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 factual and policy determinations relevant to setting the proper balance of innovation incentives under patent law.
In the third concurrence (which numbers more than thirteen pages), Judge Dyk, joined by Judges Hughes and Chen (with Judge Chen only joining the last three parts of the concurrence), points out (to begin Part IV of his opinion) that:
[T]here is tension between Mayo and the Supreme Court's later decision in Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), and that the holding of Mayo may be overbroad. The language of § 101 does cover "discover[ies]," 35 U.S.C. § 101, and there is no doubt that determining the relationship between specific genetic abnormalities and specific diseases constitutes an important discovery with proven utility. There is much to be said for the patentability of claims to such discoveries, if not drafted overbroadly.
Of the authors of the four concurring opinions, Judge Dyk stands apart in finding something beneficial in the Supreme Court's precedent on subject matter eligibility. In Part I of his opinion, Judge Dyk explains that:
In the realm of abstract ideas, the Mayo/Alice framework has successfully screened out claims that few would contend should be patent eligible, for example, those that merely apply well-known business methods and other processes using computers or the Internet. The Mayo/Alice framework has thus proven to be both valuable and effective at invalidating overly broad, non-inventive claims that would effectively "grant a monopoly over an abstract idea."
In support of his position, he cites Trading Techs. Int'l, Inc. v. IBG LLC (Fed. Cir. 2019); SAP Am., Inc., v. Investpic, LLC (Fed. Cir. 2018); Credit Acceptance Corp. v. Westlake Servs. (Fed. Cir. 2017); Elec. Power Grp., LLC v. Alstom S.A. (Fed. Cir. 2016); Intellectual Ventures I LLC v. Capital One Bank (Fed. Cir. 2015); Ultramercial, Inc. v. Hulu, LLC (Fed. Cir. 2014); and buySAFE, Inc. v. Google, Inc. (Fed. Cir. 2014). However, Judge Dyk also notes that the Federal Circuit's subject matter eligibility precedent "has allowed room for claims that do more than recite conventional applications of abstract concepts," citing Ancora Techs., Inc. v. HTC Am., Inc. (Fed. Cir. 2018); Finjan, Inc. v. Blue Coat Sys., Inc. (Fed. Cir. 2018); and Enfish, LLC v. Microsoft Corp. (Fed. Cir. 2016) in support.
In Part II of his opinion, Judge Dyk defends the need for Alice/Mayo framework, contending that "[d]espite assertions to the contrary, the doctrines of novelty under § 102, obviousness under § 103, and enablement and written description under § 112 cannot adequately guard against the dangers of overclaiming." Judge Dyk also notes that these provisions do not "typically allow early stage resolution of the 'threshold' issue of patent eligibility . . . necessary to avoid the costs of lengthy litigation," and therefore concludes that the patent eligibility analysis of "§ 101 serves an important purpose not served by these other provisions in the Patent Act." Offering an example of the alleged inadequacy of the other provisions to guard against overclaiming, Judge Dyk suggests that "[i]f the first person to identify the relationship between a genetic abnormality and a disease had sought a broad patent on a method of searching for genetic abnormalities and determining their relationship to disease, the claims would have been neither anticipated nor obvious."
For Judge Dyk, "[t]he problem with § 101 arises not in implementing the abstract idea approach of Alice, but rather in implementing the natural law approach of Mayo," explaining in Part III of his opinion that "[a]lthough Mayo's framework is sound overall, I share the concerns expressed by my dissenting colleagues that the Mayo test for patent eligibility should leave room for sufficiently specific diagnostic patents." However, as Judge Hughes indicated in his concurrence, Judge Dyk states that "it is the Supreme Court, not this court, that must reconsider the breadth of Mayo."
In Part IV of his concurrence, Judge Dyk elaborates on the tension between the Supreme Court's decisions in Mayo and Myriad, stating that:
Myriad thus recognized that an inventive concept can sometimes come from the discovery of an unknown natural phenomenon and its application for a diagnostic purpose. This appears to be in tension with Mayo. Under Mayo, a natural phenomenon itself, no matter how narrow and specific, cannot supply the requisite "inventive concept."
Judge Dyk suggests that "it would be desirable for the Supreme Court to refine the Mayo framework to allow for sufficiently specific diagnostic patent claims with proven utility," contending that "[t]he inventive concepts in this area may lie primarily in the application of a natural law."
According to Judge Dyk, however, the refinements to the Mayo framework that are needed are "limited." In particular, Judge Dyk explains in Part V of his opinion that "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." However, "the application must be more than determining the precise correlation of a known relationship using prior art processes, as was the case in Mayo itself."
With respect to the claims at issue in Athena, Judge Dyk suggests in Part VI of his concurrence that "this case may involve claims that could be patent eligible under []his suggested approach." He points out that "claims 7–9 do not claim the natural law itself—the relationship between MuSK autoantibodies and MG, a rare neurological disorder—but rather claim specific methods of diagnosing neurological disorders like MG by detecting MuSK autoantibodies." Thus, according to Judge Dyk, Athena, unlike Mayo, "involves a 'discovery' of the relationship, not mere determination of the precise correlations of a known natural law using prior art processes." Judge Dyk concludes his opinion by suggesting that "this case could provide the Supreme Court with the opportunity to refine the Mayo framework as to diagnostic patents."
