On July 3rd, the Fed. Cir. denied Athena’s petition for rehearing en banc. The three-page order is a 7/5 denial accompanied by more than 80 pages of concurrences and dissents. Concurring in various combinations are Judges Lourie, Hughes, Dyk, Reyna, Prost, Hughes and Taranto, with Dyk and Chen doing most of the writing. The dissenters were Judges Newman, Moore, Wallach, Stoll and O’Malley with Moore and Newman as the main authors.
I wish I had the staff to provide you with a condensed account of the opinions, but they draw the lines between the Judges who believe that denial was required because they could not distinguish (or did not think that the S. Ct. would distinguish) Prometheus v. Mayo from the facts of Athena v. Mayo and the dissenters who think the Fed. Cir. can and should.
Part I. The Concurrences
One theme, succinctly summarized by Judge Lourie appears to be shared by all of the Judges:
“If I could write with a clean slate, I would write an exception to patent eligibility [“PE”], as respects natural laws, only claims directed to the natural law itself, e.g., E=mc2, F=ma…etc. I would not exclude uses or detection of natural laws. The laws of [102, 103 and 112] provide other filters to determine what is patentable….because the claims recited only what the [S. Ct.] called a natural law together with well understood, conventional activities, the Court concluded the claims were ineligible under s. 101.”
Judge Lourie offers little hope for the simple “If A, then B” claim:
“[Our decisions] have distinguished between new method of treatment claims, and unconventional laboratory tests on the one hand, and, on the other hand, diagnostic methods that consist of routine steps to observe the operation of natural law, a clean line.”
But not a very rewarding line, if one is trying to patent a simple “If A, then B” diagnostic test, without a treatment step or a “second invention” in the claims.
Judge Hughes sums up the primary theme for both the majority and the dissenters when he asks the S. Ct. or Congress to provide: “[s]tandards [that] 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.”
Judge Dyk begins his concurrence with his opinion that ss. 101, 103 and 112 cannot curtail “the dangers of overclaiming,” and presents as an example the claims from In re BRCA1- & BRCA2-Based Heritary Canceer Test Patent Litigation, 774 F.3d 755 (Fed. Cir. 2014)(“Ambry”) that were “directed to ‘the patent-ineligible abstract idea of comparing BRCA sequences and determining the existence of alterations.'” Although the claims were not restricted to the alteration being detected or to detection of the risk of any specified type of cancer or any other condition, Judge Dyk believes that the claimed “broad concept” was properly found patent-ineligible under s. 101, “though the claims may well have survived challenge under ss. 102, 103, and 112.” While this was a holding based on claims to an abstract idea, he notes:
“The problem with s. 101 arises not in implementing the abstract idea approach of Alice but rather in implementing the natural law approach of Mayo.”
True enough, and it is somewhat interesting to see the Judge splitting the Mayo/Alice test into two parts. Judge Dyk also agrees with the dissenters that the “Mayo test” for PE should leave room for sufficiently specific diagnostic patents, but that “Mayo left no room for us to find typical diagnostic claims [ed. note: I call them “If A, then B” tests] PE absent some inventive concept at Mayo step 2.”
Judge Dyk goes on to note that the central correlation between MuSK autoantibodies and MG in Athena and the correlation between the metabolite levels and optimal drug efficacy in Mayo are “similar” in that they both set forth a natural law. At Mayo step 2, both the how-to Mayo claim elements and the how-to Athena claim elements are conventional and do not supply the requisite inventive concept.
Judge Dyk goes on to agree that there is tension between Mayo and AMP v. Myriad, in that Myriad suggests that discoveries, such as new applications of knowledge derived from isolation and characterization of the BRCA genes, may be patent eligible, including claims to the correlation between the risk of certain cancers and “specific mutations in the BRCA1 gene.” However, as Judge Dyk specifically noted in Meriel, “[u]nder Mayo, a natural phenomenon itself, no matter how narrow and specific, cannot supply the requisite ‘inventive concept.'” Judge Dyk now wants the S. Ct. to “refine” the Mayo test to allow for “sufficiently specific diagnostic patent claims with proven utility.”
