Creative Representation | Expert Litigation

Federal Circuit Affirms Grant of Declaratory Judgment Obtained by BartkoZankel in High Profile Non-Invasive Prenatal Genetic Testing Patent Case

June 12, 2015

The U.S. Court of Appeals for the Federal Circuit affirmed the Northern District’s grant of summary judgment in favor of BartkoZankel’s clients Natera, Inc. and DNA Diagnostics, Corp. in Natera v. Sequenom, Inc.  In a consolidated appeal, the Federal Circuit upheld the ruling of District Court Judge Susan Illston that the patent-in-suit is invalid because its claims are not directed to patentable subject matter under 35 U.S.C. § 101.  The widely-read patent law blog Patently-O stated that the case “has significant long-term implications for patent-eligibility not only in biotechnology, but in other fields where invention is based primarily on discovery.”

Natera and its laboratory partner DNA Diagnostics offer the Panorama® prenatal genetic test.  Unlike earlier prenatal genetic tests that require amniocentesis, Natera’s test uses a simple blood sample from the mother.  Natera, with its advanced bioinformatics, detects cell-free fetal DNA and provides a report with less risk to both the mother and the fetus.  Sequenom, Inc. had alleged that Natera’s test infringed the patent-in-suit.

In January 2012, Natera filed a declaratory judgment action seeking a ruling that Sequenom’s ‘540 Patent is not valid and not infringed by Natera.  Two other participants in the non-invasive prenatal testing market—Ariosa Diagnostics, Inc. and Verinata, Inc.—also filed declaratory judgment lawsuits regarding the ‘540 Patent.  The District Court consolidated the suits.  On summary judgment, Judge Illston ruled that the asserted claims of the ‘540 Patent are not directed to patentable subject matter under the Supreme Court’s Mayo Collaborative Services v. Prometheus Laboratories, Inc. (2014).  On appeal, the Federal Circuit panel unanimously agreed that the ‘540 Patent claims are not patent eligible.  (View a PDF copy of the Opinion.)

BartkoZankel’s Paul Schuck and Sony Barari represented Natera throughout the litigation.  Paul Schuck commented:  “We are pleased that the Federal Circuit confirmed Natera’s position that the patent-in-suit is not valid.  Natera is now free to compete in the marketplace and to develop even more advanced and innovative testing products.”  Additional coverage regarding the case can be found in the attached PDF.