In PROMEGA CORP. v. LIFE TECHNOLOGIES CORP., Appeal Nos. 2013-1011, -1029, and -1376, the Federal Circuit reversed the district court’s grant of the plaintiff’s motion for summary judgment that the asserted claims are not invalid for lack of enablement and reversed the district court’s grant of the defendant’s motion for JMOL of noninfringment under 35 U.S.C. § 271(f)(1).

Promega sued LifeTech for infringing four Promega patents and one Tautz patent relating to methods or kits for simultaneously determining the alleles present in a set of “short tandem repeats” (STR) loci from DNA samples. LifeTech manufactures one component of its genetic testing kits in the United States, which it ships overseas to its manufacturing facility in the United Kingdom for assembly.  The district court found the Promega patents enabled but, after trial, granted LifeTech’s motion for JMOL of noninfringement under § 271(f)(1).

The Federal Circuit reversed the district court’s finding of enablement.  The Federal Circuit concluded the unrecited STR loci combinations are part of the claim scope given the unpredictability of the field.  During prosecution, Promega argued the claims were patentable because the prior art did not disclose methods for evaluating the specific sets of STR loci recited in the claims, which was critical because the specific sets could not be determined without undue experimentation. Stating Promega cannot decide to “sing a different tune” for the purposes of infringement, the Federal Circuit held the Promega patents do not enable a skilled artisan to practice the full breadth of the claim scope without undue experimentation.

Regarding infringement of the Tautz patent, the Federal Circuit concluded Congress did not limit a company’s liability under § 271(f)(1) to shipping components overseas to third parties, but also included shipping components overseas to themselves or a foreign subsidiary. Additionally, the Federal Circuit held a party may be liable under § 271(f)(1) for supplying or causing to be supplied a single component for combination outside the United States when the component shipped is a “substantial portion” of the components of the accused products.  Accordingly, the Federal Circuit held LifeTech liable for infringement.