Ukraine Adopts "Bolar Implementation" Law – Game Changer
On 5 June 2025, the Law of Ukraine No. 4454-IX dated 15 May 2025, "On Amendments to Certain Laws of Ukraine Regarding the Implementation of the Bolar Provision” (the "Law”), entered into force. This legislative reform marks a fundamental shift in how patent disputes between pharmaceutical companies are addressed in Ukraine, particularly about the so-called "Bolar exemption.”
The Bolar provision is a legal exception under which a third party’s use of a patented invention is not considered an infringement. Specifically, it allows for research and regulatory preparation of generic medicinal products based on a valid patent, enabling their swift market entry once patent protection expires.
In Ukraine, the Bolar provision was first introduced in 2020 and is set out in paragraph 5 of Article 31 of the Law of Ukraine "On the Protection of Rights to Inventions and Utility Models.” Under this rule, it is not considered a patent infringement to import or use a patented invention (or utility model) in Ukraine if it is done exclusively for research purposes, including the preparation and submission of documents required for the registration of a medicinal product.
However, in practice, the provision has been interpreted in light of other applicable legislation—such as the Law of Ukraine "On Medicinal Products,” the Procedure for Expert Evaluation of Registration Materials, and the Procedure for State Registration of Medicinal Products. Based on these norms and existing case law, the submission of a registration dossier for a generic medicinal product while a patent remains valid has been treated by courts as an infringement of the patent holder’s rights. Such acts were regarded as preparatory steps toward introducing the product into civil circulation, and therefore as an unlawful encroachment on the exclusive rights granted under Article 28 of Law of Ukraine "On the Protection of Rights to Inventions and Utility Models.”
Key Changes Introduced by the Law
The Law amends several core legislative acts, particularly the Law of Ukraine "On Medicinal Products” and the Law of Ukraine "On the Protection of Rights to Inventions and Utility Models,” to significantly streamline the registration process for generic medicines. In particular:
Applicants for medicinal product registration will no longer be required to submit a copy of the patent or licence, or a confirmation letter of non-infringement of third-party rights during the state registration of the medicinal product.
The existence of an active patent will not serve as grounds for refusal of state registration of a medicinal product.
The following actions will be permitted: (1) importation into Ukraine of goods manufactured using the patented invention for research purposes, (2) use of the invention in research, (3) state registration of the generic medicinal product, its storage and export to third countries, as well as its manufacture for storage or export purposes.
At the same time:
Applicants for registration of a generic medicinal product will be obliged to notify the patent holder and the Ukrainian IP office in writing in advance.
The circulation of medicinal products manufactured using a patented invention in Ukraine will be prohibited until the patent expires.
A new ground for cancelling the state registration of an already registered medicinal product is added – the entry into legal force of a court decision on the infringement of patent rights due to introducting medicinal product into circulation in Ukraine before the patent expires.
The patent holder will have the opportunity to recover lost profits from the infringer in court in an amount not less than the income received by the infringer from such unlawful activity.
In the event of illegal introduction into circulation and/or use of a medicinal product, as well as any illegal use before the termination of the validity of IP rights to an invention, the infringer, based on a relevant court decision, must pay a fine to the state budget in the amount of five times the sum of proceeds from the sale of such medicinal products.
Conclusions
For generic drug manufacturers, this opens up the opportunity to prepare for market entry in advance and launch medicines more quickly after patent protection expires. In the future, this will contribute to lower prices and expanded patient access to more affordable medicines.
At the same time, the updated legislation significantly impacts patent holders and the long-established approach to protecting their rights. This new approach will require more proactive and broader involvement in monitoring competitors’ actions, documenting infringements, assessing damages, and timely recourse to the courts. Importantly, protecting infringed rights is now only possible retrospectively, rather than preventively, as was previously permitted by law.