Court Upholds Right Of Scientists And Patients To Challenge Gene Patents
ACLU And PUBPAT Lawsuit Challenging Patents On Breast Cancer Genes Can Go Forward
FOR IMMEDIATE RELEASE
CONTACT: (212) 549-2666; media@aclu.org
NEW YORK – A federal district court ruled today that patients and scientists can challenge patents on human genes in court, allowing a lawsuit challenging patents on two human genes associated with hereditary breast and ovarian cancer to move forward.
The lawsuit was filed by the American Civil Liberties Union and the Public Patent Foundation (PUBPAT), a not-for-profit organization affiliated with Benjamin N. Cardozo School of Law. The groups charge that the patents are illegal and restrict both scientific research and patients' access to medical care, and that patents on human genes violate the First Amendment and patent law because genes are "products of nature."
"We hope this challenge is the beginning of the end to patents on genes, which limit scientific research, learning and the free flow of information," said Chris Hansen, a staff attorney with the ACLU First Amendment Working Group. "No one should be able to patent a part of the human body."
The lawsuit, Association for Molecular Pathology, et al. v. U.S. Patent and Trademark Office, et al., was originally filed on May 12 in the U.S. District Court for the Southern District of New York on behalf of breast cancer and women's health groups, individual women, geneticists and scientific associations representing approximately 150,000 researchers, pathologists and laboratory professionals. The lawsuit was filed against the U.S. Patent and Trademark Office (USPTO), as well as Myriad Genetics and the University of Utah Research Foundation, which hold the patents on the BRCA genes. The defendants asked the court to dismiss the case but today's ruling allows the lawsuit to proceed.
Because the ACLU's lawsuit challenges the whole notion of gene patenting, its outcome could have far-reaching effects beyond the patents on the BRCA genes. Approximately 20 percent of all human genes are patented, including genes associated with Alzheimer's disease, muscular dystrophy, colon cancer, asthma and many other illnesses.
The court noted the significance of this case. The court's opinion stated, "The widespread use of gene sequence information as the foundation for biomedical research means that resolution of these issues will have far-reaching implications, not only for gene-based health care and the health of millions of women facing the specter of breast cancer, but also for the future course of biomedical research… The novel circumstances presented by this action against the USPTO, the absence of any remedy provided in the Patent Act, and the important constitutional rights the Plaintiffs seek to vindicate establish subject matter jurisdiction over the Plaintiffs' claim against the USPTO."
"We look forward to proving in court that human gene patents should never have been granted in the first place," said Daniel B. Ravicher, Executive Director of PUBPAT and co-counsel in the lawsuit. "Companies should not able to own the rights to a piece of the human genome. Specific tests or drugs can be patented, but not genes themselves."
The specific patents the ACLU is challenging are on the BRCA1 and BRCA2 genes. Mutations along the BRCA1 and 2 genes are responsible for most cases of hereditary breast and ovarian cancers. Many women with a history of breast and ovarian cancer in their families opt to undergo genetic testing to determine if they have the mutations on their BRCA genes that put them at increased risk for these diseases. This information is critical in helping these women decide on a plan of treatment or prevention, including increased surveillance or preventive mastectomies or ovary removal.
The patents granted to Myriad give the company the exclusive right to perform diagnostic tests on the BRCA1 and BRCA2 genes and to prevent any researcher from even looking at the genes without first getting permission from Myriad. Myriad's monopoly on the BRCA genes makes it impossible for women to access alternate tests or get a second opinion about their results and allows Myriad to charge a high rate for their tests.
"The patents on BRCA 1 and BRCA 2 restrict women's access to genetic testing and interfere with their medical care," said Sandra Park, staff attorney with the ACLU Women's Rights Project. "We hope that at the conclusion of this lawsuit, the court declares the patents unconstitutional and invalid."
Several major organizations, including the American Medical Association, the March of Dimes and the American Society for Human Genetics, filed friend-of-the-court briefs in support of the challenge to the patents on the BRCA genes.
Attorneys on the case include Hansen and Aden Fine of the ACLU First Amendment Working Group; Park and Lenora Lapidus of the ACLU Women's Rights Project; and Ravicher of PUBPAT. Tania Simoncelli, the ACLU's science advisor, provides expert guidance on the case.
