The issue in the Myriad Genetics and Prometheus Labs cases could be expressed this way: work of man or work of nature? A gene exists as a part -a very tiny part of a human being - but it would never be able to be known or isolated without a technology that a private company invents and markets.
A 2-1 panel of the U.S. Federal Circuit Court of Appeals in Washington, D.C., on Thursday upheld the biotechnology company's right to patent "isolated" genes known as BRCA1 and BRCA2, which account for most inherited forms of breast and ovarian cancers. The American Civil Liberties Union, which brought the case, argued that patents on human genes violated the First Amendment and patent law because genes are “products of nature.”
This decision comes off remand, five months after the Supreme Court, in a case involving a blood test developed by Prometheus Laboratories, unanimously ruled that companies were not permitted to patent observations about natural phenomena.
The Court said: “Everything and everyone comes from nature, following its laws, but the compositions here are not natural products. They are the products of man, albeit following, as all materials do, laws of nature.”
But based on the Supreme Court remand, the court denied the company's effort to patent methods of "comparing" or "analyzing" DNA sequences. Women who test positive using Myriad's gene test, called BRACAnalysis, have an 82 percent higher risk of breast cancer and a 44 percent higher risk of ovarian cancer in their lifetimes.