The refinement Judge Dyk proposes would, of course, exclude claims to the natural phenomena per se, e.g., “Claim 1. Lightning”[ed. note: my example]. He continues by proposing that “[f]or there to be a PE application of a natural law, there must be a ‘discovery.'” Here he cites a S. Ct. decision, Brenner v. Manson, that requires that a claimed invention must be sufficiently “refined and developed” so as not to overly preempt “whole areas of scientific development.”
Judge Dyk comes back to Brenner v. Manson when he discusses the need for the s. 101 natural law exception to be “necessarily informed by the utility requirement of s. 101. He argues that PE claims should have an “established utility” and “because of their breadth, the claims in Mayo would not be eligible at step one.”
Now Judge Dyk essentially reverses his opinion in Meriel that discovery of the utility of a naturally occurring correlation can never provide the required “inventive step”:
“However, if the claim is sufficiently tied to a specific and useful application of a natural law at Mayo step one, that application itself should serve as the necessary inventive concept at Mayo step two. Yet at step two, the application must be more than determining the precise correlation of a known relationship using prior art process, as was the case in Mayo itself…Thus Mayo’s claims only involved determining the precise correlations of a law of nature that was already well-known.”
Judge Dyk goes on to identify claims in Athena “that could be patentable under this suggested approach” that he hopes that the S. Ct. will adopt to “refine the Mayo framework as to diagnostic patents.” Hear, hear! Note that Judge Dyk’s concurrence was joined by Reyna and Chen. This order could have granted rehearing en banc by an 8/4 majority, and Judge Dyk’s framework for revision would have eventually gone to the S. Ct. with his refinements adopted by the majority of the Fed. Cir.
Judge Chen begins by taking a leisurely stroll through the major precedent that we all know well by now – and concludes that Mayo effectively reversed Diehr and attacked Flook. He pauses to demonstrate that, absent the correlating step, the Mayo claims to administering the drug and the further step of determining the level of the metabolite would be PE(!). He concludes that “[t]he notion that adding claim language can convert an otherwise PE claim into a patent-ineligible claim is counter intuitive and a very difficult thing to explain to 8000 patent examiners.” (He notes that the “wherein” clauses should be given no weight in determining patentability.)
He goes on to state the obvious in criticizing the “process of determining what the claim is “really about” when the claim is viewed in pieces, rather than as a whole, [that] can be highly subjective and impressionistic…by assigning some [limitations] as significant and others as insignificant. Judge Chen then observes:
“Mayo’s framework is in tension on its face with Diehr, which was equally clear in requiring that a patent claim be considered as a whole, without putting aside any natural law or otherwise dissecting the claim into new versus old elements…”Importantly, Mayo does not say that it nullified this key ‘limitation’ expressed in Diehr.”
Judge Chen argues that the S. Ct. should resolve whether or not Diehr is still good law in view of Mayo, since, in the 30 years since Diehr, the PTO has granted many patents on diagnostic claims that “do not hold up well against Mayo’s more searching, claim dissection scrutiny.”
He goes on to review how the Athena claims are not PE post-Mayo, but argues that the statutory and precedential sanction of patentable “discoveries” strongly suggests that some discoveries, such as the one embedded in the Athena claims “have always been contemplated as patentable subject matter.” However, he notes that he “is not aware of the Supreme Court ever addressing the meaning of “discovers” in 101, separately from “invents”, and that the Court should “speak to that statutory question.”
Part II. The Dissenters
Judge Moore begins by noting that all of the judges agree that “If A, then B” Athena-type diagnostic claims should be PE. But she disagrees that Mayo requires that the Athena claims be found patent ineligible, and that Mayo can be distinguished.
She begins by stating that, since Mayo, the Fed. Cir. has invalidated every diagnostic claim it has considered as not PE. She follows with a review of the medical importance of the patents that have failed the Mayo test and concludes that “[w]e have turned Mayo into a per se rule that diagnostic kits and techniques are ineligible.” She then reviews decisions in which the Supreme Court rejected “rigid or per se rules” going all the way back to Chakrabarty. Interestingly, she notes that Judge Dyk in Ariosa recognized that there is a “problem with Mayo insofar as it concludes that inventive concept cannot come from the discovery of something new in nature…inventive concept can come…but…from the creativity and novelty of the discovery of the law itself.”
