Will Medical Diagnostic Methods Ever Be Patent-Eligible?
Medical diagnostic methods have an immense value in medicine because they are critical in identifying, describing, and treating different types of diseases. Forasmuch as they require tremendous financial and human resources, entities that run R&D projects on new medical diagnostics should be somehow incentivized to invest in developing these life-saving methodologies.1 Granting patent protection for their inventions seems to be the most reasonable and effective solution. Ironically, most of the diagnostic methods’ inventors repeatedly face United States Patent and Trademark Office (USPTO) rejections or invalidity threats. It is because they usually use commonly known techniques and “often rely on scientific concepts that are ineligible for patenting, such as natural phenomena” or laws of nature.2 While this is often true, it cannot be stated that those diagnostic methods lack inventive concepts.
As 35 U.S.C. § 101 states, one can obtain a patent for a “new and useful process, machine, manufacture, or composition of matter” and improvements thereof. The United States Supreme Court has emphasized numerous times that § 101 contains an implicit exception for “[l]aws of nature, natural phenomena, and abstract ideas.”3 In the well-known case Alice Corp. v. CLS Bank, the Supreme Court summarized this notion and established a two-tiered test for assessing patentability of inventions that fit in the category of judicial exceptions.4 If a patent claim falls under one of the judicial exceptions, the next step is to check whether an element or a combination of elements in the patent is “sufficient to ensure that the patent in practice amounts to significantly more.”5 If an answer to the second question is positive, the subject matter is patentable.6
The U.S. Supreme Court upended medical diagnostic methods patents for the first time in March 2012.7 In the game-changing decision of Mayo Collaborative Servs. v. Prometheus Labs., Inc., the Court unanimously held that the method claim that used a relationship between a drug metabolite in a patient’s bloodstream and this drug’s efficacy simply recited a law of nature; therefore, it did not deserve patentability under § 101.8 According to the Court, a correlation between a presence of a biological material and a disease is a law of nature, and using conventional methods to determine this relationship is “not sufficient to transform . . . [it] into a patent-eligible application of such a law.”9 As a result, the Court invalidated the claim.10
Only one month after the Mayo decision, the § 101 rejection rate of medical diagnostic methods at the United States Patent and Trademark Office (“USPTO”) “grew from 7% to 32% . . . and continued to climb to a high of 64% and to 78% among final office actions just prior to abandonment.”11 Many, including the solicitor general and twelve active members of the U.S. Court of Appeals for the Federal Circuit (“CAFC”), expressed their hopes that the Supreme Court would review Athena Diagnostics, Inc. v. Mayo Collaborative Services12 and clarify the law as it pertains to patent eligibility of medical diagnostic methods; in particular, those that detect “a molecule never previously linked to the condition using novel man-made molecules and a series of specific chemical steps never previously performed.13 Regardless of all voices from the community, on January 13, 2020, the Supreme Court denied Athena’s petition and refused to dive into § 101 of the Patent Act, obviously deferring clarification of this patentability issue to Congress.14 It is widely discussed that the denial to revisit Athena, may be a death-knell for medical diagnostics.
It is true that the Senate held three hearings on patent eligibility in 2019, which followed the draft bill to revise 35 U.S.C. § 101 and § 112(f).15 However, in light of differing views among members on the Hill and upcoming elections, it is not likely that legislation will materialize anytime soon. As of now, medical diagnostics’ inventors have a better than zero chance to obtain or save patents in this significantly important field of personalized medicine.
Approximately $50 to $75 million in the United States. Leslie Kushner, Patenting Diagnostic Tests: Can We Expect Changes?, Law.com (Jan. 13, 2020), https://www.law.com/2020/01/13/patenting-diagnostic-tests-can-we-expect-changes [https://perma.cc/KVF8-XRM5].↩
Updates on Diagnostic Method Patent Eligibility, JDSupra (Jul. 26, 2019), https://www.jdsupra.com/legalnews/updates-on-diagnostic-method-patent-54921 [https://perma.cc/N7UN-GJXZ]↩
See, e.g., Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 589 (2013); Bilski v. Kappos, 561 U.S. 593, 594 (2010); Diamond v. Diehr, 450 U.S. 175, 185 (1981); Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980).↩
See Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208 (2014).↩
Id. at 218.↩
Id. at 217-18.↩
Heidi Ledford, U.S. Supreme Court Upends Diagnostics Patents, Nature Intl. Weekly J. of Science (Mar. 21, 2012), https://www.nature.com/news/us-supreme-court-upends-diagnostics-patents-1.10270 [https://perma.cc/9A43-QH9Z].↩
Mayo Collaborative Servs. v. Prometheus Labs, 566 U.S. 66, 92 (2012).↩
Id. at 67, 79 (internal citation omitted).↩
Id. at 92.↩
Collen Chien & Jiun Ying Wu, Decoding Patentable Subject Matter, 2018 Patently-O Pat. L.J. 1, 15, available at https://bit.ly/2oBO1i5 [https://perma.cc/52P9-AWAC].↩
See generally Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC, 915 F.3d 743 (Fed. Cir. 2019), cert. denied, 2020 WL 129579 (U.S. Jan. 13, 2020) (No. 19-430).↩
Petition for Writ of Certiorari at (i), Athena Diagnostics, Inc. v. Mayo Collaborative Servs., 2020 WL 129579 (U.S. Jan. 13 2020)(No.19-430), available at https://www.supremecourt.gov/DocketPDF/19/19-430/117672/20191001160357068_19-xxxx%20-%20Athena%20Diagnostics%20Inc.%20v.%20Mayo%20Collaborative%20Services%20LLC%20-%20cert.%20petition.pdf [https://perma.cc/H5PQ-JZV6].↩
Kevin E. Noonan, U.S. Supreme Court on Eligibility: Nothing to See Here, Move Along, Patent Docs (Jan. 13 2020), https://www.patentdocs.org/supreme_court [https://perma.cc/DLT5-R49C.↩
Kevin Hickey, Cong. Research Serv., R45918, Patent-Eligible Subject Matter Reform in the 116th Congress 34 (2019), available at https://fas.org/sgp/crs/misc/R45918.pdf [https://perma.cc/7XYD-6G6F].↩