Alternative Reasoning for Supreme Court’s Life Sciences Subject Matter Eligibility Jurisprudence | McDonnell Boehnen Hulbert & Berghoff LLP

Last week, IP Law360 published an erudite and provocative article by Joseph Matal and his colleagues regarding the Supreme Court’s recent subject matter jurisprudence in the context of earlier decisions in the 19th and early 20th Centuries (see “How Mayo V. Prometheus Strays From Patent Precedent“).  These decisions included Le Roy v. Tatham, 55 U.S. 156 (1852) (manufacture of lead pipes); Burr v. Duryee, 68 U.S. 531 (1863) (hat-making machinery); Mitchell v. Tilghman, 86 U.S. 287 (1874) (methods for making fat-acid and glycerin from natural fats); and Eibel Process Co. v. Minnesota & Ontario Paper Co., 261 U.S. 45 (1923) (related to paper-making machines) as examples.  While not every one of these cases held that the patent at issue recited eligible subject matter, the article maintains that together they set forth consistent, well-established principles of subject matter eligibility.  In particular, these authors argued that the principle that discovery of a “law of nature” did not preclude patentability of an application thereof was so well-established that Mr. Matal and his colleagues quote the Rivise and Caesar treatise to the effect that “‘where the inventor was . . . also the discoverer of the law or force utilized,’ the claimed invention was patentable even if ‘it appeared that the application or utilization of the law became self-evident as soon as the principle was formulated.'”  Charles W. Rivise & A.D. Caesar, Patentability and Validity §33-34 (1936).

The article identifies the Court’s decision in Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948), as the case where the Court’s eligibility jurisprudence turned (wrongly), leading to later cases culminating in the Court’s decision in Mayo Collaborative Services v. Prometheus Laboratories Inc., 566 U.S. 66 (2012), which decision Mr. Matal asserts “is at war with the rest of the Supreme Court’s eligibility jurisprudence and with core premises of the patent system.”  This is a sentiment with which many patent practitioners would agree.  The remainder of the article is a respectful explication of why the Court’s recent subject matter eligibility decisions are inconsistent with the earlier precedents discussed therein.

But there is perhaps another perspective.  Perhaps stare decisis (or doctrinal consistency), particularly when considered in a historical context measured in centuries, is not the proper role of the Court (while recognizing the necessity for such consistency over shorter timeframes to avoid serious societal disruption; see, e.g., Dobbs v. Jackson Women’s Health Organization, 597 U.S. ___ (2022)).  Strict compliance with earlier precedent would have prevented the Court from deciding Brown v. Board of Education the way it did in view of Plessy v. Ferguson, after all.  It may be better to think about the role of the Court in the “checks and balances” constitutional scheme is to remain a constant check on how or whether the other branches have exceeded their constitutional authority, and regarding subject matter eligibility that is certainly a strong basis for the current state of the law.

Mr. Matal and his colleagues are correct, of course, in identifying Funk Bros. v. Kalo Inoculants as a break point in the Court’s considerations of the proper scope of subject matter eligibility, and that the Court’s decision in Mayo (and Myriad) were consistent with this decision (albeit being inconsistent with the earlier precedent cited by Mr. Matal).  This leads straightforwardly to a consideration of why the Court has taken this tack, and a comparison of the earlier cases cited by Mr. Matal regarding their eligible subject matter with the ineligible subject matter under Funk Bros., Mayo, and Myriad provides a suggested common thread.

And that thread is subject matter, and its underlying natural laws, related to biological inventions.  It is entirely possible that without subscribing completely to District Court Judge Sweet’s rationale for why a gene should not be patent-eligible (being the “physical embodiment of biological information”) the Court is concerned with permitting patenting of biological inventions based on natural laws regarding biology.  Professor Andrew Torrance has advanced this argument in his paper “Nothing under the Sun That Is Made of Man” (Torrance, Andrew W., 2021, “Nothing Under the Sun that is Made of Man,” 2020 Mich. St. L. Rev.).  (This thinking can be extended to include a basis for the Court’s distaste for inventions implicating human thought, no matter how attenuated it may be in practice.)  In addition, it is evident that Justice Breyer in particular has such concerns in his dissent in LabCorp v. Metabolite and Mayo (see Noonan, K.E., 2022, “Justice Breyer: No Friend to IP Law,  21 UIC Rev. Intell. Prop. L. 58).  Thus, one method for determining whether there is such a prejudice against biological invention would be to make a hypothetical comparison or two between those cases that the Court would have been likely to have found to be eligible in the era discussed by Mr. Matal and colleagues and what the Court has decided since Funk Bros.

