Life Technologies Corp. v. Promega Corp. (2017)

By Donald Zuhn --

Earlier today, in Life Technologies Corp. v. Promega Corp., the Supreme Court reversed a determination by the Federal Circuit 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, holding instead "that a single component does not constitute a substantial portion of the components that can give rise to liability under §271(f)(1)."

The Federal Circuit had earlier determined in Promega Corp. v. Life Technologies Corp. that substantial evidence supported a jury's finding that Life Technologies infringed U.S. Patent No. RE37,984 ("the Tautz patent") under 35 U.S.C. § 271(f)(1), and therefore had reversed the District Court's grant of judgment as a matter of law (JMOL) of noninfringement.  The Tautz patent, which is owned by Max-Planck-Gesellschaft zur Förderung der Wissenschaften E.V. and exclusively licensed to Promega, claims a kit for testing at least one STR locus that contains: (1) a mixture of primers; (2) a polymerizing enzyme such as Taq polymerase; (3) nucleotides for forming replicated strands of DNA; (4) a buffer solution for the amplification; and (5) control DNA.  Life Technologies manufactures genetic testing kits that provide components for carrying out a multiplex amplification of STR loci from DNA samples, wherein the kits contain (1) a primer mix; (2) Taq polymerase; (3) PCR reaction mix including nucleotides; (4) a buffer solution; and (5) control DNA.

In 2010, Promega sued Life Technologies for infringement of the Tautz patent (as well as four other patents owned by Promega), alleging that Life Technologies had sold kits that were not covered by the license agreement between the parties (the license agreement limited Life Technologies' use of the patents-in-suit to activities related to legal proceedings, i.e., live forensic investigations conducted by police officers).  The parties moved for summary judgment on infringement and invalidity, with the District Court determining that Life Technologies' sales outside the license agreement's field of use were infringing.  Following trial, the jury returned a verdict of willful infringement.  Life Technologies then moved for JMOL and the District Court granted the motion, finding that Promega had failed to present sufficient evidence to sustain a jury verdict under § 271(f)(1), and vacated the finding of infringement.

On appeal, the Federal Circuit reversed the District Court's grant of JMOL of noninfringement.  The panel was divided as to the finding of infringement under § 271(f)(1), but the divide centered on another aspect of the statute.  With regard to the issue of whether infringement under § 271(f)(1) requires that at least two components be supplied from the U.S., the Federal Circuit held "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," and "based on the facts of this particular case . . . conclude[d] that substantial evidence supports the jury's verdict that LifeTech is liable for infringement under § 271(f)(1) for shipping the Taq polymerase component of its accused genetic testing kits to its United Kingdom facility."

The Supreme Court granted certiorari to determine whether a party that supplies a single component of a multicomponent invention for manufacture abroad can be held liable for infringement under § 271(f)(1).  As the Court pointed out in its opinion, Life Technologies manufactured all but one component of its kits in the United Kingdom -- manufacturing Taq polymerase in the United States and then shipping the Taq polymerase to its United Kingdom facility to be combined with the other four components of the kit.

The Court began by noting that § 271(f)(1) reads as follows (with 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.

According to the Court, "[t]he threshold determination to be made is whether §271(f)(2)'s requirement of 'a substantial portion' of the components of a patented invention refers to a quantitative or qualitative measurement."  Life Technologies argued that § 271(f)(1) establishes a quantitative threshold, and Promega countered that a "substantial portion" of the components includes a single component if that component is sufficiently important to the invention.

In answering the threshold inquiry, the Court noted that the Patent Act does not define the term "substantial," and that the ordinary meaning of the term was of "little help," since "[a]ll agree the term is ambiguous and, taken in isolation, might refer to an important portion or to a large portion."  However, when the Court looked at the context in which the term appears in the statute, that context pointed to a quantitative meaning.  In particular, the Court indicated that the terms "all" and "portion" in the statute convey a quantitative meaning.  The Court also noted that "there is nothing in the neighboring text to ground a qualitative interpretation."

The Court declined Promega's invitation to adopt a "case-specific approach" in which the factfinder would have to decipher whether the components at issue are a "substantial portion" under either a qualitative or quantitative test, stating that "[h]aving determined the phrase 'substantial portion' is ambiguous, our task is to resolve that ambiguity, not to compound it by tasking juries across the Nation with interpreting the meaning of the statute on an ad hoc basis."  Moreover, the Court noted that:

[C]onsidering the qualitative importance of a component . . . might just as easily complicate the factfinder's review.  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, Promega has not identified any component covered by the Tautz patent 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.

