[Ip-health] Unanimous Supreme Court decision invalidates Prometheus diagnostic test patents and reverses Federal Circuit decision

Krista Cox krista.cox at keionline.org
Tue Mar 20 11:07:06 PDT 2012


In a major patent ruling today, the Supreme Court of the United States
issued a unanimous decision in Mayo v. Prometheus Laboratories. The case,
heard twice before the Federal Circuit (once before the Supreme Court's
ruling in Bilski and once after), has been closely followed because of its
impacts on personalized medicine and potential implications for the Myriad
Genetics case on the BRCA genes. The Supreme Court reversed the Court of
Appeals for the Federal Circuit and held that Prometheus' patents-at-issue
were not eligible for patent protection.

The facts of the case are as follows. Prometheus Laboratories was the sole
and exclusive licensee of the patents and sold diagnostic tests based upon
these patents. The patents concern the use of thiopurine drugs to treat
autoimmune diseases, such as Crohn's desease or ulcerative colitis. The
body metabolizes thiopurine drugs and causes metabolites to form in a
patient's bloodstream. Because metabolization varies from patient to
patient, different doses are necessary in order to reduce side effects but
still maintain effective treatment levels. The patents at issue emobody
findings that certain concentrations indicate the dosage was too high,
whereas other concentrations indicated too low of a dosage. After using the
Prometheus diagnostic tests, Mayo subsequently announced that it would
begin using and selling its own test. Prometheus then brought action
against Mayo for patent infringement.

The District Court in the case granted summary judgment in Mayo's favor,
but the Federal Circuit reversed. Mayo filed a petition for writ of
certiorari with the Supreme Court granted, but then vacated and remanded
for further consideration in light of Bilski. The Federal Circuit then
reaffirmed its earlier decision and Mayo again filed for certiorari which
was again accepted.
Justice Breyer wrote the opinion which can be found here.

In holding that the patents-at-issue were not patentable, the Court found
that more than one must do more than a mere application of a law of nature
to render such a law patent eligible. It stated that a patent that
describes the relation set forth in natural law does does not do enough to
permit a patent.

Providing instructions on applying natural laws does not transform
"unpatentable natural laws into patent eligible applications of that laws."
The case focused, in large part, on Section 101 of the Patent Act which the
Court noted includes an implicit exception that laws of nature are not
patentable subject matter.

The Court focused its decision, in part, on the reasoning for the implicit
exception and implications patents can have on future innovation. Citing
past precedent in Gottschalk v. Benson, 409 U.S. 63 (1972), the Court noted
that phenomena of nature and abstract principles are "basic tools" of
science and "monopolization of those tools through the grant of a patent
might tend to impede innovation more than it would tend to promote it." The
Court also noted that the claimed processes involved "upholding the patents
would risk disproportionately tying up the use of the underlying natural
laws, inhibiting their use in the making of further discoveries."
Repeatedly, the opinion emphasizes the "concern that patent law not inhibit
further discovery by improperly tying up the future use of laws of nature"
and that

there is a danger that the grant of patents that tie up their use will
inhibit future innovation permised upon them, a danger that becomes acute
when a patented process amounts to no more than an instruction to 'apply
the natural law,' or otherwise forecloses more future invention than the
underlying discovery could reasonably justify.

In addition to its concerns regarding future research and development, the
Court also noted that the process claimed by Prometheus involved activity
already well-understood and utilized by the scientific community:

To put the matter more succinctly, the claims inform a relevant audience
about certain laws of nature; any additional steps consist of
well-understood, routine, conventional activity already engaged in by the
scientific community; and those steps, when viewed as a whole, add nothing
significant beyond the sum of their parts taken separately. For these
reasons we believe that the steps are not sufficient to transform
unpatentable natural correlations into patentable applications of those

The opinion rejected the US Government's position that "virtually any step
beyond a statement of a law of nature" transforms an unpatentable law into
an patent-eligible application. In rejecting this position, the Court found
that such an approach would make the implicit law of nature exception to
Section 101 a "dead letter."

Finally, the Court made one important clarification regarding its 2010
decision in In re Bilski. Although the Federal Circuit found that the
"machine or transformation" test is an "important and useful clue" to
patent eligibility under the guidance of the Bilski decision, the Supreme
Court noted here that "we have neither said nor implied that the test
trumps the 'law of nature' exclusion."
It also cited the differing of opinion, recognizing that patent protection
is a "two-edged sword." Although amici on Prometheus' side claimed need for
patent protection to encourage discoveries, amici for Mayo, including the
American Medical Association, the American College of Medical Genetics, the
American Hospital Association, the American Society of Human Genetics, the
Association of American Medical Colleges, and the Association for Molecular
Pathology, among others, argued that

"claims to exclusive rights over the body's natural responses to illness
and medical treatment are permitted to stand, the result will be a vast
thicket of exclusive rights over the use of critical scientific data that
must remain widely available if physicians are to provide sound medical

The case will likely have implications for American Molecular Pathology v.
Myriad Genetics. The arguments against the patent eligibility of the BRCA1
and BRCA2 genes rest on the same case law and principles cited by the
Supreme Court in Prometheus. The issues of application of well-understood
research tools, field preemption and implications for further innovation
are all major factors in the Myriad case. Additionally, the Court relied on
the same precedent cited in favor of AMP, including Gottschalk v. Benson,
Diamond v. Diehr, Diamond v. Chakrabarty and Funk Brothers Seed Co. v. Kalo
Inoculant Co.

I would expect that the Supreme Court will ask the Federal Circuit to
re-hear the Myriad case and to decide it in light of the Prometheus ruling
(much as the Federal Circuit re-heard Prometheus after the Supreme Court
decided Bilski). Based on the guidance of the Supreme Court in Prometheus,
the Federal Circuit could reverse its ruling in Myriad. Alternatively, if
the Federal Circuit comes down on the same side and upholds Myriad's
patents, the case could be appealed again to the Supreme Court.

Additional coverage of the case is available via Pharmalot.

Krista L. Cox
Staff Attorney
Knowledge Ecology International
(202) 332-2670

More information about the Ip-health mailing list