Ukraine enacts law implementing the Bolar provision

On June 5, 2025, the Law of Ukraine “On Amendments to Certain Laws of Ukraine Regarding the Implementation of the Bolar Provision” came into force, aligning Ukrainian legislation with the international legal standards. The changes affect the laws “On Medicines” and “On the Protection of Rights to Inventions and Utility Models” and are expected to have a significant impact on the pharmaceutical industry and the patent protection system.

The Bolar provision is a legal mechanism that allows companies to prepare generic medicines for market entry before the expiration of the patent on the original medicinal product, provided that such actions are solely for registration of medicinal product and not for commercial sale.

Under the new legislation, certain activities carried out while preparing a medicinal product for state registration are no longer considered patent infringement. This includes importing, storing, manufacturing, or transporting a product containing a patented invention, as long as these actions are strictly aimed at conducting research, preparing and submitting documents for registration of medicinal product, conducting expert evaluations of registration materials, or performing other procedural steps necessary for completing the registration procedure before the patent on the original drug expires are no longer considered a patent violation.

In addition, the law introduces several further provisions. It clarifies the liability rules for patent infringement and sets out detailed requirements for labeling products manufactured for export during the period of supplementary protection.

With these changes, Ukraine has taken a meaningful step toward harmonizing its legal system with the international practices and has laid the groundwork for faster market entry of generic medicines immediately after the expiration of patent protection. This development opens new opportunities for manufacturers of generic medicinal products and contributes to improving patient access to affordable treatments.