Supreme Court to hear oral arguments in Myriad case
Myriad Genetics will deliver an oral argument at the US Supreme Court today (Monday, April 15) defending its patents covering isolated human gene sequences linked to breast and ovarian cancer.
The Supreme Court has been asked to rule on whether genetic material is patentable subject matter after the Association for Molecular Pathology and the American Civil Liberties Union filed a lawsuit against Myriad claiming that it is unconstitutional to patent products of human nature. The patents were invalidated by a New York district court in 2010 but upheld by the US Court of Appeals last year.
While US patent law states that naturally occurring products are not patent eligible, the US Patent and Trademark Office has been granting patents for isolated genes for 30 years, and Myriad claims it has granted almost 3,000 patents for isolated DNA molecules.
Myriad’s patents also give the company exclusive rights to perform diagnostic testing on the BRCA1 and BRCA2 genes, which its opponents argue will stifle diagnostic testing and research.
But in its Supreme Court brief, Myriad argued that the gene mutations “were never available to the world until Myriad’s scientists applied their inventive faculties to a previously undistinguished mas of genetic matter and created a new chemical entity … resulting in significant new applications for human health.”
In a statement published on its website, the Utah-based company added that it has never sought to patent genes as they exist in the human body. “Rather, Myriad created synthetic molecules of DNA in the laboratory that are used to test patients for increased risk of breast cancer and ovarian cancer.”
Richard Marsh, Myriad’s general counsel, said that strong IP protection is critical to Myriad and other companies’ ability to save and improve patients’ lives.
James DeGraw, a partner at Ropes & Gray LLP, said the case is "shaping up as the most important business case on this term’s Supreme Court docket.”
“If the court follows the opening provided in the US’ amicus brief, there is a significant chance that the biotechnology industry will need to seriously reconsider its approach to research and intellectual property protection,” he said.
