
Yesterday, a unanimous Supreme Court strongly reaffirmed a principle that has existed in our case law for over 150 years: laws of nature, natural phenomena and abstract ideas cannot be patented. This principle may seem obvious, but companies have sidestepped it for years by cleverly drafting applications that pass muster with the patent office.
The decision in Mayo Collaborative Services v. Prometheus Labs. involved patents on methods of correlating blood test results and drug toxicity. The Court found them invalid because the patents do nothing more than claim a law of nature -- how a patient reacts to a drug.
The ACLU filed an amicus brief in the case, arguing that these patents improperly prevent physicians from considering whether to change a patient’s treatment in light of blood test results and therefore violate patent law and the First Amendment, which protects scientific thought. Prometheus’ monopoly allowed it to sue when Mayo wanted to develop and use its own test for determining whether a patient was responding well to a drug.
The Court acknowledged the harmful impact on medicine and innovation: “Unlike, say, a typical patent on a new drug or a new way of using an existing drug, the patent claims do not confine their reach to particular applications of those laws [of nature] . . . . they tie up the doctor’s subsequent treatment decision.” While it is possible for others to come up with a new drug without infringing patents on existing drugs, a doctor cannot invent around the natural reaction of a patient to a drug. We have similarly argued that patents on human genes are a barrier to advancements in medicine and research because they grant a monopoly on the genes themselves.
Article I of the Constitution grants Congress the power to issue patents if they “promote the progress of science.” The Court’s decision reinforced this constitutional limitation by recognizing that patents on laws and products of nature can impede, rather than encourage, future innovation.
If you agree that human genes should not be patented, join our Take Back Our Genes campaign!
(Originally posted on ACS Blog.)
Learn more about gene patenting: Sign up for breaking news alerts, follow us on Twitter, and like us on Facebook.
Stay informed
Sign up to be the first to hear about how to take action.
By completing this form, I agree to receive occasional emails per the terms of the ACLU's privacy statement.
By completing this form, I agree to receive occasional emails per the terms of the ACLU's privacy statement.
Learn More About the Issues on This Page
Related Content
- Press ReleaseSep 2025
Women's Rights
Aclu Opposes Department Of Labor’s Proposal To Strip Wage Protections From Home Care Workers. Explore Press Release.ACLU Opposes Department of Labor’s Proposal to Strip Wage Protections from Home Care Workers
WASHINGTON — The American Civil Liberties Union has filed a public comment opposing the Department of Labor’s (DOL) proposed rule, “Application of the Fair Labor Standards Act to Domestic Service,” which would eliminate hard-won wage and hour protections for millions of the nation’s paid caregivers, who are disproportionately Black and Brown women and are among the poorest workers in the labor force. The proposal would change the definition of in-home “companionship” services under the Fair Labor Standards Act (FLSA), the federal law whose protections include a minimum hourly wage and overtime pay for work performed beyond 8 hours in a single day, or 40 hours in a single week. Under the proposed new definition, millions of home care workers would no longer be entitled to those protections. Additionally, while agencies and other third-party employers of home care workers currently are required to comply with the FLSA, DOL proposes to excuse those employers from the statute’s requirements. These actions would undo DOL’s 2013 regulations, which extended FLSA protections to home care workers after decades of exclusion. “Even though they currently are entitled to receive the minimum wage and overtime, home care workers are among the most vulnerable in our nation’s labor force, facing wage theft and unsafe working conditions, and living in poverty,” said Gillian Thomas, senior counsel in the ACLU Women's Rights Project. “The Department of Labor ’s proposed rule change would strip away the meager economic security that FLSA coverage provides to these essential workers, who take care of our elders and our loved ones with disabilities. By enabling greater exploitation by corporate home care providers, DOL will drive more workers out of a field already facing a profound labor shortage and deprive millions of families of the care they rely on.” ACLU’s comment highlights that the exclusion of home care workers from the FLSA’s protections stems directly from the legacy of slavery and Jim Crow. When Congress passed labor laws like FLSA and the Social Security Act in the 1930s, lawmakers carved out from those statutes’ coverage domestic workers as well as agricultural workers—the two fields in which formerly enslaved people and their descendants were most likely to work—in order to win southern lawmakers’ support. Although Congress eventually amended the FLSA to bring such workers within the law’s protection, DOL did not fully effectuate that intent until it issued regulations in 2013. “Today, home care workers still are disproportionately women of color, and most of whom are women and people of color, provide essential care yet remain among the poorest and least protected in our economy. Rescinding DOL’s 2013 rules not only will make them much poorer—it will shamefully revive a legal exclusion firmly rooted in racism and misogyny,” added Thomas. DOL’s 2013 rule recognized the realities of the modern home care industry, in which workers are well-trained professionals who are supporting families of their own, and in which third-party agencies—rather than care recipients themselves—employ care workers, reaping billions in profits. Entitlement to minimum wage and overtime pay has provided economic security for a workforce made up overwhelmingly of women, and particularly Black women and immigrant women. Such protections not only have helped lift wages for one of the nation’s lowest-paid professions, but also has ensured stable, quality care for seniors and people with disabilities. ACLU’s comment further explains that the proposed rule violates the Administrative Procedure Act. DOL has effectively suspended the 2013 rule without proper notice and comment, and its justifications for abandoning longstanding protections are arbitrary, capricious, and unlawful. The ACLU urges the department to preserve the 2013 rule, which corrected a historic injustice, advanced gender and racial equity, and strengthened the home care workforce. The full comment is available here. - Press ReleaseAug 2025
