Per Curiam.
A petition for rehearing en banc was filed by appellants Athena Diagnostics,
Upon consideration thereof,
IT IS ORDERED THAT:
FOR THE COURT
Lourie, Circuit Judge, with whom Reyna and Chen, Circuit Judges, join, concurring in the denial of the petition for rehearing en banc.
I concur in the court's decision not to rehear this case en banc. In my view, we can accomplish little in doing so, as we are bound by the Supreme Court's decision in Mayo. Some of us have already expressed our concerns over current precedent. E.g., Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC, 915 F.3d 743, 753 n.4 (Fed. Cir. 2019); Ariosa Diagnostics, Inc. v. Sequenom, Inc., 809 F.3d 1282, 1284 (Fed. Cir. 2015) (Lourie, J., concurring in the denial of rehearing en banc); id. at 1287 (Dyk, J., concurring in the denial of rehearing en banc).
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&equalsmc2, F&equalsma, 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. In Mayo Collaborative Services v. Prometheus Laboratories, Inc., the claims at issue were held by the Court to be directed to the relationship between the concentration of metabolites in the blood and the likelihood that a drug dose will be ineffective, which it referred to as a law of nature. 566 U.S. 66, 74-75, 77, 132 S.Ct. 1289, 182 L.Ed.2d 321 (2012). The other steps—administering a drug and detecting the level of a specific metabolite—added only "[p]urely `conventional or obvious' `[pre]-solution activity'" that was "not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law." Id. at 79, 132 S.Ct. 1289 (second alteration in original) (quoting Parker v. Flook, 437 U.S. 584, 590, 98 S.Ct. 2522, 57 L.Ed.2d 451 (1978)); see Bilski v. Kappos, 561 U.S. 593, 610-11, 130 S.Ct. 3218, 177 L.Ed.2d 792 (2010) ("[T]he prohibition against patenting abstract ideas `cannot be circumvented by attempting to limit the use of the formula to a particular technological environment' or adding `insignificant postsolution activity.'" (quoting Diamond v. Diehr, 450 U.S. 175, 191-92, 101 S.Ct. 1048, 67 L.Ed.2d 155 (1981))); Flook, 437 U.S. at 590, 98 S.Ct. 2522 ("The notion that post-solution activity, no matter how conventional or obvious in itself, can transform an unpatentable principle into a patentable process exalts form over substance."). Because the claims recited only what the Court called a natural law together with well-understood, conventional activity, the Court concluded the claims
In applying Mayo, we have accordingly held claims focused on detecting new and useful natural laws with conventional steps to be ineligible. E.g., Cleveland Clinic Found. v. True Health Diagnostics LLC, 859 F.3d 1352, 1363 (Fed. Cir. 2017), cert. denied, ___ U.S. ___, 138 S.Ct. 2621, 201 L.Ed.2d 1026 (2018); Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1378 (Fed. Cir. 2015), cert. denied, ___ U.S. ___, 136 S.Ct. 2511, 195 L.Ed.2d 841 (2016). In Cleveland Clinic, the claims recited a specific assay to detect the protein MPO, the enzyme-linked immunosorbent assay. 859 F.3d at 1357-58, 1362. Ariosa similarly involved a specific technique to amplify and detect DNA, the polymerase chain reaction. 788 F.3d at 1377. But in both cases, the patents' specifications described these techniques as well-understood and conventional. Cleveland Clinic, 859 F.3d at 1355; Ariosa, 788 F.3d at 1377. We concluded that using these routine assays to detect new natural phenomena did not transform the claims into patent eligible applications. Cleveland Clinic, 859 F.3d at 1362-63; Ariosa, 788 F.3d at 1376-77.
In contrast, new method of treatment patents do not fall prey to Mayo's prohibition. E.g., Vanda Pharm. Inc. v. West-Ward Pharm. Int'l Ltd., 887 F.3d 1117, 1136 (Fed. Cir. 2018). Nor have unconventional arrangements of known laboratory techniques, even if directed to a natural law. Rapid Litig. Mgmt. Ltd. v. CellzDirect, Inc., 827 F.3d 1042, 1051 (Fed. Cir. 2016). But this case involves neither scenario. Athena's claims recite observing a natural law using a radioimmunoassay that the specification describes as "standard" and "known per se in the art." U.S. Patent 7,267,820 col. 3 ll. 33-37, col. 4 ll. 10-12. The claims do not recite a new method of treatment or an unconventional combination of steps to detect the natural law. The 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—but we cannot premise eligibility solely on the natural law's novelty. Mayo, 566 U.S. at 73, 132 S.Ct. 1289 (concluding that "the steps in the claimed processes (apart from the natural laws themselves) involve wellunderstood, routine, conventional activity previously engaged in by researchers in the field" (emphasis added)); Flook, 437 U.S. at 591-92, 98 S.Ct. 2522 ("[T]he novelty of the mathematical algorithm is not a determining factor at all" and "is treated as though it were a familiar part of the prior art."). 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.
Amici and others have complained that our eligibility precedent is confused. However, our cases are consistent. They have 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, a clear line. Beyond that, I do not see a way clear to distinguish Mayo in a useful, principled, fashion. Software is another matter, but such patents are not before us here.
I therefore concur in the decision of the court not to take this case en banc because I do not believe we can convincingly distinguish Mayo in this case.
The 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. I agree that the language in Mayo, as later reinforced in Alice, forecloses this court from adopting an approach or reaching a result different from the panel majority's. I also agree, however, that the bottom line for diagnostics patents is problematic. But this is not a problem that we can solve. As an inferior appellate court, we are bound by the Supreme Court.
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.
Dyk, Circuit Judge, with whom Hughes, Circuit Judge, joins, and with whom Chen, Circuit Judge, joins as to Parts IV, V, and VI, concurring in the denial of the petition for rehearing en banc.
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.
Despite 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. In Mayo, the Supreme Court rejected the argument that "other statutory provisions"—specifically §§ 102, 103, and 112—could adequately "perform th[e] screening function" served by § 101. 566 U.S. at 89, 132 S.Ct. 1289. Although the Court recognized that the § 101 patent eligibility inquiry "might sometimes overlap" with considerations of novelty and non-obviousness under §§ 102 and 103, it concluded that "to shift the patent-eligibility inquiry entirely to these later sections risks creating significantly greater legal uncertainty, while assuming that those sections can do work that they are not equipped to do." Id. at 90, 132 S.Ct. 1289. Those sections and § 112 do not adequately address "the risk that a patent on the [natural] law would significantly impede future innovation." Id. at 90-91, 132 S.Ct. 1289; see also Mark Lemley et al., Life After Bilski, 63 Stan. L. Rev. 1315, 1329-32 (2011) (outlining differences between §§ 101 and 112). Nor do these other provisions typically allow early stage resolution of the "threshold" issue of patent eligibility, Bilski, 561 U.S. at 602, 130 S.Ct. 3218, necessary to avoid the costs of lengthy litigation. Thus, § 101 serves an important purpose not served by these other provisions in the Patent Act.
A simple example in the area of diagnostic patents illustrates this point. If 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. Nor is it likely that they would they have been invalid for lack of enablement (since a representative species was disclosed) or written description (the overall conception being in the mind of the inventor). The only barrier to such broad patent claiming is § 101.
In fact, one of the diagnostic patents that we have held unpatentable under § 101 had exactly that problem of overbreadth. In In re BRCA1- & BRCA2- Based Hereditary Cancer Test Patent Litigation, 774 F.3d 755 (Fed. Cir. 2014), we held that genetic testing claims were directed to the "patent-ineligible abstract idea of comparing BRCA sequences and determining the existence of alterations" of the gene. Id. at 763. We noted the breadth of the claims, explaining that they "are not restricted by the purpose of the comparison or the alteration being detected," nor "limited to the detection of risk of breast or ovarian cancer." Id. at 763-64. Indeed, the claims encompassed "comparisons for purposes other than detection of
The problem with § 101 arises not in implementing the abstract idea approach of Alice, but rather in implementing the natural law approach of Mayo. Although 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. But it is the Supreme Court, not this court, that must reconsider the breadth of Mayo.
Although the Supreme Court's decision in Mayo did not make all diagnostic claims patent ineligible, as we previously held in Ariosa, 788 F.3d at 1376-77, Mayo left no room for us to find typical diagnostic claims patent eligible, absent some inventive concept at Mayo step two. The panel here correctly concluded that Mayo controls.
The inventors of U.S. Patent 7,267,820 ("the '820 patent") discovered that myasthenia gravis ("MG"), a neurological disorder, can be diagnosed by detecting the presence of MuSK autoantibodies in bodily fluid. See Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC, 915 F.3d 743, 747 (Fed. Cir. 2019). At Mayo step one, the claims are directed to a natural law: "the correlation between the presence of naturally-occurring MuSK autoantibodies in bodily fluid" and certain neurological diseases like MG. Id. at 750. This is similar to the correlation between "concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm," which the Supreme Court held "sets forth a natural law" in Mayo, 566 U.S. at 77, 132 S.Ct. 1289.
