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Particular Aspects of US Patent Law in Biotechnologies

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Biopatent Law: European vs. US Patent Law

Part of the book series: SpringerBriefs in Biotech Patents ((BRIEFSBIOTECH))

Abstract

A patent is defined as an exclusive right or rights provided by a government to an inventor for a certain period of time in exchange for the public disclosure of an invention. Patent protection can be sought in many of the major countries throughout the world. This chapter addresses the processes and rules followed by the Patent Offices of the USA and Europe. Although efforts have recently been made to harmonize the US patent system with Europe and the rest of the world, this chapter focuses on similarities and differences in the processes of obtaining patent protection in these two countries prior to the recent adoption of the most significant overhaul of the US patent system in more than half a century, the Leahy-Smith America Invents Act (AIA).

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Notes

  1. 1.

    MPEP § 2138 (8th ed. Rev. August 9, 2012).

  2. 2.

    Board of Educ. ex rel. Bd. of Trustees of Florida State University v. American Bioscience, Inc., 333 F.3d 1330, 1338 (Fed. Cir. 2003).

  3. 3.

    Townsend v. Smith, 36 F.2d 292, 295 (Ct. Cust. App. 1929).

  4. 4.

    Townsend, 36 F.2d at 295.

  5. 5.

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

  6. 6.

    Hybritech, 802 F.2d at 1376.

  7. 7.

    MPEP § 2138 (8th ed. Rev. August 9, 2012).

  8. 8.

    Emery, Howe, and Marcella v. Ronden and Rabel, 188 U.S.P.Q. 264, 269 (P.T.O. Bd. Pat. Int. 1974).

  9. 9.

    Naber v. Cricchi, 567 F.2d 382, 385 (Ct. Cust. App. 1977).

  10. 10.

    MPEP § 2138 (8th ed. Rev. August 9, 2012).

  11. 11.

    Griffith v. Kanamaru, 816 F.2d 624, 626 (Fed. Cir. 1987).

  12. 12.

    MPEP § 2138 (8th ed. Rev. August 9, 2012).

  13. 13.

    Fujikawa v. Wattanasin, 93 F.3d 1559, 1566–1567 (Fed. Cir. 1996).

  14. 14.

    Fujikawa, 93 F.3d at 1567.

  15. 15.

    Paulik v. Rizkalla, 760 F.2d 1270, 1273 (Fed. Cir. 1985).

  16. 16.

    35 U.S.C. § 102(g)(1) (2006).

  17. 17.

    Interference procedures are complex processes that are beyond the scope of this explanation. See MPEP § 2138 (8th ed. Rev. August 9, 2012) for additional details.

  18. 18.

    European Patent Convention art. 60(2) (2010).

  19. 19.

    European Patent Convention art. 54(3) (2010).

  20. 20.

    Novelty will be further discussed infra.

  21. 21.

    The very basics of the AIA will be discussed in this text, but the full details of the AIA are beyond the scope of this text.

  22. 22.

    If a claim is anticipated by multiple references—without any one reference disclosing all of the claim elements—the claim may be obvious in light of the prior art references. Obviousness is discussed infra.

  23. 23.

    The USPTO will examine the application on a claim by claim basis, breaking each claim into its separate elements. The USPTO will then attempt to find a prior art reference that contains each element of an individual claim. For simplicity’s sake, though, this text will refer to the application as a whole rather than repeatedly stating “each element of each claim of an application” 35 U.S.C. § 102(a) (2006).

  24. 24.

    35 U.S.C. § 102(a) (2006).

  25. 25.

    There are famous examples of the “lost” document that was published in a foreign language in a foreign country that has served as prior art.

  26. 26.

    The PCT application must designate the USA and eventually be published in English.

  27. 27.

    35 U.S.C. § 102(e) (2006).

  28. 28.

    35 U.S.C. § 102(g)(2) (2006).

  29. 29.

    Under US copyright law, two separate authors can have a copyright to the same work if both authors completely independently created the work—not realizing that a duplicate work was created elsewhere. That concept is not allowed in US patent law.

  30. 30.

    35 U.S.C. § 102(b) (2006).

  31. 31.

    European Patent Convention art. 54(1) (2010).

  32. 32.

    European Patent Convention art. 54(2) (2010).

  33. 33.

    European Patent Convention art. 54(3) (2010).

  34. 34.

    European Patent Convention art. 54(2) (2010).

  35. 35.

    European Patent Convention art. 55(1)(a) (2010).

  36. 36.

    European Patent Convention art. 55(1)(b) (2010).

  37. 37.

    35 U.S.C. § 112 (2006).

  38. 38.

    Fujikawa v. Wattanasin, 93 F.3d 1559 (Fed. Cir. 1996).

