In Ukraine, as in many other countries, the issue of intellectual property (IP) in the pharmaceutical industry is a subject of ongoing discussion and requires special attention. The ongoing war in the country has further exacerbated existing problems and created new challenges for the IP rights protection system.

One of the key issues is the infringement of patent rights and data exclusivity (exclusive rights to medical research data). It is not uncommon for generic drugs to be registered before the expiration of patents on the original drugs, which undermines the innovative potential of pharmaceutical companies and reduces their incentive to develop new drugs. The lack of an effective “patent lineage” mechanism (verification of drugs for plagiarism) contributes to this situation.

The proliferation of counterfeit products is also a serious problem. In Ukraine’s pharmaceutical market, particularly in the online sales segment, there has been a significant increase in the volume of illegal and counterfeit products. This not only harms IP rights holders but also poses a serious threat to public health, as the quality and safety of such medicines often fail to meet established standards.

The ongoing war in Ukraine has led to an increase in the use of compulsory licensing mechanisms to ensure the public’s access to essential medicines. Compulsory licensing is a mechanism that allows a country’s government to authorize the production and sale of a patented product (such as a medicine) without the patent holder’s consent. While such actions may be justified by humanitarian considerations, they potentially carry the risk of violating Ukraine’s international obligations, particularly under the TRIPS Agreement.

In addition, Russia’s armed aggression against Ukraine has led to numerous delays and problems with renewing the terms of patents and registration certificates due to the destruction of infrastructure, a lack of resources at patent offices, and issues with international communication.

The activities of the Ministry of Health of Ukraine play an important role in addressing IP issues in the pharmaceutical sector. However, some of the Ministry’s initiatives and actions may have an ambiguous impact on the protection of IP rights. In particular, the simplification of the registration procedure for generic drugs and the application of compulsory licensing mechanisms, although aimed at ensuring the availability of medicines, may infringe upon the rights of patent holders of original medicines.

Law of Ukraine No. 2145-IX of March 24, 2022, adopted in response to the Russian Federation’s armed aggression, also helped resolve a number of issues in the field of intellectual property. The law introduces significant changes to the field of intellectual property and is of great importance for the protection of intellectual property rights under martial law.

Law No. 2145-IX establishes a presumption of force majeure for the entire duration of martial law, which exempts rights holders from liability for failure to fulfill certain obligations related to the protection of intellectual property rights. In particular, the deadlines for filing applications for industrial property rights, paying fees, and responding to requests from the Patent Office have been extended. Importantly, this law provides for the possibility of reinstating intellectual property rights lost due to the inability to complete the relevant procedures as a result of military operations. This provision is of particular importance to pharmaceutical companies, which may face difficulties in meeting deadlines related to patents, drug registration, and data exclusivity.

Overall, Law No. 2145-IX demonstrates Ukraine’s commitment to striking a balance between protecting intellectual property rights and the need to account for the circumstances of martial law. However, it is important to remember that the successful application of this law’s provisions requires a clear procedure for confirming force majeure circumstances and effective cooperation between rights holders and government agencies.

Thus, the situation regarding the protection and enforcement of intellectual property rights in Ukraine’s pharmaceutical sector is characterized by a number of serious challenges, which are further complicated by the armed conflict. The top priorities for addressing these challenges are:

• improving “patent litigation” mechanisms to prevent patent infringements;
• stepping up the fight against the production and distribution of counterfeit medicines;
• striking a balance in the area of compulsory licensing to take into account the interests of both the state and patent holders;
• harmonizing public policy on ensuring access to medicines with the need to protect intellectual property rights and stimulate innovation.

Addressing these issues requires a comprehensive approach and cooperation among all stakeholders, including government agencies, pharmaceutical companies, rights holders, consumers, international organizations, and legal professionals. Only in this way is it possible to create an effective and balanced system for protecting intellectual property rights in the pharmaceutical industry, one that would promote innovation and ensure public access to high-quality and safe medicines.