Written by Jeffrey C. Wu, Ph.D. and Brenden S. Gingrich, Ph.D.

I. Summary

The Supreme Court in Life Technologies Corp. v. Promega Corp. held that providing a single component of a multicomponent invention for manufacture abroad does not give rise to patent infringement liability under 35 U.S.C. § 271(f)(1).

II. Background

Promega sublicensed U.S. Reissue Patent No. RE 37,984 (“the Tautz patent”) to Life Technologies for the worldwide manufacture and sale of DNA amplification kits in particular fields of use. Life Technologies manufactured one of the five kit components, Taq polymerase, in the U.S. and shipped it to the UK, where the five components were combined. When Life Technologies began selling the kits outside the licensed fields of use, Promega sued Life Technologies under 35 U.S.C. § 271(f)(1). This provision states that a supplier who “supplies or causes to be supplied in or from the United States all or a substantial portion of the components of a patented invention” and actively induces the combination of such components outside the U.S. is liable for infringement.

Following a jury trial in which the District Court entered a judgment of non-infringement as a matter of law in favor of Life Technologies, Promega appealed to the Federal Circuit. On appeal, the Federal Circuit reversed and reinstated the jury’s verdict finding Life Technologies liable under § 271(f)(1). The Federal Circuit found that the dictionary definition of “substantial” is “important” or “essential,” and therefore held that a single important component, such as Taq polymerase in a DNA amplification kit, could be a “substantial portion” of the kit. Life Technologies then sought Supreme Court review of the Federal Circuit’s decision.

III. Supreme Court Review

In reviewing the Federal Circuit’s decision, the Supreme Court once again turned to the dictionary definition of “substantial,” finding that the term may refer either to “qualitative importance” or to “quantitatively large size.” In determining whether “qualitative importance” or “quantitative” size should prevail, the Court looked to the meaning of the surrounding terms. The Court held that “all” and “portion” convey a quantitative meaning - “all” referring to the entire quantity without reference to importance and “portion referring to a quantity less than ‘all.’” Based on this and additional linguistic evidence, the Court held that the proper statutory interpretation of “substantial” required a quantitative measurement, rejecting any qualitative assessment. Having found that “substantial portion” referred solely to a quantitative measurement, the Court held that a single component could never constitute a “substantial portion” of a multicomponent system.

IV. Remaining Questions

The Supreme Court’s decision left two key issues unresolved.

How Many Components are a “Substantial Portion”

The Supreme Court chose not to address what percentage of the quantitative number of components may make up a substantial portion. In a concurrence in part, Justice Alito stated: “today’s opinion establishes that more than one component is necessary, but does not address how much more.” However, relying on its decision that a single component can never meet the requirement of a “substantial portion,” it appears that a single component of a two component system cannot be a substantial portion. Therefore, a substantial portion must apparently be greater than 50% of the total components.

Determining the Number of Components

A second unresolved question by the Court relates to how the number of components is determined. Because the parties agreed that there were five components, the Court did not consider “how to identify the ‘components’ of a patented invention or whether and how that inquiry relates to the elements of a patent claim.” Nevertheless, based on the facts in this case, it appears that limiting the number of “components” when drafting patent claims may be an important consideration for infringement under § 271(f)(1). The more “components” there are in an invention, the more difficult it may be to demonstrate that the “substantial portion” of components requirement is met when alleging infringement under § 271(f)(1).