A petition for rehearing en banc was filed by defendants-appellants Sequenom, Inc. and Sequenom Center for Molecular Medicine, LLC. The petition for rehearing was first referred to the panel that heard the appeal, and thereafter, to the circuit judges who are in regular active service. A response was invited by the court and filed by plaintiffs-appellees Ariosa Diagnostics, Inc. and Natera, Inc. A poll was requested, taken, and failed.
Upon consideration thereof,
IT IS ORDERED THAT:
(1) The petition for rehearing en banc is denied.
(2) The mandate of the court will issue on December 9, 2015.
LOURIE, Circuit Judge, with whom MOORE, Circuit Judge, joins, concurring in the denial of the petition for rehearing en banc.
I concur in the court's denial of rehearing en banc in this case, based on the precedent of Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. ___, 132 S.Ct. 1289, 182 L.Ed.2d 321 (2012). I do so because I find no principled basis to distinguish this case from Mayo, by which we are bound. I write separately to express some thoughts concerning laws of nature and abstract ideas, which seem to be at the heart of patent-eligibility issues in the medical sciences.
Since the Supreme Court's decision in Bilski v. Kappos, 561 U.S. 593, 130 S.Ct. 3218, 177 L.Ed.2d 792 (2010), the issue of patent eligibility under § 101 has been of key importance in the adjudication of patent cases, particularly in the field of software. The Court's decisions in Mayo, Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. ___, 133 S.Ct. 2107, 186 L.Ed.2d 124 (2013), and Alice Corp. v. CLS Bank International, 573 U.S. ___, 134 S.Ct. 2347, 189 L.Ed.2d 296 (2014), have further brought the focus onto the field of medical diagnostics.
The Supreme Court in Mayo determined that the claims in that patent "set forth laws of nature." It further held in Mayo that steps additional to those setting forth laws of nature in a claimed process must add something "that in terms of patent law's objectives ha[ve] significance" to the natural laws, such that those steps transform the process into an inventive application of those laws. Mayo, 132 S.Ct. at 1299. Moreover, the Court rejected "post-solution activity that is purely conventional or obvious" as not significant enough to bring a claimed invention within the realm of patent-eligible subject matter. Id. (internal quotation marks and alteration omitted).
Alice relates to the third specific exception to eligibility — abstract ideas — and its discussion also incorporates the requirement of an "inventive concept" beyond "conventional steps." It held that claims that amount to nothing more than instruction to apply an abstract idea are not patent eligible, although application of the abstract idea may be. In my view, neither of the traditional preclusions of laws of nature or of abstract ideas ought to prohibit patenting of the subject matter in this case.
Abstract steps are, axiomatically, the opposite of tangible steps; that which is not tangible is abstract. But steps that involve machines, which are tangible, steps that involve transformation of tangible subject matter, or tangible implementations of ideas or abstractions should not be considered to be abstract ideas. In Bilski, the Supreme Court supported this proposition when it described our earlier machine-or-transformation test as a useful clue, albeit not the only test, for eligibility.
Conversely, abstract ideas are essentially mental steps; they are not tangible even if they are written down or programmed into a physical machine. Alice, in affirming this court, held that claims that amount to nothing significantly more than instruction to apply an abstract idea are not patent eligible. But the fact that steps are well-known, although relevant to other statutory sections of the patent law, does not necessarily make them abstract.
The claims at issue in Sequenom's patent are directed to methods for detecting paternally-inherited fetal DNA in maternal blood samples, and performing a prenatal diagnosis based on such DNA. Following Mayo, which held that certain steps merely recite natural laws and that the remaining steps must be sufficiently innovative apart from the natural laws, the panel in this case held that the claims do not involve patent-eligible subject matter. Appellants and amici have argued before us in briefs that a broad range of claims of this sort appear to be in serious jeopardy. It is said that the whole category of diagnostic claims is at risk. It is also said that a crisis of patent law and medical innovation may be upon us, and there seems to be some truth in that concern.
