Earlier today the United States Supreme Court denied certiorari to Sequenom, Inc., which will let stand a decision of the United States Court of Appeals for the Federal Circuit that ruled a truly revolutionary medical test to be patent ineligible.
The discovery at the heart of the innovation in question resulted in a test for detecting fetal genetic conditions in early pregnancy that avoided dangerous, invasive techniques that are potentially harmful to both the mother and the fetus. The Federal Circuit concluded that the discovery was “a significant contribution to the medical field,” but that did not matter insofar are patent eligibility is concerned.
The invention, which became embodied in U.S. Patent No. 6,258,540, claimed certain methods of using cffDNA. The patent teaches technicians to take a maternal blood sample, keep the non-cellular portion (which was “previously discarded as medical waste”), amplify the genetic material that only they had discovered was present, and identify paternally inherited sequences as a means of distinguishing fetal and maternal DNA. The claimed method does not preempt other demonstrated uses of cffDNA.
Judge Linn, who wrote a separate concurring opinion, explained that given the unnecessarily sweeping language of the Supreme Court’s decision in Mayo he was constrained to agree that the patent claims at issue were ineligible. Judge Linn explained that the Supreme Court lumped all post-solution conventional activity together as if it necessarily had to be qualitatively the same. Judge Linn wrote:
The Supreme Court’s blanket dismissal of conventional post-solution steps leaves no room to distinguish Mayo from this case, even though here no one was amplifying and detecting paternally-inherited cffDNA using the plasma or serum of pregnant mothers. Indeed, the maternal plasma used to be “routinely discarded,” because, as Dr. Evans testified, “nobody thought that fetal cell-free DNA would be present.”
Judge Linn concluded “Sequenom’s invention is truly meritorious.”
In March 2016, Sequenom filed a Petition for Writ of Certiorari in the Supreme Court of the United States, challenging the decision of the United States Court of Appeals for the Federal Circuit in Ariosa Diagnostics, Inc. v. Sequenom, Inc. “We think that there is a compelling case for the Supreme Court to step in,” said Sequenom’s counsel Thomas Goldstein, the founder of the widely popular SCOTUS Blog, said at the time the Petition was filed. “The issue turns entirely on how to read the Court’s cases. The stakes could not be higher for the life sciences. And this is undoubtedly a breakthrough invention that illustrates the harm from the Federal Circuit’s ruling.”
The single question presented by Sequenom in the petition for certiorari denied by he Supreme Court was as follows:
Whether a novel method is patent-eligible where: (1) a researcher is the first to discover a natural phenomenon; (2) that unique knowledge motivates him to apply a new combination of known techniques to that discovery; and (3) he thereby achieves a previously impossible result without preempting other uses of the discovery?
If the Supreme Court were to have taken the case they would have been required to reconsider the overwhelming breadth and scope of their prior ruling in Mayo Collaborative Servs. v. Prometheus Labs. Obviously, the Supreme Court is not ready to reconsider Mayo.
For innovative companies in the life sciences space the only possible short-term relief will come from Congress if they choose to amend 35 U.S.C. § 101 to undo the damage done in recent years by the Supreme Court. Efforts within the industry have been underway on multiple levels to rally support for a legislative fix that would overrule the Supreme Court’s recent forays into patent eligibility, but time is short for the 114th Congress and the Obama Administration would simply not be receptive anyway. Perhaps a new year, a new Congress and a new President that will have a more pro-patent view than does President Obama will result in a different outlook. For now, the industry will continue to suffer the consequences of the Supreme Court’s ignorance on the issue of patent eligibility.