Ukraine introduces new rules for renewal of patents for medicines: what will change
8 May 18:29
The Ministry of Economy of Ukraine has approved new rules that allow pharmaceutical companies to extend the validity of their patent rights to inventions, such as new medicines. This was reported by "Komersant Ukrainian" with reference to the relevant ministry.
The Ministry of Economy has approved the Procedure for Consideration of Applications for Additional Protection of Rights to Inventions No. 1803 dated March 19, 2025, which has already been registered with the Ministry of Justice.
This is especially important in cases where a drug has just appeared on the market and the main patent is already coming to an end.
The new rules are another step towards bringing Ukrainian legislation in line with European standards, as we committed to in the Association Agreement with the EU. They replace the outdated instruction and finally establish clear, modern conditions for continuing the protection of rights to inventions, primarily medicines,” commented Deputy Minister of Economy of Ukraine Vitaliy Kindrativ.
According to him, the innovations are important for the pharmaceutical industry, which invests heavily in the development of new medicines. The possibility to extend the protection of patent rights gives development companies more time to implement innovations and at the same time creates transparent, fair rules for all market players – both for original manufacturers and generic manufacturers.
What is additional protection of an invention and why is it needed?
When a patent for an invention expires, but the product – for example, a new medicine – has just appeared on the market, the company runs the risk of not being able to recoup its investment in time. To solve this problem, there is a mechanism of additional protection, which is an opportunity to extend patent protection for several more years, up to a maximum of five.
Such protection is especially relevant in the pharmaceutical industry, where the development of a single drug can take up to 10 years or more, and the costs reach hundreds of millions of dollars. Therefore, companies that invest heavily in new medicines should have the legal ability to protect their developments from copying and entry of cheaper analogs into the market for longer.
Read also: Ukraine to simplify production of generics – analogs of original medicines
What do the new rules provide for?
The adopted document defines clear and up-to-date rules on how to obtain an additional protection certificate (APC). It replaced the old instruction, which no longer corresponded to the current legislation.
It now clearly defines
- what documents must be submitted to obtain additional protection;
- how long such an application is considered and who makes the decision;
- what to do if the company is denied – the appeal procedure;
- additional protection may be valid for up to 5 years after the expiration of the main patent.
In addition, the procedure for filing documents has been streamlined – the deadlines, application form, requirements for the applicant and criteria for making a positive decision have been established.
Why is it important?
The new procedure is in line with European legislation, in particular, Regulation (EC) No. 469/2009. Its implementation is not only a fulfillment of our obligations to the EU under the Association Agreement, but also an important signal to international investors: Ukraine has clear and reliable rules for protecting original innovative developments.
This creates a level playing field for competition, reduces legal uncertainty, and makes the Ukrainian market more attractive to global pharmaceutical companies. And most importantly, it stimulates local investment in R&D and promotes the development of domestic production of innovative drugs.
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