ACLU Challenges Patents On Breast Cancer Genes

The
American Civil Liberties Union and the Public Patent Foundation at
Benjamin N. Cardozo School of Law (PUBPAT) filed a lawsuit today
charging that patents on two human genes associated with breast and
ovarian cancer stifle research that could lead to cures and limit
women's options regarding their medical care. Mutations along the
genes, known as BRCA1 and BRCA2, are responsible for most cases of
hereditary breast and ovarian cancers. The lawsuit argues that the
patents on these genes are unconstitutional and invalid.

"Knowledge about our own bodies and
the ability to make decisions about our health care are some of our
most personal and fundamental rights," said Anthony D. Romero,
Executive Director of the ACLU. "The government should not be granting
private entities control over something as personal and basic to who we
are as our genes. Moreover, granting patents that limit scientific
research, learning and the free flow of information violates the First
Amendment."

Today's lawsuit was filed in U.S.
District Court for the Southern District of New York on behalf of
breast cancer and women's health groups, individual women and
scientific associations representing approximately 150,000 researchers,
pathologists and laboratory professionals against the U.S. Patent and
Trademark Office (PTO), as well as Myriad Genetics and the University
of Utah Research Foundation, which hold the patents on the BRCA genes.
It is the first to apply the First Amendment to a gene patent challenge.

The patents granted to Myriad give
the company the exclusive right to perform diagnostic tests on the
BRCA1 and BRCA2 genes and to prevent any researcher from even looking
at the genes without first getting permission from Myriad. According to
the lawsuit, such monopolistic control over these genes hampers
clinical diagnosis and serves as a disincentive for research because
Myriad not only has the right to enforce its patents against other
entities but also has the rights to future mutations discovered on the
BRCA2 gene. The gene patents are also illegal under patent law because
genes are "products of nature."

"Patents are meant to protect
inventions, not things that exist in nature like genes in the human
body," said Chris Hansen, a staff attorney with the ACLU. "Genes
isolated from the human body are no more patentable than gold extracted
from a mountain."

Many women with a history of breast
and ovarian cancer in their families opt to undergo genetic testing to
determine if they have the mutations on their BRCA genes that put them
at increased risk for these diseases. This information is critical in
helping these women decide on a plan of treatment or prevention,
including increased surveillance or preventive mastectomies or ovary
removal. However, the fact that Myriad can exclude others from
providing this testing has several negative consequences for patients:
many women cannot afford the more than $3,000 Myriad charges for the
test; patients cannot get second opinions on their test results; and
patients whose tests come back with inconclusive results do not have
the option to seek additional testing elsewhere.

"Women whose doctors recommend
genetic testing should be able to find out whether they have the gene
mutations linked to breast and ovarian cancer so that they are able to
make choices that could save their lives, and these patents interfere
with their ability to do so," said Lenora Lapidus, Director of the ACLU
Women's Rights Project.

"The patents on the BRCA genes block
women's access to medical information necessary for making vital health
care decisions, impeding their control over their own bodies," said
Sandra Park, staff attorney with the ACLU Women's Rights Project.

Because the ACLU's lawsuit
challenges the whole notion of gene patenting, it could have far
reaching effects beyond the patents on the BRCA genes. Approximately 20
percent of all human genes are patented, including genes associated
with Alzheimer's disease, muscular dystrophy, colon cancer, asthma and
many other illnesses.

"Scientific research and testing
have been delayed, limited or even shut down as a result of gene
patents, stifling the development of new diagnostics and treatments,"
said Tania Simoncelli, ACLU science advisor. "The government should be
encouraging scientific innovation, not hindering it."

"Patenting human genes is counter to
common sense, patent law and the Constitution," said Daniel B.
Ravicher, Executive Director of PUBPAT and co-counsel in the lawsuit.
"Genes are identified, not invented, and patenting genetic sequences is
like patenting blood, air or e=mc2."

If Myriad's BRCA genes patents were
invalidated, the clinicians, pathologists and researchers represented
by the ACLU would be able to engage freely in research, testing and
clinical practice involving the BRCA1 and BRCA2 genes, and the patients
would be able to obtain second opinions on test results and have access
to genetic testing services from multiple, and perhaps more affordable,
sources.

In addition to several individual women patients, plaintiffs in the case include:

* Association for Molecular Pathology

* American College of Medical Genetics

* American Society for Clinical Pathology

* College of American Pathologists

* Haig Kazazian, MD, Professor in the Department of Genetics at the University of Pennsylvania School of Medicine
* Arupa Ganguly, PhD, Associate Professor in the Department of Genetics at the Hospital of the University of Pennsylvania
* Wendy Chung, MD, PhD, Director of Clinical Genetics at Columbia University

*
Harry Ostrer, MD, Professor of Pediatrics, Pathology and Medicine and
Director of the Human Genetics Program at New York University School of
Medicine

*
David Ledbetter, PhD, Professor of Human Genetics and Director of the
Division of Medical Genetics at the Emory University School of Medicine
* Stephen Warren, PhD, William
Patterson Timmie Professor of Human Genetics and Chair of the
Department of Human Genetics at Emory University
* Ellen Matloff, M.S., genetic counselor
* Elsa Reich, M.S., Professor in the Department of Pediatrics (Human Genetics Program) at New York University
* Breast Cancer Action
* Boston Women's Health Book Collective (Our Bodies Ourselves)

Attorneys on the case, Association for Molecular Pathology, et al. v. U.S. Patent and Trademark Office, et al.,
include Hansen and Aden Fine of the ACLU First Amendment Working Group;
Lapidus and Park of the ACLU Women's Rights Project; and Ravicher of
PUBPAT. Simoncelli, the ACLU's science advisor, provides expert
guidance on the case.

Plaintiff and supporter statements and a copy of the complaint can be found online at: www.aclu.org/brca