Federal Circuit,  December 15, 2014m 2013-1011, 1029, 1376

In Promega Corp., the U.S. Court of Appeals for the Federal Circuit (CAFC) addressed whether Life Technologies had exceeded the scope of their license from Promega – and made infringing sales – and whether Promega’s asserted claims were invalid for lack of enablement.

Promega owns four of the five patents at issue, and is the exclusive licensee of the other (the “Tautz” Patent). The Patents relate to the amplification of regions (loci) of DNA containing short terminal repeats (STRs). Because the number of STRs at particular loci varies between individuals, analyzing multiple STR loci can provide a genetic fingerprint specific to an individual. The patents at issue, and Life Technologies’ kits, relate to the simultaneous testing of these different loci within the same reaction.

Life Technologies’ kits contained five different components, only one of which was manufactured in the U.S.; this component was exported to the U.K., where the kits were assembled and sold worldwide. Life Technologies had a license to use the five patents for forensic investigations conducted by law enforcement agencies. However, after Life Technologies purportedly began selling kits for other uses, Promega sued. Life Technologies argued that their sales were entirely within the scope of the license, but that in any event, Promega’s four patents were invalid for lack of enablement.

The Federal Circuit found that Promega’s asserted claims were not enabled for their full scope because they recited kits for amplifying regions of DNA “comprising” particular loci. Noting that Promega had repeatedly stated during prosecution (to overcome art rejections) that the addition of even one more loci made it highly unpredictable whether the detection method would still be operable, the court held that the claims were not enabled for the additional “unrecited” loci encompassed by the term “comprising.”

Additionally, at trial, the jury had found all of Life Technologies’ worldwide sales to be infringing sales, with those overseas sales found to infringe under 35 U.S.C. § 271(f)(1). The Federal Circuit addressed this infringement issue as it applied to the Tautz Patent, since Life Technologies did not challenge the validity of the Tautz Patent. Life Technologies argued that there could be no infringement under § 271(f)(1) as a matter of law because they shipped the component overseas to themselves; however, the court found this argument unavailing, finding that the term “actively induce” in § 271(f)(1) does not require the involvement of “another.”

Life Technologies also argued non-infringement (under § 271(f)(1)) because they only exported a single component from the U.S., whereas the kit of the Tautz Patent required five separate components. While acknowledging that the phrase “substantial portion of the components” in § 271(f)(1) could be construed to refer to amount, the court stated that it could also refer to importance or criticality; and in finding the exported component necessary for operation of the kit, found it to be a “substantial portion of the components” of the kit. In practical terms, and in the context of testing or diagnostic kits at least, it is probably safe to assume that each component is included for a reason and is important; therefore, under the court’s reasoning, it would seem that any portion might reasonably be considered a “substantial portion.”