August 21, 2012Client Alert

Federal Circuit Reaffirms that Isolated DNA is Patentable Subject Matter

Last week, the Court of Appeals for the Federal Circuit issued a new decision in the case, Association for Molecular Pathology v. USPTO (also known as the Myriad case). The earlier Federal Circuit opinion in the Myriad case, issued July 29, 2011, was vacated by the Supreme Court and remanded to the Federal Circuit for further consideration in light of the Supreme Court’s decision in Mayo Collaborative Services v. Prometheus, Inc., 566 U.S. ___, 132 S. Ct. 1289 (2012). In the Prometheus case, the Supreme Court considered the patentability of diagnostic method claims and ruled that claims directed to an application of a law of nature must limit their reach to a specific inventive application of the law of nature to be patent-eligible.


As with the original appeal, the issues of interest to the life sciences industry in the second Myriad decision centered on whether the Federal Circuit would reverse the District Court’s decision that held that the challenged claims were drawn to non-patentable subject matter under 35 U.S.C. § 101. The claims at issue in the Myriad patents include compositions of matter claims directed to isolated nucleotide sequences covering two human genes, BRCA1 and BRCA2, and specific mutations in those sequences, as well as diagnostic method claims relating to those sequences. Certain mutations in BRCA1 and BRCA2 are associated with increased risk for developing breast or ovarian cancer.


In the decision issued yesterday, the Federal Circuit reaffirmed that the claims directed to compositions of matter including isolated nucleotides are patent-eligible subject matter under 35 U.S.C. § 101. Each judge on the panel issued an opinion which tracked their original decision along with references to the Prometheus case.


Judge Lourie held that Prometheus is not controlling with respect to the subject matter eligibility of claims to compositions, as these are “expressly authorized as suitable patent-eligible subject matter in § 101," stating that the claimed isolated DNA molecules are man-made and not found in nature. Judge Lourie notes that, while Prometheus and earlier cases pertaining to patent eligibility of method claims “provide valuable insights and illuminate broad, foundational principles, the Supreme Court’s decisions in Chakrabarty and Funk Brothers set out the primary framework for deciding the patent eligibility of compositions of matter, including isolated DNA molecules.” However, Judge Lourie reiterated the earlier unanimous decision of the panel that the diagnostic method claims of the Myriad patents are not patent-eligible, in keeping with the Supreme Court’s decision in In re Bilski. 


Judge Moore echoes Judge Lourie’s contention that the Prometheus case is “instructive” but that earlier Supreme Court decisions such as Chakrabarty and Funk Brothers are “clearly more analogous” to the Myriad case. Referencing language from the Funk Brothers case, Judge Moore notes that the short, isolated strands of DNA claimed in the Myriad patents lead to an “enlargement of the range of … utility” as compared to nature, indicating that these claims are directed to patentable subject matter.


Similar to the other judges, Judge Bryson argues that Prometheus “does not decide” the Myriad case, but nevertheless provides guidance, and proceeds to apply some of the reasoning of Prometheus to the Myriad patents. Referring to the statement in Prometheus that a patent involving a law of nature must do “significantly more than simply describe . . . natural relations,” Judge Bryson applies this principle to the claimed compositions, arguing that the patent applicant has not done “enough” to distinguish the claimed composition from the similar product of nature.


It is likely that this will not be the final word on this topic, as the Plaintiffs are expected to petition once again for review of this decision, either by the Federal Circuit en banc or by the Supreme Court.

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