By 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