Background
Promega Corporation developed and licensed patents on DNA STR (short tandem repeat) amplification technology — the genetic testing method underlying forensic DNA fingerprinting, paternity testing, and clinical diagnostics. Life Technologies (LifeTech), a major supplier of laboratory reagents, manufactured genetic testing kits that included multiple components: a primer mix, a PCR reaction mix, buffer solution, control DNA, and Taq polymerase (an enzyme essential for the PCR amplification process). LifeTech manufactured the Taq polymerase in the United States and shipped it to the United Kingdom, where the complete kits were assembled from locally sourced and U.S.-sourced components and sold worldwide.
Promega argued that LifeTech’s export of the Taq polymerase — a single component of the five-component kit — triggered liability under 35 U.S.C. § 271(f)(1), which makes it an act of infringement to supply “all or a substantial portion of the components of a patented invention” from the United States for combination abroad. The question was whether a single component could constitute a “substantial portion” of the components.
The Court’s Holding
Judge Chen, writing for the Federal Circuit, held that a single component could in some circumstances constitute a “substantial portion” under § 271(f)(1), and that the Taq polymerase — an essential, hard-to-substitute component without which the kit would not function — qualified. The court adopted a qualitative (rather than purely quantitative) test: “substantial” means important or essential in the context of the patented invention, not simply a majority in number. One key component out of five could be substantial if it was the functional heart of the invention.
The court reinstated a jury verdict finding infringement and awarded damages reflecting LifeTech’s worldwide kit sales. LifeTech sought Supreme Court review.
Key Takeaways
- Under the Federal Circuit’s 2014 ruling, § 271(f)(1)’s “substantial portion” was a qualitative test — a single “main” or “essential” component could satisfy it, even if it was just one of many components.
- This interpretation significantly expanded U.S. patent liability for exporters of components that are combined abroad into infringing products.
- The Supreme Court unanimously reversed in Life Technologies v. Promega (2017), holding that the word “components” (plural) in § 271(f)(1) requires at least two components to be supplied from the U.S. — a single component categorically cannot constitute a “substantial portion” of the components.
- The reversal created a categorical rule that simplifies § 271(f)(1) analysis for exporters: supply one component abroad? No § 271(f)(1) liability. Supply two or more? The substantial-portion analysis applies.
Why It Matters
Promega v. Life Technologies is a critical case for any business that manufactures a product partially in the U.S. and partially or wholly assembles it abroad. The Federal Circuit’s qualitative “important component” test threatened significant liability for companies that export even a single key ingredient or part to be incorporated into a product that would infringe a U.S. patent if assembled domestically. The pharmaceutical, biotechnology, semiconductor, and advanced manufacturing industries all watched the case closely.
The Supreme Court’s reversal restored more predictable boundaries: the statute requires “components” (plural) and a single component, however essential, is not enough. This outcome gives companies exporting single functional components somewhat more protection from § 271(f)(1) liability — though § 271(f)(2), which covers supply of a component “especially made or adapted” for use in a patented invention, remains available in appropriate cases.