Decade in waiting. One and a half years of work. Ukraine enacts Bolar Exemption Law

On May 15, 2025, the Parliament of Ukraine adopted Bill No. 13087 at second reading introducing the Bolar Exemption in Ukraine.

The amendments allow manufacturers of generic drugs (analogues of original medicinal products) to undergo the marketing authorisation process and obtain a marketing authorisation certificate – before the patent for the original medicinal product expires.

Prior to the adoption of this law, the Ukrainian legislation permitted to start the marketing authorisation process of generic medicinal products only after the patent had expired. This effectively granted original medicinal product patents an extended period of legal protection, beyond the legally intended term and delayed competition in the market.

By implementing this law, Ukraine aligns itself with most EU countries where the Bolar Exemption has been in effect for many years, which contributes to strengthen competition and accelerates access to specific medicinal products for patients.

The LA Law Firm team, including Head of the Intellectual Property Practice Vitalii Savchuk and Associate in the Intellectual Property Practice Oleksandr Tsurkan, contributed to the drafting of the bill for its first and second readings. Special thanks to Managing Partner Dmytro Aleshko for his consistent coordination and key contributions from the perspective of legislative drafting.

LA Law Firm remains committed to advancing intellectual property reform in Ukraine.