Source: https://www.personalizedmedicinebulletin.com/2017/03/06/one-is-not-enough-infringement-liability-under-%C2%A7-271f1/
Timestamp: 2019-04-25 12:05:19+00:00

Document:
In Life Technologies Corp. v. Promega Corp., Slip Op. 14-1538 (Feb. 22, 2017), the U.S. Supreme Court held that the supply of a single component of a multicomponent invention for manufacture abroad does not give rise to liability under 35 U.S.C. § 271(f)(1). The Court’s decision is important for manufacturers of kit components and those that license and aggregate those components into a single commercial kit.
Respondent Promega Corp. (Promega) was the exclusive licensee of U.S. Re. No. 37,984 titled “Process for analyzing length polymorphisms in DNA regions” and referred to by the Court as the “Tautz patent.” The reissued patent covers kits and methods, one element of which is the Taq polymerase enzyme. For the purpose of the litigation, the parties agreed “that the kit covered by the Tautz patent contains 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.” Slip op. at page 2.
Petitioner Life Technologies Corp. (Life Technologies) manufactured genetic tests. The Tautz patent was licensed for the manufacture and sale of kits for use in certain licensed fields worldwide. All but one component – the Taq polymerase – was manufactured by Life Technologies in the United Kingdom, where Promega combined the Taq polymerase with the remaining four components into a kit.
At one point, Promega sued Life Technologies asserting that Life Technologies infringed the patent by selling the kits to clinical and research markets outside the licensed fields of use. Promega alleged that Life Technologies’ supply of the Taq polymerase from the United States to its United Kingdom facility triggered liability under § 271(f)(1). Slip op. at page 3.
“(f) (1) 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 U.S. Supreme Court framed the key issue for consideration as “whether the supply of a single component of a multicomponent invention is an infringing act under 35 U.S.C. § 271(f)(1).” Slip op. at page 4.
The Court focused its analysis on the Section 271(f)(1) language “substantial portion” and whether “substantial” infers a quantitative or qualitative amount. Relying on dictionary definitions, the Federal Circuit had previously determined that “substantial” as used in the statute infers “important” or “essential” and therefore, a single component can be a substantial portion of the patented invention. Slip op. at page 4. Because the evidence at trial showed that the polymerase component of the kit was a main or major component of the kit, the Federal Circuit held that Life Technologies infringed the patent.
The Supreme Court disagreed, and reversed the Federal Circuit. The Court noted that the context in which the term appears in the statute “points to a quantitative meaning….” Slip op. at 5. Having determined that the term “substantial portion” referred to a quantitative measurement, the Court then asked whether, as a matter of law, a single component can ever constitute a “substantial portion” to trigger infringement liability under § 271(f)(1).
The Court again turned to the language of the statute, focusing on the term “components” in the plural, noting that the text “specifying a substantial portion of ‘components,’ plural, indicates that multiple components constitute the substantial portion.” Slip op. at 8. The Court stated that this interpretation allowed for consistent interpretation of sections (f)(1) and (f)(2); (f)(2) applying to situations where a single especially made or adapted for use in a patented invention results in infringement liability.
Slip op. at page 10.
Thus, while the Court resolved the ambiguous language of § 271(f)(1), the Court’s holding left many questions open. While more than one component must be supplied to draw § 271(f)(1) liability, would 3 of 5 constitute a “substantial” portion? Would 2 of 4 constitute a “substantial” portion?
The Court’s holding also discredits what is appreciated by patentees and those of skill in the art, i.e., that certain components of multicomponent kits are essential to achieve the object of the invention and that there are no suitable substitutions for that element, even if the one component is not specifically made or adapted for use in the invention.

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