The U.S. Supreme Court ruled on Wednesday that the Federal Circuit erred in holding that shipment of a single component of a patented invention to be combined with others outside of the U.S. can be infringement under 35 U.S.C. § 271(f)(1). Rather, per the Court, multiple components must be shipped in order to infringe. In Life Technologies Corp. et al. v. Promega Corp. et al., case number 14-1538, the Court unanimously reversed the Federal Circuit’s 2014 ruling that Life Technologies Corp. was liable for infringing a Promega Corp. patent because it supplied a single enzyme to a facility in the United Kingdom that made DNA test kits that allegedly infringed Promega’s patents. The Court rejected the Federal Circuit’s conclusion that shipment of a single component of a multi-component invention is enough if that component is a sufficiently important part of the invention. Per Justice Sotomayor’s majority opinion: “When as in this case a product is made abroad and all components but a single commodity article are supplied from abroad, this activity is outside the scope of the statute.”
By way of background, the suit patent claimed a toolkit for genetic testing. The kit was used to take small samples of DNA and then synthesize multiple copies of a particular nucleotide sequence. This process of copying, known as amplification, generates DNA profiles that can be used by law enforcement agencies for forensic identification and by clinical and research institutions. For purposes of the litigation, the parties agree that the kit covered by the suit patent contained five components: (1) a mixture of primers that mark the part of the DNA strand to be copied; (2) nucleotides for forming replicated strands of DNA; (3) an enzyme known as Taq polymerase; (4) a buffer solution for the amplification; and (5) control DNA.
Promega was the exclusive licensee of the patent, and Life Technologies manufactured genetic testing kits. Promega sublicensed the patent to Life Technologies for the manufacture and sale of the kits for use in certain licensed law enforcement fields worldwide. Life Technologies manufactured all but one component of the kits in the United Kingdom. It manufactured that component—the Taq polymerase—in the United States. Life Technologies shipped the Taq polymerase to its United Kingdom facility, where it was combined with the other four components of the kit.
Four years into the agreement, Promega sued Life Technologies on the grounds that Life Technologies had infringed the patent by selling the kits outside the licensed fields of use to clinical and research markets. Promega alleged that Life Technologies’ supply of the Taq polymerase from the U.S. to its U.K. manufacturing facilities triggered liability under §271(f)(1). The jury returned a verdict for Promega. Life Technologies then moved for judgment as a matter of law, contending that §271(f )(1) did not apply to its conduct because the statutory phrase “all or a substantial portion” does not encompass the supply of a single component of a multicomponent invention. The district court granted Life Technologies’ motion since the evidence “showed at most that one component of all of the accused products, [the Taq] polymerase, was supplied from the United States.” The Federal Circuit reversed and reinstated the jury’s verdict of infringement, holding that “there are circumstances in which 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.” The Federal Circuit concluded that the dictionary definition of “substantial” is “important” or “essential,” which it read to suggest that a single important component can be a “‘substantial portion of the components’” of a patented invention.
The Supreme Court granted certiorari to address the question of whether the supply of a single component of a multi-component invention is an infringing act under 35 U. S. C. §271(f )(1). The Court held that it is not.
35 U. S. C. §271(f )(1) reads (emphasis added):
“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.”
The Court first determined, as a threshold matter, that §271(f)(1)’s requirement of “a substantial portion” of the components of a patented invention refers to a quantitative measurement, not a qualitative one. The Court then addressed whether, as a matter of law, a single component can ever constitute a “substantial portion” so as to trigger liability under §271(f )(1). Per the Court, “[t]he answer is no.” The Court noted §271(f)(1)’s consistent reference to “components” in the plural, saying that §271(f)(1) is targeted toward the supply of all or a substantial portion “of the components,” where “such components” are uncombined, in a manner that actively induces the combination of “such components” outside the United States. Thus, the text of the statute indicates that multiple components constitute the substantial portion. The Court referenced §271(f)(2), which reads:
“Whoever without authority supplies or causes to be supplied in or from the United States any component of a patented invention that is especially made or especially adapted for use in the invention and not a staple article or commodity of commerce suitable for substantial non-infringing use, where such component is uncombined in whole or in part, knowing that such component is so made or adapted and intending that such component will be combined 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.”
The Court noted that, whereas §271(f)(1) refers to “components,” plural, §271(f)(2) refers to “any component,” singular. And, whereas §271(f)(1) speaks to whether the components supplied by a party constitute a substantial portion of the components, §271(f)(2) speaks to whether a party has supplied “any” non-commodity component “especially made or especially adapted for use in the invention.”
The Court rejected the Federal Circuit’s observation that §§271(f)(1) and (2) concern different scenarios. Rather, the Court said that “[r]eading§271(f)(1) to cover any single component would not only leave little room for §271(f)(2), but would also undermine §271(f)(2)’s express reference to a single component ‘especially made or especially adapted for use in the invention.’”
The Court said:
Taken alone, §271(f)(1)’s reference to “components” might plausibly be read to encompass “component” in the singular…. But §271(f)’s text, context, and structure leave us to conclude that when Congress said “components,” plural, it meant plural, and when it said “component,” singular, it meant singular.
The Court declined to define how close to “all” of the components “a substantial portion” must be, holding only that one component does not constitute “all or a substantial portion” of a multi-component invention under §271(f )(1).