The Federal Circuit Has Spoken: Isolated DNA Molecules Are Patentable

August.05.2011

On July 29, 2011, the Federal Circuit delivered its opinion in Ass'n for Molecular Pathology v. U.S. Patent and Trademark Office, No. 2010-1406 (Fed. Cir. Jul. 29, 2011), holding that co-defendant Myriad Genetics' claims to isolated DNA molecules constitute patent-eligible subject matter under 35 U.S.C. § 101, and that method claims comparing and analyzing such molecules, without more, do not. The plaintiffs had filed suit seeking a declaratory judgment of invalidity, arguing that Myriad's claims fail to constitute patentable subject matter. The ruling here affirmed in part and reversed in part the decision of the lower district court, which had originally found all 15 of the disputed claims patent-ineligible. 

In the most eagerly anticipated part of its decision, the Federal Circuit found that Myriad's composition claims, covering "isolated" DNA molecules that may reveal a patient's susceptibility to breast or ovarian cancer, were patent-eligible. In reaching its decision, the court found that the isolated DNA molecules "are not the same molecules as DNA as it exists in the body; human intervention in cleaving and synthesizing a portion of a native chromosomal DNA imparts on that isolated DNA a distinctive chemical identity from that possessed by native DNA." Thus, "because the claims cover molecules that are markedly different—have a distinctive chemical identity and nature—from molecules that exist in nature," the requirements of § 101 are satisfied.

Myriad's method claims did not fare as well; those method claims limited to "comparing" or "analyzing" gene sequences (i.e., all but one of the method claims) were held not to cover patentable subject matter because "they claim only abstract mental processes, and fail the machine-or-transformation test." The Federal Circuit reasoned that "although the application of a formula or abstract idea in a process may describe patentable subject matter . . . Myriad's claims do not apply the step of comparing . . . in a process. Rather, the step of comparing . . . is the entire process claimed." However, in considering the single remaining method claim, which included the additional steps of "growing" cells and "determining" their growth rates, the Court came to the opposite conclusion. In the latter case, the claim was held to be patent-eligible because the additional steps involved "inherently transformative" physical manipulations that are "central to the purpose" of the claimed method. By contrast (according to the Court), the "comparing" and "analyzing" steps "can be accomplished by mere inspection alone." Thus, the Court's ruling is instructive as to how such claims might be drafted to preserve validity. 

While the Court's decision in Myriad provides some clarity for the biotechnology industry, this ruling may well be subject to further review, given the similarity of Myriad's method claims to those in Prometheus Labs., Inc. v. Mayo Collaborative Servs., 628 F.3d 1347, 1359 (Fed. Cir. 2010), cert. granted, 79 U.S.L.W. 3554 (U.S. Jun. 20, 2011) (No. 10-1150) (certiorari granted to consider whether the claims contain patent-eligible subject matter). Whether Myriad provides the final word on these types of claims, then, remains to be seen.