The Supreme Court of the United States unanimously held that
patent claims directed to optimizing treatment of an immune-related
disorder by administering a drug and determining whether the level
of a metabolite in a patient's blood was within a desired range
were not directed to patentable subject matter and were hence
invalid. Mayo Collaborative Services v. Prometheus
Laboratories, Inc., --- U.S. --- (March 20, 2012.). According
to the Court, "scientists already understood that the levels
in a patient's blood of certain metabolites ... were correlated
with the likelihood that a particular dosage of a thiopurine drug
could cause harm or prove ineffective." (Slip op. 4). The
patent claims at issue were directed to what "those in the
field did not know," the desired "level of -6-thioguanine
in [a] subject having [an] immune-mediated gastrointestinal
disorder." (Slip op. 5).
According to the Court, these claims "purport to apply natural
laws describing the relationships between the concentration in the
blood of certain thiopurine metabolites and the likelihood that the
drug dosage will be ineffective or induce harmful side
effects." (Slip op. 3). The question before the Court was
whether the other steps of the method
claim, "administering" the drug and
"determining" the resulting metabolite level, "add
enough to their statements of the correlations to allow
the processes they describe to qualify as patent-eligible processes
that apply natural laws." (Slip op. 8, italics in
original).
The Court held that the answer was "no." The Court
concluded that "the steps in the claimed processes (apart from
the natural laws themselves) involve well-understood, routine
conventional activity previously engaged in by researchers in the
field" (Slip op. 4), and "that the patent claims at issue
here effectively claim the underlying laws of nature
themselves." (Slip op. 24).
Throughout its opinion, the Court emphasized that "laws of
nature" are not patentable. Its apparent focus was on whether
the way in which the "law of nature" was applied
"contain[ed] other elements or a combination of elements,
sometimes referred to as an 'inventive concept,' sufficient
to ensure that the patent in practice amounts to significantly more
than a patent upon the natural law itself" (Slip op. 3). The
Court also said that "[p]urely 'conventional or
obvious' '[pre]solution activity' is normally not
sufficient to transform an unpatentable law of nature into a
patent-eligible application of such a law." (Slip op. 10).
Reviewing its prior decisions, the Court said that the multi-step
rubber-curing process in Diamond v. Diehr, 450 U.S. 175
(1981) was patentable because it was "nowhere suggested that
all of these steps, or at least the combination of those steps were
in context obvious, already in use, or purely conventional"
(Slip op. 12) and that "[t]he other steps apparently added to
the formula something that in terms of patent law's objective
had significance - they transformed the process into an inventive
application of the formula." (Id.). On the other
hand, in Parker v. Flook, 437 U.S. 584 (1978), the steps
in the claimed process (other than a formula or algorithm) were
"all 'well known' to the point where, putting the
formula to the side, there was no 'inventive concept' in
the claimed application of the formula." (Slip op. 13). As for
the process for converting binary-coded decimal numbers into pure
binary numbers claimed in Gottschalk v. Benson, 409 U.S.
63 (1972), the Court held that the claims there "purported to
cover any use of the claimed method in a general-purpose digital
computer of any type," and that "the mathematical
formula had 'no substantial practical application except in
connection with a digital computer.' ... Hence the claim (like
the claims before us) was overly broad; it did not differ
significantly from a claim that just said 'apply the
algorithm.'" (Slip op. 16).
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