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To patent or not to patent
May 2011
EDIT CONNECT
SHARING OPTIONS:
WASHINGTON D.C.—While the U.S. Court of Appeals for the
Federal Circuit ponders the fate of a landmark
biotechnology patent case on
isolated DNA in Association for Molecular Pathology, et al., v. United
States Patent and Trademark Office, et
al.,
all that scientists, doctors and patients can do is wait until the court ruling
comes down later this year.
Attorneys familiar with the issues predict that the case
will ultimately be heard and decided by the U.S. Supreme Court.
On April
4, attorneys for Myriad Genetics Inc., the American
Civil Liberties Union (ACLU) and the U.S. government presented oral arguments
before a three-judge panel in Washington, D.C., in the case which is appealing
the March 2010 ruling by federal Judge Robert Sweet, who held that human
genetic material is not subject to patent protection.
Sweet tossed out seven patents held by biotech firm Myriad
Genetics, that stemmed from
genetic sequences directly linked to breast and
ovarian cancer, ruling that the patents were invalid based on a century-old
Supreme Court doctrine
prohibiting patents for products found in nature,
according to court records. Myriad appealed.
The Federal Circuit must address
two questions on appeal: 1)
whether plaintiffs had standing to file a declaratory judgment action against
Myriad seeking to invalidate its patents; and
if so, 2) whether isolated DNA is
patent-eligible.
The case began in 2009 when the ACLU filed its
complaint
against Myriad on behalf of women who wanted to find out if they carried breast
and ovarian cancer genes, but found the testing too
expensive.
In presenting his arguments before the Federal Circuit, the
ACLU's Christopher A. Hansen
stated that DNA is a natural phenomenon found in
nature, and thus not eligible for patenting under Supreme Court precedent
because the changes made to
the DNA in the lab do not give isolated DNA a distinctive
name, character or use.
"The human
gene is a product of nature and no more
patentable than a human kidney," Hansen told the Federal Circuit. "The district
court ruling striking down
patents on human genes was a victory for the free
flow of ideas and information, and could lead to important medical and
scientific advances. The
appeals court should uphold that ruling."
Turning to the merits of the appeal, Gregory A. Castanias of
Jones Day in Washington, D.C., argued for Myriad that isolated DNA
does not
exist in nature—and would not exist but for human ingenuity. Castanias
concluded that the U.S. Patent and Trademark Office (USPTO) has been granting
patents on this subject matter for
decades; that the biotech industry is moored
on the notion that isolated DNA is patentable; and if the Federal Circuit were
to invalidate all of the
patents directed to isolated DNA, the foundation of
the biotech industry would be significantly damaged.
Kristin L. Yohannan of Morrison & Foerster in
Washington,
D.C., who attended the oral arguments, tells ddn, "In order for a declaratory judgment action to
proceed, there must be an actual threat of
litigation. Here, Myriad asserts
that it has not threatened patent infringement against any of the plaintiffs
except one—and that was over 12 years
ago. Therefore, there is no imminent
threat.
"As to the second issue, Myriad states
unequivocally that
isolated DNA is patentable," Yohannan continues, "It looks to the USPTO
Guidelines that state isolated DNA is patentable if
isolated, purified and if
its corresponding protein is identified. Myriad contends that isolating a
specific piece of DNA takes hard work and human
ingenuity—both things that the
patent system was designed to reward.
"The fatal flaw," in the
ACLU's argument, Yohannan says, is
that there is human ingenuity in identifying and isolating a specific gene
sequence.
"This is recognized by the decades-old USPTO Guidelines on
patenting DNA. In my view, it would be difficult for the Federal Circuit to
circumvent
decades of patents that cover isolated DNA," she says.
Furthermore, "if the ACLU were to prevail,
I believe that
the biotechnology industry would be adversely impacted," Yohannan adds. "That
industry has been built with the understanding that the
DNA/genes that are
being studied are patentable.
"It is worth the investment in isolating and
characterizing
DNA because the investment will be rewarded with 20 years of patent protection,
she says. "That gives companies the opportunity to
recoup its investment and
perhaps invest in the study of a new gene sequence," Yohannan says. "This is
how cures for diseases and other genetic
maladies are discovered."
But Dan Ravicher, executive director of the Public Patent
Foundation (PUBPAT), takes the case back to the beginning.
"Since the beginning, this case wasn't about patent
law," Ravicher states on the ACLU's website. "It was about
the right of women
to know what genetic mutations they might have in their own bodies, and the
right of physicians to help them in doing so. We asked
the Federal Circuit
Court of Appeals to apply patent law's longstanding prohibition on the
patenting of nature to protect these rights from patents
that the government
now agrees should have never been issued in the first place."
Code: E051127 Back |
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