October 22, 2019

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Statute Intended to Close Deepsouth Loophole Given Broad Interpretation: Promega Corp. v. Life Techs. Corp.

Addressing the requirements of infringement based on extraterritorial combinations of components, the U.S. Court of Appeals for the Federal Circuit reversed a lower court’s ruling of no infringement, finding that for a patent owner to prevail on a cause of action for active inducement, it is not necessary that a third party supply more than one component to the combination found to infringe under 35 U.S.C. § 271(f)(1), even though the statute requires an infringer to “actively induce the combination” of the components of a patented invention.  The Court also found the claims of a second set of patents to be invalid for lack of enablement.  Promega Corp. v. Life Techs. Corp., Case Nos. 13-1011; -1029; -1376 (Fed. Cir., Dec. 15, 2014) (Chen, J.) (Prost, C.J., dissenting-in-part).

The asserted patents relate to DNA amplification kits.  Specifically, the kits amplify “short tandem repeats” (STR) found in the human genome at locations called STR loci.  Variations in the number of STRs across multiple different loci can be used to identify individuals based on their DNA “fingerprint.”  This is called STR profiling.  Although desirable, it is unpredictable whether multiple STR loci can be amplified simultaneously in a “multiplex” reaction; even a single additional loci can disrupt a previously successful multiplex.

Life Tech’s accused kit consisted of five components, including a primer mix that targets particular STR loci and Taq polymerase, the enzyme that amplifies the DNA.  Life Tech manufactures Taq polymerase in the United States and then ships it to its facility in the United Kingdom for incorporation into the accused product.  The accused products are sold worldwide, including in the United States.

The district court found Promega failed to present sufficient evidence to sustain a jury verdict of infringement under § 271(f)(1) because the statute requires involvement of an unrelated party and at least two components to be supplied from the United States.  Promega appealed.

The Federal Circuit, looking to the language and legislative history of the statute, concluded that in order to “actively induce the combination,” a patent owner is only required to show that the accused infringer have a specific intent that some actor combine the components of a patented invention outside the United States and that the “actor” can even be the accused infringer.  The Court also disagreed with the district court that a single component can never constitute a “substantial portion of the components of a patented invention.”  In the present case, the claims-at-issue recited the same five components found in Life Tech’s accused kits.  Because Taq polymerase is essential to the operation of the kits, the Court explained was a “substantial portion” of the patented invention.

Promega also asserted a second set of patents.  Some of these patent claims included the transitional phrase “a set of . . . loci . . . comprising” particular STR loci.  The district court construed these “comprising” claims broadly to cover any loci combination, regardless of the number of unrecited loci, as long as the recited loci were present.  The district court denied Life Tech’s motion for summary judgment of invalidity based on enablement, finding the claims need not enable the unrecited elements.  The Federal Circuit reversed, noting that during prosecution, and in defending validity in litigation, Promega repeatedly argued that the addition of even a single locus to an existing loci combination rendered that new loci combination patentable because of the complex and unpredictable nature of the technology.  The Court found the claims invalid for lack of enablement because in this field of technology, undue experimentation would have been required in order to practice the full scope of the claims.

The Court stated that the “comprising” term that doomed Promega’s patents appeared in the specific claim limitation listing combinations of successfully co-amplifying STR loci, not in the preamble.

In dissent, Judge Prost argued that the “actively induce” language in § 271(f) necessarily means inducement of another, i.e., not the accused infringer.

© 2019 McDermott Will & Emery


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