AMA, March of Dimes and Others Support ACLU Challenge to Patents on Breast Cancer Genes

The
American Civil Liberties Union and the Public Patent Foundation
(PUBPAT), a not-for-profit organization affiliated with Benjamin N.
Cardozo School of Law, filed a motion asking a federal court to rule
that patents on two human genes associated with breast and ovarian
cancer are unconstitutional and invalid. Several major organizations,
including the American Medical Association (AMA), the March of Dimes
and the American Society for Human Genetics (ASHG), are filing
friend-of-the-court briefs in support of the motion for summary
judgment. The groups charge that the patents stifle diagnostic testing
and research that could lead to cures and that they limit women's
options regarding their medical care.

"When you patent genes, you are
really patenting knowledge," said Chris Hansen, an attorney with the
ACLU. "Granting patents on human genes limits scientific research,
learning and the free flow of information. We hope the court rules soon
that patents are meant to protect inventions, not things that exist in
nature like genes in the human body."

The lawsuit, Association for Molecular Pathology, et al. v. U.S. Patent and Trademark Office, et al.,
was originally filed on May 12 in the 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. The lawsuit was filed against the U.S. Patent
and Trademark Office, as well as Myriad Genetics and the University of
Utah Research Foundation, which hold the patents on the BRCA genes. The
lawsuit charges that patents on human genes violate the First Amendment
and patent law because genes are "products of nature."

"Human genes are products of nature
and patents on them should never have been granted in the first place,"
said Daniel B. Ravicher, Executive Director of PUBPAT and co-counsel in
the lawsuit. "There is something fundamentally wrong with companies
being able to own the rights to a piece of the human genome. Genes are
not inventions, and patenting genetic sequences is like patenting
blood, air or water."

Mutations along the genes, known as
BRCA1 and BRCA2, are responsible for most cases of hereditary breast
and ovarian cancers. 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.

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. Myriad's
monopoly on the BRCA genes makes it impossible for women to access
alternate tests or get a second opinion about their results and allows
Myriad to charge a high rate for their tests.

"The AMA is concerned that medical
patents on genes could harm patients' access to care," said Rebecca
Patchin, M.D, AMA Board Chair. "Physicians should not be stifled in
what care they can provide because someone has patented a part of human
biology. These patents are too broad and should be reined in so that no
patient is denied care."

Dr. Edward McCabe of UCLA, President
of ASHG, said, "The American Society of Human Genetics includes
thousands of members who do basic research as well as those who are
involved in clinical and patient care. The deterrents presented by the
patenting and exclusive licensing of BRCA genes continue to cause
problems in many laboratories. ASHG is therefore a party to the amicus
brief with other large and representative medical and research
organizations."

Because 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.
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.

"Every baby deserves a healthy start
in life and patenting genes stifles research and will slow, or may even
prevent, the March of Dimes from realizing that goal," said Alan R.
Fleischman, M.D., March of Dimes Medical Director. "The 540,000
American babies who face life long health challenges such as learning
disabilities, cerebral palsy, blindness and many other diseases because
they were born too soon are relying on genetic research to find a way
to prevent preterm birth and birth defects."

Nobel Prize winner Sir John Sulston,
Chair of the Institute for Science, Ethics and Innovation at the
University of Manchester, who supports the ACLU's lawsuit, said,
"Patents on human genes are harmful to the practice of science and a
disincentive to further research on those genes. Patents on genes
inhibit access to the most basic information and discourage scientific
communication and data sharing. Free sharing of this information is
vital to understanding the role of genetic variations in human disease."

Attorneys on the case include Hansen
and Aden Fine of the ACLU First Amendment Working Group; Lenora Lapidus
and Sandra Park of the ACLU Women's Rights Project; and Ravicher of
PUBPAT. Tania Simoncelli, the ACLU's science advisor, provides expert
guidance on the case.

More information about the case,
including an ACLU video featuring breast cancer patients, plaintiff and
supporter statements and declarations, the motion for summary judgment
and the legal complaint, can be found online at: www.aclu.org/brca