“The Mayo/Alice framework needs reconsideration to place pioneering or breakthrough inventions and incremental inventions on a level playing field. No such disadvantage is imposed on inventors in Europe and there is no credible policy justification for such illogical and harsh treatment.”
In Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1376 (Fed. Cir. 2015) the Federal Circuit belittled pioneering work at Oxford University, indisputably one of the world’s leading research institutions. In the Athena Diagnostics v. Mayo Collaborative Services decision handed down early in 2019, the Federal Circuit surpassed itself by belittling pioneering work representing the combined efforts of Oxford University and the Max-Plank Gesellschaft, two of the world’s leading research institutions. A petition for en banc review has been filed and is supported by amicus briefs. This article further supports the need for review, emphasizing inadequate attention paid to the positive eligibility provisions of 35 USC 101, conflict with Diamond v Diehr, an inadmissible extension of admissions within the patent description regarding a genus of techniques to cover a previously undisclosed species of techniques within the genus, and the need to give equal treatment to those who make pioneering inventions or discoveries and those whose inventions or discoveries are incremental.
The Athena Subject Matter
As explained in the background to the majority opinion, Athena Diagnostics is the exclusive licensee of U.S. Patent 7267820 (Vincent) covering methods for diagnosing neurological disorders by detecting antibodies to a protein called muscle-specific tyrosine kinase (MuSK). In particular, the methods are useful for diagnosing Myasthenia gravis (MG), which is a neurological disorder where patients experience muscle weakness and symptoms including drooping eyelids, double vision, and slurred speech.
The subject-matter claimed in claim 9 of Vincent US 7267820 on which the panel majority in Athena focused is as set out below:
A method for diagnosing neurotransmission or developmental disorders related to muscle specific tyrosine kinase (MuSK) in a mammal
comprising the step of detecting in a bodily fluid of said mammal autoantibodies to an epitope of muscle specific tyrosine kinase (MuSK), comprising
contacting MuSK or an epitope or antigenic determinant thereof having a suitable label thereon, with said bodily fluid, wherein said label is a radioactive label and is 125I,
immunoprecipitating any antibody/MuSK complex or antibody/MuSK epitope or antigenic determinant complex from said bodily fluid and
monitoring for said label on any of said antibody/MuSK complex or antibody/MuSK epitope or antigen determinant complex, wherein
the presence of said label is indicative of said mammal is suffering from said neurotransmission or developmental disorder related to muscle specific tyrosine kinase (MuSK).
The above method can be understood with reference to the disclosed embodiment with reference to the following diagram, with products of nature shown above the horizontal line and products created by human intervention shown below the horizontal line:
The panel majority held that the claim was directed to a natural law, i.e. the correlation between the presence of naturally occurring MuSK antibodies in the bodily fluid and MuSK-related neurological diseases. However, appropriate and necessary attention to detail would have revealed process steps of a qualifying transformative character, and in particular to the following ordered combination of steps:
- providing bodily fluid of a mammal, implicitly as an isolated sample (column 5 lines 18-19);
- providing 131I-labelled MusK or an epitope or antigenic determinant thereof, being a novel compound disclosed neither in Valenzuela WO 97/21811 cited by Vincent nor in earlier-dated Bowen US 5814478, apparently the earliest disclosure of the MuSK protein.
- reacting the labelled MuSK or fragment thereof with the antibody in the sample to produce an autoantibody/labelled MuSK complex, a second novel compound; and
- further reacting the complex produced with an immunoprecipitating agent (e.g. sheep IgG) to form an immunoprecipitated 3-component complex which is a third novel compound and is used for radioactive counting.
It will be apparent that three of the four eligible subject-matter categories of 35 USC 101 are relevant to the claimed subject-matter.
