“The falsehood of the allegation that the asserted claims, like those in Mayo v. Prometheus, tied up a doctor’s treatment decision by covering any use of the correlation is belied by the existence of the ELISA alternative, and is arguably a statement that ought not to have been made by a competent attorney.”
The presently pending petition for en banc review in Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC has been addressed by Sherry Knowles and Meredith Addy and is supported by a number of amicus briefs. The patent in issue has been described by the present author as a paradigm of patent eligibility, supporting the argument that en banc review is merited.
Mayo has now filed its response brief, submitted on May 7, and argues that the panel’s decision invalidating the asserted claims as ineligible properly applied the two-step Alice framework in light of precedent, that the full Court need not re-examine it, and accordingly, that Appellants’ petition should be denied. It makes the following principal points:
- The Panel correctly found the claims “directed to” a natural law after considering them as a whole.
- The Panel’s step one conclusion is consistent with Supreme Court precedent and the CAFC’s § 101 opinions. The following cases should be applied:
- Mayo v. Prometheus 566 US 66 (2012);
- Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1376-78 (Fed. Cir. 2015);
- Cleveland Clinic Found. v. True Health Diagnostics LLC, 859 F.3d 1352, 1361-62 (Fed. Cir. 2017); and
- Cleveland Clinic II in which the Court rejected as “overly superficial” the patentees’ attempt to recast its claims as directed to new laboratory techniques and not a natural law.
The following cases should be distinguished:
- Diamond v. Diehr, 450 U.S. 175 (1981), solution of a significant industrial problem;
- Rapid Litig. Mgmt. Ltd. v. CellzDirect, Inc., 827 F.3d 1042 (Fed. Cir. 2016);
- Vanda Pharms. Inc. v. West-Ward Pharms. Int’l Ltd., 887 F.3d 1117 (Fed. Cir. 2018) in which the claims did not remain “open-ended”;
- Endo Pharms. Inc. v. Teva Pharms. USA, Inc. (Fed. Cir. Mar. 28, 2019);
- Alts. Int’l ,Inc. v. Creative Compounds, LLC, 918 F.3d 1338, 1345-47 (Fed. Cir. 2019).
- Claims should not be held eligible based on recitation of man-made reagents and lack of complete pre-emption, see Mayo v. Prometheus, In re BRCA1- and BRCA2-Based Hereditary Cancer Test Patent Litig., 774 F.3d 755 (Fed. Cir. 2015), Ass’n for Molecular Pathology v. U.S. Patent & Trademark Office, 689 F.3d 1303, 1335-37 (Fed. Cir. 2012) and Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 594-95 (2013). The asserted claims here append admittedly conventional steps involving a man-made component to a claim directed to the natural correlation between the presence of MuSK antibodies and certain neurological disorders. “And because the asserted claims, like those in Mayo “tie up the doctor’s subsequent treatment decision” by covering any use of the correlation rather than applying it in a specific way, they fail the pre-emption test in any event.”
- Well-known steps recited in the claim do not impart an inventive concept to the natural correlation, see Genetic Techs. Ltd. v. Merial L.L.C., 818 F.3d 1369, 1376 (Fed. Cir. 2016) and Ariosa at 1380. “The patent sets out the inventors’ discovery of a newfound correlation between certain autoantibodies and disease, and describes as “standard techniques in the art” the exact directives in the claims for observing that correlation in a method of diagnosis. (Id. at 4-6.)”
Examining the Claims
Arguably, the claim in issue is partly directed to an ineligible natural law, in this case the “correlation between the presence of naturally-occurring MuSK autoantibodies in bodily fluid and MuSK-related neurological diseases like MG.” However, it is also at least equally directed to an eligible laboratory procedure involving newly created 135I-MuSK, the newly created two-component complex autoantibody/125I-MuSK and the transformational immunoprecipitated three-component complex autoantibody/125I-MuSK/Sheep anti-IgG, the latter two newly created substances being considered neither in the Panel opinion nor in the Mayo reply brief. The U.S. law on eligibility contains both the positive provisions set out in the four eligible categories of Section 101 and the long-standing negative judicial exclusions. As Sir John Mummery, a retired judge of the UK Court of Appeal, advised this author at a seminar organized by Hogarth Chambers on June 5, in these circumstances it is important to consider the applicable law as a whole and in a balanced manner. A criticism of the approach hitherto adopted in the United States is that the necessary balance is not observed, undue emphasis being placed on factors pointing towards exclusion and factors pointing towards positive eligibility being substantially disregarded.
An essential fallacy in the approach proposed by Mayo is summed up in the final quoted paragraph and is over-emphasis on alleged admissions in the description of the patent without distinction between admittedly known generic approaches and the several species of steps set out in combination in the claim in issue. Perhaps the most critical statement in the patent description reads:
The 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. Examples of suitable techniques include ELISA, radioimmunoassays and the like…
However, at the relevant date, assays for MuSK autoantibody in general and 135I-radioimmunoassay for MuSK autoantibody in particular, were unknown to those skilled in the art, had not been developed and more specifically had not been proved to work, iodination and immunoprecipitation being known as a generality but not having previously applied to the detection of MuSK autoantibody. As explained in the description, an ELISA assay, which apparently was the first choice of approach, proved difficult to standardize and the equivalence of the 135I-radioimmunoassay appears not to have been obvious to a skilled reader. It only became known as a result of the experiments reported in the patent.
In relation to the specific problems facing the inventors, it is not apparent that the specified method steps were “well known, routine, and conventional at the time the … patent was filed” in the language adopted in Genetic Technologies. The falsehood of the allegation that the asserted claims, like those in Mayo v. Prometheus, tied up a doctor’s treatment decision by covering any use of the correlation is belied by the existence of the ELISA alternative, and is arguably a statement that ought not to have been made by a competent attorney.
The eligibility problem can be overcome by specifying a further downstream activity e.g. administering a medicament to a patient at a newly selected dosage. Most commonly, however, the physician responsible for prescribing the new dosage will be separate from the organization that carries out the relevant tests. There will, therefore, be no single infringer against which proceedings can be instituted, and the patent, though granted and free from objection under section 101, will be of limited effectiveness. It is interesting to speculate whether this point has been made with sufficient force in proceedings before the Federal Circuit.
In Hope of Rehearing
The case will now go before the judges of the Federal Circuit for a decision on the documents presently before the Court as to whether rehearing should be ordered. It is hoped that the petition will succeed, at least to that extent and that there will be an opportunity for further submissions and oral argument before this important appeal is finally disposed of.
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