Supreme Court Declines Certiorari in Landmark Case on Biotech Patentability, Preserving Victory for BartkoZankel Genetic Testing Clients

In a high-profile patent case, the Supreme Court has preserved a victory for BartkoZankel clients Natera, Inc. and DNA Diagnostics Center, Inc.  On June 27, 2016, the Supreme Court denied a petition for a writ of certiorari in Sequenom, Inc. v. Ariosa Diagnostics, et al. (Case No. 15-1182), declining to review the district court’s ruling that the patent-in-suit was invalid because its claims were not directed to patentable subject matter.  The case has been identified by many commentators as one of the most significant decisions in the area of patentability, with the widely-read patent law blog Patently-O observing that it “has significant long-term implications for patent-eligibility not only in biotechnology, but in other fields where invention is based primarily on discovery.”  To view blog entry, click here.

BartkoZankel’s clients Natera and its partner DNA Diagnostics Center, Inc. (DDC) offer pioneering prenatal screening technologies, including the Panorama® test.  Unlike earlier prenatal genetic tests requiring amniocentesis – an invasive procedure with a significant risk of complications – the Panorama® test requires only a small blood sample from the mother.  Natera, with its advanced bioinformatics, detects fetal DNA within the maternal bloodstream and provides a genetic report earlier in the pregnancy and with less risk to both the mother and the fetus.

Sequenom had alleged that Natera’s testing infringed U.S. Patent No. 6,258,540 (“the ‘540 Patent”).  The asserted claims of the ‘540 Patent related to the amplification and detection of cell-free fetal DNA (cffDNA) in a mother’s blood serum for diagnosis of a fetus.  In January 2012, Natera, and two other companies in the cffDNA testing market, sued Sequenom and ISIS Innovation Limited (an entity affiliated with Oxford University that owns the ‘540 Patent) for a declaration of non-infringement and patent invalidity.

In the district court, BartkoZankel argued that the patent-in-suit was an attempt to obtain a monopoly on a phenomenon of nature ‒ the presence of cffDNA in the mother’s blood serum.  The additional elements of the patent’s claims were nothing more than well-known procedures for amplifying and detecting any DNA that long predated the patent.  The district court agreed.  Northern District of California Judge Susan Illston ruled that the patent-in-suit was invalid because its claims were not directed to patentable subject matter under 35 U.S.C. § 101 and the Supreme Court’s Mayo Collaborative Services v. Prometheus Laboratories, Inc. (2014) decision.

In a consolidated appeal, the U.S. Court of Appeals for the Federal Circuit unanimously affirmed Judge Illston’s grant of summary judgment in Ariosa Diagnostics, Inc., et al. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015).  View a copy of the Decision.  The Federal Circuit subsequently denied a request for rehearing en banc, recognizing that current Supreme Court precedent required the result.  View a copy of the Order.

Sequenom then sought review by the United States Supreme Court.  Despite the submission of over 20 amicus curiae briefs in support of Sequenom’s petition, the Court elected not to review the Federal Circuit’s decision and denied Sequenom’s petition for a writ of certiorari without comment.  The Court’s decision exhausts Sequenom’s appeals and finalizes the ruling that the ‘540 Patent is invalid.

BartkoZankel’s Paul Schuck and Sony Barari represented Natera and DDC throughout the litigation.  Paul Schuck commented:  “We are pleased that the district court’s ruling of invalidity is now final. Natera and others in the field are now free to compete in the marketplace and to develop even more advanced and innovative testing products.  In addition, the decision brings greater clarity to the law for determining what is patentable.”