[originally posted 3/27/2012]
In Mayo Collaborative
Servs.v. Prometheus Labs., Inc., 2012 U.S. LEXIS 2316 (U.S. 2012) [enhanced version available to lexis.com subscribers],
the Court addressed the question of whether a claim that includes a law of
nature (or a natural phenomenon or a mathematical algorithm) has "enough"
in the way of other limitations to distinguish the claim from one drawn to the
law of nature itself. However, Prometheus
Labs. arguably resolves a number of questions that have been part of the
patent eligibility debate since the Court's last decision in Bilski v. Kappos, 130 S. Ct. 3218 (2010)
[enhanced version available to lexis.com subscribers].
In this Analysis, Eric E. Bensen discusses the Court's recent decision.
The Supreme Court's
The Court began
its discussion by repeating now familiar rules:
1. Laws of nature, natural phenomena, and abstract ideas are
not patent eligible.
2. A process is not ineligible simply because it contains a
law of nature or mathematical algorithm.
3. An application of a law of nature or mathematical formula
to a known structure or process may be patent eligible.
Getting to the
heart of the matter, the court further observed that to transform a patent
ineligible law of nature into a patent eligible application of the law,
"one must do more than simply state the law of nature while adding the
words 'apply it.'" As a court explained, the question of patent
eligibility should not "depend simply on the draftsman's art,"
rather, the question of patent eligibility should be determined with reference
to the principles underlying the prohibition against patents on laws of nature,
i.e., the policy against patent
claims that preempt any use of a natural law. Thus, where a natural law is part
of the patent claim, eligibility will turn on whether the other elements, i.e., the "inventive concept,"
are sufficient to ensure that the patent claims something more than the natural
With respect to
Prometheus' patent, the question in the court's view was whether the claims
added "enough" to the natural law they recite, i.e., the correlation between the metabolites in the patient's body
and the proper dosage of the administered drug, to constitute a patent eligible
application of the natural law. Put differently, the question was whether the
claims included additional features that would provide practical assurance that
the claimed process was more than a drafting effort designed to monopolize the
law of nature they recited.
concluded that the claim limitations not drawn to the natural law, i.e., the "administering"
step, the "determining" step and the comparison of metabolite levels
(the last of which the court referred to as the "wherein" clauses)
were insufficient to distinguish the claim from a claim drawn to the natural
law itself. As a court explained, the "administering" step simply
referred to the preexisting audience of doctors who used thiopurine drugs and,
in any event, was a mere field of use limitation that was not sufficient to
render an otherwise mere law of nature patent eligible. The "wherein"
clauses, in the Court's view, merely suggested to doctors that they should take
the natural law into account when treating a patient. The
"determining" step merely told doctors to engage in a "well
understood, routine, conventional activity previously engaged in by scientists
to work in the field" and, thus, was a mere "conventional or obvious
... [pre-]solution activity" that did not transform a law of nature into a
patent eligible application of the law. The three steps viewed in combination
similarly failed to distinguish the claim from one drawn to a law of nature
itself because the three steps simply told doctors to gather data from which
they could draw an inference in light of the correlations.
Prior to Bilski, courts had only on occasion
addressed questions of patent eligibility and, one could argue, appeared
content to resolve those issues on a case-by-case basis. Since Bilski, however, whether due to the
nature of contemporary innovation or simply a new focus on a potential defense
to infringement, eligibility challenges have become commonplace. As a result,
courts have been under increased pressure to better define the contours of
Time will tell
whether the Court made much headway in that respect with its Prometheus Labs. decision. By adhering
closely to its precedent, the Court arguably did not change the law respecting
eligibility. At the same time, its holding that for a claim that incorporates a
law of nature to be patent eligible, the other elements of the claim must be
"enough" to ensure that the claim as a whole is not drawn to the law
of nature itself, if not viewed by courts as a new rule, is likely to be viewed
as at least a significant tool for resolving the eligibility question. What
constitutes "enough," however, is certain to be the source of much
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