Today the Supreme Court in Life Technologies v. Promega ruled that 35 U.S.C. § 271(f)(1) liability for supplying from the U.S. “all or a substantial portion of the components of a patented invention” is a quantitative, not qualitative, analysis of the number of components supplied such that supplying only a single component of a multicomponent invention does not give rise to liability under that section (though it might give rise to liability under § 271(f)(2) if that single component “is especially made or especially adapted for use in the invention and not a staple article or commodity of commerce suitable for substantial noninfringing use”). (see also our June 27, 2016 post on the Supreme Court’s grant of review of this case). As Justice Alito’s concurrence states, the opinion “establishes that more than one component is necessary, but does not address how much more.” So the art of litigating Section 271(f)(1) will focus on the litigants’ ability to delineate how many separate “components” are in a claimed invention and whether the resulting number of such components supplied from the U.S. is “substantial.”
The patent-in-suit claims a toolkit for genetic testing that the parties agreed has five components:
- a mixture of primers that mark the part of the DNA strand to be copied;
- nucleotides for forming replicated strands of DNA;
- an enzyme known as Taq polymerase;
- a buffer solution for “amplifying” (creating multiple copies of) the DNA;
- control DNA
Life Technologies was licensed under the patent for a specific field of use: supplying kits for law enforcement use. Life Technololigies made all components of the kits in the United Kingdom except the Taq polymerase (component 3 above), which it made in the U.S. and shipped to its United Kingdom facility (i.e., “supplied” the component from the U.S.). Life Technologies sold kits to clinical and research markets, which was outside the licensed law enforcement field of use. Promega thus sued Life Technologies for patent infringement based on selling kits outside the licensed field of use.
The specific question presented was “whether the supply of a single component of a multicomponent invention is an infringing act under 35 U.S.C. §271(f)(1).” The Supreme Court ruled that it is not. The language of Section 271(f)(1) states as follows:
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 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 to key phrase in dispute]
The Court focused on whether supplying “a substantial portion” was a quantitative (i.e., number count) or qualitative measurement. The term “substantial” in isolation is ambiguous because it can be either a quantitative or qualitative assessment — i.e., “may refer either to qualitative importance or to quantitatively large size.” But the context of where the term “substantial” is used in this statutory provision suggests a quantitative meaning:
Both “all” and “portion” convey a quantitative meaning. “All” means the entire quantity, without reference to relative importance. “Portion” likewise refers to some quantity less than all. Conversely, there is nothing in the neighboring text to ground a qualitative interpretation.
Moreover, the phrase “substantial portion” is modified by “of the components of a patented invention.” It is the supply of all or a substantial portion “of the components” of a patented invention that triggers liability for infringement.
Had a qualitative standard (i.e., importance) been intended, then the statute more readily would have been worded to omit the reference to “the components” — i.e., “all or a substantial portion of
the components of a patented invention.”
The Court declined to include a qualitative analysis into the inquiry given not only the text of the statute, but for administrative concerns that this would complicate the factfinder’s decision:
Surely a great many components of an invention (if not every component) are important. Few inventions, including the one at issue here, would function at all without any one of their components. Indeed, [patentee] Promega has not identified any component … that would not satisfy Promega’s “importance” litmus test. How are courts–or, for that matter, market participants attempting to avoid liability–to determine the relative importance of the components of an invention? Neither Promega nor the Federal Circuit offers an easy way to make this decision.
The Court next ruled that a single component does not constitute the “substantial portion” required to trigger liability. The text itself refers to supplying a substantial portion “of the components“–i.e., plural–where “such components” are uncombined.
Further, the companion Section 271(f)(2) refers to “any component” in the singular, that section stating:
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 noninfringing 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. [emphasis added to show relevant language]
So interpreting Section 271(f)(1) to focus on “components” (plural) and Section 271(f)(2) to focus on “component” (singular) allows them to work in tandem to address different considerations. In contrast, interpreting Section 271(f)(1) to include a 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 also considered the history of §271(f), which was enacted in response to the Supreme Court’s decision in Deepsouth Packing v. Laitram, 406 U.S. 518 (1972). In Deepsouth Packing, the defendant’s shrimp deviening machine had been assembled entirely within the U.S. and then shipped abroad, which activity was found to directly infringe a patent based on the claimed invention being “made” in the U.S. To avoid infringement for making the claimed combination in the U.S., the infringer continued to make all of the components in the U.S. but did not fully assemble them together in the U.S.; rather, it shipped three separate portions of the machine overseas where they were then readily combined together in just a few minutes –i.e., the claimed combination was “made” outside the U.S. The Deepsouth Court ruled that this did not constitute the invention being “made” “within the United States” under the direct infringement statute §271(a). Although that ruling may be seen as putting form over substance, the Court was very wary about extending U.S. patent law reach extraterritorially by broadly interpreting the statutory language; international comity concerns required narrowly interpreting the reach of U.S. patent statutes. So the Court left it to Congress to fill the gap through express statutory language if Congress was so inclined to do so. And that’s what Congress did in enacting Section 271(f).