More information about the case, including an ACLU video featuring breast cancer patients, plaintiff and supporter statements and declarations, today's decision and the legal complaint, can be found online at: www.aclu.org/brca
Smart Justice
+3 Issues
Association for Molecular Pathology v. Myriad Genetics
Smart Justice
+3 Issues
Association for Molecular Pathology v. Myriad Genetics
Learn More About the Issues in This Press Release
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Press ReleaseDec 2024
Smart Justice
ACLU Celebrates President Biden’s Clemency Announcement, Allowing Hundreds to Remain in Their CommunitiesACLU Celebrates President Biden’s Clemency Announcement, Allowing Hundreds to Remain in Their Communities
WASHINGTON – President Biden heeded the calls of advocates and families today by granting commutations to close to 1,500 people who were released to home confinement at the height of the COVID-19 pandemic under the CARES Act and pardons to 39 additional people, including many veterans and women. The CARES Act, passed in 2020 in response to the COVID-19 pandemic, allowed certain groups of people to serve part of their sentences at home to mitigate the dangers of COVID-19 in federal prisons. Since then, thousands of people have been allowed to serve part of their sentences at home, securing jobs, reconnecting with loved ones, and reintegrating into their communities. The American Civil Liberties Union advocated for the CARES Act and has been urging President Biden to provide clemency to CARES Act release recipients since 2021, launching a six-figure ad buy, engaging grassroots supporters, filing FOIA litigation, and more. “We are thrilled that President Biden has allowed people to remain with their families and communities, where they belong, said Cynthia W. Roseberry, director of policy and government affairs at the ACLU’s Justice Division. “The CARES Act was an unprecedented experiment in decarceration, and the data tells us it was incredibly successful. Of the over 13,000 people released, more than 99 percent have safely and successfully reintegrated into their communities. We urge Congress to build on the remarkable success of the CARES Act and pass other decarceration policies that prioritize compassion, redemption, and public safety.” “President Biden’s actions today also remind us of the incredible and unique power of executive clemency,” Roseberry continued. “The ACLU has long advocated for the categorical use of clemency to address unjust outcomes of the criminal legal system. While today’s announcement is wonderful, there is more to do in the final weeks before President Biden leaves office. We strongly urge President Biden to use his power to address this country's failed death penalty by commuting death row sentences.” According to data the ACLU obtained this year through FOIA litigation, the vast majority (71.8 percent) of those on home confinement had less than one year remaining in their sentence. Almost a quarter (23.5 percent) of CARES Act clemency recipients are older than 61 and over half (59.4 percent) are people of color. “Biden's announcement today means I can finally breathe a sigh of relief after 3.5 years of living with the fear of being sent back to prison for no reason,” said Won Lee, released on CARES Act home confinement in May 2021. “The second chance I got through the CARES Act allowed me to take care of my aging parents, restart my career, pursue a graduate degree, and receive treatment for the cancer I was diagnosed with shortly after returning home. Today's decision means I will no longer have to live with the uncertainty and fear that I will be unjustly uprooted from my life and family, who now depend on me. I am incredibly grateful and thrilled to sleep soundly tonight knowing I'll remain at home.” Learn more about the ACLU’s campaign to commute death row here: /campaigns-initiatives/president-biden-commute-the-row -
Press ReleaseSep 2024
Criminal Law Reform
+2 Issues
Judge Orders Supervision System in Washington, D.C. to Accommodate People with DisabilitiesJudge Orders Supervision System in Washington, D.C. to Accommodate People with Disabilities
WASHINGTON – A federal court granted a preliminary injunction yesterday in a case filed on behalf of people with disabilities on parole and supervised release in Washington, D.C., ordering immediate action to address discriminatory conditions faced by the two named plaintiffs. The court also denied the government’s motion to dismiss, allowing the case to proceed. The case, brought by the American Civil Liberties Union, ACLU of D.C., Public Defender Service for the District of Columbia, and Latham & Watkins LLP, challenges the federal government’s post-conviction supervision system in Washington, D.C. for systematically ignoring the needs of people with disabilities, thereby setting them up for failure on supervision and putting them at constant risk of sanctions, including incarceration. As the court held in its decision, such accommodations are likely required under federal disability