Legal Analysis of the "Bolar Exception" and Its Place in the Intellectual Property Rights Regime

Document Type : Research Article

Author

Department of law, Faculty of Humanities, Jahrom University, Jahrom, Iran

Abstract

Intellectual property law employs various mechanisms, such as exhaustion, fair use, and compulsory licensing, to balance exclusive rights with public welfare. Among these, the Bolar exemption—permitting third-party use of patented drugs for regulatory approval data generation prior to patent expiry without infringement—has received limited scholarly and legislative attention despite its strategic importance. This study investigates the normative function of the Bolar exemption within intellectual property regimes and its impact on pharmaceutical innovation. Utilizing a comparative-analytical and doctrinal legal research methodology, the paper examines the exemption’s conceptual underpinnings, jurisprudential justifications, and policy implications for pharmaceutical access. The recent adoption of this provision in Iran’s 2024 Industrial Property Protection Law is highlighted. The findings contribute to Iranian legal scholarship and offer a normative model for calibrating IP protections with public health imperatives, a balance increasingly critical in global pharmaceutical policy.

Keywords

Main Subjects


جعفرزاده، میرقاسم و غفوری، زینب (1395). جایگاه دفاع استفادة آزمایشی از اختراع در دعوای نقض حق اختراع: استثنایی مطلق یا مقید. تحقیقات حقوقی، ش 80، 157 ـ 186.
عزیزی مرادپور، حمید (1399). تأملی بر مادة 30 موافقت‌نامة تریپس و درس‌هایی از رویة قضایی سازمان جهانی تجارت. پژوهش حقوق خصوصی، د 1، ش 1، 61 ـ 75.
نیاورانی، صابر و جاوید، احسان (1395). حق دسترسی به داروهای اساسی در چارچوب موافقت‌نامة تریپس و چالش حمایت از حق بین‌المللی بشر بر سلامت. مجلة حقوقی بین‌المللی، ش 54، 29 ـ 58.
Ashok, A. (2022). Bolar Exemption as a Means for Easier Access to Medicine on Human Rights in Health Care. On Human Rights in Health Care, 37-43. Available at SSRN: https://ssrn.com/abstract=4471556
Adugna, A. B. (2021). The Place of Bolar Exception under Ethiopian Patent Law: The Need for Reform. Bahir Dar University Journal of Law, Vol. 12, No. 1, 1-26.
Bently, L. et al. (2010). Exclusions from Patentability and Exceptions and Limitations to Patentees’ Rights. WIPO: Standing Committee on the Law of Patents, Current Legal Problems, Vol. 64, No. 1, 315-347. DOI:10.1093/clp/cur011
Chawla, G. (2015). Shielding Patent Attacks: A Peek into the Defences and Exceptions to a Patent Infringement Suit. National Law School Journal, Vol. 13, Iss.1, Article 4., 77-107. Available at: https://repository.nls.ac.in/nlsj/vol13/iss1/4
Contreras, J. L. & Jacob, M. (2017). Patent pledges: global perspectives on patent law’s private ordering frontier. Edward Elgar Publishing.
Correa, M. C. (2005). The International Dimension of the Research Exception. 1-66. Available at: https://www.researchgate.net/publication/265320959_The_International_Dimension_of_the_Research_Exception%27
Correa, M. C. (2016). The Bolar Exception: Legislative Models and Drafting Options. Research Paper. Switzerland: South Centre.
Ganslandt, M. & Maskus, K. E., (2004). Parallel Import and the Pricing of Pharmaceutical Products: Evidence from the European Union. IUI Working Paper, No. 622, The Research Institute of Industrial Economics (IUI), Stockholm.
Gurgula, O. (2024). The Bolar Exemption and Patent Linkage in Ukraine. 1-24, Available at: SSRN: https://ssrn.com/abstract=4771523
Gurgula, O. & Lee, W. H., (2021). COVID-19, IP and Access: Will the Current System of Medical Innovation and Access to Medicines Meet Global Expectations?. Journal of Generic Medicine, Vol. 17, Issue. 2, 61–70.
Kostolansky, K. J. & Salgado, D. (2018). Does the experimental use exception in Patent Law have a future?. The Colorado Lawyer, Vol. 47, Issue. 1, available at: https://blog.lrrc.com/ip/2018/01/11/experimental-use-exception-patentlaw- future/.
Li, P. (2021). Bolar Exemption of the TRIPS Flexibilities: A comparative analysis between the US, Finland and China, of patenting pharmaceuticals and access to vaccines during COVID-19. Stockholm University.
Lidgard, H. H. (2008). Protecting Inventions and Promoting Innovation – A Difficult Act of Balance: A Study of the Experimental Use Exception and the Research Tool Issue. Master thesis, University of Lund, Madeleine Claesson.
Liu, K. C. (2019). Innovation, Economic Development, and Intellectual Property in India and China: Comparing Six Economic Sectors, ARCIALA Series on Intellectual Assets and Law in Asia. Springer Open.
Milenkovich, N. (1999). Deleting the Bolar Amendment to the Hatch-Waxman Act: Harmonizing Pharmaceutical Patent Protection in a Global Village. The John Marshall Law Review, Vol. 30, Issue. 3, 751-778.
Misati, E. & Adachi, K, (2010). The Research and Experimentation Exceptions in Patent Law: Jurisdictional Variations and the WIPO Development Agenda. UNCTAD- ICTSD Project on IPRs and Sustainable Development policy. UNCTAD: Available at https://unctad.org/system/files/official-document/iprs_in20102_en.pdf (Last accessed on 13 June 2021)
Munoz Tellez, V. (2022). Bolar Exception: Access to Medicines and Vaccines Implementing Flexibilities Under Intellectual Property Law, By: Correa, C. M. & Hilty, R. M., Springer International Publishing: https://doi.org/10.1007/978-3-030-83114-1
Pashkov, V. M., Golovanova, L. A., & Olefir, A. A. (2016). The impact of the Legal Regime of Intellectual Property Protection in the Pharmaceutical Market. Wiadomosci Lekarskie, tom LXIX, nr 3 (cz.II), 582-586.
Patra, S. P. (2008). Critical Appraisal of Bolar Exemption with Respect to Indian Patent Act 1970. 1-9. Available at SSRN: https://ssrn.com/abstract=1262712
Wested, J. & Minssen, T. (2018). Research and Bolar Exemptions in the U.S. and Europe: Recent Developments and Possible Scenarios, 1-11. Available at: SSRN: https://ssrn.com/abstract=3236127