Supreme Court Remands Myriad Case in Light of Mayo v. Prometheus


Remember the Myriad case, where a number of Medical Associations and individual doctors — assisted by the American Civil Liberties Union and the Public Patent Foundation — sued Myriad for a declaration that Myriad’s BRCA diagnostic testing patents were invalid because they were directed to unpatentable subject matter under § 101 of the Patent Code?  If not, see our July 29, 2011 post to refresh your recollection.

In Myriad, a panel of the Federal Circuit Court of Appeals held that Myriad’s isolated BRCA DNA claims patentable under § 101, but its method claims for analyzing patients for mutations in these genes unpatentable.  Having just found Prometheus’s claims to a different type of diagnostic test unpatentable under § 101, the Supreme Court has now remanded the Myriad case, which had been subject of a pending writ of certiorari, back to the Federal Circuit with instructions to reconsider in light of Mayo v. Prometheus.

It will be very interesting to see whether the Federal Circuit panel chooses to interpret Prometheus v. Mayo broadly enough to reverse its decision that claims to isolated DNA sequences are patentable.  Judge Lourie’s opinion in Myriad held that isolated DNA sequences are patentable because “BRCA1 and BRCA2 in their isolated state are not the same molecules as DNA as it exists in the body; human intervention in cleaving or synthesizing a portion of a native chromosomal DNA imparts on that isolated DNA a distinctive chemical identity from that possessed by native DNA.”  Slip Op. at 42.  This “distinctive chemical identity” test seems a slender reed now that the Supreme Court rejected the Federal Circuit’s holding in Mayo that the human interventions of “administering” a drug and “determining” its levels in the body conferred patentability to Prometheus’s claims.


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