IP Law Bulletin

The patent at issue, U.S. Reissue Patent No. RE37,984 (the Tautz patent), claims a five-component kit for genetic testing. Promega sublicensed the Tautz patent to Life Technologies for uses in law enforcement fields worldwide. However, as alleged in the suit, Life Technologies infringed the Tautz patent by selling the kits to clinical and research markets, which were outside the fields permitted by the license agreement. The patented kit contained five components, four of which were manufactured in the United Kingdom. The fifth component, an enzyme known as the Taq polymerase, was manufactured in the United States and shipped to the United Kingdom, where it was then combined with the other four components.

35 USC §271(f)(1) allows patent owners to pursue infringement actions when parts of a patented invention are shipped outside of the U.S. for assembly. The text of the provision reads as follows:

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. (Emphasis added).

In assessing whether manufacturing the Taq polymerase in the U.S. and shipping it to the U.K. constitutes infringement under this provision, the Court reasoned that the term “substantial portion” conveys quantity of components and not quality or significance of a single component. The Court declined to apply Promega’s suggestion to interpret “substantial portion” as either a quantitative or qualitative term. According to the Court, “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 with any one of their components.”

The Court then held that because “substantial portion” is a quantitative measurement, a single component can never constitute a “substantial portion.” The Court based its reasoning on the language of the statute, which refers to “components” in the plural. The Court, citing to companion provision 35 USC §271(f)(2), held that Congress intended the language of §271(f)(1) to include more than one component so that the two provisions can work in tandem. It reasoned that if §271(f)(1) was read to apply to a single component, it would have virtually the same scope as §271(f)(2), and §271(f)(2) would thus be superfluous. The Court also found that their holding comports with Congress’s intent to fill a gap that existed in patent law at the time that this statute was passed by “expanding the definition of infringement to include supplying from the United States a patented invention’s components,” following the Court’s decision in Deepsouth Packing Co. v. Laitram Corp. (holding that making and using a product outside of the U.S. was not infringement of a U.S. patent). While there may be liability for supplying all, a substantial portion, or maybe even two of the components of a multicomponent system from the U.S. to be made abroad, the Court held that supplying a single component of a multicomponent system falls outside of the scope of this statute.

While the Court simplified the application of §271(f)(1) for future cases, the Court’s decision leaves several questions unanswered. First, while one component is clearly insufficient, the Court chose not to specify how many components of a multicomponent invention constitute a “substantial portion” of the components to be sufficient to fall within the scope of the statute. For example, would two components suffice in a five-component system as here? Second, it is unclear how the holding of this case can be applied to an invention made up of only two components. That is, can the supply of a single component in a two-component system ever amount to “a substantial portion of the components?” It will thus be left to future cases to explore the bounds of §271(f)(1) and gain more clarity on the meaning of “substantial portion.”