Sung on Biotechnology Patent Enforcement as Illustrated by Infringement Litigation on Hepatitis C Virus Genotyping: Innogenetics, N.V. v. Abbott Laboratories, 512 F.3d 1363 (Fed. Cir. Jan. 17, 2008)
Partner, Dewey & LeBoeuf LLP; Professor & Intellectual Property Law Program Director, University of Maryland School of Law
A biotechnology patent is often viewed as the poster child for a technically complex patent litigation. The subject matter tends to fill a room with uncommon acronyms (or, more precisely, initialisms) like DNA and RNA (for deoxyribonucleic acid and ribonucleic acid, respectively). The technology is usually invented by research scientists pedigreed with Ph.D.s and other indicia of advanced education or ingenuity. Accordingly, the person of ordinary skill in the art (the objective, hypothetical standard against which many patent law determinations are measured) is high with respect to a biotechnology invention. So what is so special about the enforcement of a biotechnology patent in infringement litigation? Lawrence M. Sung addresses the characteristics of such litigation that are shared with those of other technologies as well as the aspects that are unique to biotechnology patent litigation as illustrated by the case of Innogenetics, N.V. v. Abbott Laboratories. He writes:
In the Innogenetics case, the technology involved diagnostic tools that would detect and classify hepatitis C virus (HCV) genotypes in a biological sample. This would allow medical treatment that was tailored to patients with different genotypes. The patent at issue, U.S. Patent No. 5,846,704, claimed 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 taught 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.
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The Federal Circuit held that the district court did not err in finding that Dr. [Bruce] Patterson’s report on the alleged obviousness of the asserted claims of the ‘704 patent was deficient for purposes of disclosure under . . . [Federal Rule of Civil Procedure 26]. For each of the claims that he analyzed for obviousness, Dr. Patterson merely listed a number of prior art references and then concluded with the stock phrase “to one skilled in the art it would have been obvious to perform the genotyping method in [claims 1-9 & 12-13] of the ‘704 patent.” The Federal Circuit admonished that there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness. Nowhere did Dr. Patterson state how or why a person ordinarily skilled in the art would have found the claims of the ‘704 patent obvious in light of some combination of those particular references. . . . The Federal Circuit opined that such vague testimony would not have been helpful to a lay jury in avoiding the pitfalls of hindsight that belie a determination of obviousness.
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The Federal Circuit concluded that Innogenetics erroneously argued that a method of genotyping required identifying both the presence and the absence of types in a sample and thereby distinguishing among all six types of HCV. The Federal Circuit construed the method of genotyping limitation in claim 1 to cover a method capable of detecting and classifying at least one particular type of HCV without necessarily identifying the absence of all other types. In this respect, Dr. Patterson’s expert report and trial testimony were both consistent with the construction of “method of genotyping.” In his expert report, Dr. Patterson stated that . . . [U.S. Patent No. 5,580,718 (“the Resnick patent”)] was capable of detecting and classifying types of HCV. At trial, contradicting the testimony of Innogenetics’ witnesses, he testified that the Resnick patent distinguished between two groups of HCV, type 1 HCV and all other types of HCV. Dr. Patterson’s reading of the Resnick patent was that it disclosed a method capable of identifying whether a sample contained HCV type 1 as opposed to another type of HCV. If true, this would meet the “method of genotyping” limitation of claim 1. Dr. Patterson’s failure to track the district court’s exact words did not change the substance of his testimony or render it inapplicable. The Federal Circuit therefore found improper the district court’s preclusion of Dr. Patterson’s testimony on the basis that he was using a different definition of “method of genotyping.” Accordingly, the Federal Circuit reversed the district court’s entry of JMOL [judgment as a matter of law] and remanded for a new trial on the issue of whether the Resnick patent anticipated claim 1 of the ‘704 patent.