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U.S. Supreme Court Rules Against BRCA Patents

The court's decision allows other biotechnology companies to offer BRCA testing

June 21, 2013

Written By Josh Fernandez, Writer and Web Content Coordinator

In a landmark decision, the U.S. Supreme Court ruled that genes taken from the human body could not be patented.  

The ruling, agreed on by all nine justices, affected Myriad Genetics, a company providing tests to assess disease risk. The company had patents on the BRCA1 and BRCA2 genes. A woman has about a 60 percent chance of developing breast cancer and a 15-40 percent chance of developing ovarian cancer in her lifetime, if she has a mutation in either gene.

 Healthcare advocates praised the court’s decision in Association for Molecular Pathology v. Myriad Genetics because of what it means for women affected by breast and ovarian cancers that run in families: lowered costs of, and better access to, BRCA testing.

Background and Reason for the Court’s Decision

It was not until researchers at Myriad Genetics pinpointed the exact location and sequence of both the BRCA1 and BRCA2 genes that the first screening tests were able to be developed by the company.

Myriad obtained a number of patents on these genes, which gave the company the exclusive right to isolate, study, and test an individual’s BRCA1 and BRCA2 genes and create BRCA complementary DNA, also known as “cDNA,” forms of genetic material that have been changed in the lab. Patents also allowed Myriad to set the terms and cost of testing, making it difficult for women to access other tests or seek a second opinion regarding their results.

In May 2009, a federal court ruled in agreement with a lawsuit that claimed Myriad’s patents were “unconstitutional and invalid.” However, Myriad filed an appeal which resulted in an appeals court ruling in the company’s favor. The decision was then challenged.

The Supreme Court heard arguments in April 2013. On June 13, the court decided that companies cannot patent genes that already exist in nature. Since Myriad did not create BRCA1 and BRCA2, the patents were invalidated. Patents on cDNA, however, are still valid, because it is created in the lab.

What The Court’s Ruling Means for You

Ellen T. Matloff, CGC, director of the genetic counseling program at Yale Cancer Center, says the court’s decision means there will be faster, cheaper and better BRCA testing for women and men with breast cancer.

“This may make it possible for all women diagnosed with breast cancer to have access to this testing – rather than just patients who meet high risk criteria,” Ms. Matloff tells LBBC. “Only then will we truly understand the prevalence of these mutations.”

Experts suspect other labs will quickly change to accommodate for BRCA testing. Matloff says that within hours of the court’s decision, five labs announced that they will begin offering BRCA testing, one for half of what Myriad charged to perform the test. Myriad’s testing ranges anywhere from $500 to $4,000 depending on how in depth the analysis.

Rebecca Carr, of Lafayette Hill, Pa., underwent a lumpectomy followed by chemotherapy and radiation therapy after being diagnosed with stage IIIC breast cancer. When her test results from Myriad came back positive for BRCA1 in 2004, she chose to have a mastectomy and hysterectomy.

With Myriad no longer able to patent BRCA testing, Rebecca hopes women will be able to make the best possible treatment decisions with more testing options and second opinions on test results.

“The Supreme Court’s decision means many more researchers will be able to work on these pieces of DNA,” Rebecca said. “When there’s more competition, the price goes down, and there are more chances of learning more about this disease.”

Talk with your healthcare providers or a genetic counselor to learn if genetic testing is right for you. A genetic counselor can help interpret your family and personal health histories to gauge whether you would benefit from genetic testing, explain its limits, and discuss how its results may affect prevention and treatment options available to you.

Learn more about genetic testing in our Breast Cancer Basics section of lbbc.org.

Association for Molecular Pathology v. Myriad Genetics, 569 U.S. 1 (2013).

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