Sequenom to Petition U.S. Supreme Court to Regain MaterniT21 Test Patent

With its sales and margins suffering unrelenting pressure, the beleaguered molecular testing firm Sequenom has decided to petition the United States Supreme Court in an attempt to regain a patent for a genetic test it lost three years ago.

The petition is centered around what has been referred to in laboratory circles as the “540 patent,” in reference to the last three numbers of a patent Sequenom held until 2013 that it applied to its MaterniT21 test. That assay is used to analyze cellfree fetal DNA (cffDNA) in a mother’s blood to diagnose genetic conditions. Sequenom had claimed that Ariosa Diagnostics’ Harmony Prenatal Test and Natera’s Non-Invasive Paternity Test (licensed to DNA Diagnostics Center, Inc.) infringed the ‘540 patent. Last year in June, the Federal Circuit Court of Appeals affirmed a ruling that Sequenom’s ‘540 patent relating to cffDNA failed to assert claims that were patent eligible. The appellate court said it was bound by a prior decision in the Mayo Collaborative Services v. Prometheus Laboratories, Inc. Judge Richard Linn, an appointee of President Bill Clinton, said he only went along with the majority because of the sweep of the Prometheus case, suggesting that some guidance as to how it should be applied in the future may be in order.

In the Prometheus case, the U.S. Supreme Court invalidated two patents held by Prometheus Laboratories. Those patents, which used metabolite levels in the blood-stream to guide the dosage levels of certain drugs, merely described a law of nature. The rationale in that case was applied by the courts to invalidate patenting the use of cffDNA for genetic profiling the following year, as the phenomenon was considered to be naturally occurring. Sequenom’s patent didn’t claim patent eligibility for discovery of cffDNA but for the methods that used the cffDNA. The appellate court’s June 2015 decision explained that Sequenom’s patent claims addressed a natural phenomenon used “in combination with well-understood, routine and conventional activity” that wasn’t patentable subject matter. The court explained that “groundbreaking, innovative or even brilliant discovery” wasn’t necessarily patentable. In December, the appellate court denied Sequenom’s request for a rehearing. However, one dissenting judge, Pauline Newman, an appointee of President Ronald Reagan, observed that “the new diagnostic method here is novel and unforeseen, and is of profound public benefit” and claimed that “[p]recedent does not require that all discoveries of natural phenomena or their application in new ways or for new uses are ineligible for patenting; the Court has cautioned against such generalizations.”

As a result, Sequenom is essentially asking the High Court to narrow the scenarios in which the rationale from Prometheus may be applied, stating “overly-expansive patent eligibility criteria have not only negatively impacted Sequenom’s patent, but have put into jeopardy the patentability of existing and future diagnostic method patent claims.”

“We continue to believe that the groundbreaking techniques embodied in the ‘540 patent are eligible for patent protection,” said Sequenom Chief Executive Officer Dirk van den Boom, in a statement. “More broadly, we believe our case provides a compelling opportunity for the Supreme Court to clarify patent eligibility criteria to protect the significant investments made by Sequenom and other life science organizations that have undoubtedly advanced the standard of patient care and treatment, as well as encouraging future such investments.”

Whether or not the Supreme Court would take the case remains to be seen; it only grants hearings for a tiny minority of petitions that are presented. A 2013 case it decided, Association for Molecular Pathology v. Myriad Genetics, invalidated a patent Myriad tested for the BRCA gene, suggesting that it is likely to hew to a fairly narrow path as to what kind of testing is patentable.

Takeaway: Sequenom is taking a last-ditch approach with the U.S. Supreme Court in an attempt to gain more market control over its cell-free fetal DNA assays.