By Jason Rantanen
Promega Corp. v. Life Tech. Corp. (Fed. Cir. 2014) Download Promega v Life Tech
Panel: Prost (dissenting-in-part), Mayer, Chen (author)
This decision is interesting for its enablement analysis, which revolves around the term “comprising,” and for its holding on 271(f) liability for international inducement (the portion of the opinion as to which Chief Judge Prost dissented). I’ll write more about the 271(f) issue in a subsequent post.
A few core technical details are useful for understanding this opinion. The patents at issue relate to DNA, and specifically to the amplification of particular “short tandem repeats” (STR) loci. These loci are important because they can be used to create a DNA “fingerprint” unique to each individual. These fingerprints are valuable in both criminal forensics and health sciences research.
To create these DNA fingerprints, the STR loci must first be “amplified,” which essentially means copying the DNA many times over. While the technology for DNA amplification described in the patent (polymerase chain reaction) was well known at the time of the patent application (1994), amplifying multiple STR loci at the same time (called “multiplexing”) remained challenging. A central problem with multiplexing was the extreme difficulty in predicting what would happen when a new locus was added to the multiplex. The multiplex might work or it might not, depending on the interactions between the new locus, the existing loci, and primers used in the reaction. The patents-in-suit do not purport to solve this problem generally; rather, they identify specific combinations of loci that will successfully co-amplify.
Enablement and The Use of “Comprising”: The set of claims for which enablement was an issue all contained the term “comprising” before the set of loci (not just after the preamble). Claim 23 of one of the patents-in-suit is representative:
23. A kit for simultaneously analyzing short tandem repeat sequences in a set of short tandem repeat loci from one or more DNA samples, comprising:
A single container containing oligonucleotide primers for each locus in a set of short tandem repeat loci which can be co-amplified, comprising HUMCSF1PO, HUMTPOX, and HUMTH01.
(The “HUM” terms refer to specific loci.) It’s black letter patent law that “comprising” is an “open” term; in other words, the claims encompass both products that are limited to the specific elements recited in the claims as well as those that contain those elements. Here, that meant that the claims encompassed both “products that use no loci other than those listed in the claims” as well as “any other loci combination containing those three recited loci–whether that combination includes 13, 1,1300 or 13,000 STR loci.” Slip Op. at 7. Life Tech moved for summary judgment, which the district court denied because “the asserted claims need not enable ‘unrecited elements.'” Id. at 14.
Applying the concept of commensurability, the Federal Circuit reversed. “The enablement requirement ensures that ‘the public knowledge is enriched by the patent specification to a degree at least commensurate with the scope of the claims.'” Slip Op. at 14 (quoting Nat’l Recovery Techs v. Magnetic Separation Sys., 166 F.3d 1190 (Fed. Cir. 1999)).
Here, the scope of the claims was not “less than or equal to the scope of enablement.” Id. First, the unstated STR loci combinations are not merely “unrecited elements;” “they are part of the claim scope.” And not only are they are part of the claim scope, they are an important part. Promega itself repeatedly argued the unpredictability point to the patent office during prosecution of the claims-in-suit to support their patentability over the prior art and during the litigation itself in defense of their nonobviousness. “Promega explained that without a preexisting publication or teaching, a skilled artisan ‘could not predict with any certainty whether a given set of loci would co-amplify successfully together.'” Slip Op. at 17.
These arguments proved fatal given the broad scope of Promega’s claims. This case was similar to MagSil v. Hitachi, and Wyeth v. Abbott, and the Federal Circuit concluded that “the teachings of Promega’s patents would not have enabled a skilled artisan at the time of filing to identify significantly more complicated sets of STR loci combinations that would successfully co-amplify–such as those found in LifeTech’s STR kits–without undue experimentation.” Slip Op. at 18. Ultimately, “Promega’s ‘difficulty in enabling the asserted claims is a problem of its own making.'” Id. at 18, quoting MagSil.
So does the court’s treatment of “comprising” mean that every claim using this transitional phrase is invalid. In a word, No. In more words:
It is true that when used in the preamble of a claim, the term “comprising” permits the inclusion of other steps, elements, or materials in addition to the elements or components specified in the claims.  As we stated in Gillette Co. v. Energizer Holdings, Inc., 405 F.3d 1367, 1371 (Fed. Cir. 2005), open claims “embrace technology that may add features to devices otherwise within the claim definition” (emphasis added). But the relevant usage of “comprising” here is not the one recited in the preamble. Rather, it is within the specific claim limitation that lists combinations of successfully co-amplifying STR loci, combinations whose identification and discovery Promega itself asserts is a complex and unpredictable endeavor. While the term “comprising” in a claim preamble may create a presumption that a list of claim elements is nonexclusive, it “does not reach into each [limitation] to render every word and phrase therein open-ended.”  Promega’s claims differ from customary “open-ended” claims in that Promega’s usage of “comprising” in its “open loci set” limitation, as construed, expands the claims at a key limitation in order to cover what are indisputably advances in this unpredictable art. Under the circumstances here, the numerous embodiments covered by Promega’s claims cannot be merely regarded as “unrecited elements” in a standard “open-ended” claim.
Slip Op. at 20-21.