So too as in Mayo, at step two, the additional steps of the claims here, though "set forth with some specificity," Athena, 915 F.3d at 752, "only require standard techniques to be applied in a standard way" and thus do not supply the requisite inventive concept, id. at 753. The specification explains that "[t]he actual steps of detecting autoantibodies in a sample of bodily fluids may be performed in accordance with immunological assay techniques known per se in the art." Id. at 753-54 (alteration in original). Similarly, in Mayo, adding steps "to determine the level of the relevant metabolites in the blood" was held "not sufficient to transform an unpatentable law of nature into a patent-eligible application" because those steps were "well known in the art." 566 U.S. at 79, 132 S.Ct. 1289. Therefore, the panel here correctly held that under the Mayo framework, the claims are not patent eligible under § 101. Athena, 915 F.3d at 746, 756. And the Supreme Court has instructed us to follow its precedent until the Court itself chooses to expressly overrule it.
It is nonetheless appropriate to point out that there is tension between Mayo and the Supreme Court's later decision in Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 133 S.Ct. 2107, 186 L.Ed.2d 124 (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. And Myriad suggests that such discoveries may be patent eligible. There, the patent applicant discovered a previously unknown natural phenomenon: the location and sequence of the BRCA1 and BRCA2 genes and their connection to cancer. Myriad, 569 U.S. at 582-83, 133 S.Ct. 2107. Although the Court held ineligible the claims to naturally occurring DNA sequences, it suggested that "new applications of knowledge about the BRCA1 and BRCA2 genes" could be eligible and referred to various "unchallenged claims" discussed in Judge Bryson's concurrence to our court's decision below. Id. at 596, 133 S.Ct. 2107 (emphasis in original) (citing Ass'n for Molecular Pathology v. U.S. Patent & Trademark Office, Inc., 689 F.3d 1303, 1349 (Fed. Cir. 2012) (Bryson, J. concurring)). One of these "unchallenged claims" was claim 21 of Myriad's U.S. Patent No. 5,753,441, which covered a method of detecting (using conventional methods) any of several specific mutations in the BRCA1 gene, newly discovered by the patent applicant and shown to increase a person's risk of developing particular cancers (a far narrower claim than the claims held unpatentable in BRCA1- & BRCA2).
By suggesting that such a claim could be patent eligible, 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." See Mayo, 566 U.S. at 77-78, 88-89, 132 S.Ct. 1289.
Thus, it would be desirable for the Supreme Court to refine the Mayo framework to allow for sufficiently specific diagnostic patent claims with proven utility. In the life sciences, development of new diagnostic methods is often based on researching complex biological systems. The inventive concepts in this area may lie primarily in the application of a natural law.
At the same time, Mayo's central concern was both important and consistent with the Patent Act. There is a substantial risk that overbroad claims involving natural laws may "preempt the use of a natural law" and thus "inhibit further discovery by improperly tying up the future use of laws of nature." Id. at 72, 85, 132 S.Ct. 1289. In other words, there is a risk that granting overbroad patents could reward a mere concept rather than the work subsequently done by the actual inventor. The risks associated with such overbreadth are shown by the examples discussed earlier.
At the same time, "all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas." Id. at 71, 132 S.Ct. 1289. Thus, a sufficiently specific "application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection." Id. (emphasis in original) (quoting Diamond v. Diehr, 450 U.S. 175, 187, 101 S.Ct. 1048, 67 L.Ed.2d 155 (1981)).
For there to be a patent eligible application of a natural law, there must be a "discover[y]," 35 U.S.C. § 101, and the claims must recite a specific application of that "discovery" with established utility. Otherwise, the natural law may be entirely preempted, even as to those aspects where the patent claimant has done no more than claim a broad conception. Requiring a specific application mitigates against the risk of granting patents too early—that is, before the patent applicant has devised a specific application of the natural law—and thereby prevents monopolization of the "basic tools of scientific and technological work." Mayo, 566 U.S. at 71, 132 S.Ct. 1289 (quoting Benson, 409 U.S. at 67, 93 S.Ct. 253); Brenner v. Manson, 383 U.S. 519, 534-35, 86 S.Ct. 1033, 16 L.Ed.2d 69 (1966) (noting that before a claimed invention is sufficiently "refined and developed," granting a patent "may confer power to block off whole areas of scientific development"); see generally Lemley, supra, at 1337-38 (arguing for a focus on claim scope under § 101 and noting that overly broad claims "make later improvements more costly or even impossible").
The Supreme Court's opinion in O'Reilly v. Morse, 56 U.S. (15 How.) 62, 14 S.Ct. 601 (1854), the foundation of the Court's jurisprudence on patent eligibility, appears to make this very distinction. There, the Court allowed Morse's narrower claims, which were tied specifically to his discovery: the telegraph. See id. at 112.
More recent opinions of the Supreme Court are also consistent with a focus on claims that sweep too broadly. In Benson, the Court observed that the claims were "so abstract and sweeping as to cover both known and unknown uses of" the mathematical formula at issue, and so held the claims ineligible. 409 U.S. at 67-68, 93 S.Ct. 253. Similarly, in Flook, the claims to "a formula for computing an updated alarm limit" could "cover a broad range of potential uses" and were also held ineligible. 437 U.S. at 586, 98 S.Ct. 2522. By contrast, in Diehr, the Court held eligible claims that used a well-known mathematical equation in a process of curing synthetic rubber. 450 U.S. at 191-92, 101 S.Ct. 1048. The patent claimants did "not seek to pre-empt the use of th[e] equation," but rather sought "only to foreclose from others the use of that equation in conjunction with all of the other steps in their claimed process" for curing rubber. Id. at 187, 101 S.Ct. 1048. Thus, the Supreme Court's precedents support a requirement of specific application as part of the patent eligibility inquiry as to natural laws.
To ensure against overbroad claims, the scope of the § 101 natural law exception is necessarily informed by the utility requirement of § 101. The utility requirement has its origins in the constitutional grant of Congressional authority, which contemplated that the "discoveries" entitled to patents would be limited to those of proven utility. See U.S. Const. art. I, § 8, cl. 8; Sean M. O'Connor, The Overlooked French Influence on the Intellectual Property Clause, 82 U. Chi. L. Rev. 733, 792-93 (2015). And the statutory requirement of utility has been held by the Supreme Court to require that the claimed invention have established utility, not merely the prospect of future utility. Brenner, 383 U.S. at 534-36, 86 S.Ct. 1033. In Brenner, the Supreme Court held that a patent claiming an allegedly novel process for making certain known steroids was ineligible for lack of utility. Id. The Court reasoned that without a showing of utility, "the metes and bounds of th[e] monopoly are not capable of precise delineation," and "[s]uch a patent may confer power to block off whole areas of scientific development, without compensating benefit to the public." Id. at 534, 86 S.Ct. 1033. "Unless and until a process is refined and developed to this point—where specific benefit exists in currently available form—there is insufficient justification for permitting an applicant to engross what may prove to be a broad field." Id. at 534-35, 86 S.Ct. 1033. It follows that the scope of patents involving the application of natural laws should not extend beyond established utility, and that claims that extend further are not patent eligible. Under this approach, because of their breadth, the claims in Mayo would not be eligible at step one. See Mayo, 566 U.S. at 87, 132 S.Ct. 1289 (explaining that the claim steps were "set forth in highly general language covering all processes that make use of the correlations after measuring metabolites, including later discovered processes that measure metabolite levels in new ways").
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
Requiring specific and useful application for the entire scope of the claim at Mayo step one, and more than determining precise correlations of a known natural law using prior art processes at Mayo step two, would ensure that the claims truly recite an "inventive application" of the natural law that should be eligible under § 101. This approach would help ensure that the reward of a patent goes to those who have actually done the work to develop a specific application of a natural law, not those who are the first to the patent office with broad, conceptual claims lacking proven utility in many applications.
Finally, this case may involve claims that could be patent eligible under this suggested approach. First, 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. See Athena, 915 F.3d at 747.
Because at least some of the claims here recite specific applications of the newly discovered law of nature with proven utility, this case could provide the Supreme
CHEN, Circuit Judge, concurring with denial of the petition for rehearing en banc.
"Congress plainly contemplated that the patent laws would be given wide scope." Bilski v. Kappos, 561 U.S. 593, 601, 130 S.Ct. 3218, 177 L.Ed.2d 792 (2010) (quoting Diamond v. Chakrabarty, 447 U.S. 303, 308, 100 S.Ct. 2204, 65 L.Ed.2d 144 (1980)). As the Court observed, "Congress took this permissive approach to patent eligibility to ensure that `ingenuity should receive a liberal encouragement.'" Id. Consistent with that mandate, the Court in Diamond v. Diehr, 450 U.S. 175, 101 S.Ct. 1048, 67 L.Ed.2d 155 (1981) 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, 98 S.Ct. 2522, 57 L.Ed.2d 451 (1978). Under 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 comprising a set of technical, transformative steps to test a patient for a particular medical condition. But in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66, 132 S.Ct. 1289, 182 L.Ed.2d 321 (2012), the 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. At the same time, nothing in Mayo suggests that it sought to repudiate Diehr's analysis. While I believe our court would benefit from the Supreme Court's guidance as to whether it intended to override central tenets of Diehr, Mayo's reasoning is clear and we are bound by it. Because that analysis requires the affirmance of the district court's decision to invalidate Athena's claims, I concur with this court's decision to deny the petition for rehearing en banc.
