Abbott Labs had one of those days. The Court of Appeals for the Federal Circuit affirmed the District Court’s finding that Abbott infringed Innogenetics’ patented Hepatitis C Virus genotyping technology, U.S. Patent No. 5,846,704.

The Federal Circuit did reverse and remande the earlier judgment that claim 1 of the ‘704 patent was not anticipated by U.S. Patent No. 5,580,718 (the Resnick patent). The Federal Circuit also upheld the jury’s finding that Abbott has to cough up $10 million in damages to the Belgian biotech company as well as sanctions for making a baseless claim against Innogenetics.

The technology in this case pertains to diagnostic tools that detect and 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.  Abbott’s genotyping assay kits also involve specifically hybridizing probes to the nucleic acids of the HCV’s 5’ UTR.

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 s pecifically hybridizes to the domain extending from the nucleotides at positions -291 to -66 of the 5′ untranslated region of the HCV.

The district court granted Innogenetics’ motion to exclude 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. Abbott never moved for correction or reconsideration of the written order.

In a footnote, the CAFC took the Abbott team to task noting:

This case aptly demonstrates the pitfalls of playing fast and loose with rules of discovery. Conclusory expert reports, eleventh hour disclosures, and attempts to proffer expert testimony without compliance with Rule 26 violate both the rules and principles of discovery, and the obligations lawyers have to the court. Exclusion and forfeiture are appropriate consequences to avoid repeated occurrences of such manipulation of the litigation process.

The jury concluded that claim 1 of the ‘704 patent was not anticipated and awarded $7 million in damages to Innogenetics plus found Abbott’s infringement to be willful.

The Federal Circuit also did not buy Abbott’s defense that Realtime PCR was not known to the ordinary artisan at the time of the filing of the ‘704 patent application:

[T]he district court deemed this issue forfeited because Abbott “did not raise this issue before trial when it could have been given thorough consideration. Instead it raised the issue for the first time at 9:30 p.m. on the night before the start of trial and did so simply by submitting a proposed jury instruction, rather than by bringing the matter directly to the attention of the court and opposing counsel.”

Absent extraordinary circumstances, the Seventh Circuit has stated that it rarely reaches forfeited arguments in civil litigation. Ocean Atl. Dev. Corp. v. Aurora Christian Sch., Inc., 322 F.3d 983, 1005 (7th Cir. 2003). Abbott’s belief that “there was no need to raise [its argument] prior to the court adopting a claim construction not proposed by either party” falls well short of extraordinary.

It should be noted that, forfeiture aside, Abbott’s argument lacks merit. Essentially, Abbott argues that a patent can never be literally infringed by embodiments that did not exist at the time of filing. Our case law allows for after-arising technology to be captured within the literal scope of valid claims that are drafted broadly enough. See SuperGuide Corp. v. DirecTV Enters., Inc., 358 F.3d 870, 878-80 (Fed. Cir. 2004) (finding that the claim limitation “regularly received television signal” is broad enough to encompass digital signals even though no televisions that could receive digital signals existed as of the filing date).

It also didn’t help that Abbott itself has put in evidence that Realtime PCR did exist by the time the inventors filed their PCT application in 1992. In his expert report, Abbott’s witness stated that “Realtime PCR using 5′ to 3′ exonuclease activity was pioneered around 1991 .. . .”


Because two of the three claims found to be infringed are unaffected by this ruling, this reversal will not affect either the determination that Abbott infringed Innogenetics’ HCV genotyping patent or the jury’s determination that Abbott must pay damages for its infringement.

See Innogenetics v. Abbott Laboratories, United States Court of Appeals for the Federal Circuit (07-1145).

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