ACLU and PUBPAT Argue Against Patents on Breast Cancer Genes in Appeals Court
Lawsuit Filed on Behalf of Medical Associations, Geneticists, Patients and Breast Cancer and Women’s Health Groups
FOR IMMEDIATE RELEASE
CONTACT: (212) 549-2666; media@aclu.org
WASHINGTON – Patents for two genes associated with hereditary breast and ovarian cancer should be invalidated, attorneys from the American Civil Liberties Union and the Public Patent Foundation (PUBPAT) told a federal appeals court today.
The patents allow a Utah company, Myriad Genetics, to stop all other laboratories from offering genetic tests that are crucial to making informed medical and treatment decisions.
“Patent law was never intended to interfere with the rights of scientists and doctors to conduct their research and exchange ideas freely,” said Chris Hansen, staff attorney with the ACLU Speech, Privacy and Technology Project. “Human DNA occurs in nature. It cannot belong to a particular company.”
Last year, a divided U.S. Court of Appeals for the Federal Circuit ruled that companies can obtain patents on the genes but invalidated patents on methods of comparing gene sequences. A federal district court previously had invalidated all of the challenged patents. This year, the U.S. Supreme Court vacated the appellate court decision and sent the case back for re-consideration after ruling in a similar case that patents cannot be issued on natural processes.
“Genes are not ‘invented,’ so they cannot be said to be owned by anyone,” said Daniel B. Ravicher, executive director of PUBPAT. “This is a case about whether a company own genes that occur naturally in our bodies simply because they removed them from the body. This is a genetic marker that occurs naturally in the human body. That should never be patented.”
Myriad's monopoly on the BRCA genes allows it to set the terms and cost of testing and makes it impossible for women to access alternate tests or get a comprehensive second opinion about their results. It also allows Myriad to prevent researchers from even looking at the genes without first getting permission.
The restrictions on examining the BRCA genes can have devastating results. Kathleen Maxian of Buffalo, N.Y. is suffering from late-stage ovarian cancer that she believes could have been prevented. Her sister, who is a breast cancer survivor, obtained a test from Myriad that did not look for all known genetic mutations associated with cancer and was told she was negative for mutations. Years later her sister learned that she did, in fact, have a BRCA genetic mutation -- information that Maxian could have relied on to seek preventive surgery. Numerous labs across the country have stated that they are capable of providing this comprehensive screening and would do so were it not for the patents.
"Understanding genetic risk for breast and ovarian cancer is crucial for many women facing life-changing medical decisions,” said Sandra Park, staff attorney with the ACLU Women’s Rights Project. “Patients deserve access to the best quality care and research available, and that can’t happen when only one company controls access to the genes.”
Lisbeth Ceriani, a breast cancer survivor and plaintiff in the case, was faced with having to pay for Myriad’s $4,000 test to determine if she carried a genetic mutation associated with hereditary ovarian cancer because Myriad had refused to enter into a contract with her insurance company. She was forced to wait 18 months before she was able to obtain the test through a grant, at which point she learned she did indeed carry the mutation.
“I had no other options available to me when I was seeking genetic testing for a potentially life threatening health issue,” said Ceriani. “No one corporation should be able to deny me the right to look at a piece of my body.”
The lawsuit was brought by researchers, genetic counselors, patients, breast cancer and women's health groups, and medical professional associations representing 150,000 geneticists, pathologists and laboratory professionals.