In Flook, the Court articulated the notion that something else beyond an algorithm or law of nature recited in a claim must provide the key "inventive concept" to make a claim patent-eligible. 437 U.S. at 594, 98 S.Ct. 2522. There, the claims recited a formula for computing an updated alarm limit, a number that signals the presence of an abnormal temperature, pressure, and flow rate combination indicating inefficiency or perhaps danger during catalytic conversion processes. Id. at 585, 98 S.Ct. 2522. While the Court recognized that "a process is not unpatentable simply because it contains a law of nature or a mathematical algorithm," id. at 590, 98 S.Ct. 2522, it also declared that "the discovery of such a phenomenon cannot support a patent unless there is some other inventive concept in its application." Id. at 594, 98 S.Ct. 2522. Because the recited field of use of catalytic conversion of hydrocarbons was "well known," and the formula received no credit in the analysis, the Court concluded that Flook's claim "contains no patentable invention." Id. The Court indicated that it had considered the claim "as a whole," but it did so by reviewing the claim on an element-by-element basis in search of something new and inventive, discounting the formula as "assumed to be within the prior art." Id. In so doing, the Court found no novel "inventive concept" in the claim. Id.
The Court advanced a very different analytic approach for the judicial exceptions in Diamond v. Diehr, 450 U.S. 175, 101 S.Ct. 1048, 67 L.Ed.2d 155 (1981), one that is difficult to reconcile with much of
Furthermore, Bilski recognized the interplay between Diehr and Flook, pointing out that Diehr "established a limitation on the principles articulated in [Gottschalk v.] Benson and Flook" in that "Diehr emphasized the need to consider the invention as a whole, rather than `dissect[ing] the claims into old and new elements ... in the analysis.'" Bilski, 561 U.S. at 611, 130 S.Ct. 3218 (quoting Diehr, 450 U.S. at 188, 101 S.Ct. 1048). Thus, as recently as Bilski, the Court understood Diehr as requiring consideration of the claim as a whole, including any mathematical formula or scientific principle, in the § 101 inquiry, and as rejecting any dissection of the claim in search of novel or unconventional components.
Aside from reaffirming the result in Flook, the Diehr Court addressed Flook's takeaway meaning at two different points in the opinion. First, Diehr observed: "Our recent holdings in Gottschalk v. Benson, supra, and Parker v. Flook, supra, both of which are computer-related, stand for no more than [the] long-established principles" that "[e]xcluded from such patent protection are laws of nature, natural phenomena, and abstract ideas." 450 U.S. at 185, 101 S.Ct. 1048 (citing Flook and other cases describing the judicial exceptions, e.g., "[a] principle[ ] in the abstract ... cannot be patented."). Second, Diehr explained the defect in the Flook claim in the following way: "A mathematical formula does not suddenly become patentable subject matter simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use .... All the application provided was a `formula for computing an updated alarm limit.'" Id. at 192 n.14, 101 S.Ct. 1048 (quoting Flook, 437 U.S. at 586, 98 S.Ct. 2522). The Diehr Court thus regarded the Flook claim as merely reciting a formula that would be applicable in an industrial process, but not reciting an industrial process itself.
That Diehr established a limitation on Flook and rejected the point of novelty/inventive concept approach to patent eligibility is underscored by the protests within the Diehr dissent. See Diehr, 450 U.S. at 204-16, 101 S.Ct. 1048. "Proper analysis," in the dissent's view, "must start with an understanding of what the inventor claims to have discovered—or phrased somewhat differently—what he considers his inventive concept to be." Id. at 212, 101 S.Ct. 1048. Because the claim had "no other inventive concept" other than the addition of a mathematical algorithm to the otherwise conventional claimed process for curing rubber, the dissent would have found the Diehr claim ineligible. Id. at 213-14, 101 S.Ct. 1048. The Diehr majority responded: "In order for the dissent to reach its conclusion it is necessary for it to read out of respondents' patent application all the steps in the claimed process which it determined were not novel or `inventive.' That is not the purpose of the § 101 inquiry and conflicts with the proposition recited above that a claimed invention may be entitled to patent protection even though some or all of its elements are not `novel.'" Id. at 193 n.15, 101 S.Ct. 1048.
Given 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. See, e.g., Arrhythmia Research Tech., Inc. v. Corazonix Corp., 958 F.2d 1053, 1057 n.4 (Fed. Cir. 1992) ("Although commentators have differed in their interpretations of Benson, Flook, and Diehr, it appears to be generally agreed that these decisions represent evolving views of the Court, and that the reasoning in Diehr not only elaborated on, but in part superseded, that of Benson and Flook.") (citing R.L. Gable & J.B. Leaheey, The Strength of Patent Protection for Computer Products, 17 Rutgers Computer & Tech. L.J. 87 (1991); D. Chisum, The Patentability of Algorithms, 47 U. Pitt. L. Rev. 959 (1986)); see also Edward W. Roush, Jr., Patent Law-Patentable Subject Matter-Manufacturing Process Which Includes Use of Mathematical Formula and Computer Program Constitutes Patentable Subject Matter, 13 St. Mary's L.J. 420, 428-29 (1981) ("The Diehr Court's holding is entirely consistent with title 35, section 101 subject matter standards. Although both the majority and dissent acknowledged that Diehr presented a section 101 statutory subject matter question, the dissent improperly injected considerations of section 102 novelty into its analysis. The majority in Flook employed the same rationale.").
Three decades after Diehr, Mayo provided a framework for the judicial exceptions that strongly tracked the reasoning of Flook and the Diehr dissent. Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 132 S.Ct. 1289, 182 L.Ed.2d 321 (2012). The claims in Mayo were for a method of optimizing the treatment of an immune-mediated gastrointestinal disorder comprising two physical steps: (1) administering a synthetic drug to a patient, and (2) determining the concentration level of certain metabolic byproducts in the patient's bloodstream. The claims also included two "wherein" clauses, reciting that the measured level indicates whether the patient has received a safe and effective dose. Id. at 74-75, 132 S.Ct. 1289. The Court found that the "wherein" clauses incorporate a law of nature: the relationship between concentrations of certain
Citing primarily to Flook, as well as Bilski, the Court stated that its prior decisions "insist that a process that focuses upon the use of a natural law also contain other elements or a combination of elements, sometimes referred to as an `inventive concept,' sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself." Id. at 72-73, 132 S.Ct. 1289. Because, in the Court's view, "the steps in the claimed processes (apart from the natural laws themselves) involve well-understood, routine, conventional activity previously engaged in by researchers in the field," the claims lacked any inventive concept. Id. at 73, 132 S.Ct. 1289. Moreover, the Court did not share the concerns Diehr expressed as to preserving a doctrinal distinction between §§ 101 and 102; instead, the Court noted: "We recognize that, in evaluating the significance of additional steps [beyond the law of nature] the § 101 patent eligibility inquiry and, say, the § 102 novelty inquiry might sometimes overlap." Id. at 90. Mayo's rationale thus follows the point of novelty/inventive concept reasoning of Flook and the Diehr dissent.
As such, 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. 450 U.S. at 188, 101 S.Ct. 1048. The Mayo Court indicated that it considered the claimed steps "as an ordered combination," but it excluded the law of nature from that review and concluded that the "ordered combination adds nothing to the laws of nature that is not already present when the steps are considered separately." 566 U.S. at 79, 132 S.Ct. 1289. In other words, after setting aside the law of nature, "any additional steps consist[ed] of well-understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add[ed] nothing significant beyond the sum of their parts taken separately." Id. at 79-80, 132 S.Ct. 1289. The Court found support for this understanding of the judicial exceptions in Flook, observing that, for the Flook claim, the steps of monitoring a catalytic conversion process "were all `well known,' to the point where, putting the formula to the side, there was no `inventive concept' in the claimed application of the formula." Id. at 82, 132 S.Ct. 1289. That type of "ordered combination" review ("putting the formula to the side"), however, is fundamentally different from Diehr's "claim as whole" principle, which does not carve out the judicial exception from the patent eligibility inquiry, nor does it dismiss elements that lack novelty.
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
As written, Mayo requires a patent claim to have an inventive concept apart from the recitation of a natural law. That requirement has consequences that go beyond the facts of Mayo and is certainly clear enough that we are obliged to follow it. But, as explained above, 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 a claim into new versus old elements. Moreover, nothing in Mayo suggests that it sought to repudiate anything in Diehr; it instead suggests that it sought to maintain continuity with the Court's prior cases in this area. As for Flook, the Court in Bilski acknowledged that Diehr had "established a limitation" on Flook by "emphasiz[ing] the need to consider the invention as a whole, rather than `dissect[ing] the claims into old and new elements ... in the analysis.'" Bilski, 561 U.S. at 611, 130 S.Ct. 3218 (quoting Diehr, 450 U.S. at 188, 101 S.Ct. 1048). Importantly, Mayo does not say that it nullified this key "limitation" expressed in Diehr. Furthermore, as Judge Dyk points out in his concurrence, the Court's opinion in Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 133 S.Ct. 2107, 186 L.Ed.2d 124 (2013), which issued after Mayo, could be read as potentially maintaining an open door for diagnostic claims such as Athena's, because they may be regarded as applications of knowledge of discovered natural laws. See Dyk Concurrence at 1340. Myriad thus could suggest that Mayo should not go as far as its language indicates.