Hypothetical claim 1

A method for predicting a nuclear power plant reactor failure, comprising the steps of assaying pressure in a reactor coolant tank and correlating pressure fluctuations with the likelihood of failure, wherein a pressure fluctuation of +/- 7% indicates a greater than 90% likelihood that the reactor will fail.

It is unlikely that such a claim would be considered ineligible for many of the reasons enunciated in the earlier Supreme Court cases cited in Mr. Matal’s article.  The claim involves an application of a law of nature — the effects of high pressure created by the heat generated by nuclear fission in a reactor — under circumstances entirely created by man (i.e., man-made nuclear fission in a man-made reactor).  The claim takes advantage of an application of this law of nature under circumstances that do not arise naturally, thus providing no basis for the application of the Court’s recent subject matter eligibility proscriptions.

Hypothetical claim 2

A method for predicting escalation of a hurricane to Category 5 status, comprising the steps of assaying ocean temperature along a predicted storm track, wherein the hurricane is predicted to achieve Category 5 status if the ocean temperature changes by more than 5 degrees Celsius over less than 100 miles of the storm track.

This claim presents a closer case, because it involves a natural phenomenon — a hurricane — and the relationship between ocean temperature and future severity of the storm.  However, it is also a clear application of that law of nature for a human purpose — predicting future hurricane severity and obtaining the benefits thereof — specifically applied to this particular phenomenon.

Myriad – Claim 2 of U.S. Patent No. 6,033,857, invalid under Mayo

A method for diagnosing a predisposition for breast cancer in a human subject which comprises comparing the germline sequence of the BRCA2 gene or the sequence of its mRNA in a tissue sample from said subject with the germline sequence of the wild-type BRCA2 gene or the sequence of its mRNA, wherein an alteration in the germline sequence of the BRCA2 gene or the sequence of its mRNA of the subject indicates a predisposition to said cancer.

This claim, invalidated by the Federal Circuit in applying the rubrics from Mayo, shares many of the characteristics of the hypothetical claims, specifically by making a prediction of a future eventuality — breast cancer incidence — based on the relationship between the presence of certain mutations in the BRCA2 gene with such incidence (a discovery of a natural law).  As with the relationship between heat and pressure in Hypothetical 1 and between ocean temperature and hurricane intensity in Hypothetical 2, the relationship between BRCA gene mutations and disease is a natural phenomenon that can be (and has been) exploited for human benefit.  Note that this application of the consequences of genetic analysis does not involve nor require any rights to the underlying gene to be expropriated, which was at least the apparent basis for the challenge to “gene patents” that resulted in the Myriad decision (see, e.g., Contreras, 2021, The Genome Defense).

What this assessment indicates is that the Court at this time has decided that claims that so intimately implicate fundamental biological laws (particularly but not exclusively involving human biology) should be restricted in scope.  There is precedent for this legal distinction already in U.S. patent law, specifically in the differential treatment of medical (especially surgical) methods under 35 U.S.C. § 287(c).  There are certainly arguments to be made why this is unnecessary for any fundamental legal or moral principle and, indeed, may be contrary to such principles, insofar as the recent Supreme Court decisions have impeded development of genetically based diagnostic tests.  But relying on the inconsistencies of these decisions with earlier Supreme Court precedent seems to miss the more fundamental fact that the Court does not appreciate there to be any such inconsistency and indeed believes these decisions to be entirely consistent with its role in cabining Congress’s subject matter eligibility within proper constitutional grounds in order to promote progress.

These considerations explain to some degree the Court’s refusals to grant certiorari in the many Federal Circuit decisions applying the Court’s subject matter eligibility framework to diagnostic method claims.  They also suggest that the Court’s next foray into questions involving scope of biologically related patent claims, the upcoming Amgen v. Sanofi case, is unlikely to result in any expansion of claim scope and that the Court will look favorably on the Federal Circuit’s recent decisions requiring the scope of a validly granted claim to be restricted to what has been expressly disclosed.  Such a decision, if it comes to pass, will require patent practitioners’ noted cleverness in crafting claims that are sufficient to protect commercial embodiments of inventions having extraordinarily high costs to bring to market.  It also may, in its own way, impede innovation in some inventions as much as the Court’s recent subject matter eligibility jurisprudence has.