Aria Diagnostics, Inc. v. Sequenom, Inc., No. 12-1531 (Fed. Cir. 2013)
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Conventional tests for prenatal abnormalities caused by genetic abnormalities have relied on invasive and potentially risky techniques like amniocentesis to obtain fetal cells. As an alternative, scientists developed methods of analyzing DNA extracted from fetal cells floating in maternal blood to determine fetal abnormalities and other fetal traits. These methods require separating fluids from the cells and then discarding the fluids, either plasma or serum, and then separating fetal cells from the much more common maternal cells. The 540 patent discloses methods to identify fetal genetic defects by analyzing the fluid that had commonly been discarded as medical waste: maternal plasma or serum. The new tests presented fewer risks and a better rate of abnormality detection. Ariosa sought a declaratory judgment that it could use its Harmony test without infringing the 540 patent. The district court denied the patent holder’s motion for summary judgment. The Federal Circuit vacated and remanded, finding that the district court incorrectly interpreted the asserted claim terms “amplifying” and “paternally inherited nucleic acid” and improperly balanced factors regarding issuance of a preliminary injunction.
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