Myriad Genetics discovered mutations in genes that assisted the diagnosis of the potential for breast cancer. USPTO granted the patents, and Myriad monetized their IP with new gene analysis products. The research communities represented by AUTM and BIO reacted vociferously to a District court’s decision that the patents were not valid, the decision was appealed, and stakeholders have held their collective breaths.
Late last week CAFC issued its opinion, siding mostly with Myriad. Judge Alan Lourie:
Standing to sue: “We affirm the district court’s decision to exercise declaratory judgment jurisdiction because we conclude that at least one plaintiff, Dr. Harry Ostrer, has standing to challenge the validity of Myriad’s patents.”
Gene patents: “We reverse the district court’s decision that Myriad’s composition claims to ‘isolated’ DNA molecules cover patent-ineligible products of nature under § 101 since the molecules as claimed do not exist in nature.”
Screening method claim: “We also reverse the district court’s decision that Myriad’s method claim to screening potential cancer therapeutics via changes in cell growth rates is directed to a patent-ineligible scientific principle.”
Comparing method claim: “We, however, affirm the court’s decision that Myriad’s method claims directed to ‘comparing’ or ‘analyzing’ DNA sequences are patent ineligible; such claims include no transformative steps and cover only patent-ineligible abstract, mental steps.
Judge William Bryson dissented, saying a human gene is not an invention. “Myriad’s discovery of those sequences entailed difficult work, and the identified sequences have had important applications in the fight against breast cancer. But the discovery of the sequences is an unprotectable fact,” he said.