It’s Complicated, Part 2: Life Technologies Corporation v. Promega Corporation

Adrienne Naumann recently spoke for our United States Federal Intellectual Property Developments 2018-2019 Webinar, offering her expertise for both the webinar and the corresponding E-Book. She established her own practice in 1996, exclusively focusing on intellectual property law. We’re glad to share the second article in her series here!

In Life Technologies Corporation et al. v. Promega Corporation, 137 S. Ct. 732 (2017) [hereinafter ‘Life Technologies’ and ‘Promega’] the U.S. Supreme Court [hereinafter ‘the Court’] held that U.S. patent infringement liability does not result from (i) a single non-innovative component that (ii) originates from the United States for assembly abroad. The statutory provision was 35 U.S.C. section 271(f)(1) which states that patent infringement liability exists where all or a substantial number of components of a patented technology originate from the United States for assembly in another country. In contrast, section 271(f)(2) provides liability resulting from a newly designed single U.S. component without significant non-infringing uses. Because of its potential economic consequences, all U.S. based manufacturers with international facilities should be aware of this case prior to assembly and production related business decisions.

Promega is an exclusive licensee of a U.S. patented technology for genetic testing kits. Life Technologies sublicensed this patented technology from Promega for specified limited utilities of genetic testing kits. Life Technologies manufactured one kit component in the U.S. (a previously existing widely used enzyme) and sent this component abroad for assembly with remaining components. Life Technologies then sold these kits abroad for utilities which were not authorized under Promega’s sublicensing agreement. Promega filed a patent infringement lawsuit against Life Technologies, based upon sales of kits that included this single component enzyme from the United States. The trial court granted judgment to Life Technologies, because (i) only one component of Promega’s multi-component patented technology originated from the U. S., but (ii) all or a substantial number of components must originate from the U.S for liability under section 271(f)(1). The court also stated that subsection 271(f)(2) does not apply, because the single U.S. component enzyme was a previously existing ‘commodity’ item.

However, the Federal Court of Appeals for the Federal Circuit [hereinafter ‘the Federal Circuit’] reversed the trial court and concluded that ‘all or a substantial portion’ could be either of (i) a qualitatively important component or (ii) a quantitative number of components. The court concluded that in this case the single enzyme originating from the U.S. was qualitatively a substantial potion because (i) it was important to the utility of the entire invention, and (ii) even though this enzyme was a ‘commodity’ component with numerous non-infringing uses.

The Court concluded that the quantitative interpretation of section 271(f)(1) is the exclusive meaning of section 271(f)(1), and thereby reversed the Federal Circuit’s holding. To reach its decision the Court reviewed the statutory words such as ‘all’ and ‘portion’, and concluded that the statute exclusively conveyed a quantitative meaning. The Court reasoned that under the quantitative approach, a single component cannot constitute a ‘substantial portion,’ because section 271(f)(1) consistently refers to plural components, and thereby indicates that multiple components comprise a substantial portion. The Court also observed that interpreting section 271(f)(1) to include any single component results in section 271(f) (2) becoming superfluous. The Court further stated that requiring a fact finder to resolve infringement under either a qualitative or quantitative approach would compound any ambiguity of section 271(f)(1). Finally, the Court found that it was Congress’ intent to hold a supplier liable for sending U.S. components to another country for assembly, but only under the explicit conditions of section 271(f). In sum, for the present case where only a single commodity enzyme originated from the United Sates, Life Technologies’ activity is outside the scope of section 271(f).