For more information on this case, please visit www.aclu.org/brca
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Association for Molecular Pathology v. Myriad Genetics
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Press ReleaseOct 2024
LGBTQ Rights
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At Supreme Court, Tennessee Seeks to Expand Reach of Dobbs to Ban Health Care for Transgender YouthAt Supreme Court, Tennessee Seeks to Expand Reach of Dobbs to Ban Health Care for Transgender Youth
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Press ReleaseSep 2024
Women's Rights
Civil Rights Groups Tell Federal Appeals Court that Protections for Pregnant Workers Cover Abortion CareCivil Rights Groups Tell Federal Appeals Court that Protections for Pregnant Workers Cover Abortion Care
WASHINGTON, D.C. - On Friday, a broad coalition of labor, workers’ rights, and gender justice organizations — led by the American Civil Liberties Union (ACLU), the ACLU of Arkansas, and the National Women’s Law Center (NWLC) — filed an amicus brief in the U.S. Court of Appeals for the Eighth Circuit in support of the Equal Employment Opportunity Commission’s (EEOC) regulations implementing the landmark Pregnant Workers Fairness Act (PWFA), including the regulations’ explicit protection for workers who have abortions. The PWFA, which took effect last year, was the culmination of a decade-long campaign to secure access to reasonable accommodations for workers with temporary limitations caused by “pregnancy, childbirth, and related medical conditions.” The EEOC’s regulations provide comprehensive guidance to workers, employers, and the courts about the statute’s range of protections, including job-protected time off for medical treatment and recovery. The amicus brief filed in the U.S. Court of Appeals for the Eighth Circuit supports the EEOC in a challenge by 17 red states that are trying to block the PWFA regulations’ coverage of accommodations for abortion-related care. In June, the U.S. District Court for the Eastern District of Arkansas dismissed the states’ challenge, and the states appealed to the Eighth Circuit. Their appeal includes a request that the Eighth Circuit issue a preliminary injunction of the regulations’ abortion provisions. The ACLU-NWLC brief details the federal law’s longstanding ban on discrimination against workers who obtain abortions – protection the PWFA intended to continue. The brief also documents the accounts of workers whose health and jobs were put at risk when their employers denied them accommodations, including time off, for abortion care. Such accounts illustrate the urgent need for clarity with respect to the PWFA’s coverage of abortion-related accommodations, and the devastating medical and financial consequences if such accommodations are denied. “Abortion has long been recognized as part of the full spectrum of workers’ pregnancy-related needs that are protected by the law, ” said Gillian Thomas, senior staff attorney at the ACLU’s Women's Rights Project. “The states’ challenge has created uncertainty, and seeks to deprive workers of essential, job-protected time off for abortion care, posing significant health risks and leading to forced pregnancies. The EEOC regulations are vital to ensure pregnant workers don't have to choose between their health and their jobs.” “Extremist politicians are demonstrating repeatedly their willingness to risk women’s health to advance their anti-abortion agenda,” said Gaylynn Burroughs, vice president for Education and Workplace Justice at the National Women’s Law Center (NWLC). “Let’s be clear: abortion care is pregnancy-related care, and stripping essential protections for abortion from the PWFA would endanger the health and economic security of pregnant workers.” “The Pregnant Workers Fairness Act and its regulations provide a lifeline for workers who need accommodations during the most critical periods of their lives. Attempting to strip away these protections, particularly for abortion-related needs, is an affront to the rights and well-being of pregnant workers,” said John Williams, legal director of the ACLU of Arkansas. “All people in all aspects of pregnancy, including abortion, should be treated with the care and consideration they deserve. We stand firmly with the EEOC in defending these essential protections.” A copy of the brief can be found here. -
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ACLU Condemns House Measure Against Department of Education Title IX RuleACLU Condemns House Measure Against Department of Education Title IX Rule
WASHINGTON – Today, the U.S. House of Representatives voted to pass H.J. Res. 165, a Congressional Review Act resolution disapproving of the U.S. Department of Education’s final Title IX rule providing guidance to schools on protecting students from sexual harassment, pregnancy discrimination, anti-LGBTQ discrimination, and other forms of sex discrimination. Mike Zamore, ACLU National Policy and Government Affairs Director, had the following response: “Today’s vote to completely repeal the Title IX rule takes a sledgehammer to the government’s ability to ensure that all students have the opportunity to learn free from sex discrimination and harassment. Stripping critical civil rights protections from LGBTQ students and students who are pregnant and parenting - as this resolution would do - is something that all members of Congress should strongly oppose. This is also not how Congress should act to protect the rights of students who face disciplinary action under Title IX because passing this resolution would prevent future rulemaking to ensure fair processes in school disciplinary proceedings.” The ACLU’s letter urging a “No” vote on H.J. Res. 165 can be found here: https://www.aclu.org/documents/aclu-urges-no-vote-on-h-j-res-165 The ACLU’s statement on the final Title IX rule can be found here: https://www.aclu.org/press-releases/155090