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    November 2, 2009

    Court Upholds Rights of Scientists and Patients to Challenge Gene Patents

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    DNA $.jpgSome 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.



    FOR IMMEDIATE RELEASE

    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
    forward.


    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: www.aclu.org/brca

    3 Responses to “Court Upholds Rights of Scientists and Patients to Challenge Gene Patents”

    1. Happily, the judge overturned the patents in question in a 152 page decision. I write more about it on my blog: http://sirencristy.blogspot.com/2010/03/court-overturns-gene-patenting-case.html

    2. adam says:

      they’re doing this with native heirloom crops too. patenting the genes of ancient cereal staples in iraq, afghanistan, and even thailand. it’s criminal.

    3. adam says:

      patenting our genes? are you nuts!?! can they patent the color of my eyes too?

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