Federal Circuit's 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 Ass'n 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 court's decision to exercise declaratory judgment jurisdiction, albeit on narrower grounds, by concluding that at least one Plaintiff had standing to challenge the validity of Myriad's 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 court's grant of summary judgment of invalidity under § 101. The Court also reversed the district court's decision that Myriad's 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 court's decision that Myriad's 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 Myriad's 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).

Background of Proceedings

Plaintiffs sought a declaration that fifteen claims from seven patents assigned to Myriad are drawn to patent-ineligible subject matter under 35 U.S.C. § 101. Three categories of claims were considered:

(1) composition claims directed to "isolated" human genes BRCA1 and BRCA2 (collectively "BRCA") and certain mutations in those genes that correlate with a predisposition to breast and ovarian cancers; (2) method claims directed to "analyzing" or "comparing" a patient's BRCA sequence with the normal, or wild-type, sequence to identify the presence of cancer-predisposing mutations; and (3) a method claim directed to a method of screening potential cancer therapeutics by growing cells, detecting the rate of growth, and comparing rates of cell growth in the presence or absence of a potential cancer therapeutic.

On March 29, 2010, Judge Robert W. Sweet of the United States District Court for the Southern District of New York issued a summary judgment opinion invalidating all of the composition of matter claims directed to BRCA1 and BRCA2, as well as all of the method claims, under 35 U.S.C. § 101. See Ass'n for Molecular Pathology v. U.S. Patent & Trademark Office, 702 F. Supp. 2d 181 (S.D.N.Y. 2010).

As to the threshold question of jurisdiction, the district court held that Plaintiffs, including several doctors and scientists seeking to perform clinical BRCA testing and patients unable to gain access to affordable BRCA testing, had established Article III standing under the "all the circumstances" test. Thus, they were able to bring a declaratory judgment suit challenging the validity of Myriad's patents. Id. at 390-91.

On the merits, the district court held that the challenged composition claims were drawn to non-patentable subject matter because the isolated DNA molecules fall within the judicially...