Theory and practice of intellectual property
№ 2 / 2026

ISSN (Print) 2308-0361
ISSN (Online) 2519-2744

PDF (Ukrainian)

DOI: https://doi.org/10.33731/tpip.2026.2.8

Submitted     2026-04-14
Accepted      2026-05-06
Published      2026-05-28

Practical aspects of the application of the Bolar exception in Ukraine

Vladyslav Zhuravlov
PhD student,
State organization “V. Mamutov Institute of Economic and Legal Research
of the National Academy of Sciences of Ukraine”
Kyiv, Ukraine
https://orcid.org/0009-0003-3137-3053

Abstract
The article analyses the practical aspects of applying the Bolar exception as one of the key instruments for limiting patent monopoly in the pharmaceutical sector, particularly in Ukraine. The study provides an overview of the historical background to the development of the exceptional rule, and examines its legal nature and functional purpose within the intellectual property law system. Priority was given to characterising the role of this institution in ensuring a balance between private and public interests in the context of timely access to effective and safe medicines. Particular attention was paid to international legal approaches to regulating this provision, as well as to recent developments in national legislation regarding its implementation. Several enforcement issues have been identified, in particular regarding the notification of the patent holder, as well as the lack of distinction between the use of an invention for the registration of generic medicines and new pharmaceutical products. Consequently, the need for further improvement of national legislation is justified in order to ensure a fair compromise between public needs and technological development.

Keywords: medicinal product, generic medicinal products, invention, Bolar exception, patent monopoly, intellectual property

References

Munoz Tellez, V. (2022). Bolar Exception. In: Correa, C.M., Hilty, R.M. (eds) Access to Medicines and Vaccines (135-149). Springer.
https://doi.org/10.1007/978-3-030-83114-1_5

Patil, S. S. (2020). Bolar Provision: An Experimental Use Exception to Patent Monopoly. Mukt Shabd Journal, 12(6).
http://117.244.107.132:8080/xmlui/bitstream/handle/123456789/724/Bolar%20provision%20an%20experimental%20use%20exception%20to%20patent%20monopoly.pdf?sequence=1&isAllowed=y

Mullard, A. (2014). New drugs cost US$2.6 billion to develop. Nature Reviews Drug Discovery, 13, 877.
https://doi.org/10.1038/nrd4507

Dermawan, D., & Alotaiq, N. (2025). From Lab to Clinic: How Artificial Intelligence (AI) Is Reshaping Drug Discovery Timelines and Industry Outcomes. Pharmaceuticals (Basel). 18(7), 981-1009.
https://doi.org/10.3390/ph18070981

Sun, Y., Chen, L., Jing, Z., Li, Y. Y., Kim, D., Gao, J. Y., Noroozi, R., Yi, G. Y., Tetsassi Feugmo, C. G., Klinkova, A., Sask, K., Kristiadi, A., Wang, B., Gillies, E. R., Lu, K. P., Shi, H. T. H., & Hu, P. (2025). Generative AI for the Design of Molecules: Advances and Challenges. Journal of Chemical Information and Modeling, 65(23), 12668–12690.
https://doi.org/10.1021/acs.jcim.5c02234