Examining Eligibility Factors
Each of the 135I-MuSK, the autoantibody complex and the immunoprecipitated complex falls straightforwardly within the eligible “composition of matter” category, not being directed to a single substance but to a composite article, see Chakrabarty, 447 U.S. at 308, citing Shell Development Co. v. Watson, 149 F. Supp. 279, 280 (DC 1957). No authority supports the proposition that a novel chemical compound created by the combination of separate entities is other than patent eligible. In particular, no such conclusion can be drawn from the Supreme Court opinion in Association for Molecular Pathology v. Myriad, where Thomas J. recognized cDNA as distinct from a naturally-occurring material and as unquestionably something new created by a lab technician, notwithstanding that each of the nucleotide sequences in the cDNA had been dictated by nature and not by the lab technician. Nor should steps involving these new compounds be dismissed as “conventional steps specified at a high level of generality” as in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012) since steps involving compounds new to science cannot legitimately be regarded as “conventional” or “non-routine steps” but as contended by Athena are directed to a new laboratory technique that makes use of man-made molecules.
It is also plain that the immunoprecipitated 3-component complex qualifies as a “manufacture” being a newly created article in a new form (precipitated material), with new provenance and with new utility (suitability for radioactive counting), all of which are attributes of eligibility as a “manufacture” under the criteria in Hartranft v. Wiegmann, 121 U. S. 609, 121 U. S. 615 (1887), quoted with approval in American Fruit Growers, Inc. v. Brogdex Co., 283 U. S. 1, 283 U. S. 11 (1931), Diamond v Chakrabarty, 308 and Association for Molecular Pathology v. Myriad Genetics, Inc 569 U.S. ___ , 133 S.Ct. 2107 (2013). The precipitated 3-component complex has also become for every practical purpose a new thing commercially and analytically: Parke-Davis & Co. v. H.K. Mulford Co., 189 F. 95 (C.C.S.D.N.Y. 1911) (adrenalin), Kuehmsted v. Farbenfabriken of Elberfeld Co., 179 F. 701 (7th Cir. 1910) (aspirin), Merck & Co. v. Olin Mathieson Chem. Corp., 253 F.2d 156 (4th Cir. 1958) (vitamin B12).
The claimed method therefore involves the production of patent-eligible new substances. No prior Supreme Court or Federal Circuit decision supports the proposition that they should not count towards Section 101 compliance merely because they are defined in individual steps in a multi-step method and not in stand-alone compound claims.
The attention of the panel majority had been directed to the new compound issue, but it was dismissed in a footnote:
“We note that the district court held that the “focus of the claims” was the binding of MuSK to MuSK antibodies in bodily fluid. Decision, 275 F. Supp. 3d at 310. Our cases have not described a claim to the binding of two molecules during a sequence of chemical manipulations (here, after MuSK labelling and before immunoprecipitation) as a claim to a natural law, even if such binding occurs according to natural laws. We need not resolve that issue here, as we agree with Mayo’s identification of the natural law.”
It is apparent that the alleged conflict between positive statutory eligibility as composition of matter features and judicial exception as a claim to a natural law was a significant and highly relevant legal issue that cried out for resolution, not least because it involved the doctrine of separation of powers. The need to interpret a statute as written and the inappropriateness of rewriting it were recently emphasized by Kavanaugh J. in Henry Schein v. Archer & White. However, the need to take positive provisions into account can be traced to older authority e.g. Bilski v. Kappos 561 U.S. 593 (2010) where Kennedy J. explained that: “Concerns about attempts to call any form of human activity a “process” can be met by making sure the claim meets the requirements of §101.”
It is also apparent that the overall method claimed falls as a matter of substance and not mere outward appearance within the Section 101 category of “process,” the water-soluble autoantibody starting material being transformed or reduced to the water-insoluble 3-component complex which is a different state or thing: Cochrane v. Deener, 788, quoted with approval in Parker v. Flook, 59 see e.g. footnote 9, Diamond v. Diehr, 185, Bilski v. Kappos, Association for Molecular Pathology v. Myriad Genetics 569 U.S. 576 (2013) and Alice Corp. v. CLS Bank International, 573 U.S. 208 (2014). The majority in Diehr summarized its conclusion that the claimed rubber-curing method involving the Arrhenius equation was patent-eligible in the following terms:
“We view respondents’ claims as nothing more than a process for molding rubber products, and not as an attempt to patent a mathematical formula. We recognize, of course, that, when a claim recites a mathematical formula (or scientific principle or phenomenon of nature), an inquiry must be made into whether the claim is seeking patent protection for that formula in the abstract…. On the other hand, when a claim containing a mathematical formula implements or applies that formula in a structure or process which, when considered as a whole, is performing a function which the patent laws were designed to protect (e.g., transforming or reducing an article to a different state or thing), then the claim satisfies the requirements of § 101. Because we do not view respondents’ claims as an attempt to patent a mathematical formula, but rather to be drawn to an industrial process for the molding of rubber products, we affirm the judgment of the Court of Customs and Patent Appeals.”
