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Pharmaceutical patent protection: the United States and Japan in comparative perspective

    Shinya Kimura

    *Author for correspondence:

    E-mail Address: kimura@oshaliang.com

    Osha Liang Consulting K.K., Level 28, Shinagawa Intercity Tower A, 2-15-1 Konan, Minato-ku, Tokyo, Japan

    &
    Carlyn A Burton

    Osha Liang LLP, Two Houston Center, 909 Fannin, Suite 3500, Houston, TX, USA

    Published Online:https://doi.org/10.4155/ppa-2016-0039
    Free first page

    References

    • 1 Pallin v. Singer, 36 USPQ 2d 1050 (D. Vt. 1995).
    • 2 35 U.S.C. § 287(c)(2)(C).
    • 3 35 U.S.C. § 271 (b) and (c).
    • 4 Examination Guidelines for Patent and Utility Model in Japan, Part III, Chapter 1 Eligibility for Patent and Industrial Applicability (Main Paragraph of Article 29(1) of the Patent Act).
    • 5 Tokyo High Court, Hei 12 (Gyoke) No. 65 (2002).
    • 6 M.P.E.P. § 2111.02.
    • 7 Examination Guidelines for Patent and Utility Model in Japan, Part III Chapter 2 Section 4 Claims Including Specific Expressions.
    • 8 Examination Handbook for Patent and Utility Model in Japan, Annex B, Chapter 3 Medicinal Inventions.
    • 9 Tokyo District Court, Hei 2 (Wa) No. 12094 (1992).
    • 10 Tokyo High Court, Hei 10 (Gyoke) No. 308 (2000).
    • 11 Tokyo High Court, Hei 10 (Gyoke) No. 401 (2001).
    • 12 In re Thorpe, 777 F.2d 695 (Fed. Cir. 1985).
    • 13 M.P.E.P. § 2113.
    • 14 Amgen Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340 (Fed. Cir. 2009).
    • 15 Supreme Court of Japan, Hei 24 (Ju) No. 1204 (2015).
    • 16 Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. __ (2013).
    • 17 Mayo Collaborative Serv. v. Prometheus Labs., Inc., 566 U.S. __ (2012).
    • 18 Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. __ (2014).
    • 19 2014 Interim Guidance on Patent Subject Matter Eligibility.
    • 20 M.P.E.P. § 2111.
    • 21 Examination Handbook for Patent and Utility Model in Japan, Annex B, Chapter 2 Biological Inventions.
    • 22 Altman D, Sweeney C, Yasui T. Preparing effective experimental data for pharmaceutical patent applications from US and Japanese perspectives. Pharm. Pat. Anal. 3(5), 469–473 (2014).
    • 23 M.P.E.P. § 2164.03.
    • 24 United States v. Telectronics, Inc., 857 F.2d 778 (Fed. Cir. 1988).
    • 25 Allergan, Inc., v. Sandoz Inc., 796 F.3d 1293 (Fed. Cir. 2015).
    • 26 M.P.E.P. § 2163.
    • 27 Falkner v. Inglis, 448 F.3d 1357 (Fed. Cir. 2006).
    • 28 Examination Guidelines for Patent and Utility Model in Japan, Part III Chapter 2 Section 2 Inventive Step.
    • 29 Tokyo High Court, Hei 8 (Gyoke) No. 201 (1998).
    • 30 Tokyo High Court, Hei 15 (Gyoke) No. 104 (2003).
    • 31 Intellectual Property High Court, Hei 17 (Gyoke) No. 10042 (2005).
    • 32 35 U.S.C. § 287(c)(2)(A).
    • 33 Intellectual Property High Court, Hei 17 (Ne) No. 10125 (2006).