Promega Corp. et al. v. Life Technologies Corp. et al.

Docket No. 2013-1011, -1029, -1376

December 15, 2014

Update, SCOTUS opinion (2/22/17): FC erred in its decision as “[t]he supply of a single component of a multi-component invention for manufacture abroad does not give rise to liability under 35 U.S.C. §271(f)(1)” “which prohibits the supply from the [US] of ‘all or a substantial portion of the components of a patented invention’ for combination abroad”. The Court wrote: “Section 271(f)(1) consistently refers to the plural ‘components,’ indicating that multiple components make up the substantial portion. Reading §271(f)(1) to cover any single component would also leave little room for §271(f)(2)’s express reference to a single component ‘especially made or especially adapted for use in the invention.’”

Prior update (6/27/16): Cert. granted as to question 2 (“2. Whether the Federal Circuit erred in holding that supplying a single, commodity component of a multi-component invention from the United States is an infringing act under 35 U.S.C. § 271(f)(1), exposing the manufacturer to liability for all worldwide sales.”) Question 1 will not be considered (“1. Whether the Federal Circuit erred in holding that a single entity can ‘actively’ induce itself to infringe a patent under 35 U.S.C. § 271(f)(1).”)

Brief Summary: Promega’s patents found not to enable full scope of claims. Infringement under § 271(f)(1) does not require third party and can be based on a single component of a combination as long as it constitutes a substantial portion of the patented invention.

Summary: Life Technologies appealed DC grant of SJ that Promega’s patents relating to multiplex amplification of STR loci were not invalid for lack of enablement and obviousness (not addressed here) and a ruling that it is not licensed for all uses of the asserted patents under a license agreement (“2006 Cross License”). Promega appealed grant for JMOL that LifeTech’s accused products do not infringe the patents or US RE 37984 (Tautz patent) that resulted in the vacatur of the jury verdict (damages, willfulness). The FC panel concluded the asserted claims of Promega’s patents are invalid for lack of enablement and that the Cross License does not cover all of Life-Tech’s sales. Each of Promega’s asserted claims includes a limitation reciting the phrase “‘a set of…loci’ followed by a list of particular STR loci multiplexes…ranging from a 3-plex to a 14-plex”. The DC construed the “consisting of” claims to be “limited to products that use no loci other than those listed in the claims” (“closed loci set” claims) and “comprising” claims not to be so limited (“open loci set” claims). The opinion explains that the broad language of the open loci set claims was selected “at the peril of losing any claim that cannot be enabled across its full scope of coverage” (MagSil, FC 2012 (specification did not sufficiently disclose open claim language of 10% and up (“infinity”) could be achieved); Wyeth & Cordis, FC 2013). And during prosecution and litigation, Promega argued that the claims were patentable because “the identification of new successfully co-amplifying STR loci combinations [is] unpredictable” (“fatal to [LifeTech’s] obviousness arguments”) but “when describing the scope of its claims for purposes of infringement, [it] sings a different tune” (“any and all co-amplifying loci combinations are encompassed by the claims”). The FC panel found it “sufficient to conclude, based on Promega’s own statements, that the teachings of Promega’s patents would not have enabled a skilled artisan at the time of filing to identifity significantly more complicated sets of STR loci that would successfully co-amplify…without undue experimentation” and “like the patentee in MagSil, Promega’s ‘difficulty in enabling the asserted claims is a problem in its own making.” The opinion also explained that in Wyeth a claimed a genus of chemical compounds was found not to be enabled because “practicing the full scope of the claims required ‘more than routine experimentation’ because the specification disclosed ‘only a starting point for iterative research in an unpredictable and poorly understood field’” (and Promega’s claims “similarly cover potentially thousands of undisclosed embodiments in an unpredictable field”). The FC panel also concluded the “comprising” was not used in the preamble (where it “does not reach into each [limitation] to render every word and phrase therein open-ended”) but is instead “within the specific claim limitations”. Judge Prost disagreed, believing that the statute requires the inducement of another.

The Tautz patent is directed to a process for examining polymorphism in DNA samples (mixture of primers, polymerase, nucleotides, amplification buffer, and control DNA). LifeTech manufactures Taq polymerase in the US and then ships it to the UK for incorporation into genetic testing kits that are sold worldwide, including the US. The DC found no infringement under § 271(f)(1) (liability where a party actively induces the combination of substantial portion of the components a patented invention) but the FC disagreed, concluding “actively induce” does not require a third party because it has a dictionary meaning “to bring about, to cause” (another meaning being influencing or persuading another; noting “another” is absent from the statute and the legislative history (“Congress chose language for § 271(f)(1) broader than the particular facts of Deepsouth” (US 1972)). The FC also held “that there are circumstances in which a party may be liable under § 271(f)(1) for supplying or causing to be supplied a single component for combination outside the United States” (“the ordinary meaning of ‘substantial portion’ suggests that a single important or essential component can be a ‘substantial portion of the components’ of a patented invention”). And it concluded substantial evidence supported the jury conclusion that the Taq polymerase is a “substantial portion” (by its ordinary meaning) of the components of the kits (“Life’s own witness admitted that the Taq polymerase is one of the ‘main’ and ‘major’ components of the accused kits.”) It reversed the DC’s conclusions regarding infringement under § 271(a) as erroneously requiring Promega to show all LifeTech’s sales were infringing. It also disagreed with LifeTech’s interpretation of the Cross License, finding it only applied to “forensics and paternity”.

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