the current version of the law:

submission and consideration of application for marketing authorization for a drug, submission of registration materials concerning a drug for examination, issuance of a decision to grant marketing authorization, including a drug into the State Drug Registry, issuance and obtaining of marketing authorization, other activities as necessary for obtaining marketing authorization.

The draft law is also intended to fix some irregularities regarding the procedure of obtaining SPC.

However, we expect that some time would be required for this draft to turn into the law, with various stakeholders offering their views. Meanwhile, the situation in Ukraine will remain favorable to the original drug manufacturers.