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

Mireles, Michael S.

doi:10.1007/978-981-13-7466-1_1

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

Michael S. Mireles⁴

Chapter
First Online: 28 July 2019

360 Accesses

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

1.
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.
35 USCS § 200.
3.
Id.
4.
Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980).
5.
Id.
6.
See Rajendra K. Bera, The Story of the Cohen-Boyer Patents, 96 Current Science 760, 760 (March 25, 2009).
7.
35 USC § 101.
8.
Id.
9.
Bilkski v. Kappos, 561 U.S. 593, 642–643 (2010).
10.
Id.
11.
See infra.
12.
See infra.
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.
See Kristen Osenga, Debugging Software’s Schemas, 82 Geo. Wash. L. Rev. 1832, 1839–1840 (2014) (quoting Judge Richard Linn’s observations concerning “the abstractness of the ‘abstract ideas’ test to patent eligibility”).
15.
See Jeffrey A. Lefstin, The Three Faces of Prometheus: A Post-Alice Jurisprudence of Abstractions, 16 N.C. J.L. & Tech. 647, 656 (2015) (“Even as each new case has recast the test for patent eligibility, as well as its underlying rationales, the Court has maintained the pretense that all its historical and modern subject-matter cases are coherent with each other”).
16.
Chakrabarty, 447 U.S. at 309.
17.
Id. at 305.
18.
Id. at 307.
19.
Id.
20.
Id.
21.
Id. at 308.
22.
Id. at 309.
23.
Id. at 310.
24.
Id.
25.
Id.
26.
Id. at 313.
27.
Id. at 314–315.
28.
Id. at 315.
29.
Diamond v. Diehr, 450 U.S. 175 ( 1981).
30.
Diehr, 450 U.S. at 177–178.
31.
Id.
32.
Id. at 183.
33.
Id.
34.
Id. at 184.
35.
Id. at 185.
36.
Id. at 187.
37.
Id. at 191.
38.
Id.
39.
State Street Bank & Trust Co. v. Signature Fin. Group, 149 F.3d 1368, 1373 (1998).
40.
Id.
41.
Id.
42.
Id. at 1374.
43.
Id. at 1375.
44.
Id. at 1375–1377.
45.
See Christopher M. Holman, Patent Eligibility Post-Myriad: A Reinvigorated Judicial Wildcard of Uncertain Effect, 82 Geo. Wash. L. Rev. 1796, 1799 (2014).
46.
Bilski, 561 U.S. at 604.
47.
Id.
48.
Id.
49.
Id. at 603.
50.
Id. at 607.
51.
Id. at 611.
52.
Id. at 612.
53.
Id.
54.
Mayo Collaborative Services v. Prometheus Labs, Inc., 566 U.S. 66, 73 (2012).
55.
Id.
56.
Id. at 87.
57.
N. Scott Pierce provides a historical analysis concerning similar tests concerning preemption that he argues were legislatively disposed of by the passage of Section 103. See Patent Eligibility As a Function of New Use, Aggregation, and Preemption Through Application of Principle, 23 Rich. J.L. & Tech. 1, (2017).
58.
Mayo, 566 U.S. at 74–75.
59.
Id.
60.
Id.
61.
Id.
62.
Id. at 77.
63.
Id.
64.
See Alan L. Durham, Two Models of Unpatentable Subject Matter, 31 Santa Clara Comp. & High Tech. L.J. 251, 284 (2014–2015).
65.
See Christopher M. Holman, The Mayo Framework is Bad for Your Health, 23 Geo. Mason L. Rev. 901, 919–922 (2016) (“[T]he interaction of the human body with a synthetic molecule, in particular a drug breakdown product, should not be considered a natural phenomenon because the interaction would never occur naturally, but instead only occurs as the result of active, purposeful human intervention”).
66.
Mayo, 566 at 78.
67.
Id.
68.
Id.
69.
Id. at 79.
70.
Id.
71.
