Patentable Subject Matter Under Mayo – Will the Supreme Court Reconsider?

The Federal Circuit recently denied en banc rehearing of Ariosa Diagnostics, Inc. v. Sequenon, Inc.. The original panel decision is at 788 F.3d 1371, (Fed. Cir. Jun. 12, 2015).

In the original panel decision, Judges Linn, Wallach, and Reyna decided that the claims at issue were drawn to not- patentable subject matter under the Supreme Court’s framework set forth in Mayo v Prometheus because the claims comprise the application of known diagnostic steps to natural subject matter (maternal DNA). Judge Linn had filed a concurring opinion in which he agreed with the majority decision because it faithfully applied Mayo, but he thought that the invention at issue – applying known methods to previously discarded natural material – was deserving of patent protection. He would therefore call for a new framework by which to judge patentable subject matter.

Judge Linn is not alone in his call for a new framework.  Four additional judges on the Federal Circuit believe either that the invention at issue is deserving of patent protection even under the Mayo framework, or that the Mayo framework should be overhauled. With so many judges calling for a new framework or for clarity on how to apply Mayo, a grant of certiorari is certainly possible in this important case.

The claims at issue in Ariosa are drawn to methods for detecting paternally-inherited fetal DNA in maternal blood samples, and performing a prenatal diagnosis based on such DNA. The commercial embodiment of these claims has been recognized as a breakthrough in fetal diagnostics– even by the judges that held the invention not patentable – because it allows for earlier and less invasive testing than was previously possible.

Judge Lourie and Judge Moore wrote a concurring opinion, agreeing with the panel that the case had been correctly decided under Mayo, but explaining that the current standard foreclosed too many inventions, such as the one under discussion, from being patentable. These two judges explain that it is novel to apply known methods to this particular natural material, which had previously been considered useless. While not suggesting a new framework, their opinion concludes that “it is unsound to have a rule that takes inventions of this nature out of the realm of patent-eligibility on grounds that they only claim a natural phenomenon plus conventional steps.”

Judge Dyk wrote a second concurring opinion, explaining that, while he believed that Ariosa had been correctly decided under Mayo, he would set up a new framework to determine eligible subject matter for claims involving natural phenomena. He explained that the problem with many claims drawn to the discovery of natural phenomena is that they are drawn very broadly, and therefore, if upheld, would foreclose an entire area of science. But, he explained, “if the breadth of the claim is sufficiently limited to a specific application of the new law of nature discovered by the patent applicant and [actually] reduced to practice,” then the novelty of the discovery should be enough to supply the necessary inventive concept required for patentability.

Judge Newman dissented, explaining that the claims at issue are distinguishable from those in Mayo in that “the inventors are not claiming the scientific fact of the discovery of paternal DNA in the blood of a pregnant woman; they are claiming the discovery and development of a new diagnostic method.” Judge Newman would find these claims drawn to patentable subject matter.

Stay tuned to the Big Molecule Watch for updates in the evolving law on patentable subject matter.