Federal Circuit Reaffirms Patentability Of Isolated DNA Molecules In View Of Supreme Court's Mayo v. Prometheus Decision

INTRODUCTION

On August 16, 2012, the U.S. Court of Appeals for the Federal Circuit decided Ass'n for Molecular Pathology v. Myriad Genetics, Inc., No. 2010-1406, on remand from the Supreme Court to consider the impact of Mayo Collaborative Services v. Prometheus, Inc., 566 U.S. ___, 132 S. Ct. 1289 (2012). As explained below, the Federal Circuit's ruling largely aligns with the same panel's previously vacated July 29, 2011 decision.

On the threshold issue of jurisdiction, the Court reaffirmed the district court's decision to exercise declaratory judgment jurisdiction because at least one Plaintiff had an intention to actually and immediately engage in allegedly infringing activities.

On the merits, the Court once again held— albeit in a fractured analysis —that Myriad's composition claims directed to "isolated" DNA molecules, whether limited to cDNAs or not, are 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 conclusion that Myriad's claimed method of screening potential cancer therapeutics is not patent-eligible subject matter because that method involves the creation of "transformed" host cells. 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 similar claims were held to be unpatentable in Mayo.

BACKGROUND

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 BRCA genes and 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 sequence to identify the presence of cancer-predisposing mutations; and (3) a method claim to "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 these 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). Before reaching the § 101 issue, the district court held that Article III standing existed under the Supreme Court's "all the circumstances" test, MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118, 127 (2007), because the Plaintiffs, who included several doctors and scientists, were ready and able to perform clinical BRCA testing, but prevented from doing so. Id. at 390-91.

With respect to the § 101 issues, the district court held that the composition claims were drawn to nonpatentable "products of nature," noting that isolated DNA molecules are not "markedly different" from native DNA molecules. Id. at 222, 232. With respect to the method claims, the district court, pre- Bilski, held them all patent-ineligible under the now-overruled machine-or-transformation test because the claims covered mental processes independent of any physical transformations. Id. at 233-37.

In its initial July 29, 2011 decision on appeal, the Federal Circuit affirmed the district court's standing holding because one Plaintiff, a doctor, had stated his intention to "actually and immediately engage in allegedly infringing BRCA-related activities." Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 653 F.3d 1329, 1344-47 (Fed. Cir. 2011). On the § 101 issues, the Federal Circuit reversed with respect to the composition claims, reasoning that isolated DNA are free-standing portions of native DNA molecules that are "not the same molecules as DNA as it exists in the body." Id. at 1351-52. With respect to the method claims directed to merely "analyzing" and "comparing" two DNA molecules, the Federal Circuit affirmed...