Ukraine extends Bolar provision paving the way for faster access for generics

Section 1: Extension of Bolar Provision

On 5 June 2025, the Law on Amendments to Certain Laws of Ukraine Regarding the Implementation of the Bolar Provision, which the Ukrainian parliament adopted in May came into force.

The Bolar provision is defined as legislative norms enabling faster access to the market for generic pharmaceuticals and biosimilars by allowing manufacturers to conduct R&D using the original patented medicines and apply for marketing authorisation of their generic alternatives or biosimilars before the expiry of the patents protecting the original reference medicine. This means that generics and biosimilars can be placed on the market the day after the expiration of the original product’s patent.

The new Ukrainian Law replaces the previous Bolar provision introduced in 2020 with a new extended version.

Lawmakers stated the amended Bolar provision is necessary because the previous one, which accelerated entrance of generics into the market, failed to enable generic and biosimilar companies to apply for and obtain marketing authorisation for their products before the expiry of patent protection of the original reference medicines.

This means that although generic companies could conduct some activities (e.g. import, R&D, etc.) necessary to develop generic versions after the original product’s patent expiry, they could not apply for and obtain marketing authorisation until the expiry of the reference product patents.

The new rules introduced by the Law provide the following actions that can be conducted before the patent’s expiration without triggering-patent rights infringements:

• The manufacturer can prepae and submit data (i.e. a dossier) for generic product marketing authorisation – the patented invention can be  imported  and used for R&D purposes, and the medicine containing the patented product can manufactured, stored and transported.
• These medicines can be manufactured (and can undergo related actions) for the purpose of export from Ukraine, but only within the term of additional protection granted to the invention.
• Manufacturers can apply for and obtain marketing authorisation of the generic product or biosimilar including submission and assessment of applications and dossiers for marketing authorisation of medicinal products and can enter information on generic or biosimilar medicinal products into the State Register of Medicinal Products.  The manufacturer can obtain a marketing authorisation certificate and can participate in other actions related to the medicine’s authorisation.

The Law also introduces additional safeguards to secure protection for patent right holders:

• Before applying for marketing authorisation, it is mandatory to send written notification to each holder of a patent (e.g. supplementary protection certificate, SPC) for the respective invention. The notification must be done no later than 80 calendar days before submitting the application.
• Significant penalties can be levied in the event of infringement of patent rights for medicines, including recovery of lost profits, and fines ranging from 100% to 500% of the gains through the commercialisation of the infringing product.

This amended balanced regime is expected to have a positive impact on competition by allowing faster access of generic medicines and biosimilar to the market for good-faith market players, and the reduction of prices for therapies and health-care budgets, particularly when medicines are procured through tenders or reimbursed.

Section 2: Renewal of IP-related deadlines

As previously reported, in April 2022 the Ukrainian parliament suspended certain terms and deadlines related to the protection of IP rights (i.e. registrations extensions, state fees payment, submission of objections, etc.) and terms for the acquisition of such rights (i.e. registration of inventions). This suspension was introduced in connection with and for the duration of the martial law regime (plus 90 days).

On 31 May 2025, this suspension was lifted and the following was applied:

• The resumption of suspended deadlines for acquiring and maintaining IP rights with a minimum grace period of 75 days from 31 May 2025. This means that if after the above-stipulated renewal, the deadline should expire within these 75 days but the expiration is valid only after the grace period is over.
• Fees for industrial designs, trademarks, semiconductor topographies, patents, and geographical indications must be paid in accordance with the previously extended deadlines. The fees are considered timely if paid within the grace period. Failure to pay results in the termination of IP rights.
• Trademark renewal fees that were due but unpaid during martial law are deemed timely if settled within 75 days, ensuring a ten-year extension of trademark validity.

The suspension of the above deadlines has been lifted primarily to prevent unjustified extension of IP rights to inventions (i.e. utility models) whose term of validity expired during the period of martial law and cannot be extended.

For more information on regulation of medicines in Ukraine and the protection of IP rights, contact your regular CMS contact or our local experts Borys Danevych.