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Inventorship Standards for Biotechnology Inventions Under the U.S. and Japanese Patent Acts

Abstract

This article highlights differences between the United States and Japanese inventorship standards by comparing a U.S. Federal Circuit decision and a Tokyo District Court decision in which inventorship of the same invention was disputed. It further discusses how Japanese courts, by applying Japanese inventorship standards, would not find one of the U.S. researchers in this case to be inventors, despite the Court of Appeals for the Federal Circuit (CAFC) finding inventorship while applying the U.S. standard. It argues that the U.S. standard is over-inclusive by including individuals who did not contribute to any part of the inventive process, but that the Japanese standard is too difficult to meet and may exclude inventors who made an important contribution. The over-inclusive U.S. standard is influenced by the legacy of “first-to-invent”: a formality requirement that all individual inventors must contribute to every claim to file a single application and a substantive requirement that an inventor’s prior joint invention is the prior art against her later invention unless the same group of individual inventors made both inventions. The article concludes with a discussion of the advantages and disadvantages of applying the U.S. and Japanese standards for determining inventorship of biotechnology inventions and proposes a harmonization of inventorship standards through the leadership of the World Intellectual Property Organization.

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Notes

  1. 964 F.3d 1365 (Fed. Cir. 2020).

  2. Dana-Farber Cancer Inst., Inc. v. Ono Pharm. Co., 964 F.3d 1365, 2020 U.S. App. LEXIS 21704, 2020 U.S.P.Q.2d (BNA) 10775; Dana-Farber Cancer Inst., Inc. v. Ono Pharm., 379 F. Supp.3d 53 (D. Mass. 2016).

  3. Tokyo District Court, Aug. 21, 2020, Hei 29 (Wa) 27378. The Intellectual Property High Court affirmed the decision. IP High Court, March 17, 2021, Rei (Ne) 10052.

  4. Judgment of Tokyo District Court, Aug. 21, 2020, Hei 29 (wa) 27378.

  5. Dana-Farber Cancer Inst., Inc., 964 F.3d 1368.

  6. Id., at 1369.

  7. Id., at 1369–70.

  8. Id., at 1372 (quoting IMMUNOPOTENTIATIVE COMPOSITION, US PAT 8728474).

  9. Dana-Farber Cancer Inst., Inc., 379 F. Supp.3d 78.

  10. Dana-Farber Cancer Inst., Inc., 964 F.3d 1370.

  11. Dana-Farber Cancer Inst., Inc., 964 F.3d 1371 (quoting Eli Lilly & Co. v. Aradigm Corp., 376 F.3d 1352, 1358 (Fed. Cir. 2004)).

  12. Dana-Farber Cancer Inst., Inc., 964 F.3d 1371.

  13. Id., at 1372.

  14. Judgment of Tokyo District Court, Aug. 21, 2020, Hei 29 (wa) 27378.

  15. The broadest claim, Claim 1 of the patent resulting from the parent application, recites a cancer treatment medication comprising an anti-PD-L1 antibody as an active ingredient to block a PD-L1 inhibitive signal.

  16. U.S. Constitution, Art. 1, §8, Cl. 8.

  17. Chisum (2020), § 2.02.

  18. 35 U.S.C. § 100(f).

  19. 35 U.S.C. § 100(g).

  20. 35 U.S.C. § 116(a)

  21. This definition was introduced by the Patent Law Amendments Act of 1984, Pub. L. 98-622, § 104, 98 Stat. 3385 (current version at 35 U.S.C. § 116 (2006)). For the legislative background, see Fellmeth (2012), p. 73.

  22. 35 U.S.C. § 111(a).

  23. Tresansky (1979), p. 96.

  24. The first-inventor-to-file provision became effective on March 16, 2013. Leathy–Smith America Invents Act, Public Law 112, Sept. 16, 2011.

  25. Leahy–Smith America Invents Act, PL 112-29, Sept. 16, 2011, 125 Stat 284 (codified at 35 U.S.C. § 102(a), (f)). For the first-to-invent priority rule, see Chisum (1981), p. 397; Takenaka (2002), p. 621.

  26. Chisum (2020), § 2.03[1].

  27. In re Bass, 474 F.2d 1276 (C.C.P.A. 1973).

  28. Chisum (1981), p. 402.

  29. 35 U.S.C. § 118.

  30. 35 U.S.C. § 102.

