In A Fetal Genetic Test Case, Court Provides Additional Guidance To Address Traditional Equitable Factors For A Preliminary Injunction


In Aria Diagnostics, Inc. v. Sequenom, Inc., No. 12-1531 (Fed. Cir. Aug. 9, 2013), the Federal Circuit vacated and remanded the district court's decision denying a preliminary injunction against Aria Diagnostics, Inc., now know as Ariosa Diagnostics, Inc. ("Ariosa"), holding that the district court incorrectly interpreted the asserted claims and improperly balanced factors regarding issuance of a preliminary injunction.

U.S. Patent No. 6,258,540 ("the '540 patent") is owned by Isis Innovation Limited ("Isis") and exclusively licensed to Sequenom, Inc. ("Sequenom"). The '540 patent claims methods to detect fetal genetic characteristics by analyzing non-nucleated free floating fetal DNA ("cffDNA") obtained from a maternal blood sample. Ariosa filed a DJ action against Sequenom seeking a declaration that its Harmony test did not infringe the '540 patent. Sequenom counterclaimed for infringement and moved for a preliminary injunction to prevent Ariosa from making, using, or selling its Harmony test. The district court denied Sequenom's motion, and Sequenom appealed.

On appeal, the parties disputed the proper standard of review for claim construction in the context of a preliminary injunction. The Federal Circuit noted that it recognized some flexibility on that point, but that even under a more relaxed standard, the district court erred in its claim construction, and as a consequence, erred in finding a substantial question of noninfringement.

"While the facts may show that damages would be reparable, this assumption is not sufficient. In the face of that kind of universal assumption, patents would lose their character as an exclusive right as articulated by the Constitution and become at best a judicially imposed and monitored compulsory license." Slip op. at 13.

The Court reviewed the district court's construction of the terms "paternally inherited nucleic acid" and "amplifying" in the claims. The district court construed "paternally inherited nucleic acid" to mean "DNA sequence known [in advance] to be received only from the father which is not possessed by the mother." Slip op. at 5 (alteration in original) (citation omitted). The Federal Circuit held that this construction was incorrect, noting that the term did not incorporate any inherent meaning about the timing or method of detecting the paternal characteristic. Under the district court's construction, however, infringement could only occur after a user knows the father's...

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