Ukraine Aligns with EU Standards: New Rules Extend Patent Protection for Pharmaceutical Inventions

On March 19, 2025, the Ministry of Economy of Ukraine approved a regulatory update that would strengthen patent protection for pharmaceutical innovations. The new procedure - Order No. 1803 on the Review of Applications for Supplementary Protection Certificates (SPC) - is intended to assist pharmaceutical companies in extending the duration of their patent rights for inventions approaching the end of their basic patent term.

Extended Protection for Pharmaceutical Innovations

The updated framework provides a legal pathway for extending patent protection by up to five additional years beyond the expiration of the basic patent. This mechanism is particularly vital in the pharmaceutical sector, where lengthy research and development (R&D) cycles as well as substantial investments are standard. The supplementary protection gives companies more time to recoup their costs, sustain innovation, and maintain a competitive edge in the market.

Key Features of the New Procedure

Replacing an outdated set of guidelines, the new procedure introduces a modernized system for obtaining supplementary protection, including:

• Defined documentation requirements for obtaining supplementary protection.
• Clear timelines for filing and reviewing applications. The application must be submitted within six months from the date of the data publication on the state registration of the invention or from the date of the first authorization by the competent authority, whichever comes later. The application is reviewed within two months from the date of its submission.
• Established procedures for appeal in case of application rejection. The decision may be appealed by the holder of the basic patent in court in accordance with the procedure established by the Ukrainian law.
• Formalized term limits, ensuring that the SPC can extend patent protection by up to five years. The duration of supplementary protection equals the period between the patent application filing date and the first authorization from the competent authority, reduced by five years. It cannot last more than five years.

Harmonization with EU Norms

The reform aligns the Ukrainian patent law with EU Regulation No. 469/2009, bringing domestic practices in line with the European standards and signals to global investors that Ukraine supports a predictable investment-friendly intellectual property regime.

Implications for the Pharmaceutical Industry

This legislative shift is especially beneficial to originator pharmaceutical companies investing in new drug development. It also creates a balanced legal environment for generic manufacturers, promoting fairness and competition.