Innogenetics, N.V. v. Abbott Laboratories

Decision Date17 January 2008
Docket NumberNo. 2007-1161.,No. 2007-1145.,2007-1145.,2007-1161.
Citation512 F.3d 1363
PartiesINNOGENETICS, N.V., Plaintiff-Cross Appellant, v. ABBOTT LABORATORIES, Defendant-Appellant.
CourtU.S. Court of Appeals — Federal Circuit

John S. Skilton, Heller Ehrman LLP, of Madison, Wisconsin, argued for plaintiff-cross appellant. With him on the brief were Christopher G. Hanewicz, David L. Anstaett, and Randy J. Kozel; and Shannon M. Bloodworth, of Washington, DC. Of counsel on the brief was Colin G. Sandercock, Proskauer Rose LLP, of Washington, DC. Of counsel was Sarah C. Walkenhorst.

Adrian M. Pruetz, Pruetz Law Group LLP, of Manhattan Beach, California, argued for defendant-appellant. With him on the brief was Erica J. Pruetz. Of counsel on the brief was Scott B. Kidman, Quinn Emanuel Urquhart Oliver & Hedges LLP, of Los Angeles, California.

Before BRYSON, Circuit Judge, CLEVENGER, Senior Circuit Judge, and MOORE, Circuit Judge.

MOORE, Circuit Judge.

Abbott Laboratories (Abbott) appeals on a multitude of grounds the judgment entered against it by the United States District Court for the Western District of Wisconsin for infringement of Innogenetics, N.V.'s (Innogenetics) U.S. Patent No. 5,846,704 (the '704 patent). We reverse and remand for a new trial the district court's judgment as a matter of law that claim 1 of the '704 patent was not anticipated by U.S. Patent No. 5,580,718 (the Resnick patent). We also vacate the permanent injunction granted against Abbott. As for the whole host of other issues that Abbott raises on appeal, we find no reversible error and affirm the lower court's judgment in those respects. Innogenetics cross-appeals the district court's judgment as a matter of law that Abbott's infringement was not willful. Under the standards recently articulated in In re Seagate Technology, LLC, 497 F.3d 1360 (Fed.Cir. 2007) (en banc), we also affirm that aspect of the lower court's judgment.

BACKGROUND

The technology in this case pertains to diagnostic tools that not only detect but also classify hepatitis C virus (HCV) genotypes in a biological sample, which facilitates tailoring the treatment of patients with different genotypes. The '704 patent claims a method of genotyping HCV based on distinct genetic sequences that can be found in the 5 prime untranslated region (5' UTR) of the HCV genome. This method teaches specifically hybridizing probes, or short strands of nucleic acids, to a target sequence in the 5' UTR via complementary base pairing principles, and then detecting the formation of any complexes formed between the probes and the nucleic acids of the 5' UTR.

Abbott's genotyping assay kits, like the method claimed in the '704 patent, also involve specifically hybridizing probes to the nucleic acids of the HCV's 5' UTR. The kits then detect the successful formation of any specifically hybridized complexes using the process of Realtime polymerase chain reaction (PCR). Through this process, dye molecules attached to Abbott's probes are released and observable as fluorescent signals after polymerase enzymes destroy the hybridized probe-target complexes.

Innogenetics sued Abbott, asserting that Abbott's genotyping assay kits infringe claims 1, 2, and 3 of the '704 patent. Claim 1, the only independent claim on appeal, reads in its entirety as follows: A method of genotyping HCV present in a biological sample comprising hybridizing nucleic acids in a biological sample with at least one probe and detecting a complex as formed with said probe and said nucleic acids of HCV, using a probe that specifically hybridizes to the domain extending from the nucleotides at positions -291 to -66 of the 5' untranslated region of the HCV.

'704 col.113 ll.1-7.

Abbott moved for summary judgment, asserting that its kits were not infringing, that the '704 patent was invalid, and that the '704 patent had been procured by inequitable conduct. In its order denying Abbott's motions, the district court construed the claim limitation "detecting a complex as formed" to mean "detecting a complex that is or has been formed." The district court also construed the limitation in the preamble, "method of genotyping," to mean "[a] method that distinguishes among types and/or subtypes of hepatitis C virus (HCV) and classifies the HCV into a genotype or subtype." On cross motions for summary judgment, the district court denied Abbott's motion and granted Innogenetics' motion, concluding that Abbott had failed to adduce sufficient evidence to require a trial on the issue of inequitable conduct. Furthermore, the district court deemed Abbott's inequitable conduct claim "exceptional" and awarded attorney's fees to Innogenetics.

