Should companies be able to patent human genes? Today, the Supreme Court answered that profound question with a resounding NO.
Seems like common sense, right? But over the last 30 years, the U.S. Patent Office has issued patents on thousands of human genes, including genes associated with colon cancer, Alzheimer's disease, muscular dystrophy, and many other devastating diseases. The status quo meant that companies controlling gene patents had the right to stop all other scientists from examining, studying, testing, and researching our genes.
The case before the Court involved patents on two genes, BRCA1 and BRCA2, controlled by a Utah-based company named Myriad Genetics. We all have these genes, but people with certain mutations are at much higher risk of breast and ovarian cancer. It is therefore crucial for some people to have their genes tested in order to make informed medical decisions (as Angelina Jolie described in her recent op-ed). But the patents on the genes allowed Myriad to exercise a monopoly, dictating what types of testing were offered, at what cost, and the availability of second opinions.
Myriad argued that the genes become its "invention" once they are "isolated," or removed from the cell and body.
The Court rejected that view in a unanimous decision written by Justice Thomas:
"Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention."
The ruling should also impact the many other patents that were granted on "isolated" genes.
By invalidating these patents, the Court lifted a major barrier to progress in further understanding how we can better treat and prevent diseases. And in fact, the decision will help, not hinder, the biotechnology industry. Most of the industry is focused on using genes as a starting point to create new tools, tests, and therapeutics. While all of these applications could be patented, the genes themselves should remain in the public storehouse of knowledge, for scientists at universities and corporations to freely study and use. A federal task force advising the Department of Health and Human Services also concluded in 2010 that gene patents were not necessary as an incentive to finding genes, or providing genetic testing.
We also argued to the Court that a form of DNA, called complementary DNA ("cDNA"), should not be patentable when it is a mirror copy of naturally-occurring human mRNA. The Court concluded otherwise in its decision today. While we disagree with that finding, the decision as a whole represents a huge shift in patent law. The Supreme Court's ruling shields parts of the human body from the assertion of private property rights. And because cDNA is not required for genetic testing, laboratories will now be able to offer testing of the BRCA genes to their patients.
We celebrate the Court's ruling as a victory for civil liberties, scientific freedom, patients, and the future of personalized medicine. It also demonstrates the power of creating alliances and fighting for the public interest. The ACLU and the Public Patent Foundation filed the case four years ago on behalf of twenty plaintiffs, including organizations representing over 150,000 medical professionals, geneticists, breast cancer and women's health advocacy groups, and patients. Few thought we had a chance against the decades-long Patent Office practice as well as the entrenched industry position. But litigation can be a strong tool in producing change, never more than when diverse communities come together. Here, the medical, scientific, and patient communities united, and were soon joined by many others, eventually including the U.S. government. We honor the contributions everyone made to our success today.
Learn more about gene patenting, other ACLU Supreme Court cases, and your civil liberty rights: Sign up for breaking news alerts, follow us on Twitter, and like us on Facebook.
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Press ReleaseDec 2024
Free Speech
National Security
ACLU and Partners Urge Supreme Court to Block TikTok BanACLU and Partners Urge Supreme Court to Block TikTok Ban
WASHINGTON — Today, the American Civil Liberties Union, the Electronic Frontier Foundation (EFF), and the Knight First Amendment Institute at Columbia University filed an amicus brief urging the Supreme Court to block the enforcement of a law that would effectively ban people in America from using TikTok as soon as January 19, 2025. Earlier this month, the U.S. Court of Appeals for the D.C. Circuit rejected TikTok’s challenge to the law. TikTok has asked the Supreme Court for a temporary injunction to prevent the app from being banned while the court considers whether to take the case, saying that unless the justices intervene, the law will “shutter one of America’s most popular speech platforms the day before a presidential inauguration.” “The Constitution imposes an extraordinarily high bar on this kind of mass censorship,”said Patrick Toomey, deputy director of ACLU’s National Security Project. “The Supreme Court should take up this important case and protect the rights of millions of Americans to freely express themselves and engage with others around the world.” The brief argues that the D.C. Circuit failed to fully address the law’s profound implications for the First Amendment rights of the 170 million Americans who use TikTok. While the lower court’s decision correctly recognized that the statute triggers First Amendment scrutiny, it barely addressed users’ First Amendment interests in speaking, sharing, and receiving information on the platform. The court also perplexingly attempted to cast the government’s ban on TikTok as a vindication of users’ First Amendment rights, which it is not. The rights groups also explain that the law was intended to suppress certain content and viewpoints that many legislators believe could be amplified on TikTok, including the risk of foreign “propaganda.” But under the First Amendment, the government must meet a very high bar to restrict speech based on concerns about its “motivating ideology” or “perspective,” and the government has not come close to meeting that bar here. “The government should not be able to restrict speech, especially to the extent here, based on guessing about the mere possibility of uncertain future harm,” said David Greene, civil liberties director at EFF. “The Supreme Court should put the TikTok ban on hold while it considers the DC Circuit’s erroneous ruling.” Finally, the brief underscores that the government can’t impose this type of sweeping ban unless it’s necessary to prevent extremely serious and imminent harm to national security. But the government has not provided evidence of impending harm, or evidence that banning TikTok is the only available way to address its concerns. As the brief explains, the D.C. Circuit improperly treated the government’s invocation of “national security” as a trump card and failed to hold the government to its burden. “Restricting citizens’ access to foreign media is a practice that has long been associated with repressive regimes, and we should be very wary of letting the practice take root here,” said Jameel Jaffer, executive director at the Knight First Amendment Institute at Columbia University. “It would do lasting damage to the First Amendment and our democracy if the Supreme Court let this ban go into effect even temporarily.” You can find the brief online here: https://www.supremecourt.gov/DocketPDF/24/24A587/335380/20241217144322392_24A587%20TikTok%20v%20Garland%20Amicus%20Brief%20pdfa.pdf -
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Free Speech
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Whether a law that mandates age verification for all users of social media services violates the First Amendment. -
News & CommentaryDec 2024
Free Speech
Can you define pornography? Neither can the government.Can you define pornography? Neither can the government.
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Minnesota Supreme CourtNov 2024
Free Speech
Energy Transfer LP v. Greenpeace International, Unicorn RiotEnergy Transfer LP v. Greenpeace International, Unicorn Riot
This case in the Minnesota Supreme Court asks whether the MFFIA's protections apply to newsgatherers even if they are alleged to have engaged in trespassing while newsgathering. The ACLU’s State Supreme Court Initiative, alongside the ACLU of Minnesota and law firm Biersdorf & Associations, filed a brief representing Unicorn Riot, a media organization that covered protests of the Dakota Access Pipeline. The brief argues that MFFIA and constitutional reporter’s privileges, under both the U.S. and Minnesota constitutions, protect Unicorn Riot from having to comply with Energy Transfer’s subpoenas.