Association for Molecular Pathology Applauds Gene Patent Decision

What does the Association for Molecular Pathology (AMP) have in common with actress Angelina Jolie?

Simple: Both have crossed paths with the molecular diagnostic firm Myriad Genetics in recent months. But the association did so before the U.S. Supreme Court—where AMP claimed victory on Thursday.

More details below:

The case: Association for Molecular Pathology v. Myriad Genetics, Inc., pitted the association and other parties against Myriad, which creates proprietary tests to analyze the risk factors for certain diseases. The company received a significant boost in attention  (opens in a new tab) after Jolie told the public about her double mastectomy and that she had used a Myriad genetics test  (opens in a new tab) to determine her breast cancer risk. The company held patents on the isolated DNA coding that its breast cancer and ovarian cancer tests target, genes known as BRCA1 and BRCA2. It was those patents, which prevented anyone other than Myriad from working with the genes, that were at issue in the case. AMP and other groups, including the American Civil Liberties Union, sued the company in 2009, arguing that genes should not be patentable, no matter whether naturally occurring or synthetic.

The ruling: The judgment, in effect, invalidates Myriad’s patents on BRCA1 and BRCA2. In a unanimous decision, the court found that naturally occurring human DNA couldn’t be patented but that synthetic DNA (known as cDNA) could be. Justice Clarence Thomas explained the difference in the majority opinion  (opens in a new tab) [PDF]: “cDNA does not present the same obstacles to patentability as naturally occurring, isolated DNA segments. Its creation results in an exons-only molecule, which is not naturally occurring. Its order of the exons may be dictated by nature, but the lab technician unquestionably creates something new when introns are removed from a DNA sequence to make cDNA.” Justice Antonin Scalia wrote a concurring opinion but did not join the parts of the majority opinion going into the deeper details of molecular biology, writing that he was “unable to affirm those details on my own knowledge or even my own belief.” (Patent Docs offers a deeper analysis of the opinion  (opens in a new tab).)

AMP reacts: In a statement  (opens in a new tab) [PDF] Thursday, AMP hailed the decision, praising the court’s conclusion that “separating [a] gene from its surrounding genetic material is not an act of invention.” Calling the decision “groundbreaking,” AMP President Jennifer L. Hunt, MD, MEd, said, “There is no question that this is a critical and right decision for the future of medicine and science. Biomedical researchers, clinicians, and most importantly patients will see great benefit from this development.”

Angelina Jolie drew attention to Myriad Genetics’ patents when announcing she had received a double mastectomy after using its test. (photo by Gage Skidmore/Flickr)