Sequenom Loses Patent Dispute on Appeal

The Federal Circuit appeals court affirmed that Sequenom's Patent No. 6,258,540 (referred to as the '540 Patent) relating to cell-free fetal DNA (cffDNA) didn't assert claims that were patent eligible and was thus invalid. The decision confirms a trial court ruling that addresses a dispute between Sequenom and Ariosa Diagnostics, Inc., Natera Inc., and DNA Diagnostics Center, Inc. regarding alleged infringement of that patent. Sequenom's patent relates to its MaterniT21 test. Sequenom claimed Ariosa's Harmony Prenatal Test and Natera's Non-Invasive Paternity Test (licensed to DNA Diagnostics Center, Inc.) violated the '540 Patent. The trial and circuit appeals courts agreed that the patent claims addressed a natural phenomenon that wasn't patentable subject matter.

The dispute arises out of a discovery of cffDNA in maternal plasma and serum. Two doctors took pre-existing, known technologies and applied them to this new discovery for diagnostic purposes. Doing so could avoid more risky and invasive tests previously used prenatally. The '540 patent didn't claim patent eligibility for the cffDNA discovery but rather the methods for using that cffDNA. Relying on U.S. Supreme Court decisions regarding patentable subject matter in Mayo Collaborative Services v. Prometheus Laboratories, Inc. and Association for Molecular Pathology v. Myriad Genetics, the appeals court agreed with a trial court's finding of patent ineligibility, explaining the '540 Patent "focused on the use of a natural phenomenon in combination with well-understood, routine, and conventional activity"—that is, routine methods applied in using the cffDNA found in maternal plasma and serum.

The court acknowledged Sequenom's arguments that no one else was using maternal plasma or serum (which had typically been discarded) to find paternally-inherited cffDNA and that the discovery of cffDNA was a "significant human contribution" to the medical field. However, quoting the Supreme Court decision in Myriad, the court concluded that "'groundbreaking, innovative or even brilliant discovery'" and significant contributions to the medical field don't necessarily mean there is a patentable subject matter.

Ariosa Diagnostics, Inc. v. Sequenom, Inc., Fed. Cir., No. 2014-1139, No. 2014-1144, 6/12/15.

Takeaway: Looking to the Supreme Court's Mayo and Myriad decisions, another court has refused to uphold a patent linked to a naturally occurring phenomenon.