Today, as predicted by many commentators, the Supreme Court set aside the ruling by the Fed. Cir. that claims to isolated DNA sequences that are the BRCA 1 or 2 gene, or fragments thereof, are patentable subject matter. The Supreme Court ordered the Fed. Cir. to reconsider its 2-1 panel decision in view of its recent opinion in Prometheus that assays to optimizing drug efficacy based on measuring metabolite levels were no more than attempts to patent natural phenomena.
It is not entirely clear what guidance the Prometheus opinion provides for the appealed DNA claims in the Myriad decision. After all, the claims closest to the invalidated Prometheus claims were the claims to a method of locating mutations in a subject’s BRCA DNA by comparing it to a benchmark, or wild-type BRCA sequence. In the Supreme Court’s opinion, Justice Breyer contrasted the claims at issue with claims to a new compound:
“Unlike, say, a typical patent on a new drug or a new way of using an existing drug, the [Promethus claims] do not confine their reach to particular applications of those [natural laws].”
To invalidate claims to isolated DNA sequences, the Fed. Cir. and the Supreme Court would have to specifically interpret Chakrabarty to require that, to be “new” under section 101, a compound must exhibit a utility not possessed by the compound pre-isolation, even if the compound pre-isolation is structurally different than the compound post-isolation. If the Fed. Cir. were simply to rely on In re Bergy, as I and others have suggested in previous posts on Myriad, it is difficult to imagine the Fed. Cir. reversing itself on this issue.
Even if gold in a streambed is not different from gold in a Krugerrand, isolated DNA in a “test tube” is different from a DNA sequence that is one part of chromosomal DNA. However, the Supreme Court just added a “something more” requirement to a claim to optimizing a drug regimen, and the Court may be poised to put a “something more” requirement on a structurally novel chemical compound. I just hope that if the judges or justices go down this path, and hold that isolated DNA is a “natural product,” they give us some hint of how to meet the “something more” requirement, going forward. They might also consider what “going forward” means.