The Experimental Use defense in Patent Infringement Litigations: An Absolute or Conditional Exception?

Document Type : Original Article

Authors

1 IP Department, Faculty of Law, Shahid Beheshti University

2 Intellectual Property Department, Faculty of Law, Shahid Beheshti University

Abstract

One of the defenses to patent infringement is the experimental use of the invention. This exception is accepted in The Registration of Patents, Industrial Designs and Trademarks Act of 2008. The Act, however, has no clue on the criterion for application of this exception and no case in this regard has yet been brought before the Iranian courts. On the other hand, some of the patent systems, namely the German and the U.S. one, have recognized a distinction between the commercial intent of the use and a non-commercial one as a criterion of the permissible act. Accordingly, the experiments done with a non-commercial purpose should be allowed while the ones with a commercial intent would be considered as an infringement. The case law of the two above-mentioned systems, however, shows otherwise. The current essay intends to investigate the different cases of experimental use and tries to show that the considered distinction cannot function effectively as a criterion to apply the exception especially where the purpose of the use is non-commercial but the patent is used extensively or vice versa where the use is done with a commercial intent but there is a public interest in permitting the act.

Keywords

Main Subjects


فهرست منابع
الف) منابع فارسی
قوانین و مقررات
1. قانون اساسی جمهوری اسلامی ایران.
2. قانون ثبت اختراعات، طرح‌های صنعتی و علائم تجاری مصوب 1386.
3. آیین‌نامۀ اجرایی قانون ثبت اختراعات، طرح‌های صنعتی و علائم تجاری مصوب 1387.
4. طرح حمایت از مالکیت صنعتی (ثبت اختراعات، طرح‌های صنعتی و علائم تجاری)، مصوب 1394 کمیسیون قضایی و حقوقی مجلس شورای اسلامی.
5. سیاست‌های کلی نظام در دورۀ چشم‌انداز، مصوب 1382.
6. سند چشم‌انداز بیست ساله، مصوب 1382.
7. نقشۀ جامع علمی کشور، مصوب 1389.
مقاله
8. حبیبا، سعید، شاکری، زهرا، سه‌گام، «آزمونی فراروی مصرف­کنندگان آثار ادبی و هنری»، مجلۀ تحقیقات حقوقی، بهار 1392، شمارۀ 61.
9. عرفان‌منش، محمدحسین، عباسی، محمود، زاهدی، مهدی، «استفاده از اختراع ثبت‌شده در تحقیقات آزمایشگاهی (مطالعه تطبیقی)»، فصلنامۀ اخلاق زیستی، دورۀ 5، پاییز 1394، شمارۀ 17.
10. عزیزی مرادپور، حمید، «تأملی بر مادۀ 30 موافقت‌نامۀ تریپس و درس‌هایی از رویۀ قضایی سازمان جهانی تجارت»، فصلنامۀ پژوهش حقوق خصوصی، سال اول، پاییز 1391، شمارۀ 1.
11. عزیزی مرادپور، حمید، «تأملی بر محدودیت‌های حقوق دارندگان حق اختراع»، پژوهش‌های حقوق تطبیقی، دورۀ 16، بهار 1391، شمارۀ 1.
ب) منابع خارجی
lawes
12. Convention For the European Patent For the Common Market (Community Patent Convention) 1975 (76/76/EEC).
13. Deutsche Patentgesetz 1981.
14. The Drug Price Competition and Patent Term Restoration Act 1984.
15. United States Code Title 35 – Patents, Updated May 2015.
Books
16. Fisher, Matthew, Fundamentals of Patent Law Interpretation and Scope of Protection,  Hart Publishing, USA, 2007.
17. Gervais, Daniel, The TRIPS Agreement: Drafting History and Analysis, Sweet & Maxwell, Third Edition, 2008.
18. Gilat, David, Experimental Use and Patents, IIC Studies, Studies in Industrial Property and Copyright Law, Volume 16 Published by the Max Planck Institute for Foreign and International Patent, Copyright and Competition Law, Munich, 1995.
19. Jones, Michael E., Walter Toomey, M. Nancy Aiken & Michelle Bazin, Intellectual Property Law Fundamentals, Carolina Academic Press, Durham, North Carolina, 2014.
20. Kommers, Donald P., and Russell A. Miller, The Constitutional Jurisprudence of the Federal Republic of Germany: Revised and Expanded, Duke University Press, 2012.
21. Kunihisa, Masuoka, Court Decisions Related to the Experimental Use Exception Under Common Law and Under State Law (Bolar Provision) in the United States, Institute of Intellectual Property, Japan, March 2004.
22. Kur, Annette, European Intellectual Property Law: Text, Cases and Materials, Cheltenham [u.a.], Elgar, 2013.