No valid distinction can be discerned between the rubber molding process of Diehr and the diagnostic method of Athena. The claimed process equally transforms the initial autoantibody into a different state or thing. The method of claim 9 cannot be regarded as an attempt to patent the correlation which was held to be a natural law, especially as it covers only a preferred one of two alternative detection methods disclosed in the patent. The diagnostic method is equivalent “an industrial process” because it is commercialized on a mass-scale by medical diagnostic companies.
The panel majority over-emphasized the doctrine in Supreme Court precedent that a law of nature or other ineligible element should be treated as prior art, the position being explained in Diamond v. Diehr as follows:
“…we did not hold in Flook that the mathematical algorithm could not be considered at all when making the § 101 determination. To accept the analysis proffered by the petitioner would, if carried to its extreme, make all inventions unpatentable, because all inventions can be reduced to underlying principles of nature which, once known, make their implementation obvious. The analysis suggested by the petitioner would also undermine our earlier decisions regarding the criteria to consider in determining the eligibility of a process for patent protection. See, e.g., Gottschalk v. Benson, supra; and Cochrane v. Deener, 94 U. S. 780 (1877).”
Repeatedly throughout its opinion, the panel majority held that the claimed subject-matter was 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 applied conventional techniques to detect that natural law, this allegedly being an admission made in the description of the patent specification itself. However, a more logical analysis of what was said in the description is that the detection steps fell within a genus of known immunoassay techniques, which should not be held to be an admission that these steps considered as species within the genus were also conventional. Indeed, the proposition that the radio assay technique developed by Vincent was conventional involving standard techniques in a standard way when it resulted in man-made compounds new to science is clearly self-contradictory.
The decision repeats the poisonous doctrine that to supply an inventive concept the sequence of claimed steps must do more than adapt a conventional assay to a newly discovered natural law; it must represent an inventive application beyond the discovery of the natural law itself. The Mayo/Alice framework needs reconsideration to place pioneering or breakthrough inventions and incremental inventions on a level playing field. Whereas incremental inventors only have to make a single invention or discovery, for eligibility these pioneering inventors need to make two inventions or discoveries. The return for the qualifying second invention is ashes: it is left open to others to find ways other than the second invention for performing the detection steps, after which those others can freely benefit from the fundamental discovery or breakthrough and the original inventors receive nothing. No such disadvantage is imposed on inventors in Europe and there is no credible policy justification for such illogical and harsh treatment, which was not meted out to James Watt, Samuel Morse or Alexander Graham Bell. A better rule is in The Telephone Cases 126 U.S. 1, 531 (1888):
“It may be that electricity cannot be used at all for the transmission of speech except in the way Bell has discovered, and that therefore, practically, his patent gives him its exclusive use for that purpose; but that does not make his claim one for the use of electricity distinct from the particular process with which it is connected in his patent. It will, if true, show more clearly the great importance of his discovery, but it will not invalidate his patent.”
The continuing relevance of the rule in the Telephone Cases was affirmed by Justice Stevens in Bilski v. Kappos, 561 U.S. 593 (2010), where he said, also with reference to O’Reilly v. Morse, 56 U.S. 62 (1853):
“One might think that the Court’s analysis means that any process that utilizes an abstract idea is itself an unpatentable, abstract idea. But we have never suggested any such rule, which would undermine a host of patentable processes.”
It is to be sincerely hoped that the petition for en banc review will be granted and that the present unsatisfactory decision will be reversed. Indeed, the most appropriate outcome would be disapproval of the whole chain of unsatisfactory Federal Circuit decisions in life sciences inventions, including Ariosa.