Adoption of Bolar Exemption Bill to ensure medicine accessibility for patients

Interfax-Ukraine, February 20, 2025

Vitalii Savchuk, Partner at LA Law Firm,
Head of Intellectual Property Practice

Oleksandr Tsurkan, Intellectual Property Lawyer at LA Law Firm

Bolar Exemption allows generic drug manufacturers to start marketing authorization process for a medicinal product before the patent for the generic medicinal product expires.

The main advantage is that generic drug manufacturers can start selling such medicinal products the day after the patent expires, which ensures their rapid availability on the market. Due to competition and a wide choice, the medicine price can decrease, which benefits the patient.

Bolar Exemption in Ukraine

"Within the EU, the mechanism for implementing Bolar Exemption is enshrined in Directive 2001/83/EC. In Ukraine, this exemption has been implemented in the Law of Ukraine On the Protection of Rights to Inventions and Utility Models as part of the 2020 intellectual property reform. Despite the use of similar provisions of the Directive, Bolar Exemption has not yet been implemented in Ukraine due to the decision of the Supreme Court. The court said generic marketing authorization is only possible after the patent expires. As a result, an additional monopoly on a particular technology appears on the market, which lasts for several years (the time required to register a generic),” Oleksandr Tsurkan said.

“Bolar Exemption has long been widely used in the EU, the United States, and a number of other developed countries. Its correct implementation does not limit the rights of patent holders. On the contrary, it strengthens trust in patents, bringing us closer to global standards,” Vitalii Savchuk said.

For Bolar Exemption full implementation, it is necessary to amend, first of all, the Law of Ukraine On the Protection of Rights to Inventions and Utility Models and the Law of Ukraine On Medicinal Products."

“Patents must be respected, like any property right. By introducing Bolar [Exemption] in Ukraine, we must take into account the concerns that patent holders have been conveying to the professional community in recent years: the judicial system is not perfect, and the premature entry of a generic into the market is extremely difficult to both stop and compensate for,” Vitalii Savchuk added. “Ukrainian and international intellectual property law allows any product to be brought to the market the day after the patent expires, but not earlier. The bill, which I have the honor to present, takes into account the positions of various market participants. We listened to a lot before writing it.”

Bill presentation

On February 11, 2025, the LA law firm team presented the experience of EU countries in implementing Bolar Exemption at a meeting of the Verkhovna Rada Committee on National Health and submitted their own bill for discussion.

The bill provides for the possibility of filing an application for marketing authorization of generic medicinal products before the expiration of the patent. Meanwhile, the document contains a number of safeguards against the premature entry of generic medicinal products into the market:

• ban on market entry before the patent expires;
• prohibition of any commercialization (advertising, marketing, sale offers);
• determination of the date of introduction into circulation – not earlier than the next day after the patent expiration;
• increased fines for patent infringement.

Thus, generic manufacturers will be able to enter the market immediately after the expiration of the patent, and patent holders will be able to make potential violations of their patents an expensive pleasure for violators.

Bill's priority

By the decision of the National Security and Defense Council of Ukraine of February 12, 2025, the Bolar Exemption adoption is defined as a priority task and a one-month deadline is set for its implementation.

Expected consequences

Borrowing Bolar Exemption from highly developed countries will balance the interests of innovative and generic manufacturers, expand the range of products in pharmacies and revive market competition in Ukraine. These initiatives will contribute to a gradual reduction in the cost of some medicinal products, which is one of the priorities in the healthcare sector.

“During martial law in Ukraine, patents are valid indefinitely, and there are already cases where patents are valid for 27 years, despite the maximum legal protection period for medicinal products of 25 years. Unlike other countries, new generic medicinal products have not been able to enter the market in Ukraine for almost three years. Changing this state of affairs and the parallel implementation of Bolar [Exemption] will have favorable consequences for the market in the fairly short term,” Vitalii Savchuk concluded.

LA Law Firm remains committed to advancing this reform.