In a split decision, the Federal Circuit has re-affirmed that isolated human DNA falls within the scope of patentable subject matter, notwithstanding the Supreme Court’s intervening Mayo v. Prometheus decision. Association for Molecular Pathology v. USPTO and Myriad Genetics, Inc., at 62 (Fed. Cir. Aug. 16, 2012) ("Myriad").


This decision follows an appeal to the Supreme Court that was returned to the Federal Circuit for further consideration in light of Mayo Collaborative Services v. Prometheus, Inc., 566 U.S. _, 132 S. Ct. 1289 (2012) (holding that a process of determining proper drug dosage was not patentable, because it did not provide sufficient "inventive concept" above and beyond the underlying law of nature). Myriad was appealing a district court decision granting summary judgment that all of the challenged claims directed to (1) isolated DNA, coding for BRCA1 and BRCA2 mutations associated with breast and ovarian cancers (2) diagnostic methods containing only "analyzing" or "comparing" steps, and (3) screening methods that required the growing of transformed eukaryotic host cells were not patent eligible under 35 U.S.C. § 101. Association for Molecular Pathology v. U.S. Patent & Trademark Office, 702 F. Supp. 2d 181 (S.D.N.Y. 2010).

Federal Circuit Decision

The majority stressed that the appeal was not about policy considerations but "solely whether the claims to isolated BRCA DNA, to methods for comparing DNA sequences, and to a process for screening potential cancer therapeutics meet the threshold test for patent-eligible subject matter in light of various Court holdings, including Mayo." The majority acknowledged Mayo’s impact, holding that it provides "valuable insights and illuminat[ing] broad, foundational principles" to the patentability of method claims. Ultimately, however, the majority found older Court precedent – in Chakrabarty (holding that claims to engineered bacteria are patent eligible) and Funk Brothers (holding that claims to mixed bacterial cultures were not patent eligible) – more compelling. Applying Chakrabarty and Funk Brothers, the majority held that “the challenged [isolated DNA] claims are drawn to patent eligible subject matter because the claims cover molecules that are markedly different – have a distinctive chemical structure and identity – from those found in nature.”

In a dissent, Judge Bryson asserted that isolating DNA from the human body is no more than “snapping a leaf from a tree.” The majority found the analogy inapt: “[s]napping a leaf from a tree is a physical separation, easily done by anyone,” while “[c]reating a new chemical entity is the work of human transformation, requiring skill, knowledge, and effort.”

In dismissing an attempt by the district court to characterize isolated DNAs as not markedly different than native DNAs because their informational content is the same, the majority noted that the focus of the patent eligibility analysis should be on the thing claimed, not on what it does: “The claimed isolated DNA molecules are distinct from their natural existence as portions of larger entities, and their information content is irrelevant to that fact.”

The Federal Circuit decision quickly and unanimously disposed of the method claims holding that the claims directed solely to “comparing” or “analyzing” DNA sequences were patent ineligible on the ground that they claim only abstract mental processes and natural laws and run afoul of Supreme Court precedent, including Benson, Bilski, and Mayo. As to the claim directed to a process for screening potential cancer therapeutics, the Federal Circuit held it to be patent eligible. In so doing, the court observed that the claim does more than simply apply a law of nature because it recites steps that manipulate host cells transformed with an altered BRCA1 gene, which the court emphasized were not naturally occurring.

Impact of the Federal Circuit Decision

The Federal Circuit’s finding that composition claims to isolated DNAs is patentable subject matter is welcome news for biotechnology and pharmaceutical companies and is consistent with established USPTO practice of granting patent protection for such claims. Nonetheless, the Federal Circuit’s divided opinion with regard to claims to isolated DNAs could set the stage for reconsideration by an en banc panel and possibly another Court decision addressing patent eligibility under 35 U.S.C. § 101.