In a unanimous decision, the SCOTUS ruled last month in Life Technologies Corp. et al. v. Promega Corp. et al., that shipment of a single component of a patented invention to be combined with others outside of the U.S. does not constitute infringement under 35 U.S.C. § 271(f)(1).
The decision reverses a previous decision by the Federal Circuit in this case ruling that shipment of a single component of a patented invention to be combined with others outside of the U.S. falls under the scope of infringement under 35 U.S.C. § 271(f)(1).
35 USC §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 analysis of the SCOTUS revolved around the interpretation of whether "all or a substantial portion of the components" can comprise or not a single component.
At the core of the case is a genetic testing kit manufactured by Life Technologies. The kit comprises 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. Life Technologies manufactured all components of the kit in the United Kingdom, except for one. The Taq polymerase was manufactured in the United States and then shipped to its United Kingdom facility, where it was combined with the other four kit components.
Life Technologies sublicensed the patent for the genetic testing kits from Promega, for the manufacture and sale of the kits for a certain licensed use worldwide. However, after Life Technologies began selling the kits outside the licensed fields of use, Promega sued Life Technologies for patent infringement under §271(f)(1), based on the supply by Life Technologies of the component Taq polymerase from the U.S. to its U.K. manufacturing facilities.
In the decision, the SCOTUS concluded that “a single component does not constitute a substantial portion of the components that can give rise to liability under §271(f )(1).”
The Court, however, did not clarify how many components would amount to a "substantial portion", a question that is left to lower courts to decide on a case-by-case basis.