Patent Law Reform. To Be Continued…

Over the past year, ongoing attempts to reform Ukraine’s patent legislation and align it with European standards have yet to yield visible results in legislative amendments. Discussions, publications, working groups, memoranda, and even drafts of certain regulatory legal acts continue to fuel debate and controversy surrounding potential changes. Currently, key areas of focus include (1) the validity of patent rights during martial law, (2) the Bolar exemption, and (3) PTE/SPC. Let’s explore each of these.

Validity of Patent Rights During Martial Law

Everyone remembers the storm of discussions sparked by the adoption of the Law of Ukraine On the Protection of Interests of Persons in the Sphere of Intellectual Property During Martial Law Introduced in Connection with the Armed Aggression of the Russian Federation Against Ukraine, of 1 April  2022, No. 2174-IX (commonly known among professionals as the Terms Law). Its provision stating that “intellectual property rights, the term of which expires on the day martial law is introduced in Ukraine or during the period of martial law, shall remain valid until the day following the termination or cancellation of martial law” stirred significant unrest within the previously calm patent community.

This provision is phrased in such a way that it is impossible to limit its application to specific types of intellectual property rights, as it refers to the continued validity of all intellectual property rights without exception, whose term was due to expire on the day martial law was introduced or during its duration.

We have already discussed the implications of this provision for, among others, pharmaceutical patents. Supporters of a so-called “limited interpretation” — i.e., the impossibility of extending the validity of patents during martial law — argue that it allegedly contradicts Ukraine’s specific patent legislation and international legal instruments in this area. On the other hand, proponents of interpreting the Law precisely as it is written emphasize the unjustified nature of such a limited interpretation and highlight the “special status” of this law during martial law. Naturally, this debate raises questions about which law should be considered “special” and applicable to disputed legal relationships.

This situation led to the emergence of numerous draft laws, each proposing its own version of how to regulate the issue of patent rights terms during martial law.

Draft Law No. 9383, submitted to the Verkhovna Rada of Ukraine and recommended for adoption by the Parliamentary Committee on Economic Development, eventually, after prolonged discussions and work on its text, became the Law of Ukraine On the the Protection of Interests of Persons in the Sphere of Intellectual Property During Martial Law Introduced in Connection with the Armed Aggression of the Russian Federation Against Ukraine of 16 April 2025, No. 4362-IX, which will enter into force on 31 May 2025 (hereinafter – Law No. 4362-IX).

Law No. 4362-IX is quite concise and provides for the recognition of the Terms Law as invalid.

The adopted law did not put an end to the discussion regarding the extension/non-extension of patent validity during martial law, so it is expected that these discussions will continue in courtrooms.

Ultimately, the interpretation of the disputed provision and its corresponding application is carried out by the courts when considering specific cases, where the parties present their respective view of the correct interpretation of the mentioned provision. Judicial practice generally shows that courts tend to recognize the validity of patent rights whose expiration fell during the period of martial law. However, we still do not have a legal opinion from the Supreme Court of Ukraine on this specific issue.

One related question, which indirectly concerns the terms of validity of patent rights and for which a legal position has already been established in judicial practice, is the following: If a violation of patent rights occurred during the term of a valid patent, any subsequent attempt to legitimize that violation — for example, due to the introduction of martial law in Ukraine or the adoption of the Law — is deemed unacceptable. As a result, such a violation must cease. We mentioned this position in last year’s ULF review, and it remains unchanged to this day.

The Ukrainian Bolar Exemption

In practice, under current patent law, the Ukrainian version of the Bolar exemption (some argue it doesn’t exist at all) essentially permits the following actions, which are not considered infringements of patent rights: (1) the importation of goods manufactured using an invention (or utility model) into the customs territory of Ukraine in accordance with the procedure established by law for research purposes; and/or (2) the use of an invention (or utility model) in research conducted to prepare and submit information required for the registration of a medicinal product.

It is worth noting that this version of the Bolar Exemption aligns fully with the provisions of Directive 2004/27/EC, as the relevant provision of Ukrainian law was formulated considering that directive.

Currently, there is an established and consistent judicial practice whereby the registration of a generic medicinal product (obtaining marketing authorization) and the submission of an application for such registration before the expiration of patent rights is considered an infringement of intellectual property rights to the invention. As a result, any registration of generic drugs carried out during the term of a valid patent is deemed a violation of the patent holder’s rights. Initially, this judicial approach was met with criticism, but it eventually became clear that the current law does not permit any other form of legal interpretation or enforcement.

This led to active discussions about the need to amend Ukraine’s patent law — at the very least, to legislatively permit the state registration of a generic medicinal product before the expiration of patent protection.

According to the afore-mentioned NSDC Decision, and referencing information regarding the intentions of participants in the Ukrainian pharmaceutical market to reduce prices by 30% for the most in-demand essential medicines starting from March 1, 2025, to improve public access, the Cabinet of Ministers of Ukraine is required, within one month, to ensure the development and submission to the Verkhovna Rada of Ukraine of a draft bill on the implementation of the Bolar  rule into national legislation.