The claims in this case perhaps should be in jeopardy, not because they recite natural laws or abstract ideas, but because they may be indefinite or too broad. But they should not be patent-ineligible on the ground that they set forth natural laws or are abstractions.
Claim 1 is directed to a method for detecting a paternally inherited nucleic acid of fetal origin from a pregnant female comprising amplifying a paternally inherited nucleic acid and detecting the presence of a paternally inherited nucleic acid. Claim 21 is directed to a method of performing a prenatal diagnosis comprising providing a maternal blood sample, separating the sample into a cellular and non-cellular fraction, detecting the presence of a nucleic acid, and providing a diagnosis. Both of these claims contain the nucleus of patent-eligible subject matter.
As the panel noted, the natural phenomenon here is the presence of cell-free fetal DNA ("cffDNA") in maternal plasma, which, when subjected to certain conventional steps, has led to an important new development: diagnosis of possible birth defects without using highly intrusive means. Applications of natural phenomena or laws to a known process "may well
The claims might be indefinite or too broad in that they do not specify how to amplify and detect, or how to separate, detect, and diagnose. Or they perhaps attempt to claim all known methods of carrying out those steps. But the finer filter of § 112 might be better suited to treating these as questions of patentability, rather than reviewing them under the less-defined eligibility rules.
It is not disputed that fractionating blood, amplifying DNA, and analyzing DNA to detect specific gene sequences are known techniques in the art. As all other steps in the claims are individually well-known, the innovative aspect of the claims appears to be the improvement in the method of determining fetal genetic characteristics or diagnosing abnormalities of fetal DNA, consisting of use of the non-cellular fraction of fetal DNA obtained from a maternal blood sample.
The claim to this invention, then, might have been better drafted as a so-called Jepson claim, which recites what is in the prior art and what is the improvement. Such a claim might read, perhaps with more details added: "In a method of performing a prenatal diagnosis using techniques of fractionation and amplification, the improvement consisting of using the non-cellular fraction of a maternal blood sample."
Regardless, we are not experts in drafting claims to protect new biological procedures and we are not in a position to rewrite claims or review a hypothetical claim. But against the accusation that such a claim to the invention might be considered mere draftsmanship and thus still ineligible under the seemingly expansive holding of Mayo, it must be said that a process, composition of matter, article of manufacture, and machine are different implementations of ideas, and differentiating among them in claim drafting is a laudable professional skill, not necessarily a devious device for avoiding prohibitions. This is true despite the Supreme Court's affirmance of this court in Alice, where we had held, by a 7-3 vote, that method and media claims in inventions of the type claimed there were essentially the same.
But focusing on the claims we have rather than those we might have had, the claims here are directed to an actual use of the natural material of cffDNA. They recite innovative and practical uses for it, particularly for diagnostic testing: blood typing, sex typing, and screening for genetic abnormalities. And it is undisputed that before this invention, the amplification and detection of cffDNA from maternal blood, and use of these methods for prenatal diagnoses, were not routine and conventional. But applying Mayo, we are unfortunately obliged to divorce the additional steps from the asserted natural phenomenon to arrive at a conclusion that they add nothing innovative to the process.
Moreover, the claims here are not abstract. There is nothing abstract about performing actual physical steps on a
In sum, it is unsound to have a rule that takes inventions of this nature out of the realm of patent-eligibility on grounds that they only claim a natural phenomenon plus conventional steps, or that they claim abstract concepts. But I agree that the panel did not err in its conclusion that under Supreme Court precedent it had no option other than to affirm the district court.
DYK, Circuit Judge, concurring in the denial of the petition for rehearing en banc.