23. Machlup, Fritz, An Economic Review of the Patent System, Study No. 15 of the subcommittee on Patents, Trademarks, and Copyrights of the Committee on the Judiciary. United States Senate, 85th Congress, 2nd Sess., Washington, GPO, 1958.
24. Robinson, William, The Law of Patents for Useful Inventions, Little, Brown & Co., Boston, 1890.
25. Yamane, Hiroko, Interpreting TRIPS: Globalisation of Intellectual Property Rights and Access to Medicines, Hart Publishing, USA, 2011.
Articles
26. Baluch, Andrew S., Relating the Two Experimental Uses in Patent Law: Inventor's Negation and Infringer's Defense, Boston University Law Review, Vol. 87:213, 2007.
27. Bee, Richard E. , Experimental Use as an Act of Patent Infringement, Journal of the Patent Office Society, Vol. 39, No. 5, 1957.
28. Benyamini, Amiram, Patent Infringement in the European Community, IIC Studies, Studies inIndustrial Property and Copyright Law, Volume 13, Published by the Max Planck Institute for Foreign and International Patent, Copyright and Competition Law, Munich, 1993.
29. Bible, Sonya J., Does The Experimental-Use Defense to Patent Infringement Still Exist?, 13 SMU Science and Technology Law Review 17, 2009-2010.
30. Chrocziel, Peter, Die Benutzung patentierter Erfindungen zu Versuchs- und Forschungszwecken, Heymann, Köln, Vol 67, 1986.
31. Devlin, Alain, Restricting Experimental Use, Harvard Journal of Law & Public Policy, Vol 32, 2009.
32. Dreyfuss, Rochelle Cooper, Protecting the Public Domain of Science: Has the Time For an Experimental Use Defense Arrived?, Arizona Law Review, Vol 46, 2004.
33. Dreyfuss, Rochelle Cooper, Varying the Course in Patenting Genetic Material: A Counter-Proposal to Richard Epstein's Steady Course, NYU Law School, Public Law Research Paper 59, 2003.
34. Eichmann, H., Produktionsvorbereitung und Versuche vor Schutzrechtsablauf, 1977, GRUR 304.
35. Eisenberg, Rebecca S., Patents and the Progress of Science: Exclusive Rights and Experimental Use, The University of Chicago Law Review, 1989.
36. Goddar, Heinz. "Experimental Use Exception The European Perspective." Patent World, 2001.
37. Hagelin, Ted, The Experimental Use Exemption to Patent Infringement: Information on Ice, Competition on Hold, University of Florida Law Review, Vol. 58, 2006.
38. Hantman, Ronald D., Experimental Use as an Exception to Patent Infringement, Journal of the Patent and Trademark Office Society, Vol. 67, No. 12, 1985.
39. Hoffman, David C., A Modest Proposal: Toward Improved Access To Biotechnology Research Tools By Implementing A Broad Experimental Use Exception, Coraell Law Review, Vol. 89, 2004.
40. Lemley, Mark A., The Economics of Improvement in Intellectual Property Law, Texas Law Review, Vol. 75:989, 1997.
41. Ruess, Peter, Accepting Exceptions?: A Comparative Approach to Experimental Use in U.S. and German  Patent Law, Marquette Intellectual Property Law Review Vol. 10, 2006.
42. Strandburg, Katherine J., What Does the Public Get?  Experimental Use and the Patent Bargain, Wisconsin Law Review, 2004.
43. Straus, Joseph, Zur Zulässigkeit klinischer Untersuchungen am Gegenstand abhängiger Verbesserungserfindungen, GRUR, 1993.
Internet sites
44. Association Internationale pour la Protection de la Propriété Intellectuelle (AIPPI), Yearbook 1992/III, pages 282 - 283 Q105, Available at: https://www.aippi.org (last visited on 22.02.2016)
cases
45. Canada - Patent Protection of  Pharmaceutical Products, Report of the WTO Panel, WTO Document WT/DS114/R of 2000, Available at www.wto.org
46. Embrex, Inc. v. Serv. Eng'g Corp., 216 F.3d 1343, 1349 (Fed. Cir. 2000).
47. Ethofumesate, Bundesgerichtshof, of February 21 1989 - [1990] GRUR, 997.
48. Klinische Versuche I, Bundesgerichtshof, of July 11 1995 - [1996] GRUR, 109.
49. Klinische Versuche II, Bundesgerichtshof, of 17 April 1997 - [1997] NJW, 3092.
50. Madey v. Duke Univ., 307 F.3d 1351, 1362-63 (Fed. Cir. 2002).
51. Roche Prods., Inc. v. Bolar Pharm. Co., 733 F.2d 858, 863 (Fed. Cir. 1984).
52. Withmore v. Cutter; 29 F. Cas. 1120 (Supreme Court 1813).