law, specifically the Rehabilitation Act of 1973. The preliminary injunction requires that the United States Parole Commission and the Court Services and Offender Supervision Agency (CSOSA), the two federal agencies responsible for supervision in D.C., assess what reasonable accommodations the two named plaintiffs require to have an equal opportunity to succeed on supervision, and provide all such required accommodations. “Absent an injunction,” the court’s decision reads, “the Parolees will be forced to participate in the Government’s supervision programs on an unequal footing just because of their disabilities.” People on supervision in D.C. are required to comply with myriad and onerous rules. For people with disabilities, navigating these complex conditions is even more challenging. For example, Plaintiff Mr. Mathis — a 70-year-old military veteran with congestive heart failure that limits his ability to walk — struggles to travel throughout the city to attend frequent supervision meetings that often conflict with necessary medical procedures and hospitalizations. His supervision officer required him to wear an ankle monitor even after his doctor warned the monitor would jeopardize his health due to his heart condition. Plaintiff Mr. Davis, who lives with chronic pain stemming from third-degree burns as well as mental health conditions, also faces disability-related barriers getting to required meetings. Yet failing to meet any of these conditions, even something as simple as missing an appointment, can land a person back in jail or prison, even when no new criminal conduct is alleged. The court agreed that “absent immediate relief, the Parolees will face irreparable harm; namely, obstacles to success on supervision solely because of their disabilities, which expose them to downstream harms like revocation and reincarceration.” The court did not decide whether it will ultimately certify a class that could yield relief for all people on supervision in D.C. who need accommodations. Instead, the court directed the parties to agree on a schedule for further proceedings on that issue. “The undue hardships faced by people with disabilities on federal criminal supervision in the District of Columbia have gone unaddressed for too long,” said Scott Michelman, legal director, ACLU of the District of Columbia. “This decision is a victory for equal treatment and common sense.” “The Court’s opinion emphatically rejects the federal government's ‘do-nothing’ policy for people with disabilities on supervision in Washington, D.C., who have been forced to navigate onerous requirements without accommodations for decades,” said Allison Frankel, staff attorney with the ACLU Criminal Law Reform Project. “This ruling ensures that our named Plaintiffs will have the accommodations they need to have a fair shot at completing parole and remaining in their communities.“ “We are thrilled the Court recognized that the Parole Commission and CSOSA must accommodate our clients’ disabilities so that they have an equal opportunity to succeed on supervision,” said Zoé Friedland, staff attorney with the Public Defender Service for the District of Columbia. “We will keep fighting to make this relief permanent and systemic so that all people on supervision have an equal chance to succeed.” The decision on the preliminary injunction can be found here: /cases/mathis-v-united-states-parole-commission?document=Preliminary-Injunction-Opinion The complaint can be found here: /documents/w-mathis-v-united-states-parole-commission-complaint -
Press ReleaseJul 2024
Smart Justice
Just City And Legal Advocates Challenge Tennessee’s Unprecedented Bail LawJust City And Legal Advocates Challenge Tennessee’s Unprecedented Bail Law
MEMPHIS, Tenn. — Today, the American Civil Liberties Union (ACLU) Criminal Law Reform Project, ACLU of Tennessee, and Simpson Thacher & Bartlett LLP filed a lawsuit on behalf of Just City Memphis to challenge the constitutionality of Tennessee’s unprecedented new bail law, arguing that the law violates the Fourteenth Amendment by mandating unfair bail hearing procedures and discriminatory wealth-based detention. The law makes Tennessee the only state in the country to prohibit judges from considering whether people appearing before them will be able to pay for release. The new law, which went into effect on May 1, targeted successful bail reforms that Shelby County implemented following an agreement with the ACLU, ACLU of Tennessee, Just City, and other local advocates. The agreement required the examination of a person’s financial circumstances prior to any bail decision; individualized bail hearings with counsel no later than three days after a person’s arrest; and imposition of secured money bail only as a last resort. As a result, more people returned home to their communities while at the same time lowering the number of people rearrested for new crimes. By rolling back these reforms, the Tennessee legislature has created a two-tiered system of justice, leaving those who cannot afford to pay detained