By James R. Major, D.Phil.
What is patentable subject matter? Five years ago, many practicing U.S. patent attorneys might have said “anything under the sun that is made by man,” a quote from a 1980 U.S. Supreme Court decision. However, the Supreme Court recently decided Mayo Collaborative Services v. Prometheus Laboratories, Inc., holding that for patentable subject matter “one must do more than simply state [a] law of nature while adding the words ‘apply it.’” The reach of Prometheus was unclear until last week’s decision by the U.S. Court of Appeals for the Federal Circuit not to rehear an appeal in Ariosa Diagnostics, Inc. v. Sequenom, Inc.
The technology at issue in Ariosa was extremely simple. The patentees discovered was that pregnant women naturally carry fetal DNA in their bloodstream. The patent in Ariosa was challenged on the grounds that claims for detecting the DNA essentially recited a law of nature. The district court agreed with the challengers. The patent owner appealed the decision to a three-member panel of the Federal Circuit, who upheld the district court. We commented on this stage of proceedings in a previous issue of IP Law Update. But last week, the Federal Circuit decided not to review the panel’s decision.
The decision was not unanimous, however. One judge, for example, felt compelled to follow Supreme Court precedent, but was concerned that the decision would discourage innovation in the life sciences. Interestingly, one judge did not feel so compelled, arguing that the facts at issue in Ariosa were distinguishable from those in Prometheus.
So, why the concern? Because there was a feeling that the Federal Circuit would somehow limit the reach of Prometheus. It was felt that screening for numerous genetic defects based on a simple blood draw from a pregnant woman had to be patentable. But, the Federal Circuit, the nation’s “Patent Court” could not—or would not—rein in Prometheus. So, this valuable medical advance is not patentable subject matter in the United States.
The practical fallout from last week’s decision is difficult to predict. The patent owner may seek review of the panel’s decision by the Supreme Court. But, it seems unlikely that the Supreme Court will take-up the case, given the Federal Circuit’s decision not to review their own panel’s decision. So, the life sciences industry is left with two examples of what is not patentable subject matter—Prometheus and Ariosa—and no examples of what is patentable subject matter. What is required to navigate the rapids of Prometheus and Ariosa? Perhaps Prometheus’s decision saving grace is that adding “unconventional steps” to a “law of nature” may be sufficient for patentable subject matter. Alternatively, applicants may have to resort to a skillful blend of patent and administrative law.