  39. 39.

    Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d 1473 (Fed. Cir. 1998).

  40. 40.

    Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555 (Fed. Cir. 1991).

  41. 41.

    Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co., 598 F.3d 1336 (Fed. Cir. 2010).

  42. 42.

    Martina Schuster, Sufficient Disclosure in Europe: Is There a Separate Written Description Doctrine Under the European Patent Convention? 76 UMKC L. Rev. 491 (2007).

  43. 43.

    European Patent Convention art. 83 (2010).

  44. 44.

    European Patent Convention art. 84 (2010).

  45. 45.

    European Patent Convention art. 123(2) (2010).

  46. 46.

    European Patent Convention art. 88(4) (2010).

  47. 47.

    37 C.F.R. § 1.56 (2012).

  48. 48.

    37 C.F.R. § 1.56 (2012).

  49. 49.

    37 C.F.R. § 1.56 (2012).

  50. 50.

    Dayco Products, Inc. v. Total Containment, Inc., 329 F.3d 1358 (Fed. Cir. 2003).

  51. 51.

    McKesson Information Solutions, Inc. v. Bridge Medical, Inc., 487 F.3d 897 (Fed. Cir. 2007).

  52. 52.

    Therasense, Inc. v. Becton, Dickinson and Co., 649 F.3d 1276, 1288 (Fed. Cir. 2011).

  53. 53.

    Therasense, 649 F.3d at 1291–1292.

  54. 54.

    European Patent Convention art. 124(1) (2010).

  55. 55.

    European Patent Convention art. 124(2) (2010).

  56. 56.

    35 U.S.C. § 103 (2004).

  57. 57.

    KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398 (2007).

  58. 58.

    Graham v. John Deere Co., 383 U.S. 1 (1966).

  59. 59.

    35 U.S.C. § 102 (2004).

  60. 60.

    35 U.S.C. § 103(a) (2004).

  61. 61.

    35 U.S.C. § 103(c) (2004).

  62. 62.

    Hindsight bias refers to the concept that many patentable inventions appear obvious with the benefit of hindsight, despite not being obvious to those skilled in the art prior to their disclosure.

  63. 63.

    See, e.g., KSR Int’l Co., 550 U.S. at 407.

  64. 64.

    Id.

  65. 65.

    Id.

  66. 66.

    KSR Int’l Co., 550 U.S. at 421.

  67. 67.

    Id.

  68. 68.

    Id. at 418.

  69. 69.

    KSR Int’l Co., 550 U.S. at 406; secondary considerations are also known as Graham factors due to the case in which they were first cited. Graham v. John Deere Co. of Kan. City, 383 U.S. 1, 17 (1966).

  70. 70.

    See generally KSR Int’l Co., 550 U.S. at 418 (citing secondary considerations throughout the opinion).

  71. 71.

    See, e.g., Perfect Web Techs., Inc. v. InfoUSA, Inc., 587 F.3d 1324 (Fed. Cir. 2009).

  72. 72.

    Unless otherwise indicated, Europe as used herein refers to the application of patent law by the European Patent Office (EPO).

  73. 73.

    Trade-Related Aspects of Intellectual Property Rights art. 27, n5, April 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, 33 I.L.M. 81 [hereinafter TRIPS].

  74. 74.

    European Patent Convention art. 56, 14th ed. Available at http://www.epo.org/law-practice/legal-texts/html/epc/2010/e/ar56.html.

  75. 75.

    See, e.g., Case T-0159/95 (Bd. App. EPO 2000).

  76. 76.

    See Guidelines for Examination in the EPO, Part G—Chap. VII-3 (June 20, 2012).

  77. 77.

    Case T1203/97.

  78. 78.

    See Guidelines for Examination in the EPO, CVII, 5 (June 20, 2012).

  79. 79.

    See Guidelines for Examination in the EPO, CVII, 5.1 (June 20, 2012).

  80. 80.

    See Guidelines for Examination in the EPO, CVII, 5.2 (June 20, 2012).

  81. 81.

    Id.

  82. 82.

    See Guidelines for Examination in the EPO, CVII, 5.3 (June 20, 2012).

  83. 83.

    Id.

  84. 84.

    35 U.S.C. § 112 (2004).

  85. 85.

    Eli Lilly & Co. v. Barr Laboratories Inc., 251 F.3d 955, 963 (Fed. Cir. 2001).

  86. 86.

    See, e.g., Eli Lilly & Co., 251 F.3d at 963.

  87. 87.

    Leahy-Smith America Invents Act (AIA), Public Law 112–29, 125 Stat. 284 (September 16, 2011).

  88. 88.

    35 U.S.C. § 282 (2011).

  89. 89.