At the final pre-trial conference, the district court granted Innogenetics' motion in limine and excluded testimony on obviousness by Abbott's witness, Dr. Patterson. However, the written order commemorating the conference rulings inaccurately stated that defendant was precluded from entering any evidence of obviousness at trial. Aware of the mistake, Abbott nonetheless never, moved for correction or reconsideration of the written order, noting only that it wished to preserve an objection on the issue. Additionally, the district court precluded the following evidence related to anticipation: 1) U.S. Patent No. 6,071,693 (the Cha patent) on the grounds that Abbott did not disclose the patent as an anticipating prior art reference until the last day of discovery and 2) any testimony beyond the actual words and content of the Cha PCT application from Dr. Cha, the inventor of the Cha patent and the Cha PCT application, on the grounds that he had not been tendered as an expert witness and that an expert report had not been submitted.

Because Abbott conceded that its entire noninfringement argument had been predicated on a construction of the claims that the court had not adopted, the district court entered judgment as a matter of law of literal infringement against Abbott for literal infringement of claims 1, 2, and 3 of the '704 patent. The case then proceeded to a bifurcated jury trial with only Abbott's affirmative defense, of anticipation tried during the liability phase. At trial, Abbott presented the international patent application for the invention claimed in the Cha patent and the testimony of its expert, Dr. Bruce Patterson, that the Resnick patent anticipated claim 1 of the '704 patent. However, before the case went to the jury, the district court granted judgment as a matter of law of no anticipation by the Resnick patent based on its determination that Dr. Patterson's testimony "rested on an inaccurate understanding of the construction of the limitation `genotyping.'" The jury concluded that claim 1 of the '704 patent was not anticipked.1 During the damages phase of trial, the jury awarded $7 million in damages to Innogenetics and found Abbott's infringement to be willful.

Post-trial, the district court denied Abbott's motion for a new trial on infringement, and invalidity and for judgment as a matter of law or a new trial on damages. However, the district court did grant Abbott's motion for judgment as a matter of law that infringement was not willful. The district court also granted Innogenetics' motion for a permanent injunction.

On appeal, Abbott challenges a myriad of issues, including the district court's claim construction, summary judgment of literal infringement, evidentiary exclusions as to. Abbott's obviousness and anticipation defenses, judgment as a matter of law that the Resnick patent did not anticipate claim 1 of the '704 patent, summary judgment of no inequitable conduct, award of attorney's fees to Innogenetics for Abbott's counterclaim of inequitable conduct due to its exceptionality, and grant of a permanent injunction. On cross-appeal, Innogenetics challenges the district court's judgment as a matter of law overturning the jury verdict of willful infringement. We address each of these issues in turn.

ANALYSIS
I. INFRINGEMENT
A. Claim Construction

We begin our inquiry with the district court's claim construction, which we review de novo. Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448, 1456 (Fed.Cir. 1998) (en banc). Abbott takes umbrage with the district court's construction of the two-letter word "as" from the claim limitation "detecting a complex as formed with said probe and said nucleic acids of HCV." According to Abbott, the word "as" limits the claims at issue to detecting hybridized complexes in a contemporaneous manner. Hence, Abbott asserts that its products are not encompassed by the '704 patent because they detect the formation of a hybridized complex through the observation of fluorescence emitted after the complex has been destroyed, and not the actual complex itself. We conclude that the claim language makes no such distinction. Abbott's proposed construction unduly limits the claims of the '704 patent by divorcing the word "as" from its full context, "as formed with said probe and said nucleic acids of HCV." The district court properly construed the claim limitation as detecting the formation of probe-target complexes, regardless of whether the method of detecting requires destroying the probe-target complex itself.

In determining the meaning of a disputed claim limitation, we look primarily to the intrinsic evidence of record, examining the claim language, the written description, and the prosecution history. Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed.Cir.2005) (en banc). Words of a claim "are generally given their ordinary and customary meaning" as understood by a person of ordinary skill in the art. Id. at 1312-13. Claims are read in view of the specification, which is the single best guide to the meaning of disputed terms. Id. at 1315. "In examining the specification for proper context, however, this court will not at any time import limitations from the specification into the claims." CollegeNet, Inc. v. ApplyYourself, Inc., 418 F.3d 1225, 1231 (Fed.Cir.2005) (c...

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