Immigrants' Rights
+2 Issues
Aclu Raises Alarm Over Trump Administration Seeking To Ban Non-citizens From Accessing Community Health And Education Programs. Explore Press Release.ACLU Raises Alarm Over Trump Administration Seeking to Ban Non-Citizens from Accessing Community Health and Education Programs
WASHINGTON – The American Civil Liberties Union has filed a public comment in opposition to the Department of Health and Human Services’ (HHS) unlawful, harmful, and sweeping directive seeking to exclude immigrant communities from participating in vital community health and education services that benefit everyone. Last month, HHS issued a directive declaring that 13 programs will no longer be open to all and will instead for the first time be considered programs restricted under a law enacted nearly three decades ago, the Personal Responsibility and Work Opportunity Reconciliation Act (PRWORA). These programs include community health centers, mental health and substance use treatment programs, Head Start, the Title X Family Planning Program, and many others. The directive conflicts with PRWORA and upends longstanding guidance respected by four prior administrations. “This arbitrary and harmful directive exemplifies this administration’s tunnel vision, which prioritizes its anti-immigrant crusade, no matter the harms,” said Ming-Qi Chu, deputy director of the ACLU Women’s Rights Project. “If HHS does not abandon this cruel and unlawful directive, hundreds of thousands of children will have their early childhood education disrupted, millions will lose access to life-saving health care like family planning services, cancer screenings, and addiction treatment, and many people with disabilities, including U.S. citizens, could have their care delayed due to bureaucratic immigration status checks. It serves no one’s interest to deny people these essential services, and HHS must withdraw this incredibly misguided directive.” The ACLU’s comment highlights that the directive is unlawful, arbitrary, and capricious, fails to meaningfully consider the impacts of the action, and will harm communities across the country – from children in schools, to people with disabilities, to low-income families denied essential health care, to people recovering from substance use disorder, to survivors of gender-based violence. The comment also notes that the directive will cause a chilling effect that harms immigrant communities that remain eligible, including for mixed status families and others who may be fearful or confused about whether seeking health care might expose them to immigration enforcement or retaliation. “The Directive has triggered chaos and uncertainty both for administering agencies and the individuals, families, and communities who rely on the services at stake. […] It will deprive children of access to crucial early educational programming and undermine access to essential and life-saving health care for children and their families. It will also disproportionately burden mixed-status families, people with disabilities, and survivors of gender-based violence,” the comment reads. The comment is available here: https://www.aclu.org/documents/aclu-comment-in-opposition-to-hhs-directive-on-prwora - Press ReleaseJul 2025
Women's Rights
Plaintiffs In Head Start Lawsuit File Motion To Amend Complaint To Challenge New Hhs Rule Targeting Immigrant Families. Explore Press Release.Plaintiffs in Head Start Lawsuit File Motion to Amend Complaint to Challenge New HHS Rule Targeting Immigrant Families
SEATTLE, Wash. — Today, parent advocacy groups and a coalition of Head Start providers — plaintiffs in an ongoing lawsuit challenging the Trump administration’s unlawful attacks on the Head Start program — announced they have requested to amend their complaint to challenge the U.S. Department of Health and Human Services’ (HHS) latest directive, which seeks to exclude many immigrant families from accessing early childhood education by restricting participation in Head Start based on immigration status. Yesterday, HHS issued a directive reinterpreting a nearly 30-year-old law to expand the definition of “federal public benefit” under the 1996 Personal Responsibility and Work Opportunity Reconciliation Act (PRWORA) to now include Head Start — effectively making some immigrant children ineligible for the first time in the program’s history. The agency provided no implementation guidance to Head Start agencies and declared the policy effective immediately, while also noting that PRWORA’s verification requirements remain unchanged. The lack of clarity around how the directive will be enforced is creating confusion and fear among providers and families alike. “In Chicago, our programs already see families living in fear — including refugees, undocumented parents, and those here on student visas. Many are paralyzed, unsure if it’s safe to bring their children to Head Start. This directive adds to that fear, denying children critical educational opportunities and threatening the well-being of entire communities,” said Lauri Frichtl, executive director, Illinois Head Start. In response, plaintiffs are seeking to amend their lawsuit to challenge this unlawful reinterpretation, which contradicts PRWORA and the Head Start Act and threatens to undermine a program that has served over 40 million children and families across the country. "In Alameda County, hundreds of children and thousands of jobs will be affected by this directive. Locally over half of the children from these programs come from immigrant families and the directive will significantly chill participation in our Head Start programs,” said Clarissa Doutherd, executive director of Parent Voices Oakland. “Immigrants are threaded through the fabric of our communities and threatening them tears communities apart.” The plaintiffs include parent groups Parent Voices Oakland and Family Forward Oregon, and the Head Start associations of Washington state, Illinois, Pennsylvania, and Wisconsin. Plaintiffs in the case are represented by the American Civil Liberties Union, the ACLU of Washington, the ACLU of Illinois, and the Impact Fund. “HHS is defying Congress by attempting to impose an immigration-based restriction that neither PRWORA nor the Head Start Act requires or permits,” said Ming-Qi Chu, deputy director of the Women's Rights Project at the ACLU. “In the nearly 30 years since Congress enacted PRWORA, Head Start has never been understood as a ‘federal public benefit.’ Reinterpreting PRWORA now to exclude immigrant children is unlawful and a direct attack on some of the very families this program was created to serve. It is clearly inconsistent with the statute’s text and Congress’ purpose.” “Not only are these exclusions illegal, but the administration has escalated its attack on Head Start, children, and families by declaring that HHS’s unilateral reinterpretation of a law passed by Congress takes effect immediately. This is a clear attempt to evade the required review process, and we are asking the Court to hold the administration accountable to the rule of law,” said Lori Rifkin, litigation director at the Impact Fund. The administration's staff cuts, delays, and immigration directive threaten the vital early education, health, and social services that more than 800,000 children and families rely on each year. Plaintiffs are urging the court to declare this multi-pronged dismantling of Head Start unlawful and unconstitutional, and to block the administration’s continued defiance of Congress’ mandate to serve low-income families. An overview of the case can be found here. A copy of the motion to amend complaint can be found here.Affiliates: Illinois, Washington - Press ReleaseJul 2025
Women's Rights
Plaintiffs In Head Start Case Vow To Challenge New Hhs Rule Seeking To Block Some Immigrant Families From Accessing Early Childhood Education. Explore Press Release.Plaintiffs in Head Start Case Vow to Challenge New HHS Rule Seeking to Block Some Immigrant Families from Accessing Early Childhood Education
WASHINGTON — Today, the U.S. Department of Health and Human Services (HHS) issued a press release announcing a notice of interpretation of a nearly 30-year-old law to restrict access to critical early education programs for immigrant families. The agency’s action unlawfully expands the definition of “federal public benefit” for HHS under the 1996 Personal Responsibility and Work Opportunity Reconciliation Act (PRWORA) to include Head Start — effectively making certain children ineligible for Head Start for the first time in the program’s history. HHS’s notice offers no implementation guidance to Head Start agencies and declares the interpretation is effective immediately. HHS also notes that verification requirements under PRWORA remain unchanged, which makes the full scope of the operational impact of the policy unclear. If the notice takes effect, plaintiffs in a lawsuit that was filed in April challenging attacks by the Trump administration to Head Start vow to amend their complaint to fight back against this new attack on Head Start. The plaintiffs include parent groups Parent Voices Oakland and Family Forward Oregon, and the Head Start associations of Washington state, Illinois, Pennsylvania, and Wisconsin. Plaintiffs in the case are represented by the American Civil Liberties Union, the ACLU of Washington, the ACLU of Illinois, and the Impact Fund. “Head Start was created to serve low-income children and families, including immigrant communities who are vital to our economy and our future. This directive attempts to force agencies to turn away the very families we are legally mandated to support. It’s a cruel and unlawful move that threatens the wellbeing of children and the stability of entire communities,” said Joel Ryan, executive director, Washington State Head Start & Early Childhood Education and Assistance Program. “Head Start has been a cornerstone in communities across the country. We urge Head Start providers to continue to serve children and refrain from making any immediate changes to enrollment policy until they have an opportunity to fully evaluate their legal obligations,” said Jennie Mauer, executive director of the Wisconsin Head Start Association. “As part of its broader attack on working families, this administration is unlawfully attempting to rewrite the PRWORA to make it harder for children to access critical early childhood education. No agency – including HHS – has ever defined early education as a restricted ‘federal public benefit,’” said Jennesa Calvo-Friedman, senior staff attorney at the ACLU Women’s Rights Project. “The Head Start Act clearly states it is an education program with the purpose to ‘promote the school readiness of low-income children,’ and includes both statutory and regulatory criteria which impose no eligibility restriction based on immigration status.” "Implementation of this directive will create fear and confusion for immigrant families about enrolling their children in Head Start regardless of what their legal status may be. This will harm children and destabilize Head Start programs,” said Lori Rifkin, litigation director at the Impact Fund. “If the administration moves forward with publication of this notice, we will take legal action.” The case page can be found here.Affiliates: Washington, Illinois