At 10 am this morning, the Court of Appeals for the Federal Circuit will hear oral arguments in high profile gene-patent case of Association for Molecular Pathology, et al. v. USPTO. In a sweeping opinion, Southern District of New York Judge Robert Sweet held the Myriad Genetics gene patent claims invalid as merely claiming products of nature.
The patents cover the BRCA1 and BRCA2 gene mutations that, when present, indicate a high likelihood of developing breast cancer. In addition to claims to the isolated genes themselves, challenged claims are also directed toward methods of isolating the genes in order to test for whether the mutation is present. These patents have led to more than a billion dollars in revenue for Myriad Genetics and the University of Utah.
The court rejected the patentee’s claims to have invented the isolated BRCA1/2 gene as a product of nature — holding that the “isolated” form does not alter the fundamental quality of DNA as it exists in the body nor the information that it encodes. In addition, the court found the methods of comparison invalid under the Federal Circuit’s now defunct machine or transformation test.
In an e-mail, Hal Wegner correctly suggested that the key threshold question for this case will be whether Federal Circuit will reject the case on jurisdictional grounds. The ragtag group of declaratory judgment plaintiffs is led by the ACLU and the Public Patent Foundation.
More than two-dozen friend-of-the-court briefs were filed. Most notably, the U.S. Government in its brief argues that isolated but otherwise unmodified genomic DNA is not patentable.