  31. 35 U.S.C. § 102(b).

  32. Helsinn Healthcare S.A. v. Teva Pharms. USA, Inc., 139 S. Ct. 628 (2019), IIC 50:755 (2019). https://doi.org/10.1007/s40319-019-00834-9. Because the exception under § 102(b) applies to the inventor’s own sale, an invention that sells more than one year from the filing date constitutes the prior art.

  33. Leahy–Smith America Invents Act, PL 112-29, Sept. 16, 2011, 125 Stat 284 (codified as 35 U.S.C. § 102(f)).

  34. Chisum (2020), § 10.10[4][b]. The USPTO relied on 35 U.S.C. § 101 to reject an application naming AI as the inventor. In re Application of Application No. 16/524,350 (available at: https://www.uspto.gov/sites/default/files/documents/16524350_22apr2020.pdf).

  35. 35 U.S.C. § 135.

  36. 35 U.S.C. § 256.

  37. Sewall v. Walters, 21 F.3d 411, 415 (Fed. Cir. 1994).

  38. Hybritech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1376 (Fed. Cir. 1986).

  39. Burroughs Wellcome Co. v. Barr Labs., Inc., 40 F.3d 1223, 1228 (Fed. Cir. 1994).

  40. It is not necessary to confirm the utility or function of isolated DNA sequences. Fiers v. Revel, 984 F.2d 1164 (Fed. Cir. 1193). Conception is complete even if the sequence identified includes errors. Sanofi-Aventis v. Pfizer, Inc., 733 F.3d 1364 (Fed. Cir. 2013).

  41. Burroughs Wellcome Co. v. Barr Labs., Inc., 40 F.3d 1223, 1231 (Fed. Cir. 1994).

  42. Id., at 1228.

  43. Trovan, Ltd. v. Sokymat S.A., Irori, 299 F.3d 1292, 1301–02 (Fed. Cir. 2002).

  44. Vanderbilt Univ. v. ICOS Corp., 601 F.3d 1297, 2010 U.S. App. LEXIS 7164, 94 U.S.P.Q.2d (BNA) 1481; Vanderbilt Univ. v. ICOS Corp., 601 F.3d 1297, 1308 (Fed. Cir. 2010).

  45. Fiona Oil & Chem Co. v. Ewen, 123 F.3d 1466, 1473 (1997).

  46. Nartron Corp. v. Borg Indak, Inc., 558 F.3d 1352 (Fed. Cir. 2009).

  47. Dana-Farber Cancer Inst., Inc., 964 F.3d 1371.

  48. Kimberly-Clark Corp. v. P&G Distrib., 973 F.2d 911, 917 (Fed. Cir. 1992).

  49. Chisum (2020), §§ 10.05, 10:06.

  50. StoneEagle Services, Inc. v. Gillman, 746 F.3d 1059 (Fed. Cir. 2014).

  51. University of Pittsburgh v. Hedrick, 573 F.3d 1290 (Fed. Cir. 2009).

  52. Dana-Farber Cancer Inst., Inc., 964 F.3d 1372.

  53. Stern v. Trs. of Columbia Univ., 434 F.3d 1375 (Fed. Cir. 2006).

  54. Ethicon, Inc. v. United States Surgical Corp., 135 F.3d 1456 (Fed. Cir. 2009).

  55. Dana-Farber Cancer Inst., Inc., 964 F.3d 1372.

  56. Vanderbilt Univ., 601 F.3d 1303 (Fed. Cir. 2010).

  57. JPA § 33 ¶1.

  58. JPA § 38.

  59. JPA § 29 ¶1.

  60. Kimijima (2011), p. 32.

  61. JPA § 74.

  62. For derived inventions, JPA § 49(7), § 123 ¶1(6). For erroneous coinventors, JPA § 38, JPA §§ 49(2), 123 ¶1(2).

  63. For corrections on applications, Tokyo Dist. Ct., June 5, 1963, 14 Kaminshū (No. 6) 1074. For corrections on patents, June 12, 2001, Sup. Ct., 55 Minshū (No. 4) 793.