It remains unclear, however, why the Bolar exemption has now effectively become a rule. Nonetheless, amending national patent legislation in this area is widely associated with faster market access for medicines, lower drug prices, and improved patient access.

Currently, we have Draft Bill No. 13087 of 12 March 2025 (the Draft Law On Amendments to Certain Laws of Ukraine Regarding the Implementation of the Bolar Provision, hereinafter – the Draft), which has been adopted as a basis and, taking into consideration the current realities and the groundwork that has been laid, has every chance of becoming law.

Under the Draft, the following actions are not considered infringements of patent rights:

• Actions conducted during the term of the patent and/or the supplementary protection period aimed at preparing and submitting information, documents, and materials for the state registration of a medicinal product, specifically:

1. 1. Importation into the customs territory of Ukraine, in accordance with the law, of goods manufactured using an invention (or utility model) for research purposes (including physicochemical, preclinical, clinical, and other studies);
   2. Use of an invention (or utility model) in research (physicochemical, preclinical, clinical, and other), including the manufacture, storage, and movement of products or medicinal products containing such products that are produced as part of the said research;
   3. Other actions that, according to the law, constitute the use of an invention (or utility model) if they are necessary for manufacturing the product or medicinal product containing the product for the above-mentioned purpose;

• Manufacture during the patent term of a product or medicinal product containing the product using a patented invention for export to third countries, as well as other actions that constitute the use of the invention, provided they are necessary for manufacturing such products for export;
• Submission and examination of an application for state registration of a medicinal product, submission of materials for the expert review of registration documents, their evaluation, issuance of a registration decision, inclusion of information into the State Register of Medicinal Products, issuance or receipt of registration documents, and other registration-related actions in accordance with the law — all during the term of the patent and/or the supplementary protection period.

PTE and SPC

Since the introduction of supplementary protection certificates (SPCs) in 2020 into Ukrainian patent legislation for pharmaceutical, animal, and plant protection products — and in the absence of transitional provisions in the amended patent law to clarify and ease the shift from the PTE (patent term extension) concept to the SPC concept — certain inconsistencies between SPC and PTE remain.

Let us recall that before 16 August 2020, Ukraine had a procedure for extending a patent (PTE), which was available under the following conditions: the subject matter of the invention was a medicinal product, a veterinary product, or a plant protection product; the use of the invention required authorization from a competent authority; and legal protection extended to all objects defined in the claims of the invention. The duration of the patent extension was equal to the period between the patent application filing date and the date the relevant marketing authorization was obtained. The maximum possible extension term was up to five years.

Following the implementation of the EU-Ukraine Association Agreement and corresponding amendments to Ukrainian patent law, which took effect on 16 August 2020, the document, procedures, and set of conditions changed. Under the new rules, the subject matter must be the active pharmaceutical ingredient (API) of a medicinal product, the process for obtaining it, or its use; veterinary or plant protection products are also included. A competent authority must authorize the product’s market placement. Legal protection is now limited to the product (i.e., the API) and its use. The supplementary protection term equals the period between the invention’s filing date and the marketing authorization date, reduced by five years. The maximum extension term is still up to five years, and such protection is confirmed by a supplementary protection certificate (SPC).

At present patent law does not allow SPCs to be equated with so-called “extended” patents – i.e., those that were extended under the rules of the previous version of the patent law. These patents remain in force as extended patents until the expiration of the previously granted extension period.

However, the afore-mentioned Draft Bill regarding the Bolar exemption includes a provision stating: “For a patent for an invention whose subject matter is a medicinal product, an active pharmaceutical ingredient of a medicinal product, the process of manufacturing or use of a medicinal product, a veterinary or plant protection product, and whose term was extended… before the entry into force of this Law — the provisions on supplementary protection provided in Articles 27-1 and 31 of this Law shall apply.” This appears to be intended to equate PTEs with SPCs.

Yet, the proposed changes overlook an important nuance. All patent holders whose right to extend the patent arose before August 16, 2020, were automatically deprived of the right to SPCs on formal grounds due to the objective impossibility of meeting the new six-month deadline – since, under the previous law, they had 19 years and 6 months to exercise the extension.

There were discussions in the past about introducing transitional provisions into the new (or amended) patent law to regulate this situation — particularly regarding the right to an SPC for those patent holders who could not apply before 2020. However, as we can see, the current Draft Bill does not contain such a provision. Nor have we found other legislative initiatives that would regulate this issue or are likely to be adopted or considered. As a result, such rights holders will have to continue asserting their right to SPCs through court proceedings.

We hope that developments in each of the mentioned areas will take place in the near future and that changes to Ukrainian patent legislation will be well thought out and effective across all relevant contexts. We’re watching closely and monitoring actively – and likely applying soon. So, stay tuned!