Bolar Exemption in Ukraine: What the 2025 Reform Means for Originators and Generic Manufacturers

On 5 June 2025, Law of Ukraine No. 4454-IX “On Amendments to Certain Laws of Ukraine Regarding the Implementation of the Bolar Provision” entered into force. The law amends two key statutes – the Law “On Medicines” and the Law “On Protection of Rights to Inventions and Utility Models” – and fundamentally restructures the legal framework governing generic drug development and launch in Ukraine.

For international pharmaceutical companies operating in or supplying to Ukraine, the reform has immediate practical consequences on both sides of the market: it creates new operational freedoms for generic manufacturers while introducing sharper enforcement tools to protect originator patent rights.

1. Background: What Is the Bolar Exemption?

The Bolar exemption is a standard feature of patent law in EU member states and most developed pharmaceutical markets. It permits generic manufacturers to conduct studies, compile registration dossiers, and obtain marketing authorisations based on a patented reference product – while the patent is still in force – so that generics can enter the market on Day 1 after patent expiry.

Ukraine took an initial step toward implementing a Bolar-type provision in the 2020 patent reform, but the absence of clear procedural rules limited its practical effect. Law No. 4454-IX delivers the complete, operationally enforceable framework.

📋 Legislative timeline: Draft law No. 13087 registered 12 March 2025 → adopted by the Verkhovna Rada 15 May 2025 → signed by the President 3 June 2025 → published 4 June 2025 → in force 5 June 2025.

2. What Generic Companies May Now Do During the Patent Term

Under the updated Article 31 of the Law on Inventions, the following actions are explicitly excluded from the scope of patent infringement – including infringement of Supplementary Protection Certificates (SPCs):

1. Preparation for registration. Importation, manufacture, storage, and transport of the product for the purpose of conducting studies (physicochemical, preclinical, clinical) required to compile a registration dossier.
2. Registration proceedings. Submission of a state registration application, expert review, adoption of the registration decision, entry into the State Register, and issuance of the marketing authorisation (registration certificate). Crucially, this does not authorise commercialisation – sale, advertising, and marketing of the generic remain prohibited until the patent expires.
3. Manufacturing Waiver – export to third countries. Manufacture of the medicine during the SPC term, exclusively for export to countries where no patent protection applies. The manufacturer must apply the “UA Export” marking on the product, unless such marking would conflict with the requirements of the destination country’s regulations.

⚠️ Hard boundary: The Bolar exemption covers only pre-commercial activities. Any sale, advertising, or commercial placement of a generic medicine on the Ukrainian market before the patent or SPC expires constitutes infringement and triggers the enforcement consequences described below.

3. Mandatory 80-Day Prior Notification

The law introduces a procedural safeguard designed to give originators early visibility of upcoming generic registration activity. Any person intending to submit data for state registration of a generic medicine during the patent term is obligated to notify the patent holder in writing no later than 80 calendar days before the date on which the registration information or application is submitted to the regulatory authority.

This requirement applies regardless of whether the applicant has previously communicated with the patent holder. Failure to comply with the notification obligation is a separate risk factor that may affect the regulatory and enforcement position of the generic applicant.

4. Enforcement: Strengthened Liability for Infringement

The law significantly escalates the consequences for any commercial activity in breach of patent rights in the pharmaceutical context:

• Fines: A court may impose a fine ranging from 100% to 500% of the revenue (income) received by the infringer from the sale of medicinal products manufactured in violation of the patent holder’s rights. The fine is paid into the state budget. When determining the amount, the court takes into account the scale of the infringement, the infringer’s intent, the form and degree of fault, and other material circumstances.
• Cancellation of marketing authorisation: If a court establishes that IP rights were infringed in the course of the medicine’s circulation on the market, the state registration of that medicinal product may be cancelled.

5. Transitional Provisions: Retroactive Application

A critical point for originators holding older patents: the transitional provisions of Law No. 4454-IX expressly provide that the new rules on supplementary protection – including both the Bolar exemptions and the Manufacturing Waiver – apply to patents whose term was extended under the legislation in force prior to the 2020 patent reform.

⚠️ Strategic implication for originators: If your SPC or extended-term patent covers a product on the Ukrainian market, Law No. 4454-IX is immediately relevant. Generic companies may already be compiling registration dossiers based on your product. The 80-day notification requirement is your primary early-warning mechanism – monitor incoming notifications carefully and assess response options with Ukrainian IP counsel in advance.

Permitted (during patent/SPC term)	Prohibited
Studies: physicochemical, preclinical, clinical	Commercial sale of the generic
Compiling and submitting registration dossier	Advertising or promotion of the generic
Obtaining marketing authorisation	Any market distribution before patent expiry
Manufacture for export only (with “UA Export” marking)	Domestic commercialisation in any form

Key Takeaways

For generic manufacturers: Ukraine now provides a clear, EU-aligned Bolar framework enabling Day-1 Launch preparation. The 80-day notification obligation is a mandatory procedural step – missing it creates unnecessary legal risk.

For originator companies: The reform introduces new exposure for SPC holders. The 80-day notification mechanism is the primary tool for early detection of generic registration activity. Proactive monitoring and a prepared enforcement strategy are essential.

For both: Transitional provisions mean existing extended-term patents are already within scope. There is no grace period for legacy portfolios.