On February 22, 2017, the Supreme Court in Life Technologies Corp. Et. Al. v. Promega Corp., No. 14-1538, 2017 WL 685531, held that exporting a single component of a patented multicomponent invention from the U.S. for combination with other components for distribution and sales outside of the U.S. does not raise patent infringement liability under 35 U.S.C. § 271(f)(1). The Supreme Court reversed the Federal Circuit's decision that exporting a single important component of a patented multicomponent invention is substantial enough to invoke patent infringement under 35 U.S.C. § 271 (f)(1). 2017 WL 685531 at *1.
Under 35 U.S.C. § 271 (f)(1) of the Patent Act, “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.” (emphasis added).
At issue in this case is US Reissue Patent No. RE 37,984, which relates to a DNA genetic testing toolkit for use in law enforcement. The patented toolkit claims require 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. 2017 WL 685531 at *2. The dispute arose when the exclusive licensee, Promega Corp. (“Promega”), discovered that Life Technologies (“Life Tech”) began selling the toolkits for unlicensed uses. Life Tech manufactured four of the toolkit’s components in the United Kingdom, and only manufactured the Taq polymerase component in the U.S. before shipping it to its facility in the United Kingdom for assembly and distribution. 2017 WL 685531 at *3.
Promega sued Life Tech for patent infringement under § 271 (f)(1) claiming that Life Tech's supplying of the Taq polymerase from the United States constituted patent infringement because the Taq polymerase was a substantial portion of the patented multicomponent invention. Page 3. The District Court found that Life Tech’s supplying of a single component did not meet the “substantial portion” requirement of § 271(f)(1). 2017 WL 685531 at *4. Promega appealed, and the Federal Circuit reversed and reinstated the jury's verdict finding Life Tech liable for infringement. Id. The Federal Circuit relied on the dictionary definition that "substantial" means as "important" or "essential," and determined that the Taq polymerase component was a substantial component under § 271(f)(1), stating "there are circumstances in which a party may be liable under § 271 (f)(1) for suppling or causing to be supplied a single component for combination outside the United States." 773 F. 3d 1338, 1353 (2014).
Life Tech appealed, arguing that the there was no infringement under § 271(f)(1) because supplying one component cannot be "a substantial portion of the components of a patent[ed] invention," which refers to a quantitative measurement rather than a qualitative measurement. 2017 WL 685531 at *5. Promega argued that the statute should account for both quantitative and qualitative aspects of the components, and whether a component is substantial depends not only on the number of components, but also on their qualitative importance to the invention overall in a case-specific approach. 2017 WL 685531 at *6-7. However, the Supreme Court agreed with the Life Tech and held that the statutory requirement of "a substantial portion" refers to a quantitative measurement and that the component threshold for infringement under § 271(f)(1) must be greater than one. 2017 WL 685531 at *8. The Court also rejected the case-specific approach because the statute provides that "a substantial portion" refers to the "components" in the plural and there must be multiple components for § 271(f)(1) to attach. 2017 WL 685531 at *7.
Thus, the takeaways from the Life Tech ruling are: (1) to raise to the level of induced infringement for a party who supplies components from the United States under § 271(f)(1), the party must supply more than one component of a multicomponent invention; (2) although the Court held that shipping one component does not meet the infringement requirements of § 271(f)(1), the Court did not define how many components is sufficient to meet the threshold; and (3) the Court did not provide guidance as to how "component" is defined (e.g., whether one claim element equates to one component). In this case, each party stipulated that the patented toolkit was comprised of five separate components.