Myriad Genetics’ Latest Attempt to Maintain Its Monopoly on Our Genes Rejected
Last June, the U.S. Supreme Court issued a unanimous ruling invalidating patents on human genes. The was brought by the ACLU, along with the Public Patent Foundation, on behalf of 20medical organizations, geneticists, health advocacy groups, and patients and challenged patents controlled by Myriad Genetics on the BRCA1 and BRCA2 genes. Based on a 30-year-old U.S. Patent & Trademark Office policy, Myriad had obtained its patents on these two genes, which are closely associated with hereditary breast and ovarian cancer risk, and stopped other laboratories in the U.S. from providing genetic testing to patients, even when these labs wanted to offer different, more comprehensive, or less expensive tests.
The Supreme Court concluded that these patents violated long-standing case law prohibiting patents on products and laws of nature. “Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes. The location and order of the nucleotides existed in nature before Myriad found them. . . genes and the information they encode are not patent eligible simply because they have been isolated from the surrounding genetic material.” Dr. Francis Collins, director of the National Institutes of Health, the ruling, saying it “represents a victory for all those eagerly awaiting more individualized, gene-based approaches to medical care.”
The same day as the decision in Association for Molecular Pathology v. Myriad Genetics was issued, five laboratories they would begin offering BRCA testing to patients. In an attempt to hold on to its monopoly, Myriad took legal action against some, but not all, of its new competitors based on patent claims that were not part of the Supreme Court litigation, but should be considered invalid under current precedent. Myriad asked a federal judge in Utah to order one of the laboratories, Ambry Genetics, to stop providing testing of the BRCA genes.
The ACLU filed an amicus brief opposing Myriad’s motion for a preliminary injunction, joined by the Association for Molecular Pathology, AARP, Breast Cancer Action, and the Public Patent Foundation. We argued that Myriad seeks exclusive rights to laws of nature and that a continued monopoly on genetic information undermines the public interest because it limits patients’ options and stands in the way of new developments in medicine and genetics.
Yesterday, a federal district court judge in Utah rejected Myriad’s motion. Judge Shelby found that Myriad had failed to establish that it was likely to win its lawsuit against Ambry, because there are substantial questions about whether Myriad’s patent claims improperly monopolize products of nature, laws of nature, and abstract ideas.
While Myriad’s lawsuits can proceed—for now—patients continue to have the right to choose other BRCA genetic testing providers. They can obtain a second opinion before making life-changing medical decisions. And they can decide which laboratory will have their data. This is especially crucial because Myriad has used its patents over the genes to create the largest database in the world about BRCA genetic mutations and their medical significance and refuses to share that information with the scientific community. The decision reaffirms that one company should not be able to exclusively control our genetic information.
Learn more about gene patenting and your civil liberty rights: Sign up for breaking news alerts, , and .
Learn More About the Issues on This Page
-
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 -
MississippiJul 2024
Free Speech
Privacy & Technology
NetChoice v. FitchNetChoice v. Fitch
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.
We break down the absurd-but-true history of trying to censor sexual speech under the guise of "keeping kids safe." -
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.