A Comparative Analysis of the “Bolar Exception” in Patent Regimes and Its Role in Facilitating Generic Drug Production

Mohammadi, Amid; Dehghannejad, Marziyeh

doi:10.48311/clr.2025.101668.0

A Comparative Analysis of the “Bolar Exception” in Patent Regimes and Its Role in Facilitating Generic Drug Production

Document Type : مقالات علمی پژوهشی

Authors

Amid Mohammadi ¹

Marziyeh Dehghannejad ²

¹ Assistant Professor in Private Law, Faculty of Humanities, Jahrom University, Jahrom, Iran

² M.A. Student in Private Law, Tolu-e Mehr Non-Profit University, Qom, Iran

10.48311/clr.2025.101668.0

Abstract

The tension between the "right to access medicines" and the "patent protection system for pharmaceutical inventions" stands as one of the prominent challenges in contemporary intellectual property law. While protection for pharmaceutical patents under the TRIPS Agreement is recognized as a driver of innovation in the drug industry, this system can restrict access to essential medicines and impact public health. This study examines the so-called Bolar exception (preparatory acts) and analyzes its role in facilitating access to generic drugs and mitigating the monopoly arising from patent rights. This exception allows for the experimental production of generic drugs prior to patent expiration, thereby accelerating their market entry. The findings confirm that the Bolar exception can alleviate tensions between the patent system and the right to access medicines. However, its effective implementation requires precise regulations to prevent potential abuse by both patent holders and generic manufacturers.

Keywords

Bolar Exception

Pharmaceutical Patents

Right to Access Medicines

Generic Drugs

TRIPS Agreement

Intellectual Property Rights

Subjects

Intellectual property rights

A. Book

16. Correa, C. M. (2013). Pharmaceutical innovation, incremental patenting and compulsory licensing, Research Paper, South Centre, Jutaprint: Malaysia.

17. Muñoz 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

B. Article

18. 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.

19. 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

20. Correa, C. M. (2016). “The Bolar Exception: Legislative Models and Drafting Options”, Research Papers, South Center: 1-22., Available at: https://www.southcentre.int/wp-content/uploads/2016/03/RP66_The-Bolar Exception_EN1.pdf

21. Dinh, H., Ahamed, M., Jelic, R. (2024). “Economic Impact of Bolar Exemptions”, Available at: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4862758

22. Doubinsky, D. (2025). “Application of the Bolar Exception: Different Approaches in the Eu”, Research Papers, No. 214, South Centre, Geneva. Available at: https://hdl.handle.net/10419/312867

23. Meulenbelt, M., et al. (2024). “Are the Revisions to the EU’s ‘Bolar’ System Compatible with TRIPS?”, 1-20. Available at: http://worldtradelaw.net.

24. Milenkovich, N. (1999). “Deleting the Bolar Amendment to the Hatch-Waxman act: Harmonising Pharmaceutical Patent Protection in a Global Village”, The John Marshall Law Review, Vol. 32, Issue. 3, 751-778.

25. Patil, S. S. (2020). “Bolar Provision: An Experimental Use Exception to Patent Monopoly”, Mukt Shabd Journal, Vol. IX, Issue. VI, 5038-5034.

26. Patra, S. P. (2008). “Critical Appraisal or Bolar Exemption with Respect to Indian Patent Act 1970”, Indian Institute of Management Bodh Gaya, 1-9. Available at SSRN: https://ssrn.com/abstract=1262712

27 Rathod, S. (2017). “The Curious Case of India's Bolar Provision”, Journal of Generic Medicines, Journal of Generic Medicines, 1-5. Available at SSRN: https://ssrn.com/abstract=2971521 or http://dx.doi.org/10.2139/ssrn.2971521

28. Sitorus, L. E. (2021). “Intellectual Property and Public Health Emergency: Bolar Provision and Parallel Import”, Advances in Social Science, Education and Humanities Research, Vol. 592, Proceedings of the 2nd International Conference on Law and Human Rights, 121-126.

29. Straus, J. (1990). “Bolar Provision and the Experimental Use Exception in Europe”, IIC International Review of Intellectual Property and Competition Law, Vol.29, Isse.2, 195-214.