Having determined that the term "substantial portion" refers to a quantitative measurement, the Court next turned to the question of whether, as a matter of law, a single component can ever constitute a "substantial portion" so as to trigger liability under § 271(f)(1).  In answering that question in the negative, the Court noted that § 271(f)(1) consistently refers to "components" in the plural, stating that "[t]ext specifying a substantial portion of 'components,' plural, indicates that multiple components constitute the substantial portion."  The Court therefore held that "one component does not constitute 'all or a substantial portion' of a multicomponent invention under §271(f)(1)," adding that to resolve the question presented, the Court did not need to define how close to "all" of the components "a substantial portion" must be.

Having found that the phrase "substantial portion" in § 271(f)(1) has a quantitative, not a qualitative, meaning, and further, that § 271(f)(1) does not cover the supply of a single component of a multicomponent invention, the Court reversed the judgment of the Federal Circuit and remanded the case since only a single component of the patented invention at issue was supplied from the United States.

Life Technologies Corp. v. Promega Corp. (2017)
Opinion of the Court by Justice Sotomayor, joined by Justices Kennedy, Ginsburg, Breyer, and Kagan; joined as to all but Part II-C by Justices Thomas and Alito;
Opinion concurring in part and concurring in the judgment by Justice Alito, joined by Justice Thomas;
Chief Justice Roberts took no part in the decision of the case.

Comments

[Dan Feigelson]

Thanks, Don.

This line from the decision jumped off the page:

“Surely a great many components of an invention (if not every component) are important.”

This confuses me: this is the same court that told us that, when determining patent-eligibility, we can distill “the invention” to its “essence” or “gist”, without reference to the claims and ignoring elements of the claims under consideration that are “routine” or post-process activity. That doesn’t seem to square with identifying all the “components” of an invention.

It seems that when it’s necessary to ignore claim elements to invalidate a patent, that’s acceptable; but when it’s necessary to include claim elements in order to reach a finding of non-infringement, then those elements can’t be ignored.

Have I correctly divined the court's thinking?

[Paul Cole]

All that was necessary to the decision was that Taq polymerase is a known and generic enzyme, and its supply for any purpose does not trigger § 271(f)(1) because of its nature is that of a "staple commercial product" and not a specialised material.

Any more is exuberant pedantry in an inappropriate cause. As Sir Humphrey Appleby (of Yes Minister fame) would have said: "Have you considered all the implications of this line of reasoning?"

[EG]

"Have I correctly divined the court's thinking?"

Hey Dan,

You have and have also demonstrated how disingenuous and duplicitous SCOTUS is on that score. On the one hand they read the patent infringement statutes in 35 USC 271 narrowly and explicitly to allow accused infringers to escape. Yet conversely they read in all these implicit "exceptions" to patent-eligibility into 35 USC 101. And people wonder why the patent law bar is generally upset with SCOTUS?

BTW, I just got back from 9-10 days in Israel, including the Sea of Galilee and Jerusalem areas. Really enjoyed my trip there. Would gladly go back.

[Greg DeLassus]

"All that was necessary to the decision was that Taq polymerase is a known and generic enzyme, and its supply for any purpose does not trigger § 271(f)(1) because of its nature is that of a 'staple commercial product' and not a specialised material."

Begging your pardon, but I do not understand how this proposed rule would have served to decide a case under §271(f)(1). "Staple" is not a word that appears in §271(f)(1), so that fact that Taq is not a "staple commercial product" does not tell one anything relevant to the §271(f)(1) analysis. This would be a very sound ground on which to decide a charge of infringement under §271(f)(2), but it swings wide of §271(f)(1).

[Jeff]

Now we are obliged to tell our clients or potential clients that your 5 component patented widget (or 4 or 3 or 2) may be assembled by your competitor in Seattle with one of the components coming from Vancouver BC and you cannot stop it. And it does not matter whether component 5 is a rivet or a specialy formulated goop invented by client (that may have its own patent) to bind compinents together.

Does not 271(f)(2) cover me for the special goop situation, client asks? You reply, well "substantial" in 271(f)(2) is probably qualitative, so all your competitor will need to to show is 1 other noninfringing use for the special goop.

Why would they pursue a patent? "Hope" the law will be changed?

[Greg DeLassus]

"Now we are obliged to tell our clients or potential clients that your 5 component patented widget (or 4 or 3 or 2) may be assembled by your competitor in Seattle with one of the components coming from Vancouver BC and you cannot stop it."

Huh? No way. If they assemble the 5 component kit in Seattle, it is straightforwardly covered by §271(a). The only way that the competitor escapes liability is if they source the single component in *Seattle* and assemble the 5 components into the kit in *Vancouver*. Even then, they are still liable under §271(a) if they try to import the assembled kit back into the U.S.

In other words, the only way they escape liability under your U.S. patent is if they avoid the U.S. market. Of course, if one is concerned about your protecting a product in the Canadian market, perhaps one should acquire a Canadian patent, rather than trying to stretch U.S. §271(f) to absurd contortions to cover conduct occurring beyond the U.S. borders.

[Paul Cole]

I think Greg's last paragraph says it all.