I concur in the court's denial of rehearing en banc. In my view the framework of Mayo and Alice is an essential ingredient of a healthy patent system, allowing the invalidation of improperly issued and highly anticompetitive patents without the need for protracted and expensive litigation. Yet I share the concerns of some of my colleagues that a too restrictive test for patent eligibility under 35 U.S.C. § 101 with respect to laws of nature (reflected in some of the language in Mayo) may discourage development and disclosure of new diagnostic and therapeutic methods in the life sciences, which are often driven by discovery of new natural laws and phenomena. This leads me to think that some further illumination as to the scope of Mayo would be beneficial in one limited aspect. At the same time I think that we are bound by the language of Mayo, and any further guidance must come from the Supreme Court, not this court.
The language of Mayo is clear. The Mayo Court found that prior Supreme Court 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." Mayo Collaborative Servs. v. Prometheus Labs., Inc., ___ U.S. ___, 132 S.Ct. 1289, 1294, 182 L.Ed.2d 321 (2012) (quoting Parker v. Flook, 437 U.S. 584, 594, 98 S.Ct. 2522, 57 L.Ed.2d 451 (1978)). Patent claims directed to laws of nature are ineligible under 35 U.S.C. § 101 when, "(apart from the natural laws themselves) [they] involve well-understood, routine, conventional activity previously engaged in by researchers in the field." Id. (emphasis added). Reviewing the Court's earlier Flook decision, the Mayo Court determined that Flook's claim to a chemical process applying an "apparently novel mathematical algorithm," id. at 1298, was ineligible under § 101 because the steps of the 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 1299 (quoting Flook, 437 U.S. at 594, 98 S.Ct. 2522) (emphasis added). "[S]imply appending conventional steps, specified at a high level of generality, to laws of nature, natural phenomena, and abstract ideas cannot make those laws, phenomena, and ideas patentable." Id. at 1300. In other words, Mayo states that the inventive concept necessary for eligibility must come in the application analyzed at step two, rather than from the discovery of the law of nature itself.
Id. (emphasis added) (alterations, citations, and quotation marks omitted). "At Mayo step two, we must examine the elements of the claim to determine whether it contains an `inventive concept' sufficient to `transform' the claimed abstract idea into a patent-eligible application." Id. at 2357 (emphasis added) (quotation marks omitted). Thus Alice also holds that inventive concept must be found at step two of the framework.
Mayo has unambiguously announced a generally applicable test for determining subject-matter eligibility under § 101 with respect to laws of nature, and we are bound to follow it. We cannot confine Mayo to its facts or otherwise cabin a clear statement from the Supreme Court. "[O]nce the Court has spoken, it is the duty of other courts to respect that understanding of the governing rule of law." Rivers v. Roadway Express, Inc., 511 U.S. 298, 312, 114 S.Ct. 1510, 128 L.Ed.2d 274 (1994). A court of appeals must not "confus[e] the factual contours of [a Supreme Court decision] for its unmistakable holding" to arrive at a "novel interpretation" of that decision. Thurston Motor Lines, Inc. v. Jordan K. Rand, Ltd., 460 U.S. 533, 534-35, 103 S.Ct. 1343, 75 L.Ed.2d 260 (1983) (per curiam). As we have recognized, "[a]s a subordinate federal court, we may not so easily dismiss [the Supreme Court's] statements as dicta but are bound to follow them." Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1347 (Fed.Cir. 2010) (en banc) (citing Stone Container Corp. v. United States, 229 F.3d 1345, 1349-50 (Fed.Cir.2000)).
The panel thus held correctly that Mayo is controlling precedent that governs the outcome here. The panel's opinion aptly states and applies the two-step framework of Mayo. "First, we determine whether the claims at issue are directed to a patent-ineligible concept." Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1375 (Fed.Cir.2015) (citing Mayo, 566 U.S. at ___, 132 S.Ct. at 1292). "[T]he claims at issue, as informed by the specification, are generally directed to detecting the presence of a naturally occurring thing or a natural phenomenon, cffDNA in maternal plasma or serum. . . . [T]he claimed method begins and ends with a naturally occurring phenomenon." Id. at 1376. At the second step of the Mayo framework, the panel determined that "[t]he method at issue here amounts to a general instruction to doctors to apply routine, conventional techniques when seeking to detect cffDNA." Id. at 1377. The panel therefore found that the claims were not patent eligible under § 101. Id. at 1378.
