On June 27, 2016, the U.S. Supreme Court decided to review the Federal Circuit’s ruling of infringement under 35 U.S § 271(f)(1) based on supplying from the United States a component of a patented invention. This case may provide the Supreme Court’s view of whether and to what extent a single component may be “a substantial portion of the components of a patented invention” under § 271(f)(1).
The text of 35 U.S.C. § 271(f)(1) at issue here, which is directed to U.S. activity that leads to a combination of a patented invention abroad, states:
“Whoever without authority supplies or causes to be supplied in or from the United States all or a substantial portion of the components of a patented invention, where such components are uncombined in whole or in part, in such manner as to actively induce the combination of such components outside of the United States in a manner that would infringe the patent if such combination occurred within the United States, shall be liable as an infringer.” [35 U.S.C. § 271(f)(1)]
In this case, the Tautz patent claims a DNA processing kit that includes: (1) a mixture of primers; (2) a polymerizing enzyme (such as Taq polymerase; (3) nucleotides for forming replicated stand of DNA; (4) a buffer solution and (5) control DNA. The accused infringer LifeTech sells genetic testing kits that include a primer mix, a PCR reaction mix, a buffer solution, control DNA, and a polymerase (Taq), which is necessary for PCR amplification. LifeTech makes the Taq polymerase in the U.S., which it then ships to LifeTech’s U.K. facilities abroad to be included in genetic testing kits assembled abroad and sold throughout the world. A jury found that LifeTech infringed the Tautz patent under 35 U.S.C. § 271f)(1). The district court set aside that portion of the jury verdict, ruling that § 271(f)(1) liability requires providing more than one component.
On appeal, LifeTech argued that there was no infringement under § 271(f)(1) based on, among other things, (1) an argument that the statute requires supplying more than a single “component”, but that one must supply “components” and (2) supplying the single Taq component did not constitute supplying “a substantial portion of the components of a patented invention.” The Federal Circuit disagreed, and ruled that substantial evidence supports the jury’s infringement finding, stating:
Claim 42 of the Tautz patent recites five components: a primer mix, a polymerizing enzyme (such as Taq polymerase), nucleotides, a buffer solution, and control DNA. LifeTech’s domestic arm supplies the Taq polymerase to its facility in the United Kingdom, which both manufactures the remaining four components and assembles all the components into the accused STR kits. Taq polymerase is an enzyme used to amplify the DNA sequences in order to obtain enough replicate sample for testing. Without Taq polymerase, the genetic testing kit recited in the Tautz patent would be inoperable because no PCR could occur. LifeTech’s own witness admitted that the Taq polymerase is one of the “main” and “major” components of the accused kits. In short, there is evidence in the record to support the jury’s finding that a polymerase such as Taq is a “substantial portion” of the patented invention. [Promega v. Life Tech, 773 F.3d 1338, 1356 (Fed. Cir. 2014)]
The Supreme Court granted review of this portion of the Federal Circuit’s decision, limiting review to the second question presented in the certiorari petition:
2. Whether the Federal Circuit erred in holding that supplying a single, commodity component of a multi-component invention from the United States is an infringing act under 35 U.S.C. § 271(f)(1), exposing the manufacturer to liability for all worldwide sales.
The Supreme Court did not grant certiorari on the first question presented in the petition, which concerned whether LifeTech’s supplying a component made in the U.S. to LifeTech’s facilities abroad could constitute active inducement under § 271(1)(f)–i.e., whether a single entity can actively induce itself.
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