Through it all, there is a serious question today in patent law as to what extent Diehr remains good law in light of Mayo. We are not in a position to resolve that question, but the Supreme Court can. Resolution of the present confusion is important because if Mayo in fact overruled the principles in Diehr (as reiterated in Bilski), then that would be a significant incursion on the settled expectations that had existed for 30 years since Diehr. Relying on the Diehr framework, the Patent Office examined and granted many patents for medical diagnostic methods, establishing settled expectations in those granted property rights, and prompted companies and research institutions to organize their conduct and choices accordingly. Many of these diagnostic claims, including the ones at issue here, do not hold up well against Mayo's more searching, claim dissection scrutiny.
Judge Newman, Judge Moore, the petitioner, and the amici raise several valid concerns. But I believe the reasoning underlying recent Supreme Court decisions compels us to affirm the district court's invalidity determination here. While Diehr long established that we must evaluate "the claim as a whole" for § 101 purposes, that principle has been considerably undermined, for we've been recently instructed to ask for claims such as Athena's, "do the patent claims add enough to their statements of the correlations to allow the processes they describe to qualify as patent-eligible processes that apply natural laws?" Mayo, 566 U.S. at 77, 132 S.Ct. 1289 (emphases in original). Moreover, "[p]urely `conventional or obvious' `[pre]solution activity' is normally not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law." Id. at 79, 132 S.Ct. 1289.
It appears to me that, per Mayo, because the association of an antibody and a medical disorder is deemed to be a law of nature rather than an application of a law of nature, detecting that law of nature, by using data gathering steps or devices that can be said to be basic, conventional, or obvious, fails § 101. This is in contrast to examples, such as Diehr and Neilson, in which, as characterized by Mayo, the claimed inventions included unconventional steps beyond reliance on an abstract scientific principle. Mayo, 566 U.S. at 80-81, 83-84, 132 S.Ct. 1289. In other words, 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.
Here, the inventors of Athena's U.S. Patent No. 7,267,820 discovered an association between the disorder myasthenia gravis and the presence of muscle specific tyrosine kinase (MuSK) autoantibodies in a patient's blood. At issue are claims 7-9 reciting:
'820 patent, col. 12 ll. 31-35, col. 12 l. 62 — col. 13 l. 9.
We must accept that the association between the antibody and the disorder is a law of nature. Here, as in Mayo, data first must be gathered in order to access and observe the newly-discovered law of nature, and the claimed steps "simply tell doctors to gather data from which they may draw an inference in light of the
Claim 9 recites use of a particular label, but one that was standard to use in the art. This cannot provide the inventive concept under Mayo. As an analogy, we would not find that a claim directed to an abstract idea of communicating information through a device passes muster under § 101 simply because it limits the claimed device to, say, a Samsung Galaxy® smartphone. Nor would the Mayo claim be considered to possess an inventive concept if it had recited that the initial step of "administering a drug" be performed in a conventional way, such as orally or intravenously.
One amicus brief points out that § 101 provides that "[w]hoever invents or discovers" a new or useful process, manufacture, machine or composition of matter may be entitled to a patent, and that § 100(a) defines "invention" to mean "invention or discovery." Brief of Freenome Holdings Inc. and Achillion Pharm., Inc. as Amici Curiae in Support of Neither Party, Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC, 915 F.3d 743 (2019) (No. 17-2508). Section 100 also defines "process" to include "a new use of a known process, machine, manufacture, composition of matter, or material." § 100(b). Arguably, Athena's invention is a claim for a new use (diagnosing myasthenia gravis) of a known composition of matter (MuSK autoantibodies). Moreover, 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. See Lefstin and Menell Br. at 4-14. However, I am not aware of the Supreme Court ever addressing the meaning of "discovers" in § 101 separately from "invents," and it must be the Supreme Court, and not this court, that speaks to that statutory question, because the Court already proclaimed that "[g]roundbreaking, innovative, or even brilliant discovery does not by itself satisfy the section 101 inquiry." Myriad, 569 U.S. at 591, 133 S.Ct. 2107.
In sum, I do not think the claims here can withstand Mayo's scrutiny.
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. This category of invention, after all, is not the same as methods of entering into contracts, or horse whispering, or speed dating or other methods that animated many of the concerns underlying Bilski. The kind of lab work undertaken in discovering new diagnostics and performing the steps of such claimed inventions can only be described as being technical in nature. For several decades before Mayo, this has been the basis for why the Patent Office granted patents for many medical diagnostics—not just for the law of nature in the abstract, but as applied in the real-world medical context to diagnose patient health conditions. In any meaningful sense, this represents a practical application of the discovered law of nature, that is, it is applied science in every sense of that term. And it should be patentable subject matter in a well-functioning patent system.
The most recent Supreme Court opinions are clear in my view on how to address claims like Athena's. Even 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. Accordingly, I concur with denial of the petition for rehearing en banc.
Moore, Circuit Judge, with whom O'Malley, Wallach, and Stoll, Circuit Judges, join, dissenting from the denial of the petition for rehearing en banc.
This is not a case in which the judges of this court disagree over whether diagnostic claims, like those at issue in Athena, should be eligible for patent protection. They should. None of my colleagues defend the conclusion that claims to diagnostic kits and diagnostic techniques, like those at issue, should be ineligible. The only difference among us is whether the Supreme Court's Mayo decision requires this outcome. The majority of my colleagues believe that our hands are tied and that Mayo requires this outcome. I believe Mayo does not. The Patent Act renders eligible the invention or discovery of any new and useful process. 35 U.S.C. § 101. And the patent system exists to promote exactly this sort of specific, targeted application of a life-saving discovery, which is characterized by extraordinarily high initial market entry costs. The claims in this case should be held eligible, and they are distinguishable from Mayo.
Since Mayo, we have held every single diagnostic claim in every case before us ineligible. See Cleveland Clinic Found. v. True Health Diagnostics LLC, 760 F. App'x 1013 (Fed. Cir. 2019) ("Cleveland Clinic II"); Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC, 915 F.3d 743 (Fed. Cir. 2019); Roche Molecular Sys., Inc. v. CEPHEID, 905 F.3d 1363 (Fed. Cir. 2018); Cleveland Clinic Found. v. True Health Diagnostics LLC, 859 F.3d 1352 (Fed. Cir. 2017) ("Cleveland Clinic I"); Genetic Techs. Ltd. v. Merial L.L.C., 818 F.3d 1369 (Fed. Cir. 2016); Ariosa
We have turned Mayo into a per se rule that diagnostic kits and techniques are ineligible. That per se rule is "too broad an interpretation of this exclusionary principle [which] could eviscerate patent law." Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66, 71, 132 S.Ct. 1289, 182 L.Ed.2d 321 (2012). The Supreme Court has repeatedly cautioned against rigid or per se rules. See, e.g., Halo Elecs., Inc. v. Pulse Elecs., Inc., ___ U.S. ___, 136 S.Ct. 1923, 1932, 195 L.Ed.2d 278 (2016) (rejecting test which "is unduly rigid"); Octane Fitness, LLC v. ICON Health & Fitness, Inc., 572 U.S. 545, 551, 134 S.Ct. 1749, 188 L.Ed.2d 816 (2014) (rejecting test as "unduly rigid"); KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 419-20, 127 S.Ct. 1727, 167 L.Ed.2d 705 (2007) (cautioning against "[r]igid preventative rules"); Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722, 738, 122 S.Ct. 1831, 152 L.Ed.2d 944 (2002) (preferring that rules be interpreted "in a flexible way, not a rigid one"); Warner-Jenkinson Co., Inc. v. Hilton Davis Chem. Co., 520 U.S. 17, 32, 117 S.Ct. 1040, 137 L.Ed.2d 146 (1997) (declining to adopt a "rigid rule"); Diamond v. Chakrabarty, 447 U.S. 303, 315, 100 S.Ct. 2204, 65 L.Ed.2d 144 (1980) (declining to create a rule that "inventions in areas not contemplated by Congress when the patent laws were enacted are unpatentable per se").
In his opening statement during The State of Patent Eligibility in America Senate hearings, Senator Coons recognized that "for medical diagnostics, ... [there is] a presumption against eligibility that is nearly impossible to overcome." The State of Patent Eligibility in America, Part I: Hearing Before the Subcomm. on Intellectual Property of the S. Comm. on the Judiciary, 116th Cong. 15:36-45 (2019) (opening statement of Sen. Coons). And testimony from industry representatives confirmed that industry members and scholars think "it is unclear whether diagnostic methods are patentable in any meaningful way." See, e.g., The State of Patent Eligibility in America, Part II, 116th Cong. 7 (2019) (written testimony of Hans Sauer, Ph.D., Deputy General Counsel and Vice President for Intellectual Property, Biotechnology Innovation Organization (BIO)).
Our fervor for clarity and consistency has resulted in a per se rule that excludes all diagnostics from eligibility. I do not agree with my colleagues that Mayo requires that all of these claims in all of these cases be held ineligible. But that is where we are.