The Mayo/Alice framework works well when the abstract idea or law of nature in question is well known and longstanding, as was the situation in Mayo itself (as discussed below), earlier Supreme Court
Also, it seems to me that the Mayo/Alice framework works well with respect to abstract ideas. In my view, claims to business methods and other processes that merely organize human activity should not be patent eligible under any circumstances. See Alice, 134 S.Ct. at 2360 (Sotomayor, J., concurring); In re Bilski, 545 F.3d 943, 972 (Fed.Cir.2008) (en banc) (Dyk, J., concurring). In any event, departing from the Mayo/Alice framework with respect to abstract ideas (as opposed to discoveries of natural laws and phenomena) would create serious risks of undue preemption because of the difficulty in distinguishing between new and established abstract ideas.
But, as I see it, there is a problem with Mayo insofar as it concludes that inventive concept cannot come from discovering something new in nature — e.g., identification of a previously unknown natural relationship or property. In my view, Mayo did not fully take into account the fact that an inventive concept can come not just from creative, unconventional application of a natural law, but also from the creativity and novelty of the discovery of the law itself. This is especially true in the life sciences, where development of useful new diagnostic and therapeutic methods is driven by investigation of complex biological systems. I worry that method claims that apply newly discovered natural laws and phenomena in somewhat conventional ways are screened out by the Mayo test. In this regard I think that Mayo may not
In Myriad the patent applicant discovered a previously unknown natural phenomenon: the sequences of the BRCA1 and BRCA2 genes and their connection with cancer. Ass'n for Molecular Pathology v. Myriad Genetics, Inc., ___ U.S. ___, 133 S.Ct. 2107, 2112-13, 186 L.Ed.2d 124 (2013). While the Court found ineligible Myriad's claims to naturally occurring gDNA sequences, it suggested that "new applications of knowledge about the BRCA1 and BRCA2 genes" could generally be eligible, with reference to claim 21 of U.S. Patent No. 5,753,441 (discussed further below).
Of course, I do not suggest that a newly discovered law of nature should be patent eligible in its entirety. Laws of nature are never patentable as such, even when first discovered by the patent applicant. As Mayo recognized, "Einstein could not patent his celebrated law that E=mc
The primary concern with a patent on a law of nature is undue preemption — the fear that others' innovative future applications of the law will be foreclosed. See O'Reilly v. Morse, 56 U.S. 62, 113, 15 How. 62, 14 L.Ed. 601 (1853); Mayo, 132 S.Ct. at 1301. As Mayo emphasized, "there is a danger that the grant of patents that tie up the use [of laws of nature] will inhibit future innovation premised upon them. . . ." 132 S.Ct. at 1301; see also id. at 1304 (highlighting "the kind of risk that underlies the law of nature exception, namely the risk that a patent on the law would significantly impede future innovation").
As far back as O'Reilly v. Morse, the Supreme Court found unpatentable Morse's sweeping claim to all "marking or printing [of] intelligible characters, signs, or letters, at any distances" via "the use of the motive power of the electric or galvanic current, which I call electromagnetism,"
Similarly, in an aspect of our original Myriad decision that was not reversed by the Supreme Court, Ass'n for Molecular Pathology v. Myriad Genetics, Inc., ___ U.S. ___ 133 S.Ct. 694, 184 L.Ed.2d 496 (2012), and again in our court's recent In re BRCA1-& BRCA2-Based Hereditary Cancer Test decision, we found genetic testing claims that sought to capture "all comparisons between the patient's BRCA genes and the wild-type BRCA genes" to be overbroad and thus ineligible under § 101, noting that "[t]he covered comparisons are not restricted by the purpose of the comparison or the alteration being detected." 774 F.3d 755, 763, 765 (Fed.Cir. 2014).