indefinitely, even if they are not a flight or safety risk. Meanwhile, those who face the same charges but can afford to pay money bail are freed until trial. “Bail reform works, and it was working in Shelby County. More Tennesseans were returning home to live peacefully in their communities,” said Trisha Trigilio, senior staff attorney for the ACLU. “This shameful legislation targets low-income and marginalized Tennesseans for pointless jail time. We will not allow Tennessee lawmakers to end successful bail reform for political gain.” "Our Constitution demands that judges make individualized determinations about pretrial release," said Josh Spickler, executive director at Just City. "This law prevents judges from doing that crucial work and results in the unnecessary detention of people who pose no risk to public safety because they can't afford to pay an arbitrary bail amount. That's not how our justice system is supposed to work." “We don't have to choose between safety and justice; we can have both if we maintain a bail system that is evidence-based, fair, and constitutional.” said Stella Yarbrough, legal director at the ACLU of Tennessee. “Everyone has a basic right to freedom, and this new law contradicts decades of constitutional precedent. Freedom for the wealthy and punishment for poor people of all races violates the Constitution and disproportionately impacts Black people and people with disabilities, while doing nothing to address the systemic causes of crime—like poverty and lack of opportunity.” Simpson Thacher & Bartlett LLP Litigation Partner Craig Waldman added, “Tennessee’s law banning judges from considering an individual’s ability to pay bail is unfair and unconstitutional. The right to due process guaranteed under the Fourteenth Amendment is a bedrock of our justice system.” Just City is an organization dedicated to fighting discrimination based on race, ethnicity, and income in Shelby County criminal proceedings, and has long advocated for pretrial practices that prioritize fair and sensible release decisions over a person’s ability to pay. Their lawsuit asks the court to declare that this new bail law violates the Fourteenth Amendment and requests a preliminary injunction that would prohibit the Shelby County Sheriff from enforcing this law. -
Press ReleaseJul 2024
Reproductive Freedom
+2 Issues
Court Rejects Attempt to Dismiss Case Seeking Accountability for Wrongful Prosecution of AbortionCourt Rejects Attempt to Dismiss Case Seeking Accountability for Wrongful Prosecution of Abortion
McALLEN, Texas – A federal judge ruled today that a lawsuit seeking accountability for the unlawful investigation and prosecution of Lizelle Gonzalez can proceed, rejecting attempts by Starr County officials to have the case dismissed. Gonzalez, represented by Garza Martinez, the American Civil Liberties Union, and the ACLU of Texas was unlawfully arrested, jailed, and charged with murder after a medication abortion she had in 2022. The Starr County district attorney, assistant district attorney, and sheriff pursued and then obtained an unlawful indictment against Gonzalez even though they knew that Texas law clearly prohibits the criminal prosecution of pregnant women for conduct that ends their pregnancy. “When I first heard Lizelle’s story, I was outraged at the behavior of our elected officials,” said Cecilia Garza, attorney at Garza Martinez. “The court’s decision today to allow this case to proceed gives me hope that courts will not allow these types of egregious acts to continue. Law enforcement need to be held accountable to the laws that they took an oath to uphold.” In the motions to dismiss, the prosecutors and sheriff raised claims of legal immunity, a doctrine that they argue should insulate them from being held accountable for violating Gonzalez’s constitutional rights. The court denied their motions to dismiss, allowing Gonzalez’s case to proceed to the first stage of discovery concerning whether law enforcement can be held liable for violating her rights. “Immunity doctrine creates a culture in police departments and prosecutor offices where public officials may feel empowered to violate people’s rights, knowing they will face few – if any – consequences,” said Lauren Johnson, director of the ACLU’s Abortion Criminal Defense Initiative. “While immunity often obstructs victims of misconduct from attaining accountability, the court’s decision today to allow the case to proceed will give Lizelle a chance to pursue the justice she deserves for being unlawfully targeted and prosecuted.” “Texas is one of the most restrictive states in the country when it comes to abortion health care, but even in Texas, the laws are uniform and clear that pregnant women cannot be criminally liable for having an abortion,” said David Donatti, senior staff attorney for the ACLU of Texas. “We expect and demand that our elected officials follow the rule of law, and that is especially true for officials elected to enforce the laws with so much power over our daily lives and personal decisions.”