A court has upheld a verdict that Abbott Laboratories infringed Innogenetics’ U.S. Patent No. 5,846,704, which claims a method of genotyping the Hepatitis C Virus (“HCV”) by specifically hybridizing probes to a particular region of the HCV genome known as the 5 prime untranslated region (5′ UTR). The speed and relative inexpensiveness of the method disclosed in the patent make it possible for clinicians to learn quickly what particular genotype of HCV virus has infected their patient and thus, what antiviral medications will be most effective.

Hepatitis C viruses (HCV) are a family of positive-stranded, enveloped RNA viruses causing the majority of non-A, non-B (NANB) hepatitis. The ‘704 patent claims:

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.

The asserted novelty of the ‘704 patent is its disclosure of a method of gentotyping the HCV present in a particular biological sample. Although other researchers had developed methods of detecting HCV in the 5′ UTR, this assay can distinguish among different types and subtypes of HCV in a sample, using probes that hybridize specifically to the 5′ UTR of the HCV genome. This is a region of the HCV nucleic acid that other scientists knew could be used to detect the presence of HCV but had not realized could be used to determine and classify different HCV genotypes.

Abbott has been selling HCV genotyping assays that practice the method claimed in the ‘704 patent but do so using real-time polymerase chain reaction (PCR), a technology that it asserted was not covered by the ‘704 patent. Innogenetics obviously disagreed and filed suit.

On September 2, 2006, a jury returned a unanimous verdict for Innogenetics that the ‘704 patent was valid and the court has now determined damages and whether the infringement had been willful.

Now, the court has concluded that Abbott has not shown that it is entitled to a new trial on the issues of infringement or invalidity or to judgment as a matter of law on the issue of damages but that it is entitled to judgment as a matter of law on the issue of willful infringement. The court noted that:

Defendant conceded at the start of trial that it had no evidence to defeat plaintiff’s claim of infringement other than what was before the court on defendant’s motion for summary judgment, which I found insufficient to defeat the claim. Defendant conceded that it would be unable to prove obviousness to the jury in light of the court’s rulings and it failed to adduce sufficient evidence to persuade the jury that plaintiff’s ‘704 patent was invalid because it had been anticipated by the prior art. As to damages, plaintiff adduced sufficient evidence to support the jury’s award of $7,000,000 in damages. On the issue of willful infringement, however, plaintiff’s evidence was not sufficient to allow a reasonable jury to find that defendant acted willfully when it developed and sold its infringing products. Defendant is not entitled to a new trial on damages pursuant to Rule 60(b)(2) or (3) because it has not shown that plaintiff obtained its jury verdict through fraud or that newly discovered evidence would affect the outcome of the trial.

See related materials here: Innogenetics Wins $7 Million in HCV Patent Suit Against Abbott Labs

  Print This Post Print This Post  

Comments are closed.