COVID-19 Outbreak Calls for Scrutiny of Patentability Standards for Diagnostic Tests

By Andrew F. Halaby¹ and Jeffrey D. Morton, Ph.D.²

As the public clamors for wider availability of COVID-19 diagnostic testing, it bears noting that —  notwithstanding recent Supreme Court jurisprudence purporting to limit patent subject matter eligibility — both the United States Constitution and the United States Code contain provisions designed to incentivize and reward inventions in this and other important technological areas.

In Article I, Section 8, Clause 8, the United States Constitution gives Congress the power "[t]o promote the Progress of Science and the useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries."

And in 35 U.S.C. § 101, the patent subject matter eligibility statute, Congress has provided that "[w]hoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor . . . ."

One might think, purely on the basis of these texts, that a newly invented "process" for diagnosing COVID-19 would easily qualify as patentable.  Indeed, in a series of decisions dating back 40 years, the Supreme Court has "cautioned that courts 'should not read into the patent laws limitations and conditions which the legislature,'" i.e., Congress, "'has not expressed.'"  Bilski v. Kappos, 561 U.S. 593, 602 (2020) (quoting Diamond v. Diehr, 450 U.S. 175, 182 (1981) (quoting Diamond v. Chakrabarty, 447 U.S. 303, 308 (1980))).

Yet, the Court has actively policed patent claims in recent years, weeding out claims that it deemed ineligible for patent protection.  The Court has done so not on the basis of the statutory text but, as most recently articulated, that the inventor(s) did not articulate an "inventive concept," i.e., "something more" which is sufficient to transform inventions "drawn to" "laws of nature, natural phenomena, and abstract ideas" into patentable subject matter.  Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 217 (2014)   This, even though the Court has conceded that "all inventions at some level embody, use, reflect, rest upon, or apply" these things.  Mayo Collab. Servs. v. Prometheus Labs., 566 U.S. 66, 71 (2012).

None of these terms appears in the Constitution or Section 101. 

Yet, on these and similar bases, the Court has, within the last several years, invalidated patents on use of particular blood characteristics to optimize treatment, Mayo, 566 U.S. at 73-74, as well as artificially isolated genetic material of use in detecting or treating disease.  Ass'n for Molecular Pathology v. Myriad Genetics, 569 U.S. 576, 583-84 (2013).  The effects of these holdings have cascaded down through the lower courts, limiting — though not yet destroying — life science inventors' ability to patent the fruits of their efforts.  See, e.g., Jeffrey D. Morton & Robert A. Clarke, Improving the Prognosis for Your Diagnostic Method Patents, BNA's Patent, Trademark & Copyright Journal (March 3, 2017); Jacob C. Jones, C. Matthew Rozier, & Andrew F. Halaby, Section 101 in 2019, presented at the ABA Section of Intellectual Property Law Annual Meeting (April 11, 2019).

The Court asserts that its animating principle is "one of pre-emption" — the concern that "monopolization" of the "basic tools of scientific and technological work" might "tend to impede innovation more than it would tend to promote it."  Mayo, 566 U.S. at 71 (quoting Gottschalk v. Benson, 409 U.S. 63, 67 (1972)). 

Promoting innovation is, of course, the very point of the constitutional Patent Clause, as well as the patent statutes.  The price paid for "pre-emption" avoidance is inventions not made or attempted, for lack of sufficiently predictable return on investment.  The Court has rejected attempts within the past year, including by the United States Solicitor General, to have the Court revisit its patent eligibility jurisprudence in the life sciences arena.  Yet, the Court is not immune to current events.  Perhaps need will meet opportunity on a future cert. petition, and the Court will consider anew whether the proper balance between pre-emption avoidance and inducement to innovate has been struck.