I do not fault my colleagues, who under protest have concluded that they have no choice but to hold the claims in Athena ineligible because of Mayo. See Athena, 915 F.3d at 753 n.4 ("[W]hether or not we as individual judges might agree or not that these claims only recite a natural law... the Supreme Court has effectively told us in Mayo that correlations between the presence of a biological material and a disease are laws of nature."); see also Ariosa Diagnostics, Inc. v. Sequenom, Inc., 809 F.3d 1282, 1287 (Fed. Cir. 2015) (Lourie, J., concurring with denial of reh'g en banc) ("[I]t is unsound to have a rule that takes inventions of this nature out of the realm of patent-eligibility ... [b]ut I agree that the panel did not err in its conclusion that under Supreme Court precedent it
"Diagnosis is the foundation of medicine," and diagnostic techniques and kits when narrowly claimed are precisely the type of innovation the patent system exists to promote.
Diagnostics economically depend on strong patent protection. Because they are typically characterized as "very expensive to develop but relatively cheap to reproduce," patent protection is required to make it financially viable for continued investment in their development.
The importance of diagnostics and their cost-reducing effects on patient treatment cannot reasonably be questioned. We are hard-pressed to identify facets of modern medicine that do not employ or rely on diagnostics. Diagnostics are "crucial in mitigating the effect of disease out-breaks."
Not only do diagnostics save lives, they reduce the cost of treatment. The diagnostic industry drives medical costs down, not up. People suffering from illness or disease will do whatever they can to find a cure. Proper diagnoses allow for earlier detection of illness and targeted treatment. But without proper diagnosis, patients have to endure numerous unsuccessful and costly treatments. Both the financial burden of continued testing and treatment and the emotional and physical tolls associated with suffering from symptoms, but not knowing the cause, can be reduced or even prevented thanks to diagnostics. And when there are specific advances, discoveries, or inventions in the diagnostics industry, they must be eligible for patent protection.
Unless one opposes the notion of patent protection entirely, it cannot be reasonably disputed that claims to diagnostic kits and techniques, like pharmaceuticals, which require enormous initial investments in terms of both time and money, are the reason we suffer the promise of a monopoly. As many have explained, without patent protection, there will be little incentive for companies to invest the monumental amount of time and money necessary to develop diagnostic kits, tools and techniques. A recent article, co-written by Paul Michel, former Chief Judge of the Federal Circuit, and David Kappos, former Director of the PTO, states:
This sentiment was echoed by industry leaders during The State of Patent Eligibility in America Senate hearings held on June 4-5 & 11, 2019. See The State of Patent Eligibility in America, Part II, 116th Cong. 6-7 (2019) (written testimony of Hans Sauer, Ph.D., Deputy General Counsel and Vice President for Intellectual Property, BIO) ("Absent the ability to protect their discoveries with valid patents... companies would lack the necessary incentive to make the risky, expensive, and time-consuming investments in research and development often required to bring new technologies to market."); The State of Patent Eligibility in America, Part II, 116th Cong. 9 (2019) (written testimony of Henry Hadad, President, IPO) ("[C]onfusion about what is patent-eligible discourages inventors from pursuing work in certain technology areas, including discovering new genetic biomarkers and developing diagnostic and artificial intelligence technologies. [This] uncertainty disincentivizes the enormous investment in research and development that is necessary to fuel the innovation cycle."); The State of Patent Eligibility in America, Part I, 116th Cong. 14:46-15:05 (2019) (opening statement of Sen. Coons) ("I worry that this continuing lack of clarity ... has led to reduced investment in the expensive and intensive research and development necessary to develop next generation cures ...."); The State of Patent Eligibility in America, Part III, 116th Cong. 1:22:12-1:22:35 (2019) (testimony of Peter O'Neill, Executive Director of Cleveland Clinic Innovations) ("The work of translating discovery into commercial products requires [patent] protection to justify the investment into those discoveries. And absent clarity... we are not moving forward diagnostic discoveries to translate them into commercial products the way we would do otherwise."); The State of Patent Eligibility in America, Part III, 116th Cong. 1:22:12-1:42:28 (2019) (testimony of Corey Salsberg, Vice President and Global Head Intellectual Property Affairs for Novartis) ("Make no mistake about section 101, this is the gateway to the patent system. So what that means in practical terms is it's a guide as to which fields of technologies can support sustained investment, and which ones likely cannot, and that's why we have such deep concerns about the status quo."); The State of Patent Eligibility in America, Part III, 116th Cong. 1 (2019) (written testimony of Robert Deberardine, Chief Intellectual Property Counsel, Johnson & Johnson) ("It is only because of the United States patent system, and the predictability that it has historically provided, that we have been able to make the investments, conduct the research, and take the risks required to develop these treatments. And only with predictability will we be able [to] solve today's most challenging healthcare problems and develop the groundbreaking treatments of tomorrow. Unfortunately, the patent system in the United States today is anything but predictable.").
The math is simple, you need not be an economist to get it: Without patent protection to recoup the enormous R&D cost, investment in diagnostic medicine will decline. To put it simply, this is bad. It is bad for the health of the American people and the health of the American economy. And it is avoidable depending on our interpretation of the Supreme Court's holding in
While Mayo did not require the result the panel reached in this case, the panel could not disregard our binding precedent of cases like Ariosa, Cleveland Clinics, and Roche which have interpreted Mayo as requiring this per se rule. Thus, the only hope was en banc action.
It is my view that § 101 and Mayo, when read together and in their entireties, compel the holding that the claims in Athena are eligible. Under the Patent Act, "[w]hoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title." 35 U.S.C. § 101. Our decisions have ignored the truth that claims to specific, narrow processes, even if those processes involve natural laws, are not directed to the natural laws themselves. And contrary to the "elementary principle that ... [we must] `give effect, if possible, to every clause and word of a statute,'" our § 101 jurisprudence has largely ignored Congress' explicit instruction that a discovery can be the basis for a patentable invention. King v. Burwell, U.S. ___, 135 S.Ct. 2480, 2498, 192 L.Ed.2d 483 (2015) (quoting Montclair v. Ramsdell, 107 U.S. 147, 152, 2 S.Ct. 391, 27 S.Ct. 431 (1883)). Section 101 refers to both "invent[ion] or discover[y]," and § 100(a) expressly defines invention as any "invention or discovery." We have misread Mayo and how it fits within the framework of the judicially-created exceptions to § 101 for laws of nature, natural phenomena, and abstract ideas.
Laws of nature, natural phenomena, and abstract ideas are considered "the basic tools of scientific and technological work." Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 216, 134 S.Ct. 2347, 189 L.Ed.2d 296 (2014) (quoting Assoc. for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 589, 133 S.Ct. 2107, 186 L.Ed.2d 124 (2013)). The Supreme Court excepted these categories from § 101 to ensure that patent law does not "`inhibit further discovery by improperly tying up the future use of' these building blocks of human ingenuity." Id. (quoting Mayo, 566 U.S. at 85, 132 S.Ct. 1289). Accordingly, "patents cannot issue for the discovery" of a law of nature. Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130, 68 S.Ct. 440, 92 S.Ct. 588 (1948). Nor can a claim to the law of nature become patentable by simply "adding the words `apply it.'" Mayo, 566 U.S. at 72, 132 S.Ct. 1289 (citing Gottschalk v. Benson, 409 U.S. 63, 71-72, 93 S.Ct. 253, 34 L.Ed.2d 273 (1972)). But "an application of a law of nature ... to a known structure or process may well be deserving of patent protection." Id. at 71, 132 S.Ct. 1289 (quoting Diamond v. Diehr, 450 U.S. 175, 187, 101 S.Ct. 1048, 67 L.Ed.2d 155 (1981)). We have chosen to ignore the legal space between these principles in favor of a swiftly executing, per se rule that all diagnostic claims are ineligible. That conclusion is incorrect.
By distinguishing between claims that recite a law of nature and simply add the words "apply it," and claims that recite a concrete application of a law of nature, the Supreme Court suggests we should consider the level of specificity in the claims to determine whether the claim is even directed to the natural law. See Alice, 573 U.S. at 223, 134 S.Ct. 2347 ("[I]f a patent's
The law of nature at issue in Mayo was the "relationship between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm." 566 U.S. at 77, 132 S.Ct. 1289. Importantly, this relationship was not a new discovery. "At the time the discoveries embodied in the patents were made, scientists already understood that the levels in a patient's blood of certain metabolites ... were correlated with the likelihood that a particular dosage of thiopurine drug could cause harm or prove ineffective." Id. at 73, 132 S.Ct. 1289. While the inventors characterized the precise correlation, they could not be said to have discovered the relationship in the first place.
The Court began its analysis with the statement that "[i]f a law of nature is not patentable, then neither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself." Id. at 77-78, 132 S.Ct. 1289. It examined the limitations of the representative claim, which recited:
Id. at 74-75, 132 S.Ct. 1289.
