In Mayo Collaborative Servs.
v. Prometheus Labs. ("Prometheus Labs."), the Supreme Court will
address the patent eligibility of a claimed process for the second time in two
years. This time, at issue is a claimed process for maximizing the therapeutic
efficacy of a specific class of drugs that recites as its third limitation a
natural phenomenon, but requires the transformation of matter it in first two
limitations. The question for the court is whether the two transformative
limitations are mere data gathering steps for the third, such that the claim is
ineligible as being in substance drawn to the natural phenomenon or whether the
claim, when viewed as a whole, is eligible as drawn to a physical process that
constitutes a concrete application of the phenomenon. How the court resolves
that issue may very well have a substantial impact on how courts decide the
ever-increasing number of eligibility challenges.
Summary of of the Case (lexis.com subscribers
may access Supreme Court briefs for this case)
Patents in Suit. At issue in Prometheus
Labs. is the patent eligibility of claims for optimizing the therapeutic
efficacy of thiopurine drugs (a class of drugs used to suppress the immune
system) when used to treat certain autoimmune diseases. Claim 1 of U.S. Patent
6,355,623 is representative:
A method of optimizing
therapeutic efficacy for treatment of an immune-mediated gastrointestinal
(a) administering a drug
providing 6-thioguanine to a subject having said immune-mediated
gastrointestinal disorder; and
(b) determining the
level of 6-thioguanine in said subject having said immune-mediated
gastrointestinal disorder, wherein the level of 6-thioguanine less than about
230 pmol per 8x108 red blood cells indicates a need to increase the
amount of said drug subsequently administered to said subject andwherein the
level of 6-thioguanine greater than about 400 pmol per 8x108 red blood cells
indicates a need to decrease the amount of said drug subsequently administered
to said subject.
(Emphasis added.) In simple
terms, the claims at issue are drawn to a method that includes (1) "administering"
a particular drug to a patient, (2) "determining" the levels of the
drug's metabolites in the patient, and (3) comparing the levels of the drug's
metabolites (small molecules formed in the metabolism process) to predetermined
levels to ascertain whether the drug's dosage needs to be adjusted.
Procedural History. The district court ruled on a motion for summary
judgment that the claims were ineligible for patent protection because the
"administering" and "determining" steps were mere data gathering such that the
claims were, in substance, drawn to a natural phenomenon, i.e., the
correlation between a drug's metabolite levels and therapeutic efficacy and
toxicity. Prometheus Labs. v. Mayo Collaborative Servs., 2008 U.S. Dist.
LEXIS 25062, **17-18 (S.D. Cal. Mar. 28, 2008) [an enhanced version of this opinion is available to lexis.com
On appeal, the Federal Circuit
applied the so called "machine or transformation" test under which a
claim is patent eligible if it is tied to particular machine or transforms a
particular article into a different state or thing, which, at that time, was
the sole test used by the Federal Circuit for determining eligibility. 581 F.3d
1336, 1342 (Fed. Cir. 2009) [enhanced version / unenhanced version available from lexisONE Free Case Law].
The Federal Circuit reversed the lower court on the grounds that the
"administering" and "determining" steps were
transformative, and, thus, satisfied the "machine or transformation"
test, in that the administration of a drug necessarily transforms a body and
the determining step requires manipulation of a blood sample to obtain an
accurate measure of the drug's metabolite. Id. at 1345-47. It rejected
the lower court's conclusion that those steps were mere data gathering steps
because they were integral parts of a specific treatment protocol. Id.
at 1346. It further held that the claimed process did not preempt all uses of
the correlation between a drug's metabolite levels and therapeutic efficacy,
but rather, only the use of that correlation in a particular method of
treatment. Id. at 1349.
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