    See, e.g., Perspective on Patents: Harmonization and Other Matters: Hearing Before the Subcomm. on Intellectual Property of the Comm. on the Judiciary, 109th Cong. 182 (2005).

  90. 90.

    European Patent Convention art. 83, 14th ed. Available at http://www.epo.org/law-practice/legal-texts/html/epc/2010/e/ar83.html.

  91. 91.

    35 U.S.C. § 112 (2004).

  92. 92.

    See, e.g., MagSil Corp. v. Hitachi Global Storage Techs., 687 F.3d 1377, 1381 (Fed. Cir. 2012).

  93. 93.

    In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988).

  94. 94.

    Gould v. Quigg, 822 F.2d 1074, 1078 (Fed. Cir. 1987).

  95. 95.

    37 C.F.R. § 1.132.

  96. 96.

    See, e.g., In re Brandstadter, 484 F.2d 1395 (CCPA 1973).

  97. 97.

    European Patent Convention art. 83, 14th ed. Available at http://www.epo.org/law-practice/legal-texts/html/epc/2010/e/ar83.html.

  98. 98.

    Case No. T 19/90 at 12 (Bd. App. EPO 1990).

  99. 99.

    European Patent Convention rule 27(e). Available at http://www.epo.org/law-practice/legal-texts/html/epc/1973/e/r27.html (“describe in detail at least one way of carrying out the invention claimed using examples where appropriate and referring to the drawings, if any”).

  100. 100.

    Hitachi, Ltd. v. DaimlerChrysler AG, No. T 0063/06 at 7 (Bd. App. EPO 2008).

  101. 101.

    Case T1262/04 at 6 (Bd. App. EPO 2007).

  102. 102.

    Id.

  103. 103.

    See, e.g., Case T1329/04 (Bd. App. EPO 2005) (where no evidence was presented that a steroid hormone could be used as claimed in the application).

  104. 104.

    35 U.S.C. § 101 (2004).

  105. 105.

    Id.

  106. 106.

    See In re Bilski, 545 F.3d 943, 954 (Fed. Cir. 2008) (en banc).

  107. 107.

    Bilski v. Kappos, 130 S.Ct. 3218, 3231 (2010).

  108. 108.

    See, e.g., Classen Immunotherapies, Inc. v. Biogen Idec, 659 F.3d 1057 (Fed. Cir. 2011).

  109. 109.

    Diamond v. Chakrabarty, 447 U.S. 303 (1979).

  110. 110.

    Id. at 305.

  111. 111.

    Id. at 309.

  112. 112.

    State Street Bank and Trust Company v. Signature Financial Group, Inc., 149 F.3d 1368, 1373 (Fed. Cir. 1998).

  113. 113.

    Bilski, 130 S.Ct. at 3231.

  114. 114.

    Id.

  115. 115.

    Gottschalk v. Benson, 409 U.S. 63, 71 (1972). (“It is said that the decision precludes a patent for any program servicing a computer. We do not so hold”.).

  116. 116.

    Diamond v. Diehr, 450 U.S. 175, 187 (1981).

  117. 117.

    Bilski, 130 S.Ct. at 3225.

  118. 118.

    Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S.Ct. 1289 (2012).

  119. 119.

    European Patent Convention art. 52, 14th ed. Available at http://www.epo.org/law-practice/legal-texts/html/epc/2010/e/ar52.html.

  120. 120.

    Id.

  121. 121.

    European Patent Convention art. 54(2), 14th ed. Available at http://www.epo.org/law-practice/legal-texts/html/epc/2010/e/ar54.html.

  122. 122.

    See, e.g., Case T-0159/95 (Bd. App. EPO 2000).

  123. 123.

    See Guidelines for Examination in the EPO, Part G—Chap. VII-3 (June 20, 2012).

  124. 124.

    European Patent Convention art. 57, 14th ed. Available at http://www.epo.org/law-practice/legal-texts/html/epc/2010/e/ar57.html

  125. 125.

    See Guidelines for Examination in the EPO, Part F—Chap. II-4 (June 20, 2012).

  126. 126.

    Id.

  127. 127.

    Id.

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Authors and Affiliations

  1. Ballard Spahr LLP, 999 Peachtree Street, Suite 1000, Atlanta, GA, 30309-3915, USA

    Scott D. Marty

  2. Georgia State University, Atlanta, GA, USA

    Derek E. Constantine

  3. Maynard, Cooper & Gale, P.C., 655 Gallatin St SW, Huntsville, AL, 35801, USA

    Matthew Parker

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Marty, S.D., Constantine, D.E., Parker, M. (2014). Particular Aspects of US Patent Law in Biotechnologies. In: Biopatent Law: European vs. US Patent Law. SpringerBriefs in Biotech Patents. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-41293-6_3

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