This claim in its entirety did nothing more than describe the natural relationship between metabolite concentrations and the effective dose of a thiopurine drug. Id. at 77, 132 S.Ct. 1289. "Unlike, say, a typical patent on a new drug or a new way of using an existing drug, the patent claims d[id] not confine their reach to particular applications of those laws." Id. at 87, 132 S.Ct. 1289. The claimed steps were set forth in "highly general language covering all processes that make use of the correlations ... including later discovered processes that measure metabolite levels in new ways." Id. at 87, 132 S.Ct. 1289. Due to their breadth, the Supreme Court
The breadth and generality of the Mayo claims led to their demise, as they recited nothing more than the natural law. We have since ignored these considerations, treating every claim that includes a law of nature as directed to that law, even if the claim as a whole recites a specific way of applying that law of nature to a new and useful end. We should not ignore the considerations related to claim breadth articulated in Mayo in our § 101 analysis.
The Athena claims differ significantly from the Mayo claims. In 1960, before the invention claimed in U.S. Patent No. 7,267,820 ("the '820 patent"), scientists identified a specific category of autoantibodies that bind to and interfere with the acetyl choline receptor (AChR)—which is responsible for the transmission of signals from neurons to muscle cells—cause Myasthenia gravis ("MG"). '820 patent at 1:24-26. The presence of these anti-AChR antibodies thus indicates that the patient suffers from MG. However, 20% of patients who manifested MG-like symptoms did not have the anti-AChR antibodies. Id. at 1:34-40. It was unknown if this 20%, "have the same or a distinct and separate MG condition," id. at 1:41-42, and there was "no basis for providing an immediate clinical diagnosis for such patients," id. at 4:20-22.
The inventors of the '820 patent discovered that a different type of autoantibody that binds to and interferes with muscle-specific tyrosine kinase (MuSK)—another receptor also known to help transmit signals from neurons to muscles—can also cause MG. Id. at 1:54-61 ("The present inventors surprisingly found that many of the 20% of MG patients which do not exhibit any autoantibodies to AChR, instead have IgG antibodies ... indicating that they are afflicted with a form of MG which has a different etiology ...."). The inventors in Athena discovered that these MG sufferers produced the anti-MuSK antibody, and created a process for diagnosing MG using methods that detect the presence of that antibody. These methods had never before been used to diagnose MG. Claims 7 and 9, on which the majority focused in Athena, require the use of specific laboratory techniques to diagnose a patient based on the natural law that 20% of people having MG produce autoantibodies to the MuSK protein. Claim 7 recites:
'820 patent at Claims 1, 7.
The claims provide for a method of diagnosing patients with MG using the following concrete steps: (1) contacting the patient's bodily fluid with labeled MuSK, MuSK epitope, or other antigenic determinant that binds any anti-MuSK antibodies that may be present in the bodily fluid; (2) immunoprecipitating any resulting complexes from the bodily fluid; and (3) detecting the presence of the anti-MuSK antibody by monitoring for the label, whereby the presence of the label indicates a diagnosis of MG. Id. These steps are not set out at the "high level of generality" that concerned the Court in Mayo, and they specifically confine their reach to a specific application of the relationship between anti-MuSK antibodies and MG. While the combination of steps in Mayo amounted to little "more than an instruction to doctors to apply the applicable laws when treating their patients," 566 U.S. at 79, 132 S.Ct. 1289, claim 7 in Athena is a single, specific method for applying the applicable law.
Indeed, the majority in this case repeatedly acknowledged that the claims in Athena, unlike the claims in Mayo, contain specific, concrete steps applying the law of nature. See, e.g., Athena, 915 F.3d at 751 ("The claims at issue here involve both the discovery of a natural law and certain concrete steps to observe its operation."). As the majority further acknowledged, claim 9, which depends on claim 7, "leaves open to the public other ways of interrogating the correlation between MuSK autoantibodies and MuSK-related disorders without practicing the claim's concrete steps." Id. at 752. In fact, the '820 patent identifies alternate methods for detecting antibodies, such as MuSK-related antibodies. See '820 patent at 3:33-4:12. The claims do not "broadly preempt the use of a natural law," and do not prevent any scientist from using the natural law in association with other common processes. Mayo, 566 U.S. at 72, 132 S.Ct. 1289; see Myriad, 569 U.S. at 595-96, 133 S.Ct. 2107. The concreteness and specificity of the claims in Athena moves them from reciting a law of nature to a particular application of a law of nature. The claims are not directed to a natural law or phenomenon.
The inventiveness of the claimed discovery in the process steps should also be considered when assessing eligibility. New and useful discoveries, such as the before unknown relationship between anti-MuSK autoantibodies and MG, when applied in a "process," should pass muster as eligible under the statutory text of § 101. Our decision to entirely disregard the discovery incorporated in the claims is a misapplication of the statute. This is not to say that a claim on the discovery of a law of nature itself or a natural phenomenon should be eligible. I agree it should not. But to wholly ignore the inventiveness of the discovery when assessing patent eligibility closes our eyes to the statute enacted by Congress. Athena discovered that 20% of people suffering from MG generate autoantibodies that bind to a MuSK protein. Its claims recite concrete steps to detect the presence of autoantibodies to MuSK to diagnose MG. These antibody/MuSK complexes had never been used by prior art MG diagnostic tests. In contrast, the claims in Mayo recited a generic "determining" step, with no laboratory test at all specified by the claims, and the specification itself stated that the methods were "well-understood, routine, and conventional activity already engaged in by the scientific community." 566 U.S. at 79, 132 S.Ct. 1289. Moreover, the Court explained that scientists had routinely performed that very step on thiopurine metabolites, the metabolite being detected in the claim. Id.
I do not believe that the Supreme Court intended Mayo to be the sweeping decision it has become. Indeed, it warned us that "too broad an interpretation of" its judicial exceptions to eligibility "could eviscerate patent law" because "all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas." Mayo, 566 U.S. at 71, 132 S.Ct. 1289. 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. The last word on this from the Supreme Court came in Myriad where the Court made clear "patents on new applications of knowledge about BRCA1 and BRCA2 genes" could be eligible. 569 U.S. at 596, 133 S.Ct. 2107. To the extent that this Court has read Mayo so broadly that it precludes exactly that sort of patent, we have erred. Doing so leaves Mayo at odds with the patent statutes and the later Myriad decision.
"It's important for the judiciary to first recognize that there is a problem that needs to be addressed ... 101 remains the most important substantive patent law issue in the United States today. And it's not even close." R. Davis, Courts Can Resolve Patent Eligibility Problems, Iancu Says, LAW 360 (Apr. 11, 2019) (quoting U.S. Patent and Trademark Office Director Iancu). 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. Your only hope lies with the Supreme Court or Congress. I hope that they recognize the importance of these technologies, the benefits to society, and the market incentives for American business. And, oh yes, that the statute clearly permits the eligibility of such inventions and that no judicially-created exception should have such a vast embrace. It is neither a good idea, nor warranted by the statute. I dissent.
Newman, Circuit Judge, with whom Wallach, Circuit Judge, joins, dissenting from denial of the petition for rehearing en banc.
The majority of the court has voted not to rehear this case en banc. I write again in dissent because of the importance of medical diagnosis and the critical role of the patent system in achieving new diagnostic methods. Diagnostic methods are costly in research and development, from scientific discovery through federal approval, and are of substantial public benefit—exemplified by Athena's method of diagnosing Myasthenia Gravis in persons
The panel majority held that the new diagnostic method in U.S. Patent No. 7,267,820 ("the '820 patent") was not eligible for patenting under section 101 of the Patent Act. Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC, 915 F.3d 743 (Fed. Cir. 2019) (Newman, J., dissenting). The panel majority stated that "the Supreme Court has effectively told us in Mayo that correlations between the presence of a biological material and a disease are laws of nature," and therefore methods for determining previously unknown correlations for diagnostic purposes are not patent-eligible. Id. at 753 n.4.
The majority's position is a flawed interpretation of the Court's decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66, 132 S.Ct. 1289, 182 L.Ed.2d 321 (2012). The Court did not hold that methods of diagnosis are subject to unique patent-eligibility rules. We have mistakenly enlarged the Court's holding, in substance and in application. Rehearing en banc is warranted.
I summarize the reasons for concern:
Until Athena's invention of the diagnostic method described in the '820 patent, some 20% of patients suffering from Myasthenia Gravis were not capable of being diagnosed. The '820 patent describes and claims a multi-step method wherein for such patients the presence in bodily fluid of autoantibodies to a protein, muscle-specific tyrosine kinase (MuSK), is detected by "binding of a MuSK or its epitope, together with a revealing label, to the autoantibodies in the serum or bodily fluid." '820 patent, col. 3, l. 66-col. 4, l. 2. The '820 patent explains that "[t]he present inventors surprisingly found that many of the 20% of MG patients which do not exhibit any autoantibodies to AChR [acetyl choline receptor] instead have IgG [immunoglobulin] antibodies directed against the extracellular N-terminal domains of MuSK." Id., col. 1, ll. 54-57.
These antibodies and their reaction with the MuSK protein were not known, nor the use of this procedure to diagnose Myasthenia Gravis. The separate chemical steps of radioactive labelling, reaction of an antibody with a protein, separation of the reaction product, and analysis of radioactivity, are described in the specification as conducted by conventional methods. However, the panel majority held that this new diagnostic method is not patent-eligible, stating that "claims 7-9 are directed to a natural law because the claimed advance was only in the discovery of a natural law, and that the additional recited steps only apply conventional techniques to detect that natural law." Athena, 915 F.3d at 751. This statement is a misapplication of the patent statute, and a misperception of the Court's decision in Mayo.
