The Ministry of Economy has allowed pharmaceutical companies to extend the validity of their patent rights.
Ministry of Economy of Ukraine solidified new rules that allow pharmaceutical companies to extend the term of patents for inventions, in particular for new medicines. This is of particular importance in situations where the drug has just entered the market and the main patent is already expiring.
In accordance with the Procedure for Consideration of Requests for Additional Protection of Invention Rights dated March 19, 2025 No. 1803, the document has already been registered with the Ministry of Justice.
“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 They replace outdated instructions and finally establish clear, modern conditions for the continued protection of rights to inventions, primarily medicinal products.
This is important for the pharmaceutical industry, which invests heavily in the development of new drugs. The ability to extend patent protection gives developers more time to innovate while creating transparent, fair rules for all market players — both original and generic manufacturers.”, — explained Deputy Minister of Economy of Ukraine Vitaly Kindrativ.
When a patent expires and new drugs are just starting to go on sale, companies face the risk of not getting a return on their investment. It is for such cases that there is a mechanism of additional protection, which allows you to extend the protection for several more years – up to a maximum of five.
This mechanism is particularly important in the pharmaceutical sector, where the development of a single drug can take many years, and therefore manufacturers need additional time to protect their innovations from copying.
The new document defines the modern rules for obtaining a certificate of additional protection instead of the outdated instructions. It is now clearly regulated what documents need to be submitted, how long the examination lasts, who makes the decision, what actions can be taken in the event of a refusal and how long additional protection lasts after the end of the main patent.
This procedure is harmonized with European legislation, in particular with Regulation (EC) No. 469/2009. Its implementation is not only the fulfillment of international obligations, but also a positive signal for foreign investors that Ukraine has established transparent rules for the protection of innovations.
