SPC in Ukraine: How Case Law Shapes the Rules of the Game

The supplementary protection certificates regime has been in operation in Ukraine for nearly 6 years; however, certain nuances still persist regarding its legal certainty.

It is worth recalling that back in 2020, the concept of supplementary protection certificates (SPCs) for pharmaceutical, animal, and plant protection products was implemented into Ukrainian patent legislation.

Prior to August 16, 2020, Ukraine had a patent term extension (PTE) procedure, which was available subject to the following conditions: the subject matter of the invention was a medicinal product, a veterinary product, a plant protection product, etc.; 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 term of the patent extension corresponded to the period between the filing date of the patent application and the date of obtaining the relevant authorization for the medicinal product. The maximum possible extension term was up to 5 years.

Following the conclusion of the Association Agreement with the European Union and the introduction of relevant amendments to the Ukrainian patent law (hereinafter – the Ukrainian Patent Law), which came into force on August 16, 2020, the documentation, procedures, and set of conditions changed, namely: the subject matter of the invention must be an active pharmaceutical ingredient of a medicinal product, a process for obtaining a medicinal product, or the use of a medicinal product, as well as veterinary or plant protection products; placing a medicinal product on the market must be authorized by a competent authority; and the scope of protection is limited to the product (the active pharmaceutical ingredient of the medicinal product) and its use. The term of additional protection is equal to the period between the filing date of the patent application and the date of obtaining the relevant authorization for the medicinal product, reduced by five years. The maximum possible extension term is up to 5 years. Additional protection is confirmed by the relevant supplementary protection certificate (SPC).

The introduction of SPCs in 2020 replaced the PTE mechanism, but unclear transitional provisions caused issues: patents extended under PTE coexist with SPCs; some right holders were unable to use SPCs due to procedural obstacles; and the law initially offered no direct guidance on the interaction of these regimes during the transition.

For this reason, the key guidelines for the market today are shaped not so much by legislation as by the approaches gradually developed by the Commercial Cassation Court within the Supreme Court (CCCS), which fills the gaps in legislative regulation.

The first case that highlighted the impossibility for a right holder to obtain an SPC due to the replacement of one regulatory framework with another without any transitional provisions was case No. 910/8295/21. In this case, the Supreme Court stated that the right to extend the term of a patent for an invention has the same purpose both under the version of the law prior to August 16, 2020 and after that date, namely to compensate the patent holder for part of the effective patent term during which the invention could not be actually used, since its use requires obtaining state registration of the medicinal product.

An additional term of patent protection — beyond the expected 20 years — is intended to protect the interests of owners of inventions in the pharmaceutical and agro-chemical sectors. This refers to supplementary protection certificates, which compensate the right holder for the time that elapses between the filing of the patent application and obtaining authorization for the marketing of the product protected by the patent.

According to the Supreme Court’s position, the absence in the 2020 amendments to Ukrainian patent legislation of any reference to the rights of patent holders that arose prior to the entry into force of Article 27-1 of the Law should not deprive such holders of the possibility to exercise their right to additional protection guaranteed by international treaties that Ukraine is a party to.

By this approach, the Supreme Court effectively eliminated the legal uncertainty faced by patent holders whose rights to PTE had not been exercised prior to the change in regulation, thereby “granting” them the opportunity to obtain SPCs.

Another issue that arose in the practical application of the SPC provisions concerns the application (or non-application) to all applicants for SPCs of the following provision of Article 27-1 of the Ukrainian Patent Law: the owner of a patent for an invention, the subject matter of which is a medicinal product, has the right to extend the term of validity of intellectual property rights provided that the application for authorization to place the medicinal product on the market in Ukraine was filed within one year from the date of filing of the first such application in any country.

It should be recalled that prior to 2020, Ukrainian legislation did not contain such a requirement for obtaining additional protection. However, as a result of its application by the Ukrainian Patent Office, patent holders began receiving refusals to grant additional protection for their inventions due to non-compliance with the so-called “one-year condition”.

Once again, such right holders had to defend their right to additional protection in court, arguing that this condition cannot be applied to rights that arose earlier.

In this context, case No. 910/12688/24 is illustrative. Following its consideration, the Supreme Court concluded that the retroactive application of Article 27-1 violates Article 58 of the Constitution of Ukraine (non-retroactivity of laws) and Article 5 of the Civil Code of Ukraine (temporal effect of civil legislation).

Thus, the case law of the Commercial Cassation Court of the Supreme Court is not limited to a “mechanical” application of the provision on additional protection, as not only formal compliance is assessed, but also the substance of the claimed right.

Another highly-debated issue remains determination of the scope of protection. Formally, SPCs are linked to the active ingredient or the product authorized for placing on the market. However, in practice, questions arise regarding combination products, formulation variations, and different methods of use. The approach of the Commercial Cassation Court of the Supreme Court in this respect may be described as cautious: the court does not support automatic expansion of protection, but at the same time does not limit itself to a purely literal reading of the claims.

The relationship between PTE and SPC regimes became a transitional challenge as the law- enforcement practice struggled without legislative guidance. At present, paragraph 4 of the Transitional Provisions to the Ukrainian Patent Law, effective from June 5, 2025, states that for patents extended under PTE prior to reform of this law, the provisions for SPCs apply. This resolves the earlier uncertainty about how old and new regimes interact.

Thus, “old” patents with extended terms (PTE) are, in the context of the application of additional protection provisions, equated to SPCs as a new instrument. This is important to take into account, since, subject to compliance with the relevant requirements, the following acts are not considered infringement of patent rights during the term of additional protection:

1)    manufacturing a product or a medicinal product containing the product using the patented invention for the purpose of export to third countries, as well as other acts which are considered to be use of the invention under this Law, provided that they are necessary for the manufacture of the product or medicinal product containing the product for export to third countries;

2)    manufacturing a product or a medicinal product containing the product using the patented invention not earlier than six months before the expiry of the term of additional protection for the purpose of storing it for placing on the market after the expiry of such term, as well as other acts which are considered to be use of the invention under this Law, provided that they are necessary for the manufacture of the product or medicinal product containing the product and its storage within the specified period.

It should be noted that, as a result of the imperfect transition from one system to another, judicial practice effectively performs several functions simultaneously: interpretative, balancing, and, to some extent, rule-making. At the same time, a characteristic feature of the approach of the Commercial Cassation Court of the Supreme Court is its caution, manifested in the absence of overly broad generalizations, a focus on specific factual circumstances, and the gradual, case-by-case development of rules.

By way of summary, while formal harmonization efforts are ongoing, the Ukrainian SPC model remains reliant on judicial interpretation. Continued legal developments and case law will be crucial for achieving greater clarity and alignment with EU practice.

In conclusion, the current stage of SPC development in Ukraine is clearly transitional: the law has established only a basic framework, while its substance is being shaped through case law. In these circumstances, the Supreme Court’s practice is the key factor in determining the actual content of SPC protection and setting the boundaries of what is permissible, effectively shaping the rules of the game for the market.

In the absence of clear legislative guidance and where judicial protection is used to establish the existence of a right, SPC disputes will inevitably go beyond classical ones. Current practice in pharmaceutical cases only outlines the contours of future conflicts. The most interesting developments still lie ahead.