Friday, December 17, 2010

Prometheus STILL wins at CAFC after Supreme Court remand

Following remand from the Supreme Court, the Court of Appeals for the Federal Circuit still found that Prometheus won:

For the foregoing reasons, we reverse the judgment of
the district court and remand to the court with instruc-
tions to deny Mayo’s motion for summary judgment that
the asserted claims are invalid under § 101.

Of the earlier history, the CAFC noted:

Following our decision in Prometheus, the Supreme
Court issued a decision rejecting the machine-or-
transformation test as the sole, definitive test for deter-
mining the patent eligibility of a process under § 101.
Bilski, 130 S. Ct. at 3226-27. Instead, the Court declined
to adopt any categorical rules outside the well-established
exceptions for laws of nature, physical phenomena, and
abstract ideas, and resolved the case based on its deci-
sions in Gottschalk v. Benson, 409 U.S. 63 (1972), Parker
v. Flook, 437 U.S. 584 (1978), and Diamond v. Diehr, 450
U.S. 175 (1981), holding that Bilski’s claims to methods of
hedging risk are not patentable processes because they
attempt to patent abstract ideas. Id. at 3226, 3229-30.
The Court did not, however, reject the machine-or-
transformation test, but rather characterized the test as
“a useful and important clue, an investigative tool, for
determining whether some claimed inventions are
processes under § 101.” Id. at 3227.

The CAFC mentioned Bilkski, in turn quoting Diehr:

The Supreme Court has also established that while a
law of nature, natural phenomenon, or abstract idea
cannot be patented, “an application of a law of nature or
mathematical formula to a known structure or process
may well be deserving of patent protection.” Bilski, 130 S.
Ct. at 3230 (quoting Diehr, 450 U.S. at 188). In making
this determination, the Court has made clear that a claim
must be considered as a whole; it is “inappropriate to
dissect the claims into old and new elements and then to
ignore the presence of the old elements in the analysis.”
Id. (quoting Diehr, 450 U.S. at 188). Nonetheless, a
scientific principle cannot be made patentable by limiting
its use to a particular technological environment or by
adding insignificant post-solution activity. Diehr, 450
U.S. at 191-92.

Metabolite came up:

Mayo also asserts that the carefully
considered opinion of three Justices—allegedly cited
approvingly by five Justices in Bilski—rejected Prome-
theus’s machine-or-transformation argument for nearly
identical claims in Laboratory Corp. of America Holdings,
Inc. v. Metabolite Laboratories, Inc., 548 U.S. 124, 138-39
(2006), concluding that the claims do not cover a process
for transforming a bodily sample, but rather merely
instruct the user to obtain test results and think about
them. Finally, Mayo claims that the Supreme Court’s
decision to GVR our earlier decision in this case indicates
that a different analysis is required of us on remand.

The CAFC rejected Mayo's argument:

We disagree with Mayo. We do not think that either
the Supreme Court’s GVR Order or the Court’s Bilski
decision dictates a wholly different analysis or a different
result on remand. In our pre-Bilski decision in this case,
we held not only that Prometheus’s asserted claims recite
transformative “administering” and “determining” steps,
but also that Prometheus’s claims are drawn not to a law
of nature, but to a particular application of naturally
occurring correlations, and accordingly do not preempt all
uses of the recited correlations between metabolite levels
and drug efficacy or toxicity. The Supreme Court’s deci-
sion in Bilski did not undermine our preemption analysis
of Prometheus’s claims and it rejected the machine-or-
transformation test only as a definitive test. The Court
merely stated that “[t]he Court of Appeals incorrectly
concluded that this Court has endorsed the machine-or-
transformation test as the exclusive test.” 130 S. Ct. at
3226 (emphasis added). The Court stated that it had
previously noted in Benson, 409 U.S. at 70, that
“[t]ransformation and reduction of an article ‘to a differ-
ent state or thing’ is the clue to the patentability of a
process claim that does not include particular machines.”
Id. at 3227. Thus, the Court did not disavow the ma-
chine-or-transformation test. And, as applied to the
present claims, the “useful and important clue, an inves-
tigative tool,” leads to a clear and compelling conclusion,
viz., that the present claims pass muster under § 101.
They do not encompass laws of nature or preempt natural

Treatment, not correlation:

As discussed below,
the claims recite specific treatment steps, not just the
correlations themselves. And the steps involve a particu-
lar application of the natural correlations: the treatment
of a specific disease by administering specific drugs and
measuring specific metabolites. As such, and contrary to
Mayo’s assertions, the claims do not preempt all uses of
the natural correlations; they utilize them in a series of
specific steps. See Diehr, 450 U.S. at 187 (“Their process
admittedly employs a well-known mathematical equation,
but they do not seek to preempt the use of that equation.
Rather, they seek only to foreclose from others the use of
that equation in conjunction with all of the other steps in
their claimed process.”). The inventive nature of the
claimed methods stems not from preemption of all use of
these natural processes, but from the application of a
natural phenomenon in a series of steps comprising
particular methods of treatment. Other drugs might be
administered to optimize the therapeutic efficacy of the
claimed treatment.
We similarly reaffirm that the treatment methods
claimed in Prometheus’s patents in suit satisfy the trans-
formation prong of the machine-or-transformation test, as
they “transform an article into a different state or thing,”
and this transformation is “central to the purpose of the
claimed process.” See Bilski, 545 F.3d at 962. The trans-
formation is of the human body and of its components
following the administration of a specific class of drugs
and the various chemical and physical changes of the
drugs’ metabolites that enable their concentrations to be
determined. We thus have no need to separately deter-
mine whether the claims also satisfy the machine prong of
the test.


Blogger New said...

The outcome of the Classen patent litigation should add further nuance to this line of cases.

5:05 PM  

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