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Recently, the U.S. Court of Appeals for the Federal Circuit issued a precedential opinion in Laboratory Corp. of America Holdings v. Qiagen Sciences, LLC (No. 23-2350) reversing a Delaware jury's infringement verdict in its entirety and ordering entry of judgment of non-infringement on two DNA-sequencing patents.
ArcherDX (later succeeded by Labcorp) sued Qiagen in 2018, alleging that several DNA-library-prep kits infringed U.S. Patent Nos. 10,017,810 and 10,450,597. A five-day jury trial in August 2021 ended with findings that Qiagen willfully infringed claims 16, 17, and 19 of the '810 patent under the doctrine of equivalents and literally infringed claims 1, 5, and 19 of the '597 patent. The jury awarded roughly $4.7 million in damages. Qiagen moved for JMOL of non-infringement and, in the alternative, for a new trial. The district court denied those motions in September 2022. Qiagen appealed.
The Federal Circuit reversed. On the doctrine of equivalents, the Court held that the district court improperly allowed the jury to interpret as a fact issue whether "identical" meant "identical to a portion." The Court explained this was an issue of claim construction, and that the claim language required that "the 'second target-specific primer' must be 'identical to a second sequencing primer,'" rather than to a portion thereof. The Court further held that no reasonable jury could have found infringement under the doctrine of equivalents. On literal infringement, the Court concluded that Qiagen's forward primer could not be a "target-specific primer" because it annealed only to an adaptor common to every fragment, not to the nucleic-acid sequence "to be analyzed," and therefore also amplified non-target molecules—contrary to the district court's claim construction. Because insufficient evidence supported infringement on either patent, the Court directed entry of judgment for Qiagen, rendering Qiagen's challenges pertaining to its invalidity counterclaims and the damages award moot.
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