30. Tridico, A., Jacobstein, J., Wall, L., Henderson, F. (2014). “Facilitating Generic Drug Manufacturing: Bolar Exemptions Worldwide”, WIPO Magzine, Online Access: https://www.wipo.int/web/wipo-magazine/articles/facilitating-generic-drug-manufacturing-bolar-exemptions-worldwide

31. Wested, J. and 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

32. Watal, J. (2014). “Bolar Exception to Patent Rights: Some Economic Implications”, SCP Seminar on Exceptions and Limitations to Patent Rights, 1-21. Available at: https://www.wipo.int/edocs/mdocs/scp/en/scp_21/scp_21_ref_watal.pdf

33. Yuhe, W. & Yanfeng, X. (2008). “Comparison of Bolar Exception in China and The United States”, China Patents & Trademarks, No.3, 13-23. Available at: http://www.cpt.cn/uploadfiles/20100316133424016.Pdf

C. These and Dissertation

34. Claesson, M. (2008). protecting inventions and promoting innovation - a difficult act of balance, intellectual Property Law.

35. Garrison, C. (2006). Exceptions to Patent Rights in Developing Countries.

36. 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.

D. Case

38. Eli Lilly & Co. v. Medtronic, Inc. - 496 U.S. 661 (1990).

39. Erythropoietin II/KIRIN-AMGEN, 26-03.(1997).

40. Madey v. Duke University, 307 F.3d 1351 (Fed. Cir. 2002).

41. Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193 (2005).

42. Momenta Pharm. v. Amphastar Pharm. (686 F.3d 1348, 2012).

43. Roche Products Inc. v. Bolar Pharmaceutical Co., 733 F.2d 858 (Fed. Cir. 04/23/1984).

[In Persian]:

A. Books

44. Hestromir, Holger. (2011). Human Rights and the World Trade Organization: Inventions and Access to Medicine. Translators: Haleh Hosseini Akbarnejad and Huriyeh

45. Hosseini Akbarnejad. Tehran: Institute for Research and Legal Studies.

Mirhosseini, S. H. (2024). An Introduction to Intellectual Property Law (13th ed.). Tehran: Mizan Legal Foundation.

B. Articles

46. Azizi Muradpour, H. (2013). Reflection on Article 30 of the TRIPS Agreement and Lessons from the WTO dispute settlement body practice, Private Law Research, 1(0), 61-75.

47. Azizi Muradpour, H. and Irannejad, M. (2020). Challenges Between the Right to Access Medicine and Pharmaceutical Patents, Interdisciplinary Legal Research, 1(4), 151-187.

48. Eslamitabar, S., Ehsan L., Saeed A. M., and Fatemeh A. (2021). Intellectual Property Rights and Research and Development Challenges in the Pharmaceutical Industry, Journal of Halal Research, 4(1), 68-85. [In Persian]

49. Jafarzadeh, M. and Zeinab G. (2018). The Experimental Use defense in Patent Infringement Litigations: An Absolute or Conditional Exception?, Legal Research Quarterly, 80, 157-186. [In Persian]

50. Hekmatnia, M. and Akbari, J. (2018). Foundations of Exceptions to Use of Patent Right, Islamic Law Quarterly, 15(59), 123-161. [In Persian]

51. Monfared, M. (2015). The Conflict Between the Principle of Pharmaceutical Patent Protection and Human Rights: A Legal Interpretation of Article 27 of the TRIPS Agreement, Medical Law Quarterly, 151-187.

52. Sadeghi, M. (2010). A Discussion on Law and Economics: Legal and Economic Challenges of Registering New Pharmaceutical Use in Developing Countries, Quarterly Journal of Private Law Studies, 40(1), 159-178.

53. Sadeghi, M. and Rafe'ati, F. (2020). Comparative Study of Patentability of Drug Polymorphism in Iran and the USA, Medical Law Quarterly, 14(52), 97-116.

45. Shakeri, Z. and Hooman, S. (2024). A reading of the Binding Precedent 615 Rendered by the Supreme Court Regarding the Rights of Pharmaceutical Patents, Analysis of Judical Decisions Journal, 3(5), 112-134.

C. Laws and Regulations [In Persian]

55. Comprehensive Law on Supporting Industrial Property (2024)

56. Law on Registration of Inventions, Industrial Designs, and Trademarks (2007)

57. Law on Registration of Trademarks and Inventions (1931)

58. Law on Industrial and Commercial Marks (1925)