As reported by the NY Times.
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.
Tuesday the Supreme Court unanimously decided Mayo Collaborative Services v. Prometheus Labs, a decision of considerable significance to the diagnostics industry.
The Court reversed the Federal Circuit Court of Appeals, which had held that patent claims to “a method of optimizing therapeutic efficacy” for treatment of a specific disorder with the steps of (a) administering a specific drug; (b) determining the level of a metabolite of the drug in the patient; wherein the dosage of the drug should be increased or decreased if the level of the drug is outside of a specified range, were patentable under the §101 utility requirement.
September 22, 2011: Genetic Engineering and Biotechnology News published an article today entitled "Prometheus and Myriad Case Outcomes Will Help Shape the Future for MDx Businesses." The article addresses whether the outcome of the Myriad and Prometheus cases will affect the incentives for the development of DNA diagnostic tests and personalized medicine. The author quotes Jonathan Loeb concerning the availability of patent protection and proper claiming strategies for DNA diagnostics in light of the recent Myriad decision, and concludes "As Dr. Loeb correctly noted, the decisions in those cases will constitute a roadmap to patenting and ultimately commercializing molecular diagnostics tests and the genetic material to be used in them."