Life Technologies Corp. v. Promega Corp. — One Component Is Not ‘Substantial’ for Export Infringement Under § 271(f)(1)

Background

Promega holds patents on genetic testing kits used in forensics, paternity testing, and medical diagnostics. Life Technologies (LifeTech) licensed these patents for certain fields and manufactured the kits. The core kit comprised five components; LifeTech made one — an enzyme called Taq polymerase — in the United States and shipped it to its UK facility, where the other four components were added. Promega claimed this arrangement violated § 271(f)(1), which prohibits supplying “all or a substantial portion” of the components of a patented invention from the U.S. for combination abroad.

The district court and Federal Circuit found liability, holding that a single component could constitute a “substantial portion” if sufficiently important. The Supreme Court granted review to clarify the meaning of “substantial portion.”

The Court’s Holding

Justice Sotomayor, writing for the majority, reversed and held that a single component cannot constitute a “substantial portion” of a multi-component invention for purposes of § 271(f)(1). The word “substantial” requires a quantitative — not merely qualitative — analysis: you need to supply more than one component of a multi-component invention to trigger liability.

The Court grounded this in the text and context of § 271(f), which uses plural language (“components”) and was designed to address the loophole of shipping invention parts overseas for assembly. A qualitative “important component” test would be unworkable and would sweep in too much conduct, chilling legitimate commerce.

Key Takeaways

• Supplying one component of a multi-component patented invention from the U.S. for overseas assembly does not trigger § 271(f)(1) liability, regardless of how important that component is.
• “Substantial portion” under § 271(f)(1) is a quantitative test — it requires supplying more than a single component.
• Companies that manufacture one key part domestically and combine it with other components abroad have reduced § 271(f)(1) exposure after this ruling.
• Patent holders must look to other theories when only one component is exported.

Why It Matters

Section 271(f) was enacted in 1984 to close a loophole after the Supreme Court held that shipping disassembled parts overseas for combination did not constitute infringement. This ruling defines the boundary of that provision. For global manufacturers in biotech, pharmaceuticals, and electronics, the case confirms that moving the manufacturing of a single critical component overseas while assembling the rest of the product abroad does not automatically create U.S. patent liability.