Free Speech
Women's Rights

ACLU Challenges Patents On Breast Cancer Genes: BRCA

November 2, 2009
film screening in NYC 10/20/2009
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On May 12, 2009, the ACLU and the Public Patent Foundation, a not-for-profit organization affiliated with Benjamin N. Cardozo School of Law (PUBPAT), filed a lawsuit charging that patents on two human genes associated with breast and ovarian cancer are unconstitutional and invalid. The lawsuit was filed on behalf of four scientific organizations representing more than 150,000 geneticists, pathologists, and laboratory professionals, as well as individual researchers, breast cancer and women's health groups, genetic counselors and individual women. Individuals with certain mutations along these two genes, known as BRCA1 and BRCA2, are at a significantly higher risk for developing hereditary breast and ovarian cancers.

The U.S. Patent and Trademark Office (PTO) has granted thousands of patents on human genes – in fact, about 20 percent of our genes are patented. A gene patent holder has the right to prevent anyone from studying, testing or even looking at a gene. As a result, scientific research and genetic testing has been delayed, limited or even shut down due to concerns about gene patents.

As a result of the PTO granting patents on the BRCA genes to Myriad Genetics, Myriad's lab is the only place in the country where diagnostic testing can be performed. Because only Myriad can test for the BRCA gene mutations, others are prevented from testing these genes or developing alternative tests. Myriad's monopoly on the BRCA genes makes it impossible for women to access other tests or get a second opinion about their results, and allows Myriad to charge a high rate for their tests – over $3,000, which is too expensive for some women to afford.

The lawsuit, Association for Molecular Pathology, et al. v. United States Patent and Trademark Office, et al., was filed in the United States District Court for the Southern District of New York in Manhattan against the PTO, Myriad Genetics and the University of Utah Research Foundation, which hold the patents on the BRCA genes.

 

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BACKGROUND / RESOURCES

NEWS & COMMENTARY
> Blog: First Hearing Held in the Breast Cancer Gene Patents Challenge(10/1/2009)
> Blog: How the Patents on the Breast Cancer Genes Harm Physicians and Patients(8/28/2009)
> Release: AMA, March Of Dimes And Others Support ACLU Challenge To Patents On Breast Cancer Genes(8/27/2009)
> Blog: Genome Redacted? (8/19/2009)
> Blog: Why Gene Patents Are Unlawful (5/22/2009)
> Blog: Joanna Rudnick on the Huffington Post (video interview with Myriad CEO) (5/14/2009)
> Blog: Liberate the Breast Cancer Genes (5/13/2009)
> Release: ACLU Challenges Patents On Breast Cancer Genes (5/12/2009)
> Blog: Who Owns Your Genes? (5/12/2009)
> New York Times: Cancer Patients Challenge the Patenting of a Gene (5/12/2009)
> Blog: BRCA, Genetic Testing, and Civil Liberties: It's What Christina Applegate, Oprah, and PBS Are All Talking About (10/2/08)

STATEMENTS OF SUPPORT
> Sir John Sulston
> International Center for Technology Assessment
> Council for Responsible Genetics
> Center for Genetics and Society
> World Council of Churches - Justice, Diakonia and Responsibility for Creation Program
> United Methodist Board of Church and Society
> Ethics & Religious Liberty Commission, Southern Baptist Convention
> Facing Our Risk of Cancer Empowered (FORCE)
> Joshua Sarnoff

MORE
> Fact Sheet: Genes and Patents Q&A (HTML) (PDF)
> Public Patent Foundation, Benjamin N. Cardozo School of Law (Co-Counsel)
> www.whoownsyourbody.org
> Congressional Testimony on Gene Patents: Dr. Marc Grodman, Dr. Wendy Chung, and Dr. Katherine Mathews
> Panel Discussion: BRCA Testing And Gene Patents With Tania Simoncelli, ACLU Science Advisor
> Film: In the Family
> Genetics of Breast and Ovarian Cancer (PDQ): Major Genes: Mutations in BRCA1 and BRCA2 (National Cancer Institute )
> Genetic Testing for BRCA1 and BRCA2: It's Your Choice (National Cancer Institute)
> How Genes Work (National Institute of General Medical Sciences)
  CASE DOCUMENTS
> Opinion on Motion to Dismiss(11/2/2009)
> Amicus Brief of the Int'l Center for Technology Assessment and other scientific, cultural and environmental groups(9/10/2009)
> Amicus Brief of the National Women's Health Network and other organizations (8/28/2009)
> Amicus Brief of the American Medical Association and other medical associations (8/27/2009)
> Amicus Brief of the March of Dimes and other patient groups (8/26/2009)
> Plaintiffs' Memo in Support of Motion for Summary Judgement (8/26/2009)
> Plaintiffs' Memo in Opposition to U.S. Patent and Trademark Office's Motion to Dismiss (8/26/2009)
> Plaintiffs' Memo in Opposition to Myriad and Directors of the University of Utah's Research Foundation's Motion to Dismiss(8/26/2009)
> Plaintiffs' Statement of Material Facts(8/26/2009)
> Declarations (8/26/2009):
> Complaint (5/12/2009)
TAKE THE ACLU'S GENETIC TESTING SURVEY >>
 
 
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