Prenatal Testing Firms Take IP Fight to Federal Circuit

, The Recorder

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SAN FRANCISCO — Trouble is brewing for Sequenom as the biotech company tries to revive a prenatal testing patent that U.S. District Judge Susan Illston pronounced dead last fall.

San Diego-based Sequenom Inc. filed a 15-page motion with the U.S. Court of Appeals for the Federal Circuit in January, asking the court to take judicial notice of several scientific facts that it says are uncontested. Sequenom's opponents fired back Feb. 3, saying the facts are indeed contested and that Sequenom is trying to cover up its failure to develop a full pretrial record.

"Sequenom should not now be permitted to use the doctrine of judicial notice to belatedly correct here what it apparently views as its own mistake below," write counsel for Ariosa Diagnostics and fellow appellees Natera and Verinata Health.

The facts at issue could be critical—Illston has described the case as a close call. It turns on Section 101 patent eligibility, an issue currently in play at the U.S. Supreme Court. And the stakes are high, involving a blood test administered to more than 150,000 pregnant women since its 2012 commercial launch.

Sequenom says it patented the use of cell-free fetal DNA in maternal blood to screen for genetic disorders. It accuses Ariosa of infringing with its Harmony Prenatal Test that is marketed as a less invasive alternative to procedures like amniocentesis. Illston granted summary judgment to Ariosa last fall, ruling that the patent combined the discovery of a non-patentable law of nature with conventional scientific methods. Sequenom's stock price dropped 22 percent the following day.

On appeal Sequenom renews one of the arguments it made before Illston, that its patent is similar to a claim the Supreme Court appeared to endorse in its landmark DNA decision Association for Molecular Pathology v. Myriad Genetics. Illston rejected the argument in part because Sequenom admitted no evidence that Myriad's gene probe technology was based on conventional testing methods, like Sequenom's.

Sequenom is now asking the Federal Circuit to take judicial notice of Myriad's 1990 patent, and the "fact" that the technology supporting it was already well-established, "as stated in the 1989 editions of two leading molecular biology treatises."

The Federal Circuit has taken judicial notice of facts from scientific treatises in the past, Kaye Scholer partner Michael Malacek writes on behalf of Sequenom, and has regularly cited one of the 1989 treatises, Molecular Biology of the Cell, in its opinions. "There is no dispute about the accuracy of the content of the treatises or their authority in the field," Malacek writes.

Requests for judicial notice are often mundane affairs that generate little opposition. Not so in this case. "Sequenom's judicial notice request is an ill-conceived attempt to try to plug fatal gaps in the record far too late in the litigation process," states a response signed by Weil, Gotshal & Manges partner Edward Reines; Bartko, Zankel, Bunzel & Miller partner W. Paul Schuck and Irell & Manella partner David Gindler.

"Sequenom's counsel should not be permitted to present technical contentions as 'undisputed facts' that it merely derives from a range of treatises of its own selection," they contend.

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