Id. at 81.
72.
Id.
73.
Id.
74.
Id.
75.
Id. at 87.
76.
Id.
77.
Id.
78.
Id. at 92.
79.
Id.
80.
Timothy R. Holbrook, Method Patent Exceptionalism, 102 Iowa L. Rev. 1001, 1006–1009 (2017).
81.
Rebecca S. Eisenberg, Prometheus Rebound: Diagnostics, Nature, and Mathematical Algorithms, 122 Yale L.J. Online 341, 343–44 (2013)
82.
Id. at 343.
83.
See Jeffrey A. Lefstin, The Three Faces of Prometheus: A Post-Alice Jurisprudence of Abstractions, 16 N.C. J.L. & Tech. 647, 656 (2015).
84.
Alice Corp. v. CLS Bank International, 134 S.Ct. 2347, 2352 (2014).
85.
Id. at 2355.
86.
Id.
87.
Id.
88.
Id.
89.
Id. at 2356.
90.
Id. at 2357.
91.
Id. at 2359.
92.
See John M. Golden, Flook Says One Thing, Diehr Says Another: An Need for Housecleaning in the Law of Patentable Subject Matter, 82 Geo. Wash. L. Rev. 1765, 1792 (2014).
93.
Id. at 1792–1793.
94.
Association of Molecular Pathology v. Myriad Genetics, 133 S.Ct. 2107 (2013).
95.
Id.
96.
Id.
97.
Id. at 2112.
98.
Id. at 2113.
99.
Id. at 2116.
100.
Id. at 2117.
101.
Id.
102.
Id.
103.
Id. at 2117.
104.
Id. at 2119.
105.
Id.
106.
See Christopher Beauchamp, Patenting Nature: A Problem of History, 16 Stan. Tech. L. Rev. 257 (2013) (reviewing the “murky” history of the product of nature exception and Parke-Davis Co.).
107.
Id.
108.
Myriad Genetics, 133 S.Ct. at 2119.
109.
Myriad Genetics, 133 S.Ct. at 2119–2120.
110.
See Timothy R. Holbrook & Mark D. Janis, Expressive Eligibility, 5 U.C. Irvine L. Rev. 973, 981 (2015) (“The expressive perspective on eligibility might throw some light on Myriad’s seemingly dubious distinction between gDNA and cDNA claims in eligibility analysis.”); Dan L. Burk, the Curious Incident of the Supreme Court in Myriad Genetics, 90 Notre Dame L. Rev. 505, 507–510 (2014).
111.
See John M. Golden, Flook Says One Thing, Diehr Says Another: An Need for Housecleaning in the Law of Patentable Subject Matter, 82 Geo. Wash. L. Rev. 1765, 1767 (2014) (The Myriad court seems to indicate that, “the question of whether there is an ‘inventive act’ for purposes of subject matter eligibility seems largely to be code for the question of whether there is a ‘marked difference’ between the claimed invention and excluded subject matter, in this case a naturally occurring sequence of DNA”).
112.
See Dan L. Burk, The Curious Incident of the Supreme Court in Myriad Genetics, 90 Notre Dame L. Rev. 505, 506 (2014).
113.
See, e.g., Ultramercial v. Hulu, 772 F.3d 709, 712 (2014).
114.
Enfish, LLC. v. Microsoft Corp., 822 F.3d 1327, 1335 (2016).
115.
Id.
116.
Id. at 1335–1336.
117.
Id. at 1336.
118.
Id. at 1338.
119.
Bascom Global Internet Servs. v. AT&T Mobility LLC, 8237 F.3d 1341 (2016).
120.
Id. at 1346.
121.
Id. at 1348.
122.
Id. at 1349.
123.
Id. at 1350.
124.
Id.
125.
BRCA1-& BRCA2 – Based Hereditary Cancer Test Patient Litigation v. Ambry Genetics Corp., 774 F.3d 755 (2014).
126.
Id. at 759.
127.
Id. at 760.
128.
Id.
129.
Id.
130.
Id. at 761.
131.
Id.
132.
Id. at 763.
133.
Id. at 764.
134.
BRCA1 & BRCA2, 774 F.3d at 764.
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.
Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (2015).
137.
Id.
138.
Id.
139.
Id.
140.
Id.
141.
Id. at 1373.
142.
Id. at 1375.
143.
See Id. at 1376.
