On July 3, the Federal Circuit issued a per curiam Order in Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC, denying a petition for rehearing en banc filed by Plaintiffs-Appellants Athena Diagnostics, Inc., Oxford University Innovation Ltd., and the Max-Planck-Gesellschaft zur Forderung der Wissenschaften E.V. The Court also denied Plaintiffs-Appellants a panel rehearing.
The four page per curiam Order was accompanied by eight opinions, four concurring in the denial of the petition and four dissenting in the denial of the petition, adding an additional 82 pages to the Order. The four concurring opinions were authored by Circuit Judges Lourie, Hughes, Dyk, and Chen, with Chief Judge Prost and Circuit Judges Reyna, Taranto, and Hughes joining in one of the concurrences and Circuit Judge Chen joining in one concurrence and several parts of another. The four dissenting opinions were authored by Circuit Judges Moore, Newman, Stoll, and O'Malley, with Circuit Judges O'Malley and Stoll joining in one of the dissents and Circuit Judge Wallach joining in three of the dissents. Thus, a total of seven members of the Court (Chief Judge Prost and Circuit Judges Lourie, Dyk, Reyna, Taranto, Chen, and Hughes) authored or joined opinions concurring in the denial, and a total of five members (Circuit Judges Newman, Moore, O'Malley, Wallach, and Stoll) authored or joined opinions dissenting in the denial.
Last week, we reviewed the procedural history of the case and provided a brief summary of the eight concurring and dissenting opinions (see "Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC (Fed. Cir. 2019)"). In this post, we focus more closely on the four opinions concurring in the Order's denial of the petition for rehearing en banc. As we noted last week, the general theme of the concurrences is that the Supreme Court's decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc. left the members of the Court with no choice other than to deny the petition.
In the first concurrence, Judge Lourie, joined by Judges Reyna and Chen, declares in a 4-page opinion that the Court "can accomplish little in [rehearing the case en banc], as we are bound by the Supreme Court's decision in Mayo," adding that:
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," as Judge Lourie states, "we do not write here on a clean slate; we are bound by Supreme Court precedent."
Judge Lourie notes that the Federal Circuit has "held claims focused on detecting new and useful natural laws with conventional steps to be ineligible," citing Cleveland Clinic Found. v. True Health Diagnostics LLC and Ariosa Diagnostics, Inc. v. Sequenom, Inc. in support (without mentioning that both examples concern claims to diagnostic methods), but that "[i]n contrast, new method of treatment patents do not fall prey to Mayo's prohibition," citing Vanda Pharm. Inc. v. West-Ward Pharm. Int'l Ltd. Judge Lourie also notes that "unconventional arrangements of known laboratory techniques, even if directed to a natural law" have also been found by the Federal Circuit to be patent eligible, citing Rapid Litig. Mgmt. Ltd. v. CellzDirect, Inc. However, the instant case, as he points out, "involves neither scenario."
While explaining that "[t]he only unconventional aspect is the inventors' discovery of what the Supreme Court would call the natural law—the correlation between MuSK autoantibodies and the neurological disorder myasthenia gravis," Judge Lourie concedes that the Court "cannot premise eligibility solely on the natural law's novelty." Judge Lourie also opines that:
Under Supreme Court precedent, I do not believe that specific yet purely conventional detection steps impart eligibility to a claim that otherwise only sets forth what the Court has held is a natural law. That is the situation presented in Ariosa, Cleveland Clinic, and now Athena. Accordingly, as long as the Court's precedent stands, the only possible solution lies in the pens of claim drafters or legislators. We are neither.
And to those in the patent community (including amici) who have complained that the Federal Circuit's eligibility precedent is "confused," Judge Lourie responds that "our cases are consistent," explaining that the Court has "distinguished between new method of treatment claims and unconventional laboratory techniques, on the one hand, and, on the other hand, diagnostic methods that consist of routine steps to observe the operation of a natural law," which he finds to be "a clear line." He concludes his opinion by stating that beyond this distinction, he does "not see a way clear to distinguish Mayo in a useful, principled, fashion," and therefore is left to concur with the denial of the petition "because I do not believe we can convincingly distinguish Mayo in this case."
In the second concurrence (which at a little over a page is the shortest of the concurring opinions), Judge Hughes, joined by Chief Judge Prost and Judge Taranto, notes that "[t]he multiple concurring and dissenting opinions regarding the denial of en banc rehearing in this case are illustrative of how fraught the issue of § 101 eligibility, especially as applied to medical diagnostics patents, is." However, he also notes that while "the bottom line for diagnostics patents is problematic . . . this is not a problem that we can solve," adding that "[a]s an inferior appellate court, we are bound by the Supreme Court."
Judge Hughes concludes by stating that:
I, for one, would welcome further explication of eligibility standards in the area of diagnostics patents. Such standards could permit patenting of essential life saving inventions based on natural laws while providing a reasonable and measured way to differentiate between overly broad patents claiming natural laws and truly worthy specific applications. Such an explication might come from the Supreme Court. Or it might come from Congress, with its distinctive role in making the...
