Federal Circuit refuses to rehear Sequenom
Washington DC | 03 December 2015

The Court of Appeals for the Federal Circuit has refused to rehear Ariosa v Sequenom, paving the way for the Supreme Court to clarify what constitutes ‘natural phenomena’ under US patent law.

Federal Circuit judges dismissed Sequenom’s bid of en banc rehearing of its defeat to Ariosa Diagnostics on 2 December, meaning that the appeals court’s June ruling stands.

In June, the Federal Circuit ruled that Ariosa’s Harmony test, used for prenatal diagnosis of certain foetal characteristics, did not infringe Sequenom’s method for determining cell-free foetal DNA (cffDNA) because the patent did not meet criteria established by the Supreme Court in Mayo v Prometheus.

Sequenom claimed in its petition for a rehearing that under the Federal Circuit’s reading of Mayo, a person who first discovers a natural phenomenon can never obtain a patent “unless the step [he or she] teaches to use it is independently novel”.

The company said in a statement: “Denial of the petition was considered as a necessary first step to having the case potentially heard on appeal by the Supreme Court of the US.”

The Federal Circuit’s decision to deny an en banc rehearing makes it likely that the Supreme Court will consider the case, according to Courtenay Brinckerhoff, partner at Foley & Lardner, because of the uncertainty that currently exists in medical diagnostics.

She says: “I think most innovators in the diagnostic space will want the Supreme Court to grant cert, and provide some guidance that permits new diagnostic methods to be patented even if they are implemented with conventional techniques.”

“Right now it is very difficult to obtain a US patent on a diagnostic method. While not impossible, most US Patent and Trademark Office examiners are only willing to grant somewhat specific claims that implement the inventive diagnostic method using specific techniques, while previously it was possible to obtain broader protection.”

“This is leading innovators to consider whether they should patent their inventions or retain them as trade secrets, and some are even considering whether they should continue investing in the development of certain types of diagnostic methods.”

In a concurring opinion rejecting an en banc rehearing, Judge Alan Lourie conceded that Mayo, as well as the Supreme Court’s Alice, Myriad and Bilski decisions, have failed to clarify the much-litigated patentability concepts in Section 101.

“Appellants and amici have argued before us in briefs that a broad range of claims of this sort appear to be in serious jeopardy. It is said that the whole category of diagnostic claims is at risk. It is also said that a crisis of patent law and medical innovation may be upon us, and there seems to be some truth in that concern,” wrote Judge Lourie.

“The claims in this case [Sequenom] perhaps should be in jeopardy, not because they recite natural laws or abstract ideas, but because they may be indefinite or too broad. But they should not be patent-ineligible on the ground that they set forth natural laws or are abstractions.”

Judge Timothy Dyk agreed in his own concurring opinion, explaining: “I share the concerns of some of my colleagues that a too restrictive test for patent eligibility under 35 USC §101 with respect to laws of nature (reflected in some of the language in Mayo) may discourage development and disclosure of new diagnostic and therapeutic methods in the life sciences, which are often driven by discovery of new natural laws and phenomena.”

“This leads me to think that some further illumination as to the scope of Mayo would be beneficial in one limited aspect. At the same time I think that we are bound by the language of Mayo, and any further guidance must come from the Supreme Court, not this court.”

Author: Mark Dugdale

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