Divided Appeals Court Again Rules That Companies May Patent Breast Cancer Genes, but Invalidates Patents Comparing the Genes
Supreme Court Sent Case Back for Consideration After Ruling in Similar Case
FOR IMMEDIATE RELEASE
CONTACT: (212) 549-2666; media@aclu.org
WASHINGTON – In a 2-1 decision, a federal appeals court once again today partially reversed a lower court’s ruling in a case challenging patents on two human genes associated with hereditary breast cancer and ovarian cancer. The court ruled that companies can obtain patents on the genes but cannot patent methods to compare those gene sequences.
This is the second time the court has considered this lawsuit, brought by a group of patients and scientists represented by the American Civil Liberties Union and the Public Patent Foundation (PUBPAT). Last year, the U.S. Supreme Court ordered the case to be re-heard after ruling in a similar case that patents cannot be issued on natural processes. The same three appeals court judges re-heard the case.
“It is extremely disappointing that despite the Supreme Court’s ruling, the appeals court has failed to fully re-consider the facts of this case,” said Chris Hansen, a staff attorney with the ACLU Speech, Privacy and Technology Project. “This ruling prevents doctors and scientists from exchanging their ideas and research freely. Human DNA is a natural entity like air or water. It does not belong to any one company.”
The lawsuit against Myriad Genetics and the University of Utah Research Foundation, which hold the patents on the genes, charged that the challenged 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."
“Human genes are not like new genetic tools or drugs, which can be patented because they are manufactured,” said Daniel B. Ravicher, executive director of PUBPAT and co-counsel in the lawsuit. “It is absurd to think that a company CAN own naturally-occurring human genes simply because they removed them from the body.”
The specific patents the lawsuit challenged are on the BRCA1 and BRCA2 genes. Mutations along those genes are responsible for most cases of hereditary breast and ovarian cancers. Many women with a history of those cancers 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, preventive mastectomies or ovary removal.
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.
“This is a devastating decision for a woman’s health,” said Sandra Park, staff attorney with the ACLU Women’s Rights Project. “Patients facing life-changing medical decisions deserve the best quality care and research available. They should not be blocked from getting that care because a company owns the exclusive right to access their genes.”
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. In addition, the United States Department of Justice filed a brief for the second time, arguing that many of the gene patents issued by the Patent Office are invalid.
Attorneys on the case include Hansen and Aden Fine of the ACLU Speech, Privacy and Technology Project; Park and Lenora Lapidus of the ACLU Women’s Rights Project; and Ravicher and Sabrina Hassan of PUBPAT.
Today's decision can be found online at:
www.aclu.org/womens-rights/association-molecular-pathology-et-al-v-us-patent-and-trademark-office-et-al-decision
More information about the case, including ACLU videos featuring breast and ovarian cancer patients, plaintiff and supporter statements and declarations and the legal complaint, can be found online at: www.aclu.org/brca
Smart Justice
+3 Issues
Association for Molecular Pathology v. Myriad Genetics
Smart Justice
+3 Issues
Association for Molecular Pathology v. Myriad Genetics
Learn More About the Issues in This Press Release
-
Press ReleaseOct 2024
LGBTQ Rights
+2 Issues
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
WASHINGTON – In their brief defending the state’s ban on gender-affirming medical care for transgender youth, Tennessee Attorney General Jonathan Skrmetti has asked the Supreme Court to expand its ruling overturning Roe v. Wade and allow the state to target transgender people’s autonomy over their own bodies, too. In U.S. v. Skrmetti, three Tennessee transgender youth and their families are challenging a state law that prohibits medical providers from prescribing medical treatments to transgender youth, such as puberty blockers and hormone replacement therapies, that are allowed for minors who are not transgender. Represented by the American Civil Liberties Union, the ACLU of Tennessee, Lambda Legal, and Akin Gump Strauss Hauer & Feld LLP, the families argue that the ban violates their Equal Protection rights under the 14th Amendment. In the brief filed today, Tennessee relies on the Supreme Court’s 2022 ruling in Dobbs v. Jackson Whole Women’s Health in an attempt to justify its ban on gender-affirming health care for transgender people. The brief cites to Dobbs at least 10 times in sweeping arguments to justify government sex discrimination. “We’ve seen just how far extreme politicians will push to deny us our reproductive freedom, from banning abortion to threatening IVF to even threatening to put doctors in jail for providing emergency care, with deadly consequences for women’s lives,” said Jennifer Dalven, director of the ACLU’s Reproductive Freedom Project. “The same politicians who are trying to control women have now set their sights on transgender people and their families and are trying to control their bodies and lives. Allowing politicians to continue down this road could hold severe implications for the freedom of all people to decide what is right for their own body.” Tennessee claims that their ban on gender-affirming care does not discriminate on the basis of sex even though it bans minors of one sex from accessing health care it allows to members of another sex. A transgender girl is barred from taking doctor-prescribed estrogen because Tennessee considers it “inconsistent” with her birth-assigned sex of male but a cisgender girl with a birth-assigned sex of female is permitted to take estrogen for any purpose including to affirm her female gender identity. “Since this Project’s founding by Justice Ruth Bader Ginsburg, we have adamantly challenged efforts to limit who we can be based on our gender or ability to bear children,” said Ria Tabacco Mar, director of the ACLU’s Women’s Rights Project. “Tennessee’s attempt to limit who young people can become based on their sex shares a through-line with our nation’s history of subjugating women in the name of biology. The fight for each of us to live fully and authentically must include trans people. There is no ‘transgender’ exception to the U.S. Constitution.” In April 2023, the American Civil Liberties Union, the ACLU of Tennessee, Lambda Legal, and Akin Gump Strauss Hauer & Feld LLP sued the state of Tennessee to block S.B. 1, which prohibits medical providers from prescribing medical treatments to transgender youth, such as puberty blockers and hormone replacement therapies, that it exempts for minors who are not transgender. Following a decision by the Sixth Circuit Court of Appeals, S.B. 1 took effect in July 2023. Since 2021, 24 states have banned hormone therapies for transgender youth. “Laws like Tennessee’s are not benign regulations of medical care; they are discriminatory efforts to exclude transgender people from the protections of the Constitution,” said Chase Strangio, co-director of the ACLU’s LGBTQ & HIV Project. “These bans represent a dangerous and discriminatory affront to the well-being of transgender youth across the country and their constitutional right to equal protection under the law.” -
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. -
PodcastSep 2024
Women's Rights
How Sue Bird Is Supercharging Women's SportsHow Sue Bird Is Supercharging Women's Sports
-
Press ReleaseJul 2024
Women's Rights
LGBTQ Rights
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: /documents/aclu-urges-no-vote-on-h-j-res-165 The ACLU’s statement on the final Title IX rule can be found here: /press-releases/155090