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Half a loaf, maybe
May 2013
EDIT CONNECT
SHARING OPTIONS:
WASHINGTON, D.C.—In the case that has become generally
familiar within the pharma/biotech community, the
U.S. Supreme Court heard
arguments last month seeking to
invalidate Myriad Genetics' patents on two BRCA
genes associated
with hereditary breast and ovarian cancer.
After previously having been set aside by a district
court,
the patents were upheld by the Federal Circuit Court,
both initially and after
remand for reconsideration by the Supreme Court, which then agreed to take up
the case itself.
The lawsuit was filed by the American
Civil Liberties Union
(ACLU) and the Public Patent Foundation
(PUBPAT) on behalf of a long list of
researchers, patients, breast cancer and women's health groups and medical
professional associations.
While patent attorneys we spoke with were uniformly cautious
about reading too much into the tea leaves
based on oral arguments, they all
expressed doubt that, having taken up the case, the court would reaffirm the
Federal Circuit Court's twice-
articulated decision. Instead, the best bet seems
to be a sort of triangulation reminiscent of the Clinton Administration, where
the court will come
down on the side of a "third way" close to the position
articulated by the Obama administration's solicitor general.
According to a summary by Morrison &
Foerster's patent
lawyers, the solicitor general's "amicus
brief on behalf of the United States, nominally supporting neither party,
but …
in practical terms, is seen as supporting the challengers." In a departure from
the position of the Patent Office, the Solicitor General argues
that "isolated
but otherwise unmodified DNA is not patent-eligible."
According to the Solicitor
General, the "public's ability to
study and use native DNA would be unduly compromised if changes caused by the
extraction of naturally occurring
substances from their native environments
were sufficient to trigger patent eligibility." The Solicitor General departs
from the challengers when it
comes to "complementary DNA" molecules, which the
government describes as "synthetic molecules built by scientists to include, in
a single
contiguous DNA segment, only the exons of a naturally occurring gene,
without the introns and regulatory regions that are normally interspersed with
exon sequences in genomic DNA."
Kevin E. Noonan, a biotechnology patent lawyer and partner
with McDonnell Boehnen Hulbert & Berghoff LLP in Chicago, also
thinks the
court may take the advice of the solicitor general, one reason being that the
court might be reticent to make a more sweeping decision
because the justices
seem to appreciate that they lack a detailed understanding of the science at
issue. Noonan also points out that the BRCA genes are
something of a special
case in terms of their impact on cancer rates. In breast cancer, for example, a
single BRCA mutation drives the cancer rate from
9 percent to 90 percent. More
typically, a half-dozen or more mutations are involved.
"Unlike BRCA, if
the genetic profile is complicated enough,"
he says, "the inventor can decide not to disclose the pattern of mutations,
hide it on a gene chip and
make it very difficult to reverse engineer.
Currently, universities do the work and get the patents. This might tip the
scale to companies doing their
own development and patent filings. A LabCorp or
Quest could examine 100,000 samples of stomach cancer
cells, determine what's
different and what they have in common, then develop the test on a gene chip,
encrypted, with false negatives and positives.
"
Jennifer A. Camacho, a patent attorney and shareholder at Greenberg
Traurig LLP in Boston, finds it interesting that oral arguments did not include
much discussion of Mayo
vs. Prometheus, a
case in which Prometheus' patents were invalidated amidst much concern for what
this decision implied for the development of
personalized medicine based on
patented diagnostic tests. She thinks this may be another indication that this
time, the Supreme Court will decide as
narrowly as they must to answer the
question, perhaps focusing on the wording of the claim or the DNA in some
version of the solicitor general's
amicus
brief. Code: E051325 Back |
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