Once Again About Patents…

With over two decades of dedicated intellectual property practice under her belt, Victoria Sopilnyak has been a respected figure since 2001. Her expertise covers the intricate areas of trademarks, patents, industrial designs, utility models, copyright, and various other facets of intellectual property rights.

Victoria has built a strong reputation for protecting the IP rights of innovative pharmaceutical companies, demonstrating her ability to manage complex litigation and projects. She is actively involved in shaping Ukrainian IP legislation, demonstrating her commitment to developing the legal landscape.

Victoria is a member of the International Trademark Association, a member of the International Association for the Protection of Intellectual Property, member of the Ukrainian Bar Association, and others.

Her exceptional professional acumen has earned her high praise from prestigious legal directories such as Chambers Europe, The Legal 500 EMEA, WTR 1000, IAM Patent 1000, IP Stars and WIPR Leaders, cementing her position as a trusted authority in the field of intellectual property.

Last year was marked by repeated attempts to reform the patent legislation of Ukraine and to bring it even closer to European patent legislation. A large number of meetings of various working groups, a lot of round tables, workshops, dialogues, etc., as well as a significant number of issues in the spotlight. In this article, I will focus on the three most discussed situations: Ukrainian Bolar exemption, PTE and SPC, as well as the peculiarities of the validity of patent rights during martial law.

Ukrainian Bolar exemption

In one of the previous reviews for ULF, we mentioned that one of the most discussed amendments to the patent legislation of Ukraine at that time had become a Ukrainian version of the “Bolar exemption”. Now we already have judicial practice of applying the mentioned provisions. In fact, the Ukrainian Bolar exemption is reduced to permitting the following actions, which are not recognized as an infringement of patent rights: importation into the customs territory of Ukraine, in accordance with the procedure established by law, of goods manufactured with the use of the invention (utility model) for studies and/or (2) use of the invention (utility model) in studies conducted for the purpose of preparing and submitting information for the authorization of a medicinal product. It is worth noting that this version of the “Bolar” is consistent with the provisions of Directive 2004/27/EC, since the corresponding provision of the Ukrainian law was worded taking into account exactly the provisions of the Directive.

Currently, we have a legal opinion of the Supreme Court of Ukraine, according to which the authorization of a generic medicinal product (obtaining the marketing authorization), as well as the filing of an application for such an authorization, before the expiry of patent rights, shall be qualified as an infringement of the intellectual property rights to an invention. Therefore, all the authorizations of generic medicinal products made during the period of validity of a patent are an infringement of the rights of the patent holder, because patent law does not explicitly permit the mentioned authorization.

In the current round of discussions of the Ukrainian Bolar, the need for legislative establishment of a permit for making the state authorization of a generic medicinal product before the expiry of patent rights is widely discussed, since there is a viewpoint that the current situation does not contribute to the fast entry of a generic medicinal product into the market immediately after the expiry of the patent term, because the authorization process takes some time. At the same time, there are several proposed options for establishing the terms, during which the state authorization of a generic medicinal product can be carried out: the entire patent term or a certain period of time before expiration of the patent term. A new law on medicinal products has also been adopted in Ukraine, which will come into force after the end of the state of martial law. Obviously, the newly-proposed Ukrainian Bolar should be consistent with this law, because otherwise we will get different approaches to the application of the “Bolar exemption” due to the inconsistency of rules of the special patent law and the special regulatory law, which will again force the patent holder and applicant of a generic medicinal product to seek answers to their questions through judicial enforcement.

PTE and SPC

The introduction of supplementary protection certificates (SPC) for pharmaceutical, animal and plant protection products was completely new to Ukrainian legislation in 2020. By introducing the mentioned regulation, Ukraine implemented the relevant provisions of the European Directive and tried to fulfill its obligations under the Association Agreement with the EU, because the general rules regarding SPC were introduced for the first time for Ukraine exactly by the agreement. We have already mentioned that currently the SPCs can in no way be equated with so-called “extended” patents, the term of which was extended under the rules of the previously effective version of the patent law. They shall remain in force until the expiry of the relevant extension term. At the same time, we should note that the actual purpose of PTE (patent term extension) and SPC is the same – compensation to the rights holder of a pharmaceutical patent of a part of the effective patent term, during which the invention under the patent could not be actually used, because its use required the state authorization of the medicinal product, which takes some time.

A reminder that prior to 16 August, 2020, the patent term extension procedure (PTE) was in effect in Ukraine and was possible under the following set of conditions: the subject-matter of the invention was a medicinal product, an animal protection product, a plant protection product, etc.; the use of the subject-matter of the invention required a permit of the competent authority; the legal protection covered all the subject-matters defined by the claims. The patent term extension period was equal to the period between the date of filing the application for the invention and the date of obtaining the appropriate authorization for the medicinal product. The maximum possible term extension period is up to 5 years.

