On May 2, 2025, the Ministry of Justice of Ukraine registered Order of the Ministry of Economy of Ukraine “On Approval of the Procedure for Consideration of the Application for Supplementary Protection for Rights to Inventions” No. 1803 dated March 19, 2025 under No. 661/44067. This order shall enter into force on the date of its publication in the Official Bulletin of Ukraine.

The new Procedure establishes distinct rules for submitting and reviewing applications for the issuance of a supplementary protection certificate (SPC)*, a mechanism that allows for the extension of legal protection of an invention after the expiration of the basic patent.

In particular, the document regulates:

• requirements for the drafting of the application: which documents shall be submitted, what information is required and what exactly confirms the existence of a valid patent and for the commercialisation of a medicinal product;

• the procedure for submitting and the timeframe for consideration of applications by the relevant authority (UANIPIO);

• the procedure for making a decision on granting supplementary protection, as well as the possibility of appealing the decision if the applicant does not agree with the refusal;

• conditions and maximum duration of supplementary protection – up to five years after the expiration of the basic patent.

These new rules are crucial for the innovative development of Ukraine, – stated Vitalii Kindrativ, Deputy Minister of Economy of Ukraine:

“This is yet another step towards ensuring that Ukrainian legislation aligns with European standards, as we have committed to in the EU Association Agreement. They replace the outdated instruction and finally establish clear, modern conditions for extending the protection of invention rights – primarily for medicinal products.

This is important for the pharmaceutical industry, which invests significant funds in the development of new medicines. The possibility to extend the patent protection rights provides development companies with more time to implement innovations and at the same time establishes transparent, fair rules for all market players – both for original manufacturers and generic manufacturers”.

The provisions of the Procedure are harmonised with the European Union law, namely – with Regulation (EU) No 469/2009 of the European Parliament and of the Council, which regulates similar mechanisms for EU countries. It also meets Ukraine’s obligations under Article 220 of the EU-Ukraine Association Agreement.

“The new procedure specifies the rules for submitting, reviewing and making decisions on supplementary protection certificates – an instrument that is essential primarily for the pharmaceutical industry”, – says Olena Orliuk, Director of the UANIPIO.

According to her, the fact that the procedure is harmonised with the EU legislation is yet another step towards fulfilling Ukraine’s international obligations and integrating our patent system into the European legal framework.

“This decision will not only improve the investment climate in the field of innovations but also strengthen confidence in Ukraine as a country with predictable, modern approaches to the protection of intellectual property rights”, Olena Orliuk is convinced.

For reference:

*The Supplementary Protection Certificate is a special legal instrument that extends the term of patent protection for a particular product, most often a medicinal product or plant protection product. It allows for compensation for the time spent on state registration and obtaining a permit to place the product on the market.

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