144.
Id. at 1376.
145.
Id. at 1377.
146.
Ariosa Diagnostics, Inc., 788 F.3d at 1377.
147.
Id. at 1378.
148.
Id. at 1379.
149.
Ariosa Diagnostics, Inc. v. Sequenom, Inc., 809 F.3d 1282, 1284 (2015).
150.
Id.
151.
Id.
152.
Id. at 1287.
153.
Id.
154.
Id. at 1289–1290.
155.
Ariosa Diagnostics, Inc., 809 F.3d at 1291.
156.
Id. at 1044.
157.
Id. at 1045.
158.
Id.
159.
Id.
160.
Id.
161.
Id. at 1045–1046.
162.
Rapid Litigation Management v. CellzDirect, Inc., 827 F.3d at 1048.
163.
Id.
164.
Id.
165.
Id. at 1049.
166.
Id.
167.
Id.
168.
Id. at 1051.
169.
Id.
170.
Id. at 1052.
171.
USPTO, The July 2015 Update: Subject Matter Eligibility, addresses questions raised by applicants concerning, for example, an “explanation of the role of preemption in the eligibility analysis, including a discussion of the streamlined analysis.” 1,https://www.uspto.gov/sites/default/files/documents/ieg-july-2015-update.pdf (accessed September 1, 2017).
172.
2014 Interim Guidance on Patent Subject Matter Eligibility, 79 FR 74618, 74620 (2014).
173.
Id.
174.
Id. at 74621.
175.
Id.
176.
Id.
177.
Id.
178.
Robert W. Bahr, Formulating a Subject Eligibility Rejection and Evaluating the Applicant’s Response to a Subject Matter Eligibility Rejection, USPTO 1, https://www.uspto.gov/sites/default/files/documents/ieg-may-2016-memo.pdf (issued May 4, 2016).
179.
Id. at 2.
180.
Id. at 3.
181.
2014 Interim Guidance, 79 FR at 74622.
182.
Id. at 74623.
183.
Id.
184.
Id.
185.
Id.
186.
Id.
187.
Id.
188.
Id.
189.
Id.
190.
Id.
191.
Id.
192.
Id.
193.
Id. at 74624.
194.
Id.
195.
Id.
196.
Bahr, supra, at 2.
197.
Id. at 4.
198.
Id.
199.
2014 Interim Guidance, 79 FR at 74625.
200.
USPTO, Nature-based Products, 9–18, https://www.uspto.gov/sites/default/files/documents/mdc_examples_nature-based_products.pdf (issued December 16, 2014).
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.
Id.
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
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215.
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216.
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218.
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Id.
220.
American Bar Association, (“ABA”), Supplemental Comments Related to Patent Subject Matter Eligibility, USPTO 3–4, http://patentdocs.typepad.com/files/letter-5.pdf (issued May 4, 2016).
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McGeorge School of Law, University of the Pacific, Sacramento, CA, USA
Michael S. Mireles

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Department of Mycology and Plant Pathology, Institute of Agricultural Sciences Banaras Hindu University, Varanasi, Uttar Pradesh, India
Dr. Harikesh Bahadur Singh
Department of Biochemistry, Institute of Science, Banaras Hindu University, Varanasi, Uttar Pradesh, India
Dr. Chetan Keswani
Department of Biochemistry, Institute of Science, Banaras Hindu University, Varanasi, Uttar Pradesh, India
Dr. Surya Pratap Singh

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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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DOI: https://doi.org/10.1007/978-981-13-7466-1_1
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