However, if the breadth of the claim is sufficiently limited to a specific application of the new law of nature discovered by the patent applicant and reduced to practice, I think that the novelty of the discovery should be enough to supply the necessary inventive concept. My proposed approach would require that the claimed application be both narrow in scope and actually reduced to practice, not merely "constructively" reduced to practice by filing of a patent application replete with prophetic examples.
In my view, the breadth of the claim should be critical. Even when a patent applicant has demonstrated some particular utility for a newly discovered law of nature and reduced it to practice, the claim should be invalid unless narrowly tailored to the particular application of the law that has been developed. Claims that extend far beyond the utility demonstrated by the patent applicant and reduced to practice should be invalid, as they "too broadly preempt the use" of the underlying idea by others. Mayo, 132 S.Ct. at 1294; see also Diamond v. Diehr, 450 U.S. 175, 191-92, 101 S.Ct. 1048, 67 L.Ed.2d 155 (1981). But, so long as a claim is narrowly tailored to what the patent applicant has actually invented and reduced to practice, there is limited risk of undue preemption of the underlying idea. In Myriad the Court noted, 133 S.Ct. at 2120, that an example of a meritorious claim might be claim 21 of Myriad's U.S. Patent No. 5,753,441 ("the `441 patent"), which was not at issue in the case and which Judge Bryson discussed in his concurring opinion on our court's decision below, Ass'n for Molecular Pathology, 689 F.3d at 1348 (Bryson, J., concurring). Claim 21 of the `441 patent covers a method of detecting 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, using conventional methods. See In re BRCA1 & BRCA2, 774 F.3d at 765.
This approach appears also to be supported by Morse. The Supreme Court established in Morse that the extent to which a patentee can claim is the extent to which he has actually made some concrete use of the discovery and reduced it to practice. "The specification of this patentee describes his invention or discovery, and the manner and process of constructing and using it; and his patent . . . covers nothing more." Morse, 56 U.S. at 119. Limiting patentees to narrow applications they have actually developed and reduced to practice would be in keeping with Mayo's commandment that "simply appending
This proposed approach, limiting the scope of patents based on new discoveries to narrow claims covering applications actually reduced to practice, would allow the inventor to enjoy an exclusive right to what he himself has invented and put into practice, but not to prevent new applications of the natural law by others.
To be sure, determination of whether a claim applying a new law of nature is overbroad could present difficulties of definition and line drawing. But allowing narrow claims that have been actually reduced to practice when those claims embody an inventive, newly discovered law of nature would promote the fundamental policies underlying § 101. Requiring narrow claims and actual reduction to practice would be a reasonable accommodation in return for a more permissive inventive concept requirement. The approach would, I think, ensure that only diagnostic and therapeutic method patents limited in their claim scope would survive. These patents would provide the world with disclosure and useful applications of previously unknown natural laws, and the opportunity to obtain such patents would help to restore the incentive to make those discoveries that the patent system has historically provided.
To be clear, I do not suggest that Mayo was incorrectly decided on its particular facts. The claims at issue in Mayo contributed only routine application to a law of nature that was already well known. "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, including, in particular, [the individual metabolites measured in the claimed methods], were correlated with the likelihood that a particular dosage of a thiopurine drug could cause harm or prove ineffective." 132 S.Ct. at 1295 (emphasis added). While "those in the field did not know the precise correlations between metabolite levels and likely harm or ineffectiveness," id., "scientists
Finally, it seems to me that the approach I suggest would not change the result in this case. Sequenom's challenged claims embody a newly discovered natural phenomenon, the presence of paternally inherited cell-free fetal DNA (cffDNA) in a mother's bloodstream. Judge Linn's concurrence notes that "the amplification and detection of cffDNA had never before been done." Ariosa, 788 F.3d at 1381 (Linn, J., concurring). But the major defect is not that the claims lack inventive concept but rather that they are overbroad. See Mayo, 132 S.Ct. at 1294.
