There has been much commentary, some of it incendiary, regarding whether the Court of Appeals for the Federal Circuit is fulfilling its responsibilities under its enabling statute or failing to provide the proper pro-patent perspective in its response and implantation of the Supreme Court's jurisprudence regarding subject matter eligibility under 35 U.S.C. § 101.  The problem is illustrated by the comments provided by two members of the Court, Judges Lourie and O'Malley, in their concurrence and dissent, respectively, with the Court's per curiam denial of en banc review in Athena Diagnostics Inc. v. Mayo Collaborative Services, LLC.

Judge Lourie voices the view, first enunciated by Judge Linn in Ariosa Diagnostics, Inc. v. Sequenom, Inc., that as an inferior appellate court, its hands are tied by the Supreme Court's decisions in Mayo Collaborative Services v. Prometheus Laboratories, Inc., Alice Corp. Pty. Ltd. v. CLS Bank Int'l, and Association for Molecular Pathology v. Myriad Genetics, Inc.:

If I could write on a clean slate, I would write as an exception to patent eligibility, as respects natural laws, only claims directed to the natural law itself, e.g., E=mc2, F=ma, Boyle's Law, Maxwell's Equations, etc.  I would not exclude uses or detection of natural laws.  The laws of anticipation, obviousness, indefiniteness, and written description provide other filters to determine what is patentable.  . . .  But we do not write here on a clean slate; we are bound by Supreme Court precedent.

This view is apparently shared by seven of the Court's twelve members.  Judge O'Malley enunciates the countervailing view regarding what the Court should do to change this state of affairs, stating her opinion that the Court has gone astray in slavishly and too stringently applying the Supreme Court's precedent to unnecessarily restrict the scope of what is eligible (particularly with regard to diagnostic method claims, including the ones at issue before the Court in Athena):

I agree with all my dissenting colleagues that our precedent applies the Supreme Court's holding in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012) too broadly.  I write separately, however, because I believe that confusion and disagreements over patent eligibility have been engendered by the fact that the Supreme Court has ignored Congress's direction to the courts to apply 35 U.S.C. sections 101, et seq ("Patent Act") as written.  Specifically, the Supreme Court has instructed federal courts to read into Section 101 an "inventive concept" requirement—a baffling standard that Congress removed when it amended the Patent Act in 1952.  I encourage Congress to amend the Patent Act once more to clarify that it meant what it said in 1952.

It is clear that Congress is the ultimate (or perhaps only) solution.  But if Judge O'Malley identifies the Federal Circuit's complicity in engendering the current situation, Judge Newman in dissent enumerates the Court's application of Supreme Court precedent to diagnostic method claims, all of these decisions invalidated the patents at issue:

1. In re BRCA1- & BRCA2-Based Hereditary Cancer Test Patent Litigation, 774 F.3d 755 (Fed. Cir. 2014).  The claimed invention is a method for screening for genes linked to inherited breast and ovarian cancer, by analyzing for certain mutations in the DNA.  The court held the claims ineligible under section 101 as directed to a law of nature, and also held that identifying genetic mutations is an ineligible abstract idea.

2. Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015).  The claimed invention is a method for detecting paternally-inherited fetal abnormalities by analyzing the blood or serum of a pregnant female.  The court held the claims ineligible under section 101, while recognizing that "detecting cffDNA in maternal plasma or serum that before was discarded as waste material is a positive and valuable contribution to science."  Id. at 1380.

3. Genetic Technologies Ltd. v. Merial L.L.C., 818 F.3d 1369 (Fed. Cir. 2016).  The claimed invention is a method for detecting a coding region of DNA based on its relationship to non-coding regions, by amplifying genomic DNA with a primer spanning a non-coding sequence in genetic linkage to an allele to be detected.  The court stated that "the patent claim focuses on a newly discovered fact about human biology," id. at 1376, and that this is a law of nature and is ineligible subject matter under section 101.

4. Cleveland Clinic Foundation v. True Health Diagnostics LLC, 859 F.3d 1352 (Fed. Cir. 2017).  The claimed invention is a method for diagnosing risk of cardiovascular disease by analyzing for the enzyme myeloperoxidase ("MPO").  The court held that even though prior methods for detecting MPO were inferior, the discovery of how to directly analyze for MPO, and discovery of the relation to the risk of cardiovascular disease, although "groundbreaking, 'even such valuable contributions can fall short of statutory patentable subject matter.'"  Id. at 1363 (quoting Ariosa, 788 F.3d at 1380).

