[author: Kevin E. Noonan]
The Federal Circuit made its first attempt to implement the Supreme Court's nearly opaque jurisprudence on the scope of patent eligibility for diagnostic method claims (as set forth in Mayo v. Prometheus) in PerkinElmer, Inc. v. Intema Ltd., decided today. (The Court's AMP v. Myriad case doesn't really count, as the diagnostic method claims in Myriad had already been held patent-ineligible under the "machine-or-transformation" test set forth in In re Bilski, and the Supreme Court's Mayo decision certainly didn't expand the scope of patent eligibility.)
The case involved claims from U.S. Patent No. 6,573,103 for prenatal diagnostic testing for Down's syndrome, intended to avoid the need for invasive testing like chorionic villus sampling that incurs the risk of miscarriage. Claims 1 and 20 were set forth by the Federal Circuit panel as being representative:
Claim 1. A method of determining whether a pregnant woman is at an increased risk of having a fetus with Down's syndrome, the method comprising the steps of:
measuring the level of at least one screening marker from a first trimester of pregnancy by:
(i) assaying a sample . . . ; and/or
(ii) measuring at least one first ultrasound screening marker from an ultrasound scan . . . ;
measuring the level of at least one second screening marker from a second trimester of pregnancy, the at least one second screening marker from the second trimester of pregnancy being different from the at least one first screening marker from the first trimester of pregnancy, by:
(i) assaying a sample . . . ; and/or
(ii) measuring at least one second ultrasound screening marker from an ultrasound scan . . . ;
and determining the risk of Down's syndrome by comparing the measured levels of both the at least one first screening marker from the first trimester of pregnancy and the at least one second screening marker from the second trimester of pregnancy with observed relative frequency distributions of marker levels in Down's syndrome pregnancies and in unaffected pregnancies.
Claim 20. A method of determining whether a pregnant woman is at an increased risk of having a fetus with Down's syndrome, the method comprising the steps of:
measuring the level of at least one first screening marker from a first trimester of pregnancy by:
(i) assaying a sample . . . ; and/or
(ii) measuring at least one first ultrasound screening marker from an ultrasound scan . . . ;
determining a first risk estimate of Down's syndrome by comparing the measured level of the at least one first screening marker level from the first trimester of pregnancy with observed relative frequency distributions of marker levels in Down's syndrome pregnancies and in unaffected pregnancies;
comparing the first risk estimate with a predetermined cut-off level to initially classify the pregnant woman as screen- positive or screen-negative based on the comparison;
and if the pregnant woman is initially classified as screen-negative; measuring the level of at least one second screening marker from a second trimester of pregnancy, the at least one second screening marker from the second trimester of pregnancy being different from the at least one first screening marker from the first trimester of pregnancy, by:
(i) assaying a sample . . . ; and/or
(ii) measuring at least one second ultrasound screening marker from an ultrasound scan . . .
and determining the risk of Down's syndrome by comparing the measured level of both the at least one first screening marker from the first trimester of pregnancy and the at least one second screening marker from second trimester of pregnancy with observed relative frequency distributions of marker levels in Down's syndrome pregnancies and in unaffected pregnancies.
The panel opinion apprehends that the "key difference" between these claims was the segregation of patients into positive or negative groups, wherein only the positive groups are screened in the second trimester, embodied in the "determining step" as the "key limitation." The District Court had construed this "key limitation" as determining a risk of Down's syndrome by comparing distributions of certain markers in Down's syndrome pregnancies and "unaffected" pregnancies, and then combining the screened markers into a single risk calculation based on the results from the first and second trimester screenings. The District Court rejected PerkinElmer's summary judgment motion of patent ineligibility under § 101 (and granted Intema's summary judgment motion on patent eligibility) on the grounds that the claims are directed at a data-gathering method comprising measuring steps that satisfied the machine-or-transformation test (assaying a blood sample was transformative in the District Court's view).
The panel opinion written by Judge O'Malley and joined by Judges Bryson and Wallach, reversed the District Court's finding of patent-eligible subject matter (and affirmed summary judgment against Intema on anticipation and obviousness grounds), based on the Supreme Court's Mayo decision and the Federal Circuit's Myriad decision. "The key distinction," according to the Court, "which bears on our decision today[] is between claims that recite ineligible subject matter, and no more, and claims to specific inventive applications of that subject matter." The opinion goes on to say that the basis for making this distinction is that claims to specific applications of "patent-ineligible subject matter" (i.e., "laws of nature, natural phenomenon or abstract ideas") "do not risk the broad preemption of 'the basic tools of scientific and technological work,'" citing Benson v. Gottschalk, 409 U.S. 63, 67 (1972). In the panel's view, the claimed methods do not contain an "inventive concept" (defined as in Mayo as "other elements or a combination of elements [] sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself" and because these claims "contain[] nothing more than 'well-understood, routine, conventional activity previously engaged in by researchers in the field.'"
