On Monday, the Court of Appeals for the Federal Circuit held a hearing in the landmark lawsuit challenging gene patents before a crowded courtroom in Washington, D.C. The case, brought by the ACLU and the Public Patent Foundation on behalf of geneticists, pathologists, health advocates, and patients, seeks to invalidate Myriad Genetics' patents on two genes associated with hereditary breast and ovarian cancer, BRCA1 and BRCA2.
For over 20 years, the U.S. Patent and Trademark Office (PTO) has been granting patents on human genes, which give the patent owners exclusive rights to test and examine certain genes. About 20 percent of the human genome is now patented. But last year, federal district court Judge Robert Sweet ruled in favor of the plaintiffs' position that genes are not patentable. Myriad appealed the ruling to Court of Appeals for the Federal Circuit.
The key question at the hearing yesterday was whether an "isolated" BRCA gene, separated from the rest of a person's DNA, can be patented. The question is crucial because allowing patents on an isolated gene prevents labs from sequencing that gene in any and every patient, unless they obtain permission from the patentholder. That means patients' ability to find out about their own genetic information is dictated by the patentholder.
While everyone agrees that new techniques or processes are patentable, products of nature — like gold, or gravity — have never been patentable. We don't believe that DNA should be any different.
Arguing for the ACLU, Chris Hansen noted that isolation cannot be the test for patentability:
If a surgeon cuts me open, and slices out my kidney, and takes it out and holds it in his hand, it's an 'isolated' kidney, but it's still a kidney. It's not an invention.
Arguing alongside the ACLU yesterday was Acting Solicitor General Neal Katyal, who earlier filed a friend-of-the-court brief asserting that patents issued by the PTO covering isolated DNA are invalid. Katyal explained what led the government to reverse its previous position:
We couldn't write a brief that allowed the patentability of isolated DNA, for to do so would be to make lithium patentable, uranium, coal from the earth, and a whole variety of other substances… It was just impossible to do given the Supreme Court's clear guidance… that there is a fundamental distinction in [the patent law] between human-made inventions, on the one hand, and products of nature, on the other.
One reason why the issue of what can be patented is so important to the ACLU is that patents on knowledge and thought violate the First Amendment. The government can't grant monopolies on fields of knowledge or abstract thought. But some of Myriad's claims cover the mental process of "comparing" two sequences. As Chris explained to the judges:
There are people who have put their entire genome sequence on the web. In addition, the BRCA1 sequence can be found on the web... If your law clerks went back to your chambers, and put the whole genome sequence of someone like Professor Church at Harvard and the BRCA1 sequence side by side on your computer screen, and you went back into chambers, and all you did was let your eyes go back and forth between the two to see if they were the same or different, George Church, who sequenced his own gene, would not have infringed the [patent] claims, your law clerks would not have infringed the [patent] claims. You would've infringed the [patent] claims.
If you'd like to listen to Monday's argument, audio of the full 70-minute hearing is available on the .
The court will likely issue a ruling sometime in the next several months. In the meantime, to learn more about the case, the plaintiffs, and what you can do to help, visit www.aclu.org/brca.
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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. -
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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