Judge Moore then spends about 7 pages review of the importance of diagnostics and their dependence on strong patent protection to induce the investment needed to develop them. She then proceeds to criticize the Fed. Cir.’s precedent that has “ignored the truth that claims to specific, narrow processes, even if those processes involve natural laws, are not directed to the natural laws themselves…We have misread Mayo and how it fits within the framework of the judicially-created exceptions to s. 101 for laws of natures, natural phenomena, and abstract ideas.”
She posits that the law of nature at issue in Mayo, the relationship between metabolite concentrations and drug efficacy, was known to the art and “[w]hile the inventors characterized the precise correlation, they could not be said to have discovered the relationship in the first place…the claim in its entirety did nothing more than describe the natural relationship between metabolite concentration and the effective dose of a thiopurine drug.” She concludes that “the breadth and generality of the Mayo claims led to their demise, as they recited nothing more than the natural law.” [Ed. note: Is this the end of the road for dosing and regimen claims, that are in “add-on” patents often invalidated as inherently anticipated by the prior art method of treatment patents or publications? See also Moore, slip op. at 21].
She contrasts the Athena claims as much more sophisticated:
“The inventors in Athena discovered that these MG sufferers produced anti-MuSK antibody, and created a process for diagnosing MG using methods that detect the presence of the antibody. These methods had never been used to diagnose MG….Athena is a single, specific method for applying the applicable law.”
Accordingly, Judge Moore goes on to argue that the practice of the invention provides little preemption of the MG diagnostic space and concludes:
“I do not understand Mayo to render ineligible a claim which covers a specific concrete application of a natural law simply because such a claim is diagnostic as opposed to therapeutic. Both should be eligible…. [because of the broad brush approach we have taken in applying Mayo there is] [n]o need to waste resources with additional en banc requests. [Patentees] only hope lies with the Supreme Court or Congress.”
Judge Newman, who has been the “great dissenter” on a number of Fed. Cir. opinions in this area, argues that the S. Ct. did not hold that methods of diagnosis are subject to unique PE rules, and the “the Supreme Court’s Mayo decision did not convert diagnostic methods into laws of nature.” She emphasizes that the Athena method claims were conceded to be new and unobvious. Judge Newman reviews precedent requiring that claims be considered as a whole and argues:
“Athena’s diagnostic method is not a law of nature; it is a novel man-made method of diagnosis of a neurological disorder. The Athena diagnostic method…was unknown in the prior art. The Court in Mayo did not exclude such methods from eligibility.”
Judge Newman then compares and fails to find much factual contrast in diagnostic claims found patent ineligible by the Fed. Cir. and method of treatment claims found to be PE. She quotes from the recent Senate subcommittee hearings: “Courts have clouded the line to exclude critical medical advances like life-saving precision medicine and diagnostics.” Judge Newman concludes that “No benefit has been suggested by excluding medical diagnostic methods for the patent incentive system.”
Judge Stoll believes that the Fed. Cir. has established a bright line rule of ineligibility for all diagnostic claims. She dissents from denial of rehearing en banc of this “type of exceptionally important issue that warrants full consideration by this court.” [Ed. note: After typing for parts of three days, it court be argued that full consideration was provided by the eight opinion penned by the Judges.] Judge Stoll writes to argue that there is no statutory basis for an “inventive concept” requirement, at least since passage of the Patent Act of 1952:
“But although Congress so amended the Act decades ago, we continue to apply the invention requirement today under a new name–the ‘inventive concept’ requirement.” She calls for legislative action “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.”
Athena is now left to file a petition for cert., knowing that the S.Ct. has not granted a single one since Mayo/Myriad/Alice. At least the Supreme Court will have the benefit of 8 opinions that effectively urge, if not beg, the Court to revisit and “revise” Mayo. The Mayo Court suggested that diagnostic claims may need additional protection post-Mayo. That time has come.