On May 2, 2025, the Ministry of Justice of Ukraine registered the order of the Ministry of Economy of Ukraine “On approval of the Procedure for considering applications for additional protection of invention rights”.
“The new rules are another step towards ensuring that Ukrainian legislation meets European standards, as we committed to in the Association Agreement with the EU. They replace outdated instructions and finally establish clear, modern conditions for the extension of protection of invention rights, primarily for medicines. This is important for the pharmaceutical industry, which invests significant funds in the creation of new medicines. The ability to extend the protection of patent rights gives developing companies more time to implement innovations and at the same time forms transparent, fair rules for all market players — both for original manufacturers and for manufacturers of generics,” said Deputy Minister of Economy of Ukraine, Vitaly Kindrativ.
The New Procedure establishes clear rules for submitting and considering applications for a supplementary protection certificate (SPC) – a mechanism that allows for the continuation of legal protection of an invention after the expiry of the basic patent. The new procedure is aligned with European legislation, in particular Regulation (EC) No. 469/2009.
The document regulates:
– requirements for filing an application: what documents must be submitted, what information is required, what exactly confirms the existence of a valid patent and authorization to commercialize the medicinal product;
– the procedure for submitting and the terms for considering applications by the relevant authority (UKRNOIVI);
– the procedure for making a decision on granting supplementary protection, as well as the possibility of appealing the decision if the applicant disagrees with the refusal;
– the conditions and maximum duration of the supplementary protection – up to five years after the expiry of the basic patent.