Court Upholds Rights of Scientists and Patients to Challenge Gene Patents

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Some interesting news about the breast cancer patent lawsuit I wrote about for Slate's Double X Magazine a few months ago:  A federal district court has just agreed to hear the case. When the lawsuit was first filed, many legal experts I talked to said they were sure the case would get thrown out of court for it's unusual approach, namely that it claims that the practice of patenting genes is unconstitutional See my story about the case here. Filings and other documents related to the case available here.  And see below for the full press release about today's news:

Court Upholds Right of Scientists

and Patients to Challenge Gene Patents.


November 2, 2009

NEW YORK - A federal district court
ruled today that patients and scientists can challenge patents on human
genes in court, allowing a lawsuit challenging patents on two human
genes associated with hereditary breast and ovarian cancer to move

The lawsuit was filed by the
American Civil Liberties Union and the Public Patent Foundation
(PUBPAT), a not-for-profit organization affiliated with Benjamin N.
Cardozo School of Law. The groups charge that the patents are illegal
and restrict both scientific research and patients' access to medical
care, and that patents on human genes violate the First Amendment and
patent law because genes are "products of nature."

"We hope this challenge is the
beginning of the end to patents on genes, which limit scientific
research, learning and the free flow of information," said Chris
Hansen, a staff attorney with the ACLU First Amendment Working Group.
"No one should be able to patent a part of 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, geneticists and scientific
associations representing approximately 150,000 researchers,
pathologists and laboratory professionals. The lawsuit was filed
against the U.S. Patent and Trademark Office (USPTO), as well as Myriad
Genetics and the University of Utah Research Foundation, which hold the
patents on the BRCA genes. The defendants asked the court to dismiss
the case but today's ruling allows the lawsuit to proceed.

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.

The court noted the significance of
this case. The court's opinion stated, "The widespread use of gene
sequence information as the foundation for biomedical research means
that resolution of these issues will have far-reaching implications,
not only for gene-based health care and the health of millions of women
facing the specter of breast cancer, but also for the future course of
biomedical research... The novel circumstances presented by this action
against the USPTO, the absence of any remedy provided in the Patent
Act, and the important constitutional rights the Plaintiffs seek to
vindicate establish subject matter jurisdiction over the Plaintiffs'
claim against the USPTO."

"We look forward to proving in court
that human gene patents should never have been granted in the first
place," said Daniel B. Ravicher, Executive Director of PUBPAT and
co-counsel in the lawsuit. "Companies should not able to own the rights
to a piece of the human genome. Specific tests or drugs can be
patented, but not genes themselves." 

The specific patents the ACLU is
challenging are on the BRCA1 and BRCA2 genes. Mutations along the BRCA1
and 2 genes 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 patents on BRCA 1 and BRCA 2
restrict women's access to genetic testing and interfere with their
medical care," said Sandra Park, staff attorney with the ACLU Women's
Rights Project. "We hope that at the conclusion of this lawsuit, the
court declares the patents unconstitutional and invalid."

Several major organizations,
including the American Medical Association, the March of Dimes and the
American Society for Human Genetics, filed friend-of-the-court briefs
in support of the challenge to the patents on the BRCA genes.

Attorneys on the case include Hansen
and Aden Fine of the ACLU First Amendment Working Group; Park and
Lenora Lapidus 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, today's decision and the legal
complaint, can be found online at:

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