Representatives of the Ukrainian National Intellectual Property and Innovation Office (IP Office) visited “Darnitsa’s” production

April 6, 2023. The pharmaceutical company “Darnitsa” hosted a delegation of the Ukrainian National Office of Intellectual Property and Innovation (IP Office). During the meeting, the head of the IP Office, Olena Orliuk, and the head of the group of advisers, Bohdan Paduchak, visited the company’s production facilities and got acquainted with the advanced technologies for the production of “Darnitsa” medicines.

During the meeting, the participants also discussed urgent issues in the field of intellectual property that restrain the development of the pharmaceutical industry.

Among the issues that were discussed was the need to improve the Law of Ukraine “On the protection of the interests of individuals in the field of iIntellectual property during the martial law, introduced due to the armed aggression of the russian federation against Ukraine” and clarify the provisions that extend the validity of patents that may not be extended in accordance with the legislation of Ukraine.

Acknowledging the public importance of this law, which allowed thousands of applicants and rights holders to preserve their intellectual property rights in the face of armed aggression, the IP Office developed proposals  to improve it. Today, when judicial and law-enforcement bodies have resumed their full-fledged work and the possibility of effective protection of rights is ensured, the need to change the relevant norms of the law is becoming imperative. In addition, there is the issue of intellectual property rights that belong to the aggressor country and can be used as a source of funding for the russian federation, which requires special attention. The IP Office worked out the relevant projects and handed them over to the deputies, so the market is waiting for the registration of the relevant draft law and its adoption as soon as possible.

A separate issue for discussion was the need to improve the legal regulation of the “Bolar provision”. Currently, it is possible to submit an application for state registration of a generic drug only after the patent protection period of the original drug has expired. However, the procedure for registering a medicinal product can take up to two years, thus the generic drug is brought to the market with a significant delay. These are artificial barriers, and therefore it is crucial  to create a legal mechanism permitting the drug to undergo registration procedures during the patent period, with respect for intellectual property rights, and enter the market on the first day the corresponding patent’s protection period expires.

Decreasing the time between the moment of registration of a medicinal product and the moment of its introduction into free circulation provides an opportunity to increase the physical (expansion of the nomenclature of medicinal products) and economic (generic medicinal products are much cheaper than original medicinal products) accessibility of medicinal products for the population of Ukraine.

Olena Orliuk confirmed that this issue is also in the focus of attention of the IP Office, and it has already been brought up for discussion in the relevant working group, whose work will result in coordinated legislative changes for further adoption by legislators.