In the fourth and final concurrence (which at more than sixteen pages is the longest of the concurring opinions), Judge Chen states that "[w]hile I believe our court would benefit from the Supreme Court's guidance as to whether it intended to override central tenets of [Diamond v.] Diehr [450 U.S. 175 (1981)], Mayo's reasoning is clear and we are bound by it," adding that the analysis in Mayo "requires the affirmance of the district court’s decision to invalidate Athena's claims." Judge Chen notes, however, that "[e]ven though Athena's claims likely would be found patent-eligible under Diehr's framework, it is not an inferior court's role to dodge the clear, recent direction of the Supreme Court."
Judge Chen begins his concurrence by noting that the Supreme Court in Diehr "adopted a relatively narrow and more administrable version of the judicial exceptions to the statutory text of 35 U.S.C. § 101 compared to what the Court articulated three years earlier in Parker v. Flook, 437 U.S. 584 (1978)." He also suggests that "[u]nder Diehr's 'claim as a whole' principle, which does not divide the claim into new versus old elements, Athena's claims, particularly claims 7 and 9, likely would have been found to be directed to a patent-eligible process." However, he acknowledges that in Mayo, the Supreme Court "set forth an inventive concept/point of novelty framework, which is a more far-reaching, aggressive version of the judicial exceptions to the statute and is largely incompatible with Diehr's core rationale," even though "nothing in Mayo suggests that it sought to repudiate Diehr's analysis."
Judge Chen provides a detailed analysis of Diehr, Flook, Mayo, and Alice, before turning to Athena's claims. With respect to Diehr and Flook, Judge Chen contends that "[g]iven Diehr's evident disagreement with Flook's analysis, Diehr, as the later opinion, was widely understood to be the guiding, settled precedent on § 101 for three decades," with Diehr "reject[ing] the point of novelty/inventive concept approach to patent eligibility." According to Judge Chen, "Mayo provided a framework for the judicial exceptions that strongly tracked the reasoning of Flook and the Diehr dissent." Thus, Judge Chen argues that "Mayo is in considerable tension with Diehr's instruction to consider claims 'as a whole' and Diehr's disapproval of dissecting claims into elements and ignoring non-novel elements in the § 101 analysis." And, as Judge Chen explains:
When it comes to applying the judicial exceptions, it bears noting that the Mayo analytical approach is considerably harder to apply consistently than the Diehr framework, and more aggressive in its reach. Consider the claim in Mayo. If that claim had recited just the single step of administering a synthetic drug to a patient, that single-step claim would be patent-eligible, but lack novelty under § 102. And if that claim added a second step for determining the subsequent level of a non-naturally occurring metabolite in a patient, that claim also would pass muster under § 101, but lack novelty. But when the claim further recites a relationship between a metabolite level and its efficacy in a patient, that claim suddenly would be invalid under § 101 for violating the law of nature exception. In other words, steps 1 and 2 now get pushed aside and declared insignificant, and the last step is designated as the "focus" of the claim, i.e., the heart of the invention. The notion that adding claim language can convert an otherwise patent-eligible claim into a patent-ineligible claim is counterintuitive and a very difficult thing to explain to 8,000 patent examiners. Moreover, the process of determining what the claim is "really about" when the claim is viewed in pieces, rather than as a whole, can be highly subjective and impressionistic.
According to Judge Chen, "there is a serious question today in patent law as to what extent Diehr remains good law in light of Mayo," and he indicates that this is a question for the Supreme Court to resolve.
In the last part of his opinion, Judge Chen examines the claims at issue in Athena. While conceding that "the Supreme Court has made clear that detecting a law of nature (without more than conventional steps for accessing the law of nature) does not qualify as a patent-eligible application of a law of nature," Judge Chen notes that "given that the dual 'invention or discovery' structure consistently has been part of every Patent Act since 1790, this statutory provision suggests that at least some discoveries, including Athena's 'discovery' of how to diagnose myasthenia gravis, have always been contemplated as patentable subject matter." Thus, while Judge Chen "do[es] not think the claims here can withstand Mayo's scrutiny," he argues that "perhaps when read 'as a whole' under Diehr, claims such as claims 7 and 9 in this case could be viewed as methods of testing for a specific medical condition, employing a sequence of steps that physically transform materials," adding that "this sounds like a contribution to the 'useful arts' stated in Article I, Section 8, Clause 8 of the U.S. Constitution."
Judge Chen concludes his opinion by suggesting that:
New methods for diagnosing medical conditions, as a general matter, intuitively seem to be the kind of subject matter the patent system is designed for: to encourage the risky, expensive, unpredictable technical research and development that people would not otherwise pursue in the hope that if they discover something of great medical value, then they will be protected and rewarded for that successful effort with a patent.
Nevertheless, Judge Chen declares that he is bound by "the clear, recent direction of the Supreme Court" to concur with the denial of Athena's petition for rehearing en banc.
In a subsequent post, we will focus more closely on the dissenting opinions.
