Oral arguments were under way at the U.S. Court of Appeals for the Federal Circuit Monday morning in the closely watched Myriad Genetics appeal (Association for Molecular Pathology, et al. v. USPTO, et al.), with a panel of three Federal Circuit Judges (Lourie, Bryson, and Moore) weighing whether human genes qualify as patentable subject matter.
Ruling in a case brought by several doctors' groups, the ACLU, and the Public Patent Foundation, New York federal district court Judge Robert Sweet last year struck down Myriad's patents on two genes related to breast cancer, holding that they merely covered isolated DNA from the natural world and thus were not eligible for patent production under section 101 of the Patent Act.
In his 152-page opinion [ Download Myriad Opinion], Sweet wrote: "It is concluded that DNA's existence in an 'isolated' form alters neither this fundamental quality of DNA as it exists in the body nor the information it encodes. Therefore, the patents at issue directed to 'isolated DNA' containing sequences found in nature are unsustainable as a matter of law and are deemed unpatentable subject matter."
As The American Lawyer reported in February, acting Solicitor General Neal Kaytal was to argue for the appellees along with attorneys for the ACLU and the Public Patent Foundation, marking the first time that a Solicitor General has argued at the Federal Circuit.
In a case with implications for the entire biotechnology industry, Kaytal will attempt to explain why the government now thinks that genes should not be patentable, despite the fact that the USPTO has historically disagreed and has been issuing patents on isolated DNA for more than 30 years.
For a good background on the issues likely to be raised at oral argument, check out Joe Mullin's previous coverage of the district court's ruling and Andrew Cohen's discussion of the case at The Altantic. For the even more ambitious, an audio recording of the argument will be made available on the Federal Circuit's website later today.