Injunction, damages, infringement and invalidity decisions regarding Illumina’s fetal testing patents affirmed

Verinata Health, Inc., Illumina, Inc. v. Ariosa Diagnostics, Inc., Roche Mol. Sys., Inc.
Docket No. 22018-2198, -2303, -2305, -2306, -2317
April 24, 2020 (Non-precedential)

Brief Summary: DC denial of injunction and damages, as well as its refusal to grant JMOL of noninfringement and invalidity, affirmed.

Summary: Illumina appealed the DC denial of permanent injunction and damages issues and Ariosa cross-appealed the DC denial of its motion for a judgment as a matter of law (JMOL) on noninfringement (regarding Ariosa’s Harmony Prenatal Test, versions 1 and 2 (V1, V2)) and invalidity (anticipation, enablement). Illumina’s disputed US 7,955,794 directed to “[a] multiplex for determining whether a sample contains at least 100 different target sequences” by amplifying probes and detecting the resultant amplicons. Verinata’s (an Illumina subsidiary) US 8,318,430 disputed patent is directed to “[a] method for determining a presence of absence of a fetal aneuploidy in a fetus for each of a plurality of maternal blood samples…comprising fetal and maternal cell-free genomic DNA” (NIPT screening). Ariosa argued its tests did not infringe the ‘794 claims literally or under the doctrine of equivalents (DOE) (e.g., “the differences between the claimed amplicons and Ariosa’s readout cassettes are substantial”, “Illumina failed to prove that immobilizing and detecting readout cassettes leads to insubstantially different results from immobilizing and detecting amplicons”), but the FC panel disagreed (e.g., “fails to demonstrate that a reasonable jury could not find infringement under the” DOE, expert testimony “constitutes evidence that a reasonable mind could accept as proving infringement under the” DOE). The DC found that Ariosa was barred from challenging the validity of the ‘794 patent because of assignor estoppel but the FC panel did not reach the issue because it agreed with the DC/jury finding of no invalidity for anticipation (declining “to reweigh the credibility of the parties’ respective expert witnesses” (Impax Labs., FC 2018), concluding jury verdict to be supported by substantial evidence (i4i Ltd., FC 2010)). Ariosa argued the ‘430 patent is not enabled because it “fails to disclose an algorithm for determining the presence or absence of a fetal aneuploidy in the context of a targeted sequencing approach as claimed in claim 1, step (f)”. Ariosa agreed “that the ‘430 patent incorporates by reference disclosures of ‘[m]ethods for determining fetal aneuploidy using random sequencing techniques’” but argued “that a skilled artisan would not be able to adapt those…into non-random sequencing data without undue experimentation”, relying on inventor testimony. The FC panel disagreed, however, finding Illumina’s expert testimony to be that which “a reasonable mind might accept” to show enablement by the specification (Hybritech, FC 1986). The FC panel also found that the DC did not abuse its discretion in denying Illumina’s request for injunctive relief (four-factor eBay test (US 2006)), supplemental damages, and pre-judgment interest (Nichia, FC 2017). The FC panel explained that Illumina had not shown irreparable harm (ActiveVideo Networks (FC 2012) (indirect competition causes “[s]traight-forward monetary harm” “certainly not irreparable”)). The FC panel also found no error with the DC’s choice to consider supplemental damages after this appeal was resolved. The DC decision was therefore affirmed.

This entry was posted in Anticipation (35 USC 102), Doctrine of equivalents, Enablement, Infringement, Software. Bookmark the permalink.

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