On 20 March 2012, in Mayo Collaborative Servs v Prometheus
Labs, Inc.,1the Supreme Court of the United States
invalidated diagnostic treatment process claims for effectively
claiming the laws of nature underlying the claimed invention.
To reach this decision, the court reviewed the ‘guideposts’2
set by its previous guidance regarding patent eligibility, and
compared the claims-at-issue with those previously
considered by the court. In Mayo, the court erected a new
guidepost, one with particular relevance for the medical
community, as the decision specifically addresses medical
diagnostic treatments, but also one which may impact the
general patentability of any invention that relies upon laws of
nature or natural correlations to describe that invention.
Some patent attorneys in the United States fear that the
court’s invalidation of the medical diagnostic patents at-issue
may unduly limit the patentability of future innovation in the
medical community. This fear, in some respects, has already
come to fruition in that a US District Court recently used
Mayo’s guidance to invalidate claims drawn to methods and
systems for selecting a therapeutic regimen, as discussed
further below.3
Further, while the effect of Mayois not yet clear, and may not be
for years, another concern is that the court unduly expanded
the patent eligibility doctrine beyond its ascribed ‘screening
function’ and blurred the distinction between patent eligibility
and the concepts of anticipation and obviousness.
The Role of Screening for Patent-eligible
Subject-matter
35 U.S.C. §101, which outlines subject-matter eligible for
patent protection in the United States, has been described by
the Supreme Court as a ‘threshold test’ to be passed prior to
consideration of novelty under 35 U.S.C. §102, obviousness
under 35 U.S.C. §103, and the adequacy of the patent’s
function of this threshold test derives from the implicit,
common law exception to §101 that ‘laws of nature, natural
phenomena, and abstract ideas are not patentable.’5
In the United States, it has long been understood that while
laws of nature, natural phenomena, and abstract ideas are not
patentable, ‘an application of a law of nature or mathematical
formula to a known structure or process may well be
deserving of patent protection’.6However, the Supreme Court
has provided caution about the scope of such an ‘application’
by warning against ‘upholding patents that claim processes
that too broadly preempt the use of a natural law’7and
‘simply stat[ing] the law of nature while adding the words
“apply it”’8are not patent-eligible ‘applications’.
In Mayo, it was undisputed that the claims which are
described further below relied, at least in part, on the natural
correlations between certain metabolite levels and the
effectiveness and/or toxicity of a treatment related to those
metabolites. The ultimate question turned on whether the
claims applied that correlation in a patent-eligible manner,
which the Supreme Court determined that they did not. While
the Mayo court stopped short of deciding that diagnostic
treatment claims were as a class not patent-eligible, the
application of this decision to other patents will impact the
rapidly evolving area of medical diagnostics and similar areas
of medicine.
PLOMLEY & COUNIHAN : MAYO v PROMETHEUS: ANOTHER GUIDEPOST ON THE ROAD TO DETERMINING PATENTABILITY IN THE POST-
INDUSTRIAL AGE : VOL 12 ISSUE 5 BSLR 175
Mayo V
Prometheus
:
Another
Guidepost on
the Road to
Determining
Patentability
in the Post-
Industrial Age
JANE PLOMLEY
Partner, White & Case LLP, Washington
ROBERT COUNIHAN
Associate, White & Case LLP, New York
BIO-SCIENCE LAW REVIEW PUBLISH ED BY LAWTEXTPU BLISHING LIMITED
WWW.LAWTEXT.COM
1) Mayo Collaborative Servs v Prometheus Labs, Inc., 132 S.Ct. 1289 (2012).
2) Bilski v Kappos, 130 S.Ct. 3218, 3231 (2010).
3) SmartGene, Inc. v Adv. Bio. Labs, SA, F.Supp.2d, 2012 WL 1059611, *7-10
(D.D.C. 2012).
5) Mayo, 132 S.Ct. at 1293 (internal citations omitted).
6) Ibid., at 1293 to 1294 citing Diamond v Diehr, 450 U.S. 175, 187, 101 S.Ct.
1048 (1981).
7) Ibid., at 1294 citing O’Reilly v Morse, 15 How. 62, 112 to 120, 14 L.Ed. 601
8) Ibid., citing Benson, 409 U.S. at 71 to 72.