For example, claim 1 of the `540 patent broadly covers any method of detecting paternally inherited cffDNA from maternal serum or plasma via amplification and detection of that cffDNA. `540 patent, col. 23, 11. 61-67. Even the somewhat narrower claim 21 of the `540 patent, which recites a method of performing a prenatal diagnosis based on the presence, quantity, or sequence of paternally inherited cffDNA detected by the method of claim 1, still broadly encompasses any diagnosis of any disease, disorder, or condition. '540 patent, col. 26, 11. 4-14. Such claims appear to be impermissible attempts to capture the entire natural phenomenon of cffDNA rather than any particular applications thereof developed and actually reduced to practice by the inventors.
A future case is likely to present a patent claim where the inventive concept resides in a newly discovered law of nature or natural phenomenon, but the claim is narrowly drawn and actually reduced to practice. That case will, I hope, provide the Supreme Court with an opportunity to revisit the Mayo/Alice framework in this one limited aspect.
NEWMAN, Circuit Judge, dissenting from denial of the petition for rehearing en banc.
I agree with my colleagues that this case is wrongly decided. However, I do not share their view that this incorrect decision is required by Supreme Court precedent. The facts of this case diverge significantly from the facts and rulings in Mayo Collaborative Services v. Prometheus Laboratories, Inc., ___ U.S. ___, 132 S.Ct. 1289, 182 L.Ed.2d 321 (2012), and in Association for Molecular Pathology v. Myriad Genetics, ___ U.S. ___, 133 S.Ct. 2107, 186 L.Ed.2d 124 (2013).
In Mayo, both the medicinal product and its metabolites were previously known, leaving sparse room for innovative advance in using this information as a diagnostic dosage tool. Nonetheless, the Court recognized the principle that patent eligibility is not disabled when science is put to practical use, stating that "a new way of using an existing drug" is patent-eligible under Section 101. 132 S.Ct. at 1302.
Similar caveats accompanied the Court's decision in Association for Molecular Pathology v. Myriad Genetics, with the Court stating that "this case does not involve patents on new applications of knowledge about the BRCA1 and BRCA2 genes." 133 S.Ct. at 2120 (emphasis original). The Court further explained its holding, stating that: "We merely hold that genes and the information they encode are not patent eligible under § 101 simply because they have been isolated from the surrounding genetic material." Id.
In the case at bar, the inventors are not claiming the scientific fact of the discovery of paternal DNA in the blood of a pregnant woman; they are claiming the discovery and development of a new diagnostic method of using this information. As the panel recognized, this is a "breakthrough," for this information can now be learned not only earlier in the gestation period than was previously available, but without the risks of the previously required invasive procedures of penetrating the amniotic sac.
Precedent does not require that all discoveries of natural phenomena or their application in new ways or for new uses are ineligible for patenting; the Court has cautioned against such generalizations. Such caution takes hold for the case at bar. The new diagnostic method here is novel and unforeseen, and is of profound public benefit—"a significant contribution to the medical field," Panel Maj. Op. at 16—a "breakthrough," Panel Conc. Op. at 5. The panel's decision to withhold access to patenting, now endorsed by the en banc court's refusal to rehear the case, is devoid of support.
Nor does patenting of this new diagnostic method preempt further study of this science, nor the development of additional applications. Patenting does, however, facilitate the public benefit of provision of this method through medical diagnostic commerce, rather than remaining a laboratory curiosity.
This subject matter is not ineligible under Section 101, but warrants standard legal analysis for compliance with the requirements of patentability, that is, novelty, unobviousness, specificity of written description, enablement, etc., and whether the claims are appropriately limited, as discussed many years ago in O'Reilly v. Morse, 56 U.S. 62, 112 (1853) ("We perceive no well-founded objection to the description which is given of the whole invention and its separate parts, nor to his right to a patent for the first seven inventions set forth in the specification of his claims.").
I respectfully dissent from my colleagues' conclusion that Supreme Court precedent on Section 101 excludes this invention from eligibility for patenting. The subject matter should be reviewed for compliance with Sections 102, 103, and 112, and any other relevant provisions of the patent law.