By
Donald Zuhn —

On
Monday, the District Court for the Southern District of New York ruled in favor
of the plaintiffs in Association of
Molecular Pathology v. U.S. Patent and Trademark Office, finding the claims
of several patents directed to the BRCA1 and BRCA2 genes invalid as
encompassing non-statutory subject matter (see
"Round One Goes to the ACLU").  So what are the parties saying about
Monday's decision?

The
originally named defendants in the case included the U.S. Patent and Trademark
Office, Myriad Genetics, and the Directors of the University of Utah Research
Foundation.  The District Court's
dismissal of claims against the USPTO left Myriad Genetics and the University
of Utah Research Foundation as the remaining defendants.

While the University of Utah Research
Foundation has not issued a statement regarding the decision, Myriad Genetics
released a statement
on Tuesday in which the molecular diagnostic company announced that it will
appeal the decision to the Federal Circuit and "will continue to
vigorously defend this litigation." 
Myriad President and CEO Peter Meldrum said that "[w]hile we are
disappointed that Judge Sweet did not follow prior judicial precedent or
Congress's intent that the Patent Act be broadly construed and applied, we are
very confident that the Court of Appeals for the Federal Circuit will reverse
this decision and uphold the patent claims being challenged in this
litigation."  Mr. Meldrum
added that "[m]ore importantly, we do not believe that the final outcome
of this litigation will have a material impact on Myriad's operations due to
the patent protection afforded Myriad by its remaining patents."  Myriad noted that while the District
Court invalidated 15 claims in seven BRCA patents that the company owns or
exclusively licenses, there are 164 remaining claims in those seven patents and
an additional 16 patents covering Myriad's BRCA tests that were not challenged
in the case.

Among
the organizational plaintiffs and their counsel, the Association for Molecular
Pathology, American College of Medical Genetics, American Society for Clinical
Pathology, American Civil Liberties Union (ACLU), and Public Patent Foundation
(PUBPAT) all issued statements regarding the decision (the College of American
Pathologists, Breast Cancer Action, and Boston Women's Health Book Collective
did not issue any statements on their respective websites).

In
its press release,
the ACLU noted that "[t]he precedent-setting ruling marks the first time a
court has found patents on genes unlawful and calls into question the validity
of patents now held on approximately 2,000 human genes." ACLU First
Amendment Working Group staff attorney Chris Hansen said the decision was
"a victory for the free flow of ideas in scientific research," adding
that "[t]he human genome, like the structure of blood, air or water, was
discovered, not created.  There is
an endless amount of information on genes that begs for further discovery, and
gene patents put up unacceptable barriers to the free exchange of ideas."  With respect to the USPTO's dismissal,
the ACLU asserted that "[t]he court found that it was unnecessary to reach
the First Amendment claims against the USPTO because it had already ruled in
favor of the plaintiffs."  The
ACLU release also suggested that "[b]ecause the ACLU's lawsuit challenges the
whole notion of gene patenting, its outcome could have far-reaching effects
beyond the patents on the BRCA genes."  ACLU Women's Rights Project staff attorney Sandra Park
predicted that the decision was "the beginning of the end to patents that
restrict women's access to their own genetic information and interfere with
their medical care."

In
a statement issued by PUBPAT,
Executive Director Daniel Ravicher said that "[t]he court correctly saw
that companies should not be able to own the rights to a piece of the human
genome."  Mr. Ravicher added
that "[n]o one invented genes. 
Inventions are specific tests or drugs, which can be patented, but genes
are not inventions."

The
Association for Molecular Pathology (AMP) applauded the decision in its release.  AMP President Dr. Karen Mann called the
outcome "a landmark decision that has the potential to dramatically
improve patient access to genetic testing."  Dr. Mann suggested that the decision would also be "a
boon to personalized medicine in the purest sense as nothing is more personal
than one's genetic makeup." 
The AMP noted that it had adopted a Policy Statement on gene patenting in 2008 that "urged
an end to the practice of granting patents on single genes, sequences of the
genome or correlations between genetic variations and biological states,"
and "encouraged groups that currently hold gene patents, including higher
educational and research institutions, not to grant exclusive licenses to
access those patents."  The
AMP release contends that the decision is a "significant step forward to
eliminating future DNA patents and calls into question the appropriateness of
those already in existence."

In
its statement, the
American College of Medical Genetics (ACMG) "celebrated the US District
Court ruling [on Monday] that genes are 'unpatentable.'"  The group's release states that
"[t]he outcome of this case is likely to have far-reaching positive
implications for physicians, researchers and patients."  ACMG executive director Dr. Michael
Watson contended that "[t]he invalidation of gene patents will allow
patients to get second opinions on test results, encourage quality improvement
of current testing, allow researchers to develop new and better methods of
testing and decrease costs of laboratory testing."  ACMG President Dr. Bruce Korn added
that "[t]he successful outcome will pave the way towards genome-wide
testing, avoiding an obstacle course of patent protection of individual genes
that will prevent reporting of a complete set of results."  The group's release notes that the ACMG was
the first professional medical association to establish a position against gene
patenting (which it did in 1999).

The
American Society for Clinical Pathology's (ASCP) release
"hailed" the District Court's decision.  ASCP President Dr. Mark Stoler said the ruling "gives
patients the right to choose who will perform the test that determines whether
they are at greater risk for breast cancer — a right they never should have
been denied."  He added that as
a result of the court's decision, "[w]e have won back our natural right to
own our own genes."