Licensing multi-component inventions sourced only in part in the U.S. creates ample risk that a licensee can avoid paying any patent royalty outside the U.S. The Life Techs. decision explains why this happens.
Promega controlled a patent whose claims protected a kit used for genetic testing. The kit included five components, and the patent claims correspondingly claimed a kit including these five components. One of the components, an enzyme, was technologically special. The other four components were commercially available from sources outside the U.S. Even though, so to speak, only one component of the kit was special while the others were ordinary, all five components were needed for the kit to work.
Life Technologies procured the enzyme from the U.S., where the patent rights were in force, but then procured the other four kit components from international sources. Life Technologies assembled the kits outside the US and then sold them not only outside the US but also outside the authorized field of use. The license grant authorized sales in the law enforcement field, but Life Technologies sold these to clinical and research customers as well. Not only did Life Technologies make sales outside its licensed field, Life Technologies did not pay royalty on these sales.
Clearly, Promega was not happy with these licensee tactics inasmuch as Promega sued Life Technologies for patent infringement. Ordinarily, one expects U.S. patents to protect infringing acts occurring in U.S. territories, not outside the U.S. So, what could have been the basis for Promega to disapprove of what the licensee was doing internationally outside the U.S.? The answer is that Promega turned to 35 USC 271 (f)(1) for protection. Section 271(f)(1) is an interesting piece, as it gives U.S. patent claims some international scope (emphasis added):
35 U.S. CODE § 271.INFRINGEMENT OF PATENT
(f) (1) 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.
Sorry, no. Using a somewhat strange, quantitative analysis, the Supreme Court ruled that a single component could never constitute a substantial portion of the components of a multi-component invention. This is unlike its qualitative approach in Quanta and could be confusing to apply in situations where a combination might only include two components. Can a single component ever be a substantial part of a combination including only two components if the Supreme Court analysis is to be taken at its word?
Promega lost the battle, which allowed Life Technologies to do international business in any desired field without incurring any royalty obligation or risk of patent infringement.
What could Promega have done differently to better protect its technology in the U.S. and internationally. Both patenting strategies and agreement strategies could be available, and similar strategies could benefit any patent licensor whose invention involves multiple components: