On July 29, 2011, a divided panel of the United States Court of
Appeals for the Federal Circuit, in an appeal from the United States
District Court for the Southern District of New York, issued its
highly-anticipated decision in Association for Molecular Pathology v. U.S. Patent & Trademark Office, No. 2010-1406, slip opinion (Fed. Cir. July 29, 2011) ("Myriad") [enhanced version available to lexis.com subscribers / unenhanced version available from lexisONE Free Case Law].
Each of the three panelists authored a separate opinion, with the three
opinions consuming a total of 105 pages. The majority held that
composition of matter claims directed to "isolated" DNA molecules recite
patent-eligible subject matter under 35 U.S.C. § 101. The majority also
held that a method of screening cancer therapeutic candidates satisfies
§ 101 where the method includes the steps of "growing" transformed
cells in the presence and absence of a therapeutic candidate and
"determining" the cells' relative growth rates. On the other hand, the
majority held that methods comprising a step of "comparing" two gene
sequences or "analyzing" a gene sequence do not satisfy § 101 absent an
additional transformative step.
Genetics is a molecular diagnostic company offering tests that detect
mutations in a patient's BRCA genes. This is deemed useful because such
mutations have been correlated with a greatly increased risk of breast
and ovarian cancer.
In May 2009, a group of medical
organizations, researchers, genetic counselors, and patients
("Plaintiffs") filed suit against the University of Utah Research
Foundation, Myriad Genetics and the U.S. Patent & Trademark Office
(PTO) seeking a declaratory judgment that fifteen claims related to
aspects of BRCA diagnostic tests from seven patents assigned to Myriad
were drawn to patent-ineligible subject matter under 35 U.S.C. § 101.
The challenged claims included (1) composition of matter claims directed
to "isolated" DNA corresponding to the human BRCA genes, (2) method
claims directed to methods of detecting cancer-predisposing mutations in
a patient's BRCA genes (the "diagnostic method claims") and (3) a
method claim directed to a method of screening potential cancer
therapeutics (the "screening method claim").
Myriad moved for
summary judgment, arguing that the Plaintiffs lacked standing to bring a
declaratory judgment suit challenging the validity of its patents. The
district court denied Myriad's motion, holding that the
Plaintiffs had established standing under "all the circumstances" of the
case. The district court then granted summary judgment of invalidity to
the Plaintiffs on all 15 claims, holding that the challenged claims
were all drawn to patent-ineligible subject matter under § 101.
Federal Circuit Decision The
Federal Circuit affirmed in part and reversed in part. At the outset,
the Court unanimously affirmed declaratory judgment standing, although
on much narrower grounds than the district court. In particular, the
Federal Circuit found that only one of the Plaintiffs, Dr. Ostrer, had
alleged a sufficiently real and imminent injury for declaratory judgment
jurisdiction because he intended to immediately engage in allegedly
infringing BRCA-related activities.
As to patent eligibility,
the majority noted that § 101 encompasses a broad scope of
patent-eligible subject matter, subject to certain judicially created
exceptions, including "products of nature," "mental processes" and "laws
The Federal Circuit majority held that the
composition of matter claims recited patent-eligible subject matter
because the claimed "isolated" DNA molecules "are markedly
different-have a distinctive chemical identity and nature-from molecules
that exist in nature." Specifically, whereas native DNA exists as part
of a large, contiguous DNA molecule, isolated DNA has been cleaved or
synthesized to consist of only a fraction of a naturally occurring DNA
molecule. In other words, isolated DNA molecules are not the same as the
DNA molecules existing in nature and have "a distinctive chemical
identity from that possessed by native DNA." Thus, the majority found
that isolated DNA is not a "product of nature" and held that all of the
composition claims recited patent-eligible subject matter.
his dissenting opinion, Judge Bryson stated that isolated genes are
patent-ineligible "products of nature," arguing that the structural
differences between an isolated gene and the corresponding native gene
are irrelevant to the function and utility of the isolated gene.
to the diagnostic method claims, the Federal Circuit panel unanimously
affirmed the district court's holding that these claims were
patent-ineligible. The Court reasoned that the single step recited in
each method-either "analyzing" a nucleotide sequence or "comparing" two
nucleotide sequences-was an abstract mental step.
Circuit panel unanimously held that the screening method claim recited
patent-eligible subject matter. Using the machine-or-transformation test
as an "important clue" to the patent-eligibility of the claimed method,
the court reasoned that the claimed method involved two transformative
steps: "growing" cells and "determining" growth rate-both of which were
central to the purpose of the claimed method. Finally, the Court found
that the claimed method was not so abstract as to claim a scientific
principle because it was tied to host cells transformed with specific
genes (BRCA) and to a specific method of measuring therapeutic effect
(measuring growth rate).
Impact of the Decision In upholding the patent eligibility of isolated DNA molecules, the Myriad
decision affirmed the PTO's established practice of granting patent
protection for such molecules. It is unlikely, however, that the court's
divided decision will be the last word on the patent eligibility of
isolated DNA molecules. Reconsideration by the Federal Circuit en banc, or review by the Supreme Court, is likely.
panel's unanimous opinion on the diagnostic method claims provides some
guidance to patentees and litigants. The decision reinforces the
importance of including transformative steps in diagnostic method
claims. Patent applicants should ensure that all diagnostic method
claims recite more than simply "analyzing" or "comparing" steps. Claims
should explicitly include transformative steps, such as "administering,"
"isolating," and "determining." Conversely, litigants accused of
infringing diagnostic method claims that lack transformative steps
should consider invalidity defenses based on § 101.
If you have
any questions or wish to discuss how this decision may impact your
company, please contact your attorney at Brinks Hofer Gilson &
* * *
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requiring attention. For further information, please contact a Brinks
Hofer Gilson & Lione lawyer.
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