The opinion then sets forth how it arrived at this conclusion, which in a nutshell was that the panel did not see any distinction between these claims and the Mayo or Myriad claims. While relying on extensive language from the Court's Mayo decision, the analysis focuses much more closely on the similarities between the claims at bar and the Myriad claims (calling them "indistinguishable" from the claims in Myriad). The similarities reside completely in the fact that the Intema claims and the Myriad claims involve comparing measured biological information (between wildtype and mutant BRCA genes in Myriad and between Down's pregnancies and unaffected pregnancies here), which the panel characterizes as being merely mental activity regarding a naturally occurring relationship). These two characteristics of the claims -- that they recite "mental steps" and "natural laws" -- are sufficient to render them patent-ineligible unless, according to the opinion, they also contain that ineffable "something more" required by the Supreme Court's Mayo opinion. Surveying the claims, the opinion states that the "measuring" steps are insufficient, because (as in Mayo) the method steps encompass any and all methods for measuring the markers. Here, the patentee's attempts to provide broad support for the invention was held against them, wherein the specification was cited for reciting that "'[t]he individual measurements are obtained through known methods. . . . Any markers which are effective at each particular stage may be selected.'" As a result, the panel was able to characterize the measuring steps as encompassing "well-understood, routine, conventional activity previously engaged in by scientists who work in the field."
Similarly, the "determining" step (characterized by the District Court as a "key" limitation) was thought by the panel to comprise merely the "mental step" of comparing marker levels in Down's and unaffected pregnancies, and that the "comparing" methods comprise statistical analysis was not enough: these are also "well-understood" and "conventional" (although the opinion does not establish that it was conventional to apply Gaussian statistics for such comparisons, the patentee's further recitations in the specification that "Any of the known statistical techniques may be used. Preferably the multivariate Gaussian model is used, which is appropriate where the observed distributions are reasonably Gaussian. Such multivariate Gaussian analysis is in itself known . . . ." clearly suffices to support the panel's conclusion that the statistical handling of the data was routine and conventional). Also in this regard the panel recognizes that, as in Myriad, there is no requirement that an actual assay (BRCA gene sequencing in Myriad, taking an ultrasound here) must actually be performed; the claims are satisfied by making the comparison itself (between two printouts of gene sequences in Myriad, or between two ultrasound images here), making it a simple matter to construe the claims as encompassing the merely mental step of "comparing."
The panel gets to the heart of the matter by reaching the preemption issue, wherein "anyone who wants to use this mental step or natural law must follow the claimed process" and the root of the problem, that "there is no requirement that a doctor act on the calculated risk," both because the claims do not recite a treatment step and because the claims purportedly impact the activities of medical doctors treating patients (albeit through the intermediary of a commercial (or at least for-profit) testing laboratory (and the panel goes on to support this conclusion with reference to the different patent-eligibility fates of the claims in Classen v. Biogen Idec, where the presence of an immunization step distinguished patent-eligible from patent-ineligible subject matter).
The Court asserts the most troubling basis for its decision by comparing the claims here with Claim 20 in Myriad's U.S. Patent No. 5,747,282. The patent-eligible distinction, according to this panel, is that in Claim 20 the cell that was used to compare growth rates in the presence or absence of a test compound was non-naturally occurring (and constituted patent-eligible subject matter, and thus "their inclusion in the process made the claims patent-eligible despite the reference to an otherwise ineligible mental step."
The panel enters into Supreme Court-sanctioned flights of fancy in finding that the claims also fail the machine-or-transformation test, on the grounds that "measuring" marker levels is not transformative because "it could be performed 'without transforming the [sample], should science develop a totally different system for [assaying for a biochemical screening marker] that did not involve such a transformation,'" citing Mayo.
While it is apparent that the point is that the claims are overbroad in this respect, it should not be too much to ask that courts base their opinions (with regard to conventionality) on the conditions and limitations existing in the reality we happen to inhabit at the time they render a decision, not some hypothetical Never-Never Land of their own imagination.
This case stands as the most recent cautionary tale of how diagnostic methods claims must be crafted -- narrow, specific, encompassing particular assaying and detection steps, and encompassing some (any) patentable feature other than the naturally occurring correlation between a marker and disease. It may be hoped that claims drawn to a novel marker, or to the new appreciation that a known marker was diagnostically relevant to a particular disease, contained in claim language reciting sufficient specificity to recited methods, will be enough to pass muster. After all, Intema's claims (and the claims of most existing diagnostic method patents granted prior to the Mayo decision) were drafted without foreknowledge of the Supreme Court's return to the Benson/Flook era in Mayo, and its targeting of any claim that may impact medical treatment. Of course, the lesson from Mayo, and this case, is that such inventions should not be patented, but rather kept in a tight black box where patient data is gathered (including for security some unnecessary data) and a clinically established correlation produced. This is, of course, the antithesis of a patent regime intended to "Promote the Progress . . . of the Useful Arts" but in a capitalist society, diagnostic assays cannot reasonably be expected to be developed, or distributed, free of charge. Perhaps the courts, and the medical community, will come to face this reality before it is too late.
PerkinElmer, Inc. v. Intema Ltd. (Fed. Cir. 2012)
Panel: Circuit Judges Bryson, O'Malley, and Wallach
Opinion by Circuit Judge O'Malley
