On March 20, 2012, the U.S. Supreme Court unanimously held that
method claims for treating gastrointestinal disorders by
determining the level of certain metabolites (e.g., 6-thioguanine)
in a patient after treating with a particular drug and then
correlating the amount of drug and the level of metabolite did not
constitute patentable subject matter under 35 U.S.C. § 101.
Mayo Collaborative Servs.v. Prometheus Laboratories, Inc.,
566 U.S. __ (2012). This holding reversed the Federal Circuit,
which, after reconsidering in light of the Bilski
decision, had reaffirmed its prior holding that the claimed process
steps of (1) "administering a [thiopurine] drug" to a
patient and (2) "determining the [resulting metabolite]
level" involved the transformation of the human body or blood
taken from it and thus satisfied the Federal Circuit's
"machine or transformation test" bringing the claims into
compliance with § 101. See Prometheus Labs., Inc. v. Mayo
Collaborative Servs., 628 F.3d 1347, 1355–56, 1359
(Fed. Cir. 2010); 581 F.3d 1336, 1345, 1346–47 (Fed.Cir.
2009).
In rejecting the Federal Circuit's analysis, the Supreme Court
focused on whether the claimed processes transformed unpatentable
natural laws (correlations between certain metabolite levels and
the effectiveness of treatment) into patent eligible applications
of those laws by doing significantly more
than simply describing the natural correlations. Mayo Slip
Op. at 3, 8. Apart from the natural laws themselves, the Supreme
Court found that the other steps in the claimed processes merely
involved "well-understood, routine, conventional
activity" previously engaged in by researchers in the field.
Id. at 10–11. The other
"administering" and "determining" steps were
required to apply the laws in question and their effect was
"simply to tell doctors to apply the law somehow when treating
their patients." Id. at 13. Thus, the Supreme Court
concluded that the claims did not do significantly
more than simply describe the natural correlations
and therefore were not patent-eligible subject matter. Id.
at 8, 11, 18–19.
The Supreme Court considered and expressly rejected the
government's argument that "virtually any step beyond a
statement of a law of nature itself should transform an
unpatentable law of nature into a potentially patentable
application sufficient to satisfy § 101's demands,"
stating that the government's approach would make the "law
of nature" exception to § 101 patentability "a dead
letter." Mayo Slip Op. at 20–21. The
Supreme Court thus declined the government's invitation to
substitute §§ 102, 103, and 112 inquiries for the §
101 analysis. Id. at 22. While acknowledging the
conflicting views of the amici on this issue, the Supreme
Court pointed out that it is the role of Congress to craft more
narrowly tailored rules where necessary and that the Supreme Court
did not need to determine whether, from a policy perspective,
increased protection for discoveries of diagnostic laws of nature
is desirable. Id. at 23–24.
What This Means for You
Mere discovery of a law of nature and crafty claim drafting does not create patent-eligible subject matter under 35 U.S.C. § 101. To pass the § 101 test, a claimed process involving a law of nature must include steps that apply that law in new ways. If the additional steps merely require routine actions that prior researchers would undertake to apply the law, they will not be sufficient to make the claimed process eligible for patent protection.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.