At issue are patent claims 7-9, shown with claim 1 from which they depend:
The reaction between the specified antibodies and the MuSK protein was not previously known, and the specified claim steps had not previously been performed, separately or in combination. This method of diagnosing Myasthenia Gravis and related disorders is conceded to be new and unobvious.
The '820 patent specification teaches that each claim step is conducted by conventional procedures, that is, procedures for creating a radioactively labelled compound, reacting an antibody with a protein, separating any antibody-protein complex, and monitoring the radioactivity of the product. The panel majority holds that since the separate steps are "conventional," they do not count in the section 101 analysis, leaving claims 7-9 with only the general "concept" of "the correlation between the presence of naturally-occurring MuSK autoantibodies in bodily fluid and MuSK-related neurological diseases like MG." Athena, 915 F.3d at 750. The panel majority concluded that "[t]he '820 patent thus describes the claimed invention principally as a discovery of a natural law, not as an improvement in the underlying immunoassay technology." Id. at 751.
The Court in Mayo admonished against "too broadly preempt[ing] the use of a natural law." 566 U.S. at 72, 132 S.Ct. 1289. Claims 7-9 claim a new multi-step method of diagnosis; it is incorrect to omit from the claims the steps by which the method is performed, leaving only the "concept" of the general purpose. En banc review is needed to provide consistent and correct application of statute and precedent to methods of medical diagnosis.
The Court explained this principle in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 127 S.Ct. 1727, 167 L.Ed.2d 705 (2007):
Id. at 418-19, 127 S.Ct. 1727. The Court had explored this principle in Diamond v. Diehr, 450 U.S. 175, 101 S.Ct. 1048, 67 L.Ed.2d 155 (1981):
Id. at 188, 101 S.Ct. 1048. The Court stressed that:
Id. at 188-89; see also, e.g., Parker v. Flook, 437 U.S. 584, 594, 98 S.Ct. 2522, 57 L.Ed.2d 451 (1978) ("[A] patent claim must be considered as a whole."); Aro Mfg. Co. v. Convertible Top Replacement Co., 365 U.S. 336, 344, 81 S.Ct. 599, 5 L.Ed.2d 592 (1961) ("[I]f anything is settled in the patent law, it is that the combination patent covers only the totality of the elements in the claim and that no element, separately viewed, is within the grant.").
This established rule does not evaporate when the subject matter is a diagnostic method. The Mayo Court did not effect such a change. The Court reiterated in Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 217, 134 S.Ct. 2347, 189 L.Ed.2d 296 (2014), that "an invention is not rendered ineligible for patent simply because it involves an abstract concept" in some of its claim elements. There is no support in the Court's precedent for our abandonment of the invention-as-a-whole in determining eligibility under section 101.
The purpose of section 101 is to provide a broad statutory scope to inventive activity. See Bilski v. Kappos, 561 U.S. 593, 605, 130 S.Ct. 3218, 177 L.Ed.2d 792 (2010) ("Section 101 is a dynamic provision designed to encompass new and unforeseen inventions." (internal quotation marks omitted)); Diehr, 450 U.S. at 187, 101 S.Ct. 1048 ("[A]n application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection."). In Diamond v. Chakrabarty, 447 U.S. 303, 100 S.Ct. 2204, 65 L.Ed.2d 144 (1980), the Court observed that "Congress employed broad general language in drafting § 101 precisely because such inventions are often unforeseeable," id. at 316, 100 S.Ct. 2204, and that the legislative history of the 1952 Patent Act showed that "Congress intended statutory subject matter to `include anything under the sun that is made by man,'" id. at 309, 100 S.Ct. 2204 (quoting S. Rep. No. 1979, 82d Cong., 2d Sess., 5 (1952); H.R. Rep. No. 1923, 82d Cong., 2d Sess., 6 (1952)). The Mayo Court cautioned that
566 U.S. at 71, 132 S.Ct. 1289.
The Federal Circuit has respected this long-standing principle in contexts other than for diagnostic methods. See, e.g., McRO, Inc. v. Bandai Namco Games America Inc., 837 F.3d 1299, 1313 (Fed. Cir. 2016) ("[C]ourts must be careful to avoid oversimplifying the claims by looking at them generally and failing to account for the specific requirements of the claims." (internal quotation marks omitted)). However, we have strayed in our rulings on diagnostic methods; our flawed analysis is summarized by the majority in Athena, 915 F.3d at 753 n.4 ("We have since confirmed that applying somewhat specific yet conventional techniques ... to detect a newly discovered natural law does not confer eligibility under § 101.").
When viewed on correct law and precedent, Athena's diagnostic method meets the requirements of section 101. The appropriate analysis of patentability is under sections 102, 103, and 112; not section 101.
In Mayo the Court discussed the method at issue in that case, and concluded that "upholding the patents would risk disproportionately tying up the use of the underlying natural laws, inhibiting their use in the making of further discoveries." 566 U.S. at 73, 132 S.Ct. 1289. The Court did not hold that every diagnostic method ties up a natural law, and the Athena panel majority acknowledged that "we agree that claim 9 leaves open to the public other ways of interrogating the correlation between MuSK autoantibodies and MuSK-related disorders without practicing the claim's concrete steps." 915 F.3d at 752.
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, a multi-step method performed by a combination of specific chemical and biological steps, was unknown in the prior art. The Court in Mayo did not exclude such methods from eligibility for patenting.
Following is an outline of this court's inconsistent rulings between diagnosis and treatment of disease:
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
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.
In all of these diagnostic cases the claims were held ineligible under section 101, whether or not the method of diagnosis was new and unobvious, and independent of patentability under sections 102, 103, and 112.
1. Rapid Litigation Management Ltd. v. CellzDirect, Inc., 827 F.3d 1042 (Fed. Cir. 2016). The claimed invention is a "method of producing a desired preparation of multi-cryopreserved hepatocytes [liver cells]." Id. at 1047. The court stated that "the natural ability of the subject matter to undergo the process does not make the claim `directed to' that natural ability," id. at 1049 (emphasis omitted), and "[t]his type of constructive process, carried out by an artisan to achieve `a new and useful end,' is precisely the type of claim that is eligible for patenting," id. at 1048 (quoting Alice, 573 U.S. at 217, 134 S.Ct. 2347).
2. Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals Int'l Ltd., 887 F.3d 1117 (Fed. Cir. 2018). The claimed invention is a method of treating schizophrenia with the known drug iloperidone, where the dose is adjusted based on whether the patient is a "CYP2D6 poor metabolizer." Id. at 1121. The method uses genetic testing to determine CYP2D6 metabolism. The court held that this is "a specific method of treatment for specific patients using a specific compound at specific doses to achieve a specific outcome," id. at 1136, and is eligible under section 101.
3. Natural Alternatives Int'l, Inc. v. Creative Compounds, LLC, 918 F.3d 1338 (Fed. Cir. 2019). The claimed invention is a method of increasing athletic performance by administering beta-alanine in larger quantities. The court held the method eligible under section 101, although the mechanism was a natural effect.
4. Endo Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc., 919 F.3d 1347 (Fed. Cir. 2019). The claimed invention is a method of treating patients with oxymorphone, based on the discovery that patients with impaired kidney function need less oxymorphone for pain relief. The court stated that the method was patent-eligible, for "the claims here are directed to a treatment method, not a detection method." Id. at 1356 (emphasis in original).
The major biotech industry organizations advise that our court's application of Mayo "has caused great uncertainty to the
The amici discuss the adverse effect of our section 101 rulings on advances in medical diagnosis. Seven Law Professors state that "diagnostic tests form[ ] the basis of 60%-70% of all medical treatment decisions," and "[d]iagnostic tests have immense benefits for patient care and greatly reduce associated costs, including decreasing hospitalization and avoiding unnecessary treatment." Profs. Br. at 11 (citing The Value of Diagnostics Innovation, Adoption and Diffusion into Health Care (July 2005), available at https://dx. advamed.org/sites/dx.advamed.org/files/resource/Lewin% 20Value% 20of% 20Diagnostics% 20Report.pdf).
The Law Professors state that "[t]he economics of the R&D and commercialization of innovative diagnostic tests reflect the core economic justification for the patent system: The marginal cost of making a diagnostic test is relatively low, but the ex ante R&D costs can be enormous," stating that the cost of commercializing a diagnostic test is between $ 50-$ 100 million. Id. at 11-12 (citing Diaceutics Group, Mystery Solved! What is the Cost to Develop and Launch a Diagnostic? (2013), available at https://www.diaceutics.com/?expert-insight=mystery-solved-what-is-the-cost-to-develop-and-launch-a-diagnostic). The Law Professors state that by "creat[ing] an unduly restrictive patent eligibility doctrine under § 101, the majority decision and many other court decisions send the wrong message to innovators that groundbreaking diagnostic tests born of the biotechnological arts in the modern biopharmaceutical industry are virtually per se unpatentable under § 101." Id. at 13.
