Professor Daniel Ravicher on the steps of the U.S. Supreme Court

Supreme Court Rules That Human Genes Cannot Be Patented

June 13, 2013

CONTACT: Daniel B. Ravicher, Esq., (646) 470-2641; press@pubpat.org

Read the U.S. Supreme Court's Association for Molecular Pathology v. Myriad Genetics opinion.

WASHINGTON – The U.S. Supreme Court ruled today in a case that invalidates patents on two genes associated with hereditary breast and ovarian cancer. The case was brought by Professor Dan Ravicher of Cardozo School of Law along with the ACLU.

"Today the Supreme Court determined that there is no patent blocking on genetic diagnostic testing," Professor Ravicher said. "This completely removes that block, which is what we argued for."

He went on to say that the decision by the court will not prevent innovation in biotechnolgy, but it does mean that "nature is not patentable."

The lawsuit was filed by the Public Patent Foundation (PUBPAT), a non-profit patent reform organization affiliated with Benjamin N. Cardozo School of Law, and the American Civil Liberties Union (ACLU) on behalf of researchers; genetic counselors; patients; breast cancer and women's health groups; and medical professional associations representing 150,000 geneticists, pathologists and laboratory professionals. The patents allowed a Utah company, Myriad Genetics, to control access to the genes, thereby enabling them to limit others from doing research or diagnostic testing of the genes.

“The Patent Office’s policy of granting companies complete control over portions of our bodies is both morally offensive and a clear violation of the law,” Ravicher said. “Genes are the foundation of life, they are created by nature, not by man, and that is why we asked the Supreme Court to make sure they are not controlled by corporations through the patent system.”

Justice Clarence Thomas wrote the opinion for the court which ruled that Myriad’s discovery of the precise location and sequence of the genes at issue, BRCA1 and BRCA2, did not qualify for patents. Justice Thomas wrote for the court, “A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated.” The opinion goes on to say, “It is undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes... Groundbreaking, innovative or even brilliant discovery does not by itself satisfy the criteria” for patent eligibility, he said.

The Court did say that manipulating a gene to create something not found in nature is an invention eligible for patent protection. That left the door open for other ways for companies to profit from their research.  

Speaking about the case ACLU attorney Chris Hansen said, “Myriad did not invent the human genes at issue in this case, and they should not be allowed to patent them. The patent system was designed to encourage innovation, not stifle scientific research and the free exchange of ideas."

The patents granted to Myriad Genetics and the University of Utah Research Foundation gave them exclusive right to perform diagnostic tests on the BRCA1 and BRCA2 genes and thus to control the medical care provided to hereditary breast and ovarian cancer patients and people at high risk for these diseases. Myriad's patent on the BRCA genes allowed it to set the terms and cost of testing, a situation that made it impossible for women to access alternate tests or get a comprehensive second opinion about their results. It also allowed Myriad to prevent researchers from looking at the genes without first getting permission.

The restrictions had a direct impact on patents. Kathleen Maxian of Buffalo, N.Y. is suffering from late-stage ovarian cancer that she believes could have been prevented. Her sister, who is a breast cancer survivor, obtained a test from Myriad that did not look for all known genetic mutations associated with cancer and was told she was negative for mutations. Years later, her sister learned that she did, in fact, have a BRCA genetic mutation—information that Maxian could have relied on to seek preventive surgery. Numerous labs across the country have stated that they are capable of providing this comprehensive screening and would do so were it not for Myriad’s patents. 

“Women should not have to compromise their health because a private company controls their own genetic information,” said Sandra Park, staff attorney with the ACLU Women’s Rights Project. “Patients deserve the best available care, including access to testing and options for second opinions before making serious decisions about their health. These patents prevent them from getting that.”

Lisbeth Ceriani, a breast cancer survivor and plaintiff in the case, was faced with having to pay over $4,000 for Myriad’s testing to determine if she carried a genetic mutation associated with hereditary ovarian cancer, because Myriad had refused to enter into a contract with her insurance company. She was forced to wait 18 months before she was able to obtain the test through a grant, at which point she learned she did indeed carry a mutation.

“No woman should have to go through what I went through to take care of herself and her family,” said Ceriani. “My genes are my own. Knowledge about my own body shouldn’t belong to a corporation.”  

The case is the first challenge brought to human gene patents in the U.S. Attorneys on the case include Ravicher and Sabrina Hassan of PUBPAT; and Hansen, Park, Lenora M. Lapidus and Steven R. Shapiro of the ACLU.

For more information on this case, please visit http://www.pubpat.org/brca.htm.