The United States Court of Appeals for the Federal Circuit on
July 29, 2011 held in a split decision that isolated BRCA 1/2 DNA
molecules patented and used by Myriad Genetics Inc. for diagnosing
increased breast and ovarian cancer risk are
patentable1. The Court also found that claims on methods
of using the DNA to screen for cancer therapeutics were also patent
eligible but held that diagnostic claims directed to
"analyzing" and "comparing" DNA sequences are
The Court concluded that the isolated DNA molecules are eligible
for patent protection under 35 U.S.C. §101 and rejected the
plaintiff's arguments that the isolated DNA molecules were
naturally occurring material. Referring to the Supreme Court
precedent of Diamond v. Chakrabarty, the majority noted
that the distinction between a product of nature and a human-made
intervention for purposes of §101 turns on a change in the
claimed composition's identity compared with to what exists in
nature. Applying this test to the isolated DNA in this case, the
Court concluded that "the challenged claims are drawn to
patentable subject matter because the claims cover molecules that
are markedly different ─ have distinctive chemical
identity and nature ─ from molecules that exists in
The Court also rejected the U.S. government's position and
its proposed "magic microscope" test where a DNA molecule
would not be eligible to patent protection if it could be
visualized in the human body through and imaginary "magic
microscope". The Court indicated that that approach
misunderstands the difference between science and innovation and
fails to take into account the existence of molecules as separate
chemical entities. "The ability to visualize a DNA
molecule through a microscope, or by any other means, when it is
bonded to other genetic material, is worlds apart from possessing
an isolated DNA molecule that is in hand and usable".
Such an approach would "discourage innovation"
because "[v]isualization does not cleave and isolate the
particular DNA; that is the act of human invention"
according to the Court.
The Court also refused to change the longstanding practice of
the PTO who has been issuing patents on DNA molecules for almost 30
years: "If the law is to be changed, and DNA inventions
excluded from the broad scope of §101 contrary to the settled
expectation of the inventing community, the decision must come not
from the courts, but from Congress".
In the second step of its analysis, the Court considered the
method claims reciting a method of screening by
"comparing" or "analysing" BCRA sequences from
a tumor sample to detect genetic mutations associated with a
predisposition to cancer. The Court concluded that these claims
fail to satisfy the machine-or-transformation test set by the
Supreme Court in Bilski and that they fell outside the
scope of the §101 because they claim only abstract mental
On the other hand, the method of screening potential cancer
therapeutics was found patentable because the claim includes
transformative steps of "growing" host cells,
"determining" the growth rate of the cells and
"comparing" the growth rate.
Comment: The biotechnology and
biopharmaceutical industry will welcome this much anticipated
decision since it removes overhang over the thousands of patents
claiming "isolated DNA" issued so far by the
USPTO. However, the decision raises some issues with respect to
patents covering diagnostic-related methods because they may be
seen as merely claiming abstract mental processes. To ensure that
patents directed to diagnostic methods satisfy the
machine-or-transformation test, the claims should recite some form
of manipulation like extraction, collection of a bodily sample or
affirmative steps for obtaining a sequence to be analysed.
1 Association for Molecular Pathology v.
U.S. Patent and Trademark Office, Fed. Cir., No. 2010-1406, July
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