Amici curiae Freenome Holdings and Achillion Pharmaceuticals suggest that our jurisprudence contravenes "promot[ing] the Progress of Science and useful Arts." U.S. Const. art. I, § 8, cl. 8. These amici point to the judicial duty to construe section 101 to include both inventions and discoveries, and that discovery of a new diagnostic method is within the constitutional purpose.
I repeat that "the public interest is poorly served by adding disincentive to the development of new diagnostic methods. This is a severe criticism; and when presented by the entire industry, and stressed by thoughtful scholars, it warrants judicial attention." Athena, 915 F.3d at 762 (Newman, J., dissenting).
The judicial responsibility is to provide clear and consistent law in conformity with statute. Our holdings on medical diagnostics contravene the admonition that courts "should not read into the patent laws limitations and conditions which the legislature has not expressed." Chakrabarty, 447 U.S. at 308, 100 S.Ct. 2204.
The legislative plan is for an incentive system that supports advances in useful technologies by enabling innovators to benefit economically. The patent statute requires that the new knowledge is disclosed to the public, where it adds to the body of knowledge and, in turn, may be studied and built upon. No benefit has been suggested by excluding medical diagnostic
This case presents an opportunity for judicial review and judicial remedy. Although diagnostic methods are not the only area in which section 101 jurisprudence warrants attention, Federal Circuit precedent is ripe for reconsideration specific to diagnostic methods, to correct our application of the Mayo decision and to restore the necessary economic incentive. As summarized by Senators Chris Coons and Thom Tillis, co-chairs of the Senate Subcommittee that is conducting hearings on proposed remedial legislation, "courts have clouded the line to exclude critical medical advances like life-saving precision medicine and diagnostics," and "studies showed that investors familiar with the current lack of clarity invest less in critical research and development in areas like medical diagnostics." The Senators stated that "[e]ven some witnesses advocating against broad reform conceded that there are problems with the current system, particularly in the life sciences." Report available at https://www.law360.com/articles/1171672/what-coons-and-tillis-learned-at-patent-reform-hearings (June 21, 2019).
From my colleagues' denial of en banc review, I respectfully dissent.
Stoll, Circuit Judge, with whom Wallach, Circuit Judge, joins, dissenting from the denial of the petition for rehearing en banc.
In a series of cases since the Supreme Court's decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66, 132 S.Ct. 1289, 182 L.Ed.2d 321 (2012), we have established a bright-line rule of ineligibility for all diagnostic claims. See, e.g., Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1377 (Fed. Cir. 2015) (rejecting a diagnostic claim because the "only subject matter new and useful as of the date of the application was the discovery of the presence of cffDNA in maternal plasma or serum"). This rule as applied to the facts of this case dictated that the majority panel find the claimed invention ineligible. But, because this court's bright-line rule is based on an over-reaching and flawed test for eligibility, a test that undermines the constitutional rationale for having a patent system—promoting the progress of science and useful arts—the court should take this opportunity to correct its erroneous rule. So, while I stand by the panel decision in this case, I write separately to dissent from the denial of en banc rehearing because the question of the eligibility of diagnostic inventions is exactly the type of exceptionally important issue that warrants full consideration by this court.
Federal Rule of Appellate Procedure 35 directs us to order rehearing en banc when "the proceeding involves a question of exceptional importance." Fed. R. App. P. 35(a)(2). A question is of exceptional importance if it creates "important systemic consequences for the development of the law and the administration of justice." Watson v. Geren, 587 F.3d 156, 160 (2d Cir. 2009). As Judge Newman and Judge Moore aptly describe, a wholesale bar on patent eligibility for diagnostic claims has far-reaching and long-ranging implications for the development of life-saving diagnostic methods. The eligibility of life-saving inventions is not only one of the most important issues of patent law, but of human health. Thus, the importance of the issue here mandates that we consider it en banc.
Interpreting Mayo, our prior opinions seem to take for granted that the Supreme Court has foreclosed all avenues of patent protection for diagnostic claims. As Judge Moore points out, we have held every diagnostic claim in every case before us ineligible.
Given the importance of this question, I would urge the en banc court to take the opportunity to entertain the thoughtful argument and fully developed record that such review would provide, and reconsider this critically important issue. As Congress's recent interest in § 101 legislation has demonstrated, there are a variety of stakeholders that consider this issue to be vitally important. En banc rehearing would not only permit us to have a more extensive view of the various considerations underlying Mayo, but it would also allow us to create judicial doctrine geared toward the practical application of Mayo's principles. At the very least, en banc review would help the court develop an articulable standard for its § 101 jurisprudence moving forward.
In my view, by consistently bypassing en banc review of a critical issue that goes to the heart of this court's jurisdiction, we are abdicating our responsibility. For this reason, I respectfully dissent.
O'Malley, Circuit Judge, dissenting from the denial of the petition for rehearing en banc.
I agree with all aspects of Judge Moore's thoughtful dissent. Indeed, 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, 132 S.Ct. 1289, 182 L.Ed.2d 321 (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.
I begin with some historical perspective. After World War II, federal courts were invalidating patents at break-neck speed. Lawrence Baum, The Federal Courts and Patent Validity: An Analysis of the Record, 56 J. Patent Office Soc'y 758, 760 tbl. 1 (1974) (showing that federal appellate courts, on average, invalidated patents at a rate of 77% between 1941-1945), 777 tbl. 5 (showing that the Supreme Court invalidated patents at a rate higher than 81% from 1921-1973, except during 1953-1964 when the Court did not issue any decisions on patent validity). As Justice Jackson wrote, it seemed the only valid patent was "one which [the Supreme Court] ha[d] not been able to get its hands on." Jungersen v. Ostby & Barton Co., 335 U.S. 560, 572, 69 S.Ct. 269, 93 S.Ct. 235 (1949) (Jackson, J., dissenting). This was due, in large part, to what became known as the "invention requirement"—itself "invented" by the Supreme Court rather than Congress or the Constitution. Applying this requirement meant asking whether a patent evidenced "invention."
Congress attempted to address these criticisms by amending the Patent Act to replace the ill-defined and judicially-created invention requirement with the more workable anticipation and obviousness tests codified in Sections 102 and 103. Patent Act of 1952, Pub. L. No. 82-593, § 103, 66 Stat. 792, 798 (1952); see, e.g., H.R. 4061, 80th Cong. (1947) (as introduced to the H. Comm. on the Judiciary, July 1, 1947) ("A BILL To establish a criterion of invention with respect to patent applications and issued patents[.]"); Nat'l Patent Planning Comm'n, The American Patent System, June 18, 1943, H.R. Doc. 78-239, at 10 ("One of the greatest technical weaknesses of the patent system is the lack of a definitive yardstick as to what is invention."); id. at 5 ("The most serious weakness in the present patent system is the lack of a uniform test or standard for determining whether the particular contribution of an inventor merits the award of the patent grant.... The difficulty in applying this statute arises out of the presence of the words `invented' and `discovered.' Novelty alone is not sufficient, nor is utility, nor is the final accomplishment. There must also be present some mysterious ingredient connoted in the term `invented.'").
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. Early cases applying § 101 after the 1952 amendment, such as Parker v. Flook, 437 U.S. 584, 98 S.Ct. 2522, 57 L.Ed.2d 451 (1978), drew heavily from cases decided under the "invention" requirement. Compare Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 131, 68 S.Ct. 440, 92 S.Ct. 588 (1948) (concluding that the "aggregation of species" at issue "fell short of invention" because "[i]f there is to be invention from such a discovery, it must come from the application of the law of nature to a new and useful end"), with Flook, 437 U.S. at 591, 98 S.Ct. 2522 ("Mackay Radio and Funk Bros. point to the proper analysis for this case."). Flook therefore forged a two-part test, with respect to § 101, that is seemingly indistinguishable from the one that had been applied in many "invention" cases over twenty-five years earlier. First, Flook treated the natural law as part of "the prior art." Flook, 437 U.S. at 594, 98 S.Ct. 2522. Second, Flook asked whether what remained—apart from the prior art, i.e. the natural law—constituted "invention." Id. ("Respondent's process is unpatentable under § 101, not because it contains a mathematical algorithm as one component, but because once that algorithm is assumed to be within the prior art, the application, considered as a whole, contains no patentable invention."); see also Diamond v. Diehr, 450 U.S. 175, 204,
In fact, the disagreement here centers on whether the additional limitations in the claims, either individually or as an ordered combination, satisfy the inventive concept requirement. Compare Lourie Op. at 1336 ("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." (internal quotations omitted)), with Moore Op. at 1362 ("These [additional] steps are not set out at the `high level of generality' that concerned the Court in Mayo, and they specifically confine their reach to a specific application of the relationship between anti-MuSK antibodies and MG."). Had the Supreme Court not disregarded Congress's wishes for a second time, perhaps the outcome in this case would be different. See Lourie Op. at 1335 ("If I could write on a clean slate, ... I would not exclude uses or detection of natural laws."). 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.
'820 patent, col. 12, ll. 31-35.
Claim 7 recites:
Id. col. 12, l. 62-col 13, l. 5 (indentation added).
Claim 8 depends from claim 7 and recites that the label is a radioactive label. Id. col. 13, ll. 6-7. Claim 9 depends from claim 8 and further recites that the radioactive label is 1251. Id. col 13, ll. 8-9.
