On June 5, 2025, Ukraine’s Law No. 4454-IX, titled “On Amendments to Certain Laws of Ukraine Regarding the Implementation of the Bolar Provision”, officially came into force. The legislation introduces significant changes to Ukraine’s legal framework on pharmaceuticals and intellectual property.
The new law amends key statutes, including the Law “On Medicinal Products” and the Law “On the Protection of Rights to Inventions and Utility Models.” Most notably, it legalizes specific activities involving patented inventions during the drug development process, aligning Ukraine with international best practices.
Under the updated legislation, actions such as the manufacture, import, and transportation of a drug using a patented invention, when done for research or regulatory approval purposes are no longer considered patent infringement. This includes compiling data and submitting documents for the state registration of a medicinal product.
Furthermore, the law permits the submission and examination of registration applications for medicinal products, as well as the issuance of marketing authorizations, without violating patent rights. This provision streamlines the path for generic drug manufacturers to prepare for market entry immediately after patent expiry.
The legislation also clarifies liability for patent infringements, including the calculation of lost profits and the possibility of imposing fines. Additionally, it establishes rules for labeling products made for export under extended protection periods.
This legislative step marks an important milestone in harmonizing Ukraine’s pharmaceutical and patent regulations with European and international standards.
