Federal Circuit Clarifies Scope of § 271(f)(1), Emphasizes Full-Scope Enablement

December 15, 2014


What This Means to You

  • While broad claims can be desirable, avoid overbroad language at critical limitations.
  • Consider infringement claims under § 271(f)(1) for exported components.

Overview

In Promega Corp. v. Life Technologies Corp., the U.S. Court of Appeals for the Federal Circuit (Federal Circuit) invalidated a number of patents for lack of enablement and provided important guidance on the scope of 35 U.S.C. § 271(f)(1).

Case Background

Promega sued Life Technologies on five patents relating to kits and methods for DNA profiling. DNA profiling requires identification of specific loci on the genome corresponding to alleles, or variation between individuals, and amplification of those loci to create a measurable amount of genetic material. At the time of the invention, adding even one additional locus completely changed the reaction, and it was impossible to know whether the amplification would still occur. During prosecution, Promega argued consistently that the claims were patentable because the specific combinations of loci identified had not been disclosed before.

At the district court, Life Technologies moved for summary judgment of invalidity of four patents, which was denied. The court granted summary judgment of infringement with respect to the fifth patent. After a jury trial on willfulness and damages, a jury awarded damages based on Life Technologies’ worldwide sales, despite the fact that only one component of the infringing product was manufactured in the U.S. and then shipped overseas to a Life Technologies subsidiary. Life Technologies moved for judgment as a matter of law for failure to prove damages, which was granted. Both parties appealed.

Decision Analysis

The Federal Circuit found the first four patents invalid for lack of enablement. The relevant claims on appeal used the word “comprising” in the claim element identifying the specific loci. Because this language covered a potentially unlimited number of loci, and there was no dispute that adding even a single locus could have negatively impacted the ability to co-amplify the specific loci recited in the claims and would have constituted a new invention, the Federal Circuit invalidated the claims for lack of enablement.

On the issue of damages, the Federal Circuit reversed and held that the export of even a single component could qualify as a “substantial portion of the components of a patented invention” under § 271(f)(1). The Federal Circuit also held that inducement under § 271(f)(1) does not require “another,” and therefore a party may induce itself.

Takeaways


For patent applicants or patent holders, careful analysis is recommended before the use of “comprising” outside a claim’s preamble to avoid enablement issues. Also, if faced with an infringer shipping components overseas, consider the possibility of a claim under § 271(f)(1).

For those accused of infringing someone else’s patent, look for evidence of unpredictability when considering lack of enablement as a basis for challenging validity where the claims are drafted broadly.