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Patent-Eligible Subject Matter in the United States: An Evolving Landscape

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Abstract

The scope of patent-eligible subject matter has been evolving since the early 1980s in the United States. The US Supreme Court has attempted to restrict the doctrine in recent years; however the US Court of Appeals for the Federal Circuit has reinterpreted the Supreme Court case law to arguably cause confusion in the doctrine. The US Patent and Trademark Office attempted to clarify the doctrine, but some of the cases may be irreconcilable. Notably, interested groups are attempting to change the doctrine to return to a more expansive time. The doctrine lacks clarity and will likely continue to evolve. This paper explores the evolution of the patent-eligible subject matter doctrine, especially in the biotechnology field.

Keywords

  • USPTO
  • Biotechnology patents
  • Patent-eligible subject matter
  • Federal circuit

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Notes

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    See John M. Golden, Flook Says One Thing, Diehr Says Another: A Need for Housecleaning in the Law of Patentable Subject Matter, 82 Geo. Wash. L. Rev. 1765, 1767 (2014).

  2. 2.

    35 USCS § 200.

  3. 3.

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  4. 4.

    Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980).

  5. 5.

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  7. 7.

    35 USC § 101.

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  9. 9.

    Bilkski v. Kappos, 561 U.S. 593, 642–643 (2010).

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    Id.

  11. 11.

    See infra.

  12. 12.

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  13. 13.

    See Alan L. Durham, Two Models of Unpatentable Subject Matter, 31 Santa Clara Comp. & High Tech. L.J. 251, 261–264 (2014–2015) (“The discussion typically begins with a list of three types of unpatentable subject matter – natural laws, natural phenomena, and abstract ideas – and by the end, if a patent is denied, it is not always clear which forbidden category has been adopted”).

  14. 14.

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  15. 15.

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  16. 16.

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  57. 57.

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  84. 84.

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  93. 93.

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  94. 94.

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  95. 95.

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  107. 107.

    Id.

  108. 108.

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  109. 109.

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  110. 110.

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  111. 111.

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  112. 112.

    See Dan L. Burk, The Curious Incident of the Supreme Court in Myriad Genetics, 90 Notre Dame L. Rev. 505, 506 (2014).

  113. 113.

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  114. 114.

    Enfish, LLC. v. Microsoft Corp., 822 F.3d 1327, 1335 (2016).

  115. 115.

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  120. 120.

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  121. 121.

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  122. 122.

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  124. 124.

    Id.

  125. 125.

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  134. 134.

    BRCA1 & BRCA2, 774 F.3d at 764.

  135. 135.

    In another biotechnology case, Genetic Technologies Ltd. v. Merial LLC, the Judge Dyk determined that the diagnostic method claims at issue were patent ineligible using a relatively similar analysis. 818 F.3d 1369, 1371 (2016).

  136. 136.

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  137. 137.

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  146. 146.

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  148. 148.

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  150. 150.

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  162. 162.

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  164. 164.

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  169. 169.

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  170. 170.

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  171. 171.

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  172. 172.

    2014 Interim Guidance on Patent Subject Matter Eligibility, 79 FR 74618, 74620 (2014).

  173. 173.

    Id.

  174. 174.

    Id. at 74621.

  175. 175.

    Id.

  176. 176.

    Id.

  177. 177.

    Id.

  178. 178.

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  179. 179.

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  180. 180.

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  181. 181.

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  182. 182.

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  183. 183.

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  185. 185.

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  186. 186.

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  192. 192.

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  193. 193.

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  194. 194.

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  195. 195.

    Id.

  196. 196.

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  197. 197.

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  198. 198.

    Id.

  199. 199.

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  200. 200.

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  201. 201.

    USPTO, Subject Matter Eligibility Examples: Life Science, 28–33, https://www.uspto.gov/sites/default/files/documents/ieg-may-2016-ex.pdf (issued May 4, 2016).

  202. 202.

    Id.

  203. 203.

    USPTO, Patent Eligible Subject Matter: Report on Views and Recommendations from the Public (July 2017), available at https://www.uspto.gov/sites/default/files/documents/101-Report_FINAL.pdf

  204. 204.

    Id.

  205. 205.

    Id.

  206. 206.

    Id.

  207. 207.

    Id.

  208. 208.

    Id.

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  210. 210.

    Id.

  211. 211.

    Id.

  212. 212.

    Id.

  213. 213.

    Id.

  214. 214.

    Id.

  215. 215.

    Id.

  216. 216.

    Id.

  217. 217.

    Id.

  218. 218.

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  219. 219.

    Id.

  220. 220.

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  221. 221.

    Id. at 3.

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Mireles, M.S. (2019). Patent-Eligible Subject Matter in the United States: An Evolving Landscape. In: Singh, H., Keswani, C., Singh, S. (eds) Intellectual Property Issues in Microbiology. Springer, Singapore. https://doi.org/10.1007/978-981-13-7466-1_1

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