After adopting the Association Agreement and introducing relevant amendments to Ukrainian patent law, which came into force on 16.08.2020, the document, regulation, procedures and set of conditions became different, specifically: the subject matter of the invention should be an active pharmaceutical ingredient of a medicinal product, a process of producing a medicinal product or using a medicinal product, an animal protection product, a plant protection product; commercialization of the medicinal product should be authorized by the competent authority; legal protection is limited to the product (the active pharmaceutical ingredient of the medicinal product) and the use thereof. The term of supplementary protection is equal to the period between the date of filing the application for the invention and the date of obtaining the appropriate authorization for the medicinal product reduced by 5 years. The maximum possible term of extension is up to 5 years. The supplementary protection is confirmed by the appropriate supplementary protection certificate (SPC).

The cherry on the cake has become the lack of transitional provisions in the amended patent law, which would obviously make the transition from the PTE concept to the SPC concept clearer and simpler. But in our realities, the life of patent holders who had the right to the PTE has been divided into before and after. Because, in fact, according to only one rule of Article 27-1 of the patent law that a request for supplementary protection may be filed within 6 months from the date of publication of information on the state registration of the invention or from the date of granting the first authorization by the appropriate competent authority (depending on which of these dates is later), all the patent holders who obtained the right to patent extension prior to 16.08.2020 by default were deprived of the right to supplementary protection of their inventions based on formal grounds due to the objective impossibility of meeting the new six month deadline term, because previously they had, according to the old patent law, 19 years and 6 months. Today, such rights holders are forced to go to court and defend their right to SPC in a judicial proceeding.

The above-mentioned situation highlights only one problem related to the PTE/SPC, although in reality there are a lot more of them, and again due to the imperfections of the legal regulation of the mentioned institution by Ukrainian patent legislation, more and more problems of patent holders regarding the SPC are solved with the help of courts.

Currently, in the process of discussing the amendments to the patent law that have matured over the past few years, the possibility of including transitional provisions therein, that would regulate the situation is being discussed, particularly the right to the SPC for those patent holders who had obtained it prior to 16.08.2020, which will hopefully have a positive effect on the mentioned situation.

Validity of patent rights during martial law

A certain challenge for the field of intellectual property in the context of the validity of patent rights has been posed by the adoption of the Law of Ukraine On Protection of Interests of Persons in the Field of Intellectual Property During the State of Martial Law Imposed in Connection with the Armed Aggression of the Russian Federation Against Ukraine of 01.04.2022 No. 2174-IX, which is briefly referred to as the Law on Terms by the professional community. The mentioned law contains a regulation, which reads as follows: “the proprietary intellectual property rights, the term of validity of which expires as of the date of imposing the state of martial law in Ukraine or during the period of the state of martial law, shall remain valid until the day following the day of expiration or cancellation of the state of martial law”. As we can see, the regulation is worded in such a way that it does not seem possible to restrict its application to certain intellectual property rights, since the mentioned law declares keeping in full force and effect, without exception, all the proprietary intellectual property rights, the term of validity of which should have expired as of the date of imposition of the state of martial law in Ukraine or during the period of the state of martial law. The issue of application of the mentioned regulation, particularly to pharmaceutical patents, has become very controversial. Proponents of a theory of the so-called limited interpretation of the mentioned regulation, namely the impossibility of extending the duration of patents during the state of martial law, point to its supposed incompliance with the special patent legislation of Ukraine and international regulatory legal acts in this field. On the other hand, adherents of the interpretation of the regulation of the Law on Terms exactly as it is set out, refer to the groundlessness of the limited interpretation of the mentioned provision of the Law on Terms and the “speciality” of this particular law during the state of martial law. It is clear that, in the course of the discussion, certain questions arise as to the issue of which law is special and should be applicable to legal relations in a dispute, etc. Some clarity to the situation is brought by Draft Law No. 9383 dated 13.06.2023 submitted to the Verkhovna Rada of Ukraine, the transitional provisions of which state the following: “2. To establish that the proprietary intellectual property rights, the term of validity of which expired as of the date of imposition of the state of martial law in Ukraine or during the period of the state of martial law, and which may not be maintained in accordance with the Law of Ukraine On Protection of Rights to Inventions and Utility Models, but the validity of which was extended in accordance with the Law of Ukraine On Protection of Interests of Persons in the Field of Intellectual Property During the State of Martial Law Imposed in Connection with the Armed Aggression of the Russian Federation Against Ukraine, shall lose their validity from the date of this Law coming into legal force. However, until the moment of adoption of Draft Law No. 9383 dated 13.06.2023, if it were to be adopted in this wording, and/or other change of the current legislative provision, the discussions will not stop there and would probably to the courtroom. Currently, the question, which actually indirectly relates to the terms of validity of the patent rights and to which there is already an answer from the point of view of judicial enforcement, is the following: if an infringement of patent rights occurred during the term of validity of the patent, then the subsequent legitimization of such an infringement related, in particular, to the imposition of the state of martial law in Ukraine, the adoption of the Law on Terms, etc., is inadmissible, taking into consideration the fact that the mentioned infringement should be stopped.

As we can see, the patent sphere keeps giving reasons for lively discussion, raises a number of questions, which cannot and actually might not be answered unambiguously. There are many challenges, a lot of work and interesting patent cases ahead. So, stay tuned.