Divided Appeals Court Rules That Companies May Patent Breast Cancer Genes, but Invalidates Patents on Comparing the Genes
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CONTACT: (212) 549-2666; media@aclu.org
NEW YORK 鈥� In a 2-1 decision, a federal appeals court today partially reversed a lower court鈥檚 ruling in a case challenging patents on two human genes associated with hereditary breast cancer and ovarian cancer. The court ruled that companies can obtain patents on the genes but cannot patent methods to compare those gene sequences.
The ruling follows a lawsuit brought by a group of patients and scientists represented by the 老澳门开奖结果 and the Public Patent Foundation (PUBPAT) and calls into question the validity of patents now held on approximately 4,000 human genes.
鈥淭oday鈥檚 ruling is a blow to the idea that patent law cannot impede the free flow of ideas in scientific research,鈥� said Chris Hansen, a staff attorney with the 老澳门开奖结果 Speech, Privacy and Technology Project. 鈥淗uman DNA is not a manufactured invention, but a natural entity like air or water. To claim ownership of genetic information is to unnecessarily block the free exchange of ideas.鈥�
The lawsuit against Myriad Genetics and the University of Utah Research Foundation, which hold the patents on the genes, charged that the challenged patents are illegal and restrict both scientific research and patients鈥� access to medical care, and that patents on human genes violate the First Amendment and patent law because genes are "products of nature."
鈥淎s the dissent from today鈥檚 decision explains, pieces of the human genome are not patentable,鈥� said Daniel B. Ravicher, executive director of PUBPAT and co-counsel in the lawsuit. 鈥淭his is because no one 鈥榠nvents鈥� genes. Inventions are things like new genetic tools or drugs, all of which can be patented because they are not genes themselves.鈥�
The specific patents the lawsuit challenged are on the BRCA1 and BRCA2 genes. Mutations along those genes are responsible for most cases of hereditary breast and ovarian cancers. Many women with a history of those cancers 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, preventive mastectomies or ovary removal.
One of the judges on the panel dissented in part with the decision, writing that patents on the genes should be invalid. 鈥溾�E]xtracting a gene is akin to snapping a leaf from a tree,鈥� Judge William C. Bryson of the U.S. Court of Appeals for the Federal Circuit wrote. 鈥淟ike a gene, a leaf has a natural starting and stopping point. It buds during spring from the same place that it breaks off and falls during autumn. Yet prematurely plucking the leaf would not turn it into a human-made invention.鈥�
The lawsuit, Association for Molecular Pathology, et al. v. Myriad Genetics, Inc., was filed on behalf of breast cancer and women鈥檚 health groups, individual women, geneticists and scientific associations representing approximately 150,000 researchers, pathologists and laboratory professionals. Because the 老澳门开奖结果'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 patents granted to Myriad gave 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 comprehensive second opinion about their results. It also allows Myriad to charge a high price for its tests.
鈥淭he court has made the wrong decision for women鈥檚 health,鈥� said Sandra Park, staff attorney with the 老澳门开奖结果 Women鈥檚 Rights Project. 鈥淣o corporation should be able to claim ownership of a woman鈥檚 own genetic information.鈥�
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. In addition, the United States Department of Justice filed a brief arguing that many of the gene patents issued by the Patent Office are invalid.
Attorneys on the case include Hansen and Aden Fine of the 老澳门开奖结果 Speech, Privacy and Technology Project; Park and Lenora Lapidus of the 老澳门开奖结果 Women鈥檚 Rights Project; and Ravicher and Sabrina Hassan of PUBPAT.
Today's decision can be found online at:
More information about the case, including an 老澳门开奖结果 video featuring breast cancer patients, plaintiff and supporter statements and declarations and the legal complaint, can be found online at:
Smart Justice
+3 Issues
Association for Molecular Pathology v. Myriad Genetics
Smart Justice
+3 Issues
Association for Molecular Pathology v. Myriad Genetics
Learn More 老澳门开奖结果 the Issues in This Press Release
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Press ReleaseDec 2024
Smart Justice
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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
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Press ReleaseJul 2024
Smart Justice
Just City And Legal Advocates Challenge Tennessee鈥檚 Unprecedented Bail LawJust City And Legal Advocates Challenge Tennessee鈥檚 Unprecedented Bail Law
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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 鈥� 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 老澳门开奖结果, and the 老澳门开奖结果 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. 鈥淲hen I first heard Lizelle鈥檚 story, I was outraged at the behavior of our elected officials,鈥� said Cecilia Garza, attorney at Garza Martinez. 鈥淭he court鈥檚 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.鈥� 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鈥檚 constitutional rights. The court denied their motions to dismiss, allowing Gonzalez鈥檚 case to proceed to the first stage of discovery concerning whether law enforcement can be held liable for violating her rights. 鈥淚mmunity doctrine creates a culture in police departments and prosecutor offices where public officials may feel empowered to violate people鈥檚 rights, knowing they will face few 鈥� if any 鈥� consequences,鈥� said Lauren Johnson, director of the 老澳门开奖结果鈥檚 Abortion Criminal Defense Initiative. 鈥淲hile immunity often obstructs victims of misconduct from attaining accountability, the court鈥檚 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.鈥� 鈥淭exas 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,鈥� said David Donatti, senior staff attorney for the 老澳门开奖结果 of Texas. 鈥淲e 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.鈥