The US Court of Appeals for the Federal Circuit’s en banc opinion in Cardiac Pacemakers, Inc. v. St. Jude Medical, Inc., Nos. 2007-1296, -1347 (Fed. Cir. Aug. 19, 2009), clarifies that 35 U.S.C. § 271(f) does not apply to method claims of patents. Section 271(f) states as follows:
(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.
(2) Whoever without authority supplies or causes to be supplied in or from the United States any component of a patented invention that is especially made or especially adapted for use in the invention and not a staple article or commodity of commerce suitable for substantial noninfringing use, where such component is uncombined in whole or in part, knowing that such component is so made or adapted and intending that such component will be combined 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.
35 U.S.C. § 271(f).
In St. Jude, Cardiac owned a patent that claimed a method of heart stimulation using an implantable heart stimulator. St. Jude sold implantable cardioverter defibrillators (ICDs) that allegedly could be used to infringe a method claim of Cardiac’s patent. Some of those ICDs were shipped abroad. The district court, relying on Union Carbide Chemicals & Plastics Technology Corp. v. Shell Oil Co., 425 F.3d 1366 (Fed. Cir. 2005), found that Section 271(f) applied to method claims and that St. Jude’s shipment of ICDs abroad could result in a violation of that section. A Federal Circuit panel originally affirmed the district court’s decision on the same basis, but St. Jude’s petition for rehearing en banc was subsequently granted.
The en banc court reversed the district court’s determination that Section 271(f) applies to method claims and that damages were permitted under Section 271(f) on devices exported where the claimed method is carried out in countries other than the United States. In doing so, the en banc court expressly overruled the Federal Circuit’s Union Carbide decision to the extent that it stood for that principle.
The court noted that while the “component” of a tangible product, device or apparatus is a tangible part of the product, device or apparatus, the “component” of a method or process is a step in that method or process. This determination was based on case law and the cannon of statutory construction that requires the words of a statute to be read in context and with a view to their place in the overall statutory scheme. With respect to statutory construction, the court looked to Section 271(c), which contrasts “a component of a patented machine, manufacture, combination, or composition” with a “material or apparatus for use in practicing a patented process.” To the court, this language demonstrated Congress’ belief that a “component” was separate and distinct from a “material or apparatus for use in practicing a patented process,” and, thus, that a material or apparatus for use in practicing a patented process is not a component of that process. Rather, the components of the process are the steps of the process. The en banc court found this distinction to be significant because Section 271(f) requires that the components of the patented invention be supplied, which implies the transfer of a physical object. They held that supply of an intangible step is a physical impossibility, and thus Section 271(f) cannot apply to method claims. They also found this interpretation to be consistent with the legislative history of Section 271(f), which demonstrated an intent to protect product patents, but made almost no reference to protecting method patents.
Judge Newman dissented from the en banc court’s ruling with respect to Section 271(f). She stated that the term “patented invention” in Section 271(f) includes all statutory classes of patentable invention, including processes, and that an interpretation of Section 271(f) to exclude all process inventions is incorrect.
For more information about St. Jude, or any other matter raised in this Client Alert, please contact Sharon A. Israel, at +1 713 238 2630, Trent L. Menning, at +1 713 238 2621, or your regular Mayer Brown lawyer.
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