Should companies be able to patent human genes? For decades, the U.S. Patent and Trademark Office said yes, ultimately granting patents on thousands of genes.

Two of the genes that were patented are BRCA1 and BRCA2. The patent office approved exclusive rights over the genes because Myriad Genetics was the first to “isolate” them, or remove them from the body and cell. The patents on the genes allowed Myriad to exercise a monopoly on the genes in the United States, shutting down other labs from offering testing or second opinions and increasing the price to thousands of dollars per test.

The ACLU opposes patenting that would authorize private entities to control access to something as fundamental to humanity as our genes. In 2009, we filed a lawsuit on behalf of 20 researchers, genetic counselors, women patients, cancer survivors, breast cancer and women’s health groups, and scientific associations representing 150,000 geneticists, pathologists, and laboratory professionals. The landmark case argued that human genes are products of nature, even when “isolated,” drawing on 150 years of legal precedent forbidding patents on laws of nature, natural phenomena, and abstract ideas. The Supreme Court agreed. It invalidated the patents, in a unanimous decision written by Justice Clarence Thomas on June 13, 2013.

For Lisbeth Ceriani, a breast cancer survivor and plaintiff in our suit, the Supreme Court’s ruling was not only a source of great joy, but also a step towards a more equitable health care system. During Ceriani’s breast cancer diagnosis, she was informed that the BRCA genetic test she needed was inaccessible because the gene associated with her cancer, and the test, was under patent.

“It’s not just some abstract scientific concept, it impacts people’s daily lives, people’s mothers and sisters and wives. [It impacts] their health care decision,” Ceriani told the ACLU in 2017. “It’s a basic human right to see your own blood, your own genes.

Ten years later, Myriad has now acknowledged the Supreme Court got it right. In a remarkable statement, it said: “[W]e applaud the incredible innovation in genomics and precision medicine that has occurred since the Court reached the decision limiting patents with respect to naturally occurring DNA. Myriad does not support patents on products of nature, including naturally occurring DNA and unmodified human genes.”

Despite this consensus, our right to our own genetic information is at risk. For several years, a number of Congressmembers have supported legislation to restore patenting of laws of nature and abstract ideas, including human genes, and have made clear they will push this issue in the future. If passed, this legislation would overturn decades of Supreme Court precedent and would tear down some of the public’s only protections from the worst patent abuses.

To help understand the devastating consequences that human gene patents could have on all of us, we spoke to four people who led the fight against human gene patenting:

• Lisa Schlager, the vice president of public policy at Facing Our Risk of Cancer Empowered (FORCE), a national patient advocacy group that filed an amicus brief in support of our case.
• Karen Weck, a professor of pathology and genetics at University of North Carolina at Chapel Hill and former president of the Association for Molecular Pathology, which was the lead organization plaintiff in the litigation.
• Robert Nussbaum, a geneticist who served as an expert in the lawsuit while he was a professor at University of California San Francisco and is now Chief Medical Officer at Invitae, a genetic testing company.

Together, they share how the fight against human gene patenting has affected their health and their work. This conversation has been condensed for clarity.

ACLU: Let’s go back to the beginning. When did you first encounter the BRCA genes?

SCHLAGER: In 1999, my paternal aunt was diagnosed with breast cancer at the age of 49. She reached out to share that she had undergone genetic testing through a study they were doing to explore the prevalence of BRCA mutations in patients and their families of Ashkenazi/Eastern European descent. My aunt had tested positive for a BRCA1 mutation, and the researchers indicated they would like to test family members. I was the next oldest female in the family, and underwent counseling and testing. Three months later, my husband and I met again with the genetic counselor and learned that I too, carry a BRCA1 mutation.

NUSSBAUM: I first became aware when breast-cancer research pioneer Mary-Claire King announced the existence, although not the identity of, the BRCA1 gene in 1990. King later helped lead the fight against patenting the gene to make access to testing easier and more accurate. It remains unknown how many families may have received false negative results and subsequently, missed opportunities to diagnose their cancer early or prevent it altogether.

ACLU: What was your initial reaction when you heard that genes were being patented?

NUSSBAUM: When I heard Myriad was patenting BRCA genes, I thought that this was a single company making a big money grab based on research done by numerous other researchers, and that [what Myriad was trying to do] would require the patenting of a natural product and shouldn’t be patent-eligible. Gene patenting would be the worst thing that could happen, and would stifle innovation in the genetics and genomics testing space.

WECK: I was lucky to work at an institution that had negotiated with Myriad so that we could offer BRCA testing to women without insurance who could not afford their test. However, as someone who has been involved with molecular genetic testing for over 20 years, I experienced firsthand the inability to develop and offer clinical genetic testing for many genes that had been patented.

SCHLAGER: The BRCA gene patents resulted in exorbitant costs for testing, making it inaccessible to many people. The patents also hindered broader multigene panel testing where the BRCA genes could be combined with other mutations known to increase cancer risk such as ATM and PALB2. As with many access issues, this most affected underserved and underrepresented populations, creating greater health disparities.

ACLU: When the ACLU first brought a case against patenting these genes, why did you want to be involved?

SCHLAGER: As an organization representing people with or at risk of hereditary cancers, the patent case resonated with FORCE. At the time, all our staff were BRCA mutation carriers, as were most of our constituents. We saw the effects of gene patents on our community firsthand and wanted to support the effort.

ACLU: In your opinion or experience, what are the consequences of gene patents? Who does this harm?

WECK: The incredible advances we have seen in molecular diagnostics since the Myriad ruling clearly demonstrate the limiting effect gene patents once had on the field. In 2021, there were over 160,000 clinically orderable genetic tests offered in the U.S. which likely would not be the case if gene patents were still enforced.

For many years, gene patents prevented the scientific community from working together to develop novel diagnostics and treatments for rare and common diseases, including cancer, muscular dystrophy, Alzheimer’s disease, and heart disease. It is important that we learn from those missteps and ensure that the freedom to innovate remains in place.

ACLU: Why is it important to you that we all have fair access to genetic material?

NUSSBAUM: Making it illegal to patent genes expands the genetic testing market, enables competition, and improves laboratory practices for genetic testing through standardizing next-generation-sequencing methods, variant classification, reporting, and counseling, plus acceleration of novel disease gene discoveries and better understanding of gene-disease relationships. Today, improved access to genetic testing is reducing health care inequity through more genetic testing in historically underserved populations and, consequently, better understanding of their genetic information.

WECK: The laboratory community’s response to the COVID-19 pandemic provides a recent example of how the Myriad decision led to rapid and robust innovation in a very short time period. The RNA sequence of SARS-CoV-2 was posted publicly and immediately diagnostic developers throughout the world began validating and launching tests. According to the Government Accountability Office, from February 2020 to December 2021, the FDA received nearly 3,400 Emergency Use Authorization requests, an average of 150 per month! Had someone patented the genomic sequence of SARS-CoV-2, we could have had as few as a single test, and perhaps even available from only one laboratory, which by no means would have met the testing capacity needs over the past three years.

In 2015, following a DUI arrest, Ian Mitcham consented to having a blood sample collected to test for blood-alcohol concentration. He was advised his sample would be destroyed after 90 days. Instead, law enforcement held onto it for three years. Then, without obtaining a warrant, a detective used this old blood sample for a completely different purpose — to extract and analyze Mr. Mitcham’s DNA while investigating another crime.

As we’re arguing before the Arizona Court of Appeals tomorrow, and set forth in a friend-of-the-court brief, this clearly violated Mr. Mitcham’s constitutional rights under the Fourth Amendment. Despite this, the State makes a terrifying argument to justify its actions: that it has the power to obtain DNA profiles from any biological sample in its lawful possession, without court oversight or approval.

American Civil Liberties Union

State v. Mitcham | American Civil Liberties Union

The ACLU and the ACLU of Arizona are arguing that the government cannot genetically test any biological material it already has in its possession.

The consequences of this argument are chilling. Our DNA contains extremely personal and sensitive information, including information about our medical history, possible future health conditions, ancestry, and physical appearance. It can reveal those details not only about us, but also our family members, including future children. Combined with other public data, it can expose deeply private information — from previously unknown family histories of adoptions, misattributed paternity, risk of early mortality, or siblings we didn’t even know about. Given this, collecting and analyzing DNA constitutes a seizure and search under the Fourth Amendment. And the government must obtain a warrant before extracting it.

Yet in this case, the State claims that since Mr. Mitcham consented to provide a blood sample three years ago, it can ignore that requirement, even though he consented to the collection only for a blood-alcohol test, and the sample should have been destroyed after 90 days.

With this rationale, all of us who consent to a biological sample collection, at any point in time, for any purpose, to any government entity, may be subject to a warrantless DNA search after the fact.

This would be incredibly dangerous, considering all the contexts in which the government has lawful access to our biological material — from blood taken from newborns to screen for diseases, to organs donated for transplant, to specimens collected from survivors of sexual assault. If the State’s arguments are accepted, police could theoretically extract any person’s DNA from their biological material and create a genetic profile without a warrant.

American Civil Liberties Union

Widespread Newborn DNA Sequencing Will Worsen Risks to Genetic Privacy | ACLU

As newborn screening programs expand to include babies’ entire genomes, parents must be made aware of the privacy risks.

A number of federal government agencies collect our biological material for critical public health purposes. The National Institutes of Health collects blood, bodily fluids, tissues, and other biological materials to study the genetic and environmental factors associated with disease in order to develop new treatments. The Environmental Protection Agency collects biological samples from people living near contaminated sites or from populations that may be at higher risk of exposure to environmental pollutants to measure their exposure to contaminants. The Centers for Disease Control and Prevention collects biological samples, like blood for Ebola and nasal or throat swabs for COVID-19, to study changes to the virus and develop new treatments. It also collects blood from approximately 5,000 people each year “to assess the health and nutritional status of adults and children.”

In addition, the government collects — and people consent to the use of — biological materials for more individualized purposes, also distinct from investigating crimes. For example, some U.S. citizens and lawful permanent residents provide buccal swabs to verify their family relationships to people seeking to immigrate to the United States. People donate their biological material to help identify or locate missing family members. Olympic and Paralympic athletes submit biological samples, including blood, to the United States Anti-Doping Agency to test for prohibited substances.

In many instances, sample collection has targeted minority communities. For example, the city of Tulsa, Oklahoma hired scientists to collect DNA from Black people to identify relatives of individuals killed during the Tulsa race massacre. In Arizona, where this case is taking place, the Pima County Medical Examiner’s Office is currently working to collect DNA from Latin American individuals to help identify more than 1,200 human remains. Given this country’s history of systemic mistreatment, the risks posed by unfettered access to the genetic information of marginalized communities are unquestionable.

Without constitutional protection, there may be a greater risk of the government abusing these resources to generate and analyze genetic profiles as they please. Given how law enforcement acted in this case, and in other criminal investigations where they collect suspects’ DNA without their knowledge or consent from items they discard or throw away, this kind of abuse would not be surprising or far off. Moreover, if our privacy protections erode, so does public trust in these vital government programs. Without this trust, important medical and public health research will suffer.

Consent for the government to collect a biological sample for a particular purpose cannot authorize unfettered genetic testing for a criminal investigation. A warrant is required.

The internet is full of strong, impassioned, sometimes offensive language. In response to an activist’s post about being choked by a sheriff’s deputy, someone posted to Facebook, “Wow, brother they wanna hit our general. It’s time to strike back. Let’s burn this motherfucker’s house down.” And someone listening to music posted lyrics about “student bodies lying dead in the halls, a blood splattered treatise of hate.”

While this speech might be offensive — or even feel threatening — to some people, to others it is an expression of a political opinion, an unfiltered reaction to a recent event, or an attempt to rally support for a cause. The freedom to share provocative ideas and spark robust debate about political issues is essential to democracy, social justice, and progress. Our right to free speech generally protects such communications.

However, “true threats” are not protected by the First Amendment. The government can prosecute someone who intentionally threatens another person with death or serious bodily harm, and whose language is reasonably perceived as threatening. But can a speaker be convicted of making a true threat solely because some people could reasonably perceive it as threatening, regardless of the speaker’s intent? That’s the question before the Supreme Court in Counterman v. Colorado.

The ACLU and its coalition partners filed an amicus brief arguing that the First Amendment requires “subjective intent to threaten” as a necessary element of a true threat. In other words, to meet the legal threshold for a “true threat,” the speaker’s own intent must be taken into account. This would allow a jury to consider the speaker’s state of mind when the threat was made, and ensure that speakers aren’t criminally convicted for failures to predict how people might interpret their speech.

If a person could be convicted for any statement that could reasonably be perceived as threatening, regardless of whether they understood or intended the speech to be threatening, people would need to constantly monitor and tailor their speech to avoid potentially sparking fear in anyone who might foreseeably hear or read it. When people post on social media platforms, they would have to accurately predict how people with vastly different life experiences and perspectives might view their speech, or risk criminal prosecution.

Consider the Facebook poster saying “Let’s burn this motherfucker’s house down.” Some might reasonably believe the poster will set fire to the target’s house. But if the poster intended only to hyperbolically express outrage over an injustice, their speech shouldn’t be labeled as an unprotected “true threat.” Or consider a politician who says that if her opponent is elected, people might resort to “Second Amendment remedies.” Some might reasonably interpret her language as a threat to her opponent’s life, even if she intended it only as an appeal for votes.

Charged speech, however, is not an internet-era phenomenon. In 1969, a racial justice activist organizing a boycott of white-owned businesses spoke to a crowd of several hundred people and said, “If we catch any of you going in any of them racist stores, we’re gonna break your damn neck.” Today, an activist might tweet the same, intending only to garner solidarity. To criminally charge that person would silence them and chill those who similarly advocate for change.

Of course, even unintentionally threatening language can cause real harm. In Counterman v. Colorado, Billy Raymond Counterman sent C.W., a Colorado musician, a series of direct Facebook messages over a two-year period that made C.W. wonder if he was following her. Counterman, who is mentally ill, sent C.W. messages like “Was that you in the white Jeep?” and “I’d like to talk directly to U, I feel neglected” and “five years on FB. I miss you, only a couple physical sightings.” C.W. didn’t respond and blocked Counterman multiple times. Each time Counterman would create a new account and message C.W. again, saying, for example: “Your arrogance offends existence of anyone in my position” and “Your not being good for human relations. Die, don’t need you.” C.W. obtained a protective order and canceled some of her performances out of fear that Counterman might attend.

C.W., like many people who have been sent frightening messages online, reasonably feared for her safety. In addition to posing safety concerns, threatening language is often misogynistic, racist, or homophobic. This kind of speech causes real emotional and psychological harm. Victims, fearful of more abuse, often self-censor, leaving online spaces that once brought community and well-being.

It is essential for the government to vigorously enforce restrictions on unlawful conduct, such as prohibitions on stalking and harassment, as well as restraining order violations. But expanding the definition of “true threats” to cover speech that was never intended to threaten brings its own dangers. For example, movements for gender and racial justice often use heated rhetoric to rally support. If this speech is misunderstood as threatening and marked as a “true threat,” then activists would have to choose between risking conviction every time they say something that could be misinterpreted, and self-censoring. The fight for progress will slowly find itself silenced out of fear. This expansion could also impinge the freedom of the press. A broader legal definition of a “true threat” could come to encompass and stifle basic functions of journalism — from quoting people who hold offensive views, to publishing political cartoons, to pressing a reluctant source for comment.

As the ACLU explains in our brief, a subjective intent to threaten requirement is necessary to protect speakers from being convicted of a felony simply because someone scrolling Twitter, with a different perspective and different background, might reasonably perceive their language as threatening. We hope the court will recognize the implications of its decision for advocates, protestors, and journalists, and preserve the right to speak without fear of conviction for unintentionally threatening speech.