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Federal Circuits Myriad Decision Reaffirms Patentability of Isolated DNA Sequences

Summary of Opinion

On July 29, 2011, The U.S. Court of Appeals for the Federal Circuit decided Assn for Molecular Pathology v. Myriad Genetics, Inc. See No. 2010-1406 (Fed. Cir. July 29, 2011). The case was an appeal from a district court summary judgment decision holding that all claims of patents held by Myriad Genetics, Inc. (Myriad), including claims directed to isolated DNA molecules, were invalid under 35 U.S.C. § 101 as patent-ineligible subject matter. On the threshold issue of jurisdiction, the Federal Circuit affirmed district courts decision to exercise declaratory judgment jurisdiction, albeit on narrower grounds, by concluding that at least one Plaintiff had standing to challenge the validity of Myriads patents because that Plaintiff had an actual and imminent plan to engage in potentially infringing activities.

On the merits, the Court held that Myriad's patent composition claims directed to isolated DNA molecules, whether limited to cDNAs or not, are directed to patent-eligible subject matter under 35 U.S.C. § 101. Thus, the Court reversed the district courts grant of summary judgment of invalidity under § 101. The Court also reversed the district courts decision that Myriads method claims directed to screening potential cancer therapeutics is directed to patent-ineligible subject matter, holding that the claims were patent eligible because they contained transformative steps. The Court, however, affirmed the district courts decision that Myriads method claims directed to comparing and analyzing DNA sequences are patent ineligible because they include no transformative steps and instead cover only abstract, mental steps.

The Court's decision regarding claims directed to isolated DNA molecules followed Supreme Court precedent in construing § 101 language broadly. See 35 U.S.C. § 101; Myriad, slip op. at 36 (citation omitted) (In choosing such expansive terms . . . modified by the comprehensive any, Congress plainly contemplated that the patent laws would be given wide scope.). Notably, in deciding the patentability of Myriads method claims, the Court employed the ''machine-or-transformation'' test as a means by which to determine statutory subject matter under § 101 in light of Bilski v. Kappos, 130 S. Ct. 3218 (2010). See also Prometheus Labs., Inc. v. Mayo Collaborative Servs., 628 F.3d 1347, 1350 (Fed. Cir. 2010).


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