AMP v. USPTO ("The Myriad Case"): Status Quo on Gene Patents . . . For Now

The "Myriad Case" is the first decision to specifically address whether DNA isolated from its natural state is patentable subject matter. The Federal Circuit found that isolated DNA is patentable subject matter thereby reversing the decision of the district court. However, with regard to the subject matter patentability of isolated DNA, all three judges in the panel provided their own opinions. In this Analysis, Brian R. Dorn, Ph.D. discusses Association for Molecular Pathology v. U.S. Patent & Trademark Office, 653 F.3d 1329 (Fed. Cir. 2011) [enhanced version available to lexis.com subscribers / unenhanced version available from lexisONE Free Case Law]. He writes:

1. Subject Matter Patentability of Isolated DNA

     The highest profile aspect of this case was the issue of subject matter patentability for isolated DNA. The panel split two to one whether isolated DNA in general was patentable subject matter. In the majority decision, written by Judge Lourie, the court found that isolated DNA is patentable subject matter due to its distinctive structural characteristic. Judge Lourie focused on the breaking of bonds from its natural state: "it has been manipulated chemically so as to produce a molecule that is markedly different from that which exists in the body." Thus, the court viewed isolated DNA as a distinct chemical entity. The court also found that the informational content is irrelevant to the subject matter patentability of the composition, although the information content does inform obviousness questions. The court made the distinction between isolated DNA and purified DNA, reasoning that simple purification may not impart subject matter patentability whereas the characteristics of isolated DNA do impart subject matter patentability.

     Judge Moore concurred in the judgment of the court, but provided her own reasoning. Judge Moore also made a distinction between short and long strands of DNA. In regards to short strands of isolated DNA, Judge Moore agreed with Judge Lourie that the isolated nature of the DNA made it distinct from its natural state. Further, Judge Moore emphasized the difference in the utility of isolated DNA from DNA in its natural state. Specifically, she reasoned that isolated DNA possesses a new utility that natural DNA does not. For instance, the ability of the isolated DNA to be used in diagnostic testing is important. She explained: "Diagnostic testing . . . is not a natural utility . . . . The claimed DNA does not serve the ends of nature originally provided. Instead, the isolated DNA sequences have markedly different properties which are directly responsible for their new and significant utility."

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