Innogenetics Wins $7 Million Judgment Against Abbott for Infringing HCV Genotyping Method
By Robert Dailey --
Judge Barbara Crabb, in an opinion
issued last week,
rejected all of Abbott's post-trial motions and upheld an earlier $7 million
verdict against its diagnostics division for infringing an Innogenetics patent.
Innogenetics owns U.S. Patent Number 5,846,704 (the '704 patent), which is
directed to methods of genotyping the hepatitis C virus (HCV) by hybridizing
probes to a particular region of the HCV genome. Claim 1 covers:
1. 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 HCV.
Abbott sells HCV genotyping assays that perform the
claimed method using Realtime PCR.
Abbott argued that its assay does not infringe the patent
because Realtime PCR is an after-arising technology that was not known when
Innogenetics filed its initial parent application in 1992. The court provides several reasons for
rejecting this argument. First, SuperGuide Corp. v. DirectTV Enterprises, Inc., 358 F.3d 870 (Fed. Cir. 2004), holds
that "[t]he law does not require that the applicant describe in his
specification every conceivable and possible future embodiment of his
invention." Nevertheless, the court
provides no basis for distinguishing SuperGuide from cases in which the Federal
Circuit has held that a claim fails the written description requirement when
the patentee attempts to sweep after-arising technology into the claim's scope. See Chiron Corp. v. Genentech, Inc., 363 F.3d 1247
(Fed. Cir. 2004). Second, Realtime PCR
was already known in the art by 1992 and, therefore, does not qualify as
after-arising technology. Third, Abbott
made this argument for the first time at 9:30 p.m. on the eve of the trial
while submitting its proposed jury instructions. This contradicted Abbott's earlier averments
that it had no further theories of non-infringement. (Consequently, Judge Crabb prevented Abbott
from presenting this argument at trial.)
Abbott also argued that the '704 patent was invalid
because it was anticipated by and obvious in light of prior art directed to
detecting HCV in the 5' untranslated region (UTR). But the Innogenetics method had not merely
dealt with detecting HCV in the 5' UTR; their patent also taught how to
distinguish among (i.e., classify) different types and subtypes of HCV in the
5' UTR.
Abbott's obviousness argument rested on a combination of
prior art references. Yet Abbott offered
the court nothing more than an expert's conclusory statements of
obviousness. The court held that an
expert must at least explain how and why the asserted combination of references
renders the patent obviousness.
Abbott's anticipation argument was rejected by a jury,
whose verdict has now been upheld. This
portion of Abbott's case seems to have failed in part because Abbott refused to
offer its primary witness (a trained expert and the author of the asserted
prior art reference) as an expert. As a
mere fact witness, he was prevented from giving any opinion-related testimony
in court connected to the technology at issue. Relying on Day v. Consolidated Rail Corp., 1996 WL 257654 (S.D.N.Y.
1996), the court held that Abbott's decision to offer its "expert" as
a non-expert did not exempt the witness from the report requirement of Rule
26(a)(2)(B). (The Rule requires
witnesses who give opinion-related testimony on scientific or technical matters
to submit reports to the court during pre-trial discovery.) This left Abbott with little evidence to
bring before the jury.
The jury's damage award of $7 million was upheld and the plaintiff's motion for treble damages was denied. Judge Crabb will issue a subsequent opinion regarding the plaintiff's request for a permanent injunction.
Innogenetics v. Abbott Labs., No. 05-C-0575-C (W.D. Wis.).
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