American Civil Liberties Union

Who invented our genes? There are many possible answers to this question, but I'm pretty sure your answer wouldn't be, "Myriad Genetics."

But that question is at the heart of our ongoing challenge to patents Myriad controls on two human genes called BRCA1 and BRCA2, which are associated with inherited risk of breast and ovarian cancer. We all have these genes, but people with certain mutations are much more likely to experience cancer in their lifetimes.

Today, we asked the U.S. Supreme Court to review an appellate court’s 2-1 ruling upholding patents on two human genes associated with hereditary breast and ovarian cancer.  The case challenges patents that pose a serious barrier to using new discoveries in genetic testing and how genes influence the way cancers develop and can be treated.

BRCA1 and BRCA2 are two of the 23,000 genes in the human genome, 20 percent of which have been patented.  We all have these genes, but women with certain genetic mutations are estimated to have up to an 85 percent risk for breast cancer and 50 percent risk for ovarian cancer.  Myriad Genetics obtained patents on the “isolated” forms of the two genes, which simply means it obtained a patent on the human gene once it has been removed from the cell.  It does not matter whether the genes come from you, me or any of the other 285 million people in the U.S., or whether you have a mutation or not – the patents claim them all.  Even though laboratories around the country are fully capable of providing genetic testing for BRCA1 and BRCA2 (and were already testing patients before the patents forced them to stop), the patents in essence give a monopoly over these genes. 

Recently, Dr. James Watson filed an amicus brief opposing gene patents in our lawsuit challenging the patents on two human genes associated with hereditary breast and ovarian cancer. Dr. Watson, along with Francis Crick, identified DNA’s ability to create life through its double helical structure and its information-coding sequences in 1953. His brief explains why, from the perspective of a scientist whose work laid the foundation for all genetic research, gene patenting is “lunacy.”

Yesterday, a unanimous Supreme Court strongly reaffirmed a principle that has existed in our case law for over 150 years: laws of nature, natural phenomena and abstract ideas cannot be patented. This principle may seem obvious, but companies have sidestepped it for years by cleverly drafting applications that pass muster with the patent office.

The decision in Mayo Collaborative Services v. Prometheus Labs. involved patents on methods of correlating blood test results and drug toxicity. The Court found them invalid because the patents do nothing more than claim a law of nature -- how a patient reacts to a drug.