5. Roche Molecular Systems, Inc. v. CEPHEID, 905 F.3d 1363 (Fed. Cir. 2018).  The claimed invention is a method for detecting the pathogenic bacterium Mycobacterium tuberculosis ("MTB"), based on nucleotide content and a novel method of analysis.  The court stated that the method is new, unobvious, and "both faster and more accurate than the traditional MTB detection methods," id. at 1366, but held that the method is ineligible under section 101.

6. Cleveland Clinic Foundation v. True Health Diagnostics LLC, 760 F. App'x 1013 (Fed. Cir. 2019).  The claimed invention is the novel immunoassay to detect the correlation between blood MPO levels and cardiovascular disease.  The court held that the claims are for a law of nature and ineligible under section 101.

(Including Athena there are seven such cases.) (Conversely, as Judge Newman notes in her dissent, the Federal Circuit has repeatedly affirmed eligibility of "method of treatment" claims, in Rapid Litigation Management Ltd. v. CellzDirect, Inc.; Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Ltd.; Natural Alternatives Int'l, Inc. v. Creative Compounds, LLC; and Endo Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc.)

Both Judge Moore (writing in dissent) and Judge Chen (concurring) also recognize the problematic nature of the Court's jurisprudence on patent eligibility.  And each agree with Judge O'Malley that Congress alone can address the issue, Judge Moore stating that:

In the wake of Mayo, we have painted with a broad brush, suggesting that improved diagnostic techniques are not patent eligible.  Mayo did not go so far, and given the import of diagnostic techniques, we should reconsider this case and clarify our precedent.  Because my colleagues have declined to do so, there are no more options at this court for diagnostic patents.  My colleagues' refusal deflates the Amici's hopeful suggestion that our precedent leaves the eligibility of a diagnostic claim in front of the Federal Circuit "uncertain."  It is no longer uncertain.  Since Mayo, every diagnostic claim to come before this court has been held ineligible.  While we believe that such claims should be eligible for patent protection, the majority of this court has definitively concluded that the Supreme Court prevents us from so holding. No need to waste resources with additional en banc requests.

For those keeping score, it appears that all (or almost all) of the members of the Court believe that their patent eligibility cases have been wrongly decided.  Chief Judge Prost, joined by Judges Lourie, Dyk, Reyna, Hughes, Taranto, and Chen believe the Court's hands are tied by Supreme Court precedent, while Judges Newman, Moore, O'Malley, Wallach, and Stoll believe the Federal Circuit has the basis to distinguish Supreme precedent and hold these claims (or at least claims 7-9 of Athena's claims at issue) are patent eligible.

Judge O'Malley provides an additional avenue for Congressional intervention, related to the Supreme Court's resurrection of the "inventive concept" trope many believed was relegated to the dustbin of history by Section 103 in Giles Sutherland Rich's revision resulting in the 1952 Patent Act.  She provides an alternative to Senator Tillis' and Coons' proposed statutory abrogation of the judicial exceptions (which raises its own issues on Congressional authority and the Supreme Court's oversight on ultra vires legislative actions).  Judge O'Malley's suggestion is direct:

Had the Supreme Court not disregarded Congress's wishes for a second time [by introducing "inventive concept" into its Section 101 calculus], perhaps the outcome in this case would be different.  . . .  Indeed, claims directed to uses of natural laws rather than the natural laws themselves would be eligible under § 101 as written.  Because the Supreme Court judicially revived the invention requirement and continues to apply it despite express abrogation, I dissent to encourage Congress to clarify that there should be no such requirement read into § 101; to clarify that concepts of novelty and "invention" are to be assessed via application of other provisions of the Patent Act Congress designed for that purpose.

The issue for the Federal Circuit is not just that their views are so fractured, but that the dissension between the Judges regarding whether they should simply apply Supreme Court precedent (even incorrectly) until such time as the Supreme Court deign to address the issue, or whether their "special expertise" and Congressional mandate creates a responsibility to distinguish the Supreme Court's precedent when it does not properly apply, at least to provide incentive to the Supreme Court to provide (in its view) the correct interpretation of what is and what is not patent eligible.  In at least the view of five of the judges (and many in the patent bar) the Federal Circuit has failed in exercising it responsibility, to the extent that many openly speculate whether we need the Federal Circuit at all.