Trademark v medicine registration certificate: case law review


Ilarion Tomarov

Counsel, Attorney-at-Law

Data Protection and Privacy,
Intellectual Property,

Medicines can be sold in Ukraine only after state registration (similar to marketing authorization in EU). The authority does not oblige by the procedure for registration of a medicinal product to verify applicant`s compliance with the trademark rights of third parties. It makes sense, as otherwise state authority would need to hire experts who can define likelihood of confusion between trademarks and the name of the medicine. However, cases based on a claim of trademark owner to revoke the registration certificate as the registered name of the medicine infringes the trademark are very common in Ukrainian litigation. 

A court must resolve the dilemma: on the one hand, the Ministry of Health of Ukraine followed the registration procedure where applicant guaranteed that non-infringement of any trademark rights, and on the other hand, Ukrainian laws have no provision with such ground to revoke the registration certificate.

Provision of art. 20 of the Law of Ukraine "On Protection of Rights to Marks for Goods and Services" allows rightholder to protect trademark against preparation before the infringement committed by the registration certificate holder. Obtainment of a registration certificate can be classified as a trademark infringement, because the purpose is to put medicinal product on the market. We have not found examples of such law interpretation, however there are disputes between trademark owner and registration certificate holder in Ukrainian case law.

The first time this issue was brought in Ukraine is in "Corvalment v. Cormentol" case: the court ruled that the Ministry`s of Health of Ukraine formal compliance with the existing procedure for registration of medicines under no circumstances should prevail over the intellectual property rights and call into question the exclusive nature of the trademark (the resolution of the Higher Economic Court of Ukraine as of 08.04.2014 in the case № 910/5552/13).

In the "RENALGAN-BIOLIC" case the Supreme Court followed the same approach: formal compliance with the existing procedure for registration of medicinal products most certainly should not dominate over the trademark owner's right to prohibit the use of the mark and doubt the exclusive nature of the trademark rights (the resolution of the Commercial Cassation Court as of 19.06.2018 in the case № 910/1780/16).

In the "Citramon-Zdoroviia" case the Supreme Court revoked the respondent`s registration certificate and referred to art. 41 of TRIPS stating that enforcement procedures are available under their [members] law so as to permit effective action against any act of infringement of intellectual property rights (the resolution of the Commercial Cassation Court as of 26.02.2019 in the case № 910/7661/17). The court took into account the legal position set out in the "RENALGAN-BIOLIC" case.

Subsequently, this approach was used in another case to revoke the registration certificate based on the claim of Bayer Pharma AG concerning patent infringement (the resolution of Higher Economic Court of Ukraine as of 13.12.2016 in case № 910/10512/14). In the ongoing «Nimesin» case the court applied the same assessment of the formal compliance by the Ministry of Health of Ukraine with the procedure for registration of medicines, (the decision of the Economic Court of Kyiv as of 06.03.2020 in the case № 910/19256/16). 

Established approach definitely should be further developed in case law. For instant, if a medicines manufacturer would allowed a distributor to obtain a registration certificate it could exposed him to risk of unfaithful behavior of the registration certificate owner. It is the manufacturer who owns the patent for the invention, the trademark with the name of the medicines and ultimately the exclusive copyright to the registration documentation. 

Permission to use the registration documentation is a condition for another person to obtain the registration certificate and manufacturer has unconditional right to revoke this permission if otherwise is not agreed. However there is no procedure to transfer registration certificate after cancelling of the consent. Therefore, the right of manufacturer revoking consent should prevail over the formal requirements in the procedure of medicinal product registration.

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The article is available in Ukrainian

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