  64. JPA § 2.

  65. Tokyo Dist. Ct., Sept. 13, 2005, Hanrei Jiho No. 1916, 133 [Pfizer].

  66. Nakayama (2019), p. 45.

  67. Yoshifuji (1998), p. 188.

  68. Sup. Ct., Oct. 13, 1977, 31 Minshū (No. 6) 805.

  69. Tamura (2018), p. 53.

  70. Tamura (2018), p. 54.

  71. IP Hi. Ct., July 30, 2008, Hei 18, Gyo-ke 10048. Courts found inventorship for those who contributed to characteristic elements. See e.g. IP Hi. Ct., Sept. 30, 2008, Hei 19, Gyo-ke 10278; IP Hi. Ct., March 13, 2013, Hanrei Jihō No. 2201, 116.

  72. E.g. Mimura (2006), p. 122.

  73. IP Hi. Ct., March 25, 2016, Hei 25 (ne) 10100.

  74. Mimura (2006), p. 123. Yoshifuji (1998), p. 188. Tokyo Dist. Ct., Sept. 13, 2005, Hanrei Jihō No. 1916, 133.

  75. Dana-Farber Cancer Inst., Inc., 964 F.3d 1371.

  76. Dana-Farber, 379 F. Supp.3d 101 (the district court found that the conception of the invention was linked to the PD-L1 expression on human tumors supported by the results of experiments conducted by Dr. Freeman).

  77. Dana-Farber, 379 F. Supp.3d 96–7.

  78. Dana-Farber Cancer Inst., Inc., 964 F.3d 1371.

  79. Kimberly-Clark Corp. v. Procter & Gamble Distrib. Co., 973 F.2d 911, 917 (Fed. Cir. 1992).

  80. Vanderbilt Univ. v. ICOS Corp., 601 F.3d 1297, 1303 (Fed. Cir. 2010).

  81. IP Hi Ct., March 28, 2013, Hanrei Jihō No. 2200, 125.

  82. IP Hi Ct., May 29, 2008, Hanrei Jihō No. 2018, 146.

  83. Mueller Brass Co. v. Reading Indus., Inc., 352 F. Supp. 1357, 1372 (E.D. Pa. 1972).

  84. In re VerHoef, 888 F.3d 1362, 1365 (Fed. Cir. 2018), as amended (May 7, 2018).

  85. For a discussion of cumulative innovation, see Boudreau and Lakhani (2015), p. 4.

  86. Vertinsky (2017), p. 443; Lee (2014), p. 1.

  87. Trovan, Ltd. v. Sokymat S.A., Irori, 299 F.3d 1292, 1301–02 (Fed. Cir. 2002). Tokyo District Court followed the procedure in the Tokyo Ono Pharm case.

  88. Takenaka (2019), p. 93.

  89. Vertinsky (2017), p. 401.

  90. JPA § 33(3)–(4).

  91. Ethicon, Inc. v. United States Surgical Corp., 135 F.3d 1456 (Fed. Cir. 2009).

  92. Abbott (2019).

  93. WIPO, “AI Intelligence and Intellectual Property Policy; The WIPO Conversation on IP and AI”, https://www.wipo.int/about-ip/en/artificial_intelligence/policy.html.

  94. Stephen Thaler v. Andrei Ianch, filed with U.S. Dist. Ct. East. Dist. (available at: https://artificialinventor.com/wp-content/uploads/2020/09/Complaint.pdf).

  95. A possible rule that WIPO member states can adopt is the protocol under the European Patent Convention (EPC). Protocol on Jurisdiction and Recognition of Decisions in Respect of the Right to the Grant of a European Patent (Protocol on Recognition). There are groups of academics who have been working to develop a conflict of law rule for IP disputes. E.g. European Max Planck Group on Conflict of Laws in Intellectual Property, “Principles for Conflict of Laws in Intellectual Property The Draft” (2011), https://www.ip.mpg.de/fileadmin/ipmpg/content/clip/the_draft-clip-principles-25-03-20117.pdf. WIPO publishes a conflict of law guide for judges who handle IP disputes, see WIPO, “When Private International Law Meets Intellectual Property Law” (2019), https://www.wipo.int/edocs/pubdocs/en/wipo_pub_1053.pdf.

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Takenaka, T. Inventorship Standards for Biotechnology Inventions Under the U.S. and Japanese Patent Acts. IIC 52, 556–578 (2021). https://doi.org/10.1007/s40319-021-01064-8

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Keywords

  • Inventorship
  • Ownership
  • Biotechnology
  • U.S. Patent Act
  • Japanese Patent Act
  • First-to-invent
  • First-to-file
  • Conception
  • Reduction to practice