On June 4, the Federal Circuit issued an opinion in Alnylam Pharmaceuticals, Inc. v. Moderna, Inc., a patent case we have been watching because it attracted an amicus brief. In it, Alnylam Pharmaceuticals appealed a judgment of a district court based on the argument that the court made an error in claim construction. Judge Taranto authored the opinion for the panel. Joined by Judges Chen and Hughes, the opinion explains why the Federal Circuit found no error in the district court’s claim construction and affirmed the district court’s judgment. This is our opinion summary.
The opinion addresses the question presented by Alnylam Pharmaceuticals: “whether the district court erred in limiting the terms ‘branched alkyl’ and ‘branched C10-C20 alkyl’ through lexicography to require one carbon atom in the group to be bound to at least three other carbon atoms, where the claims are not so limited, and the specification and prosecution history specify numerous examples of branching where a carbon atom is bound to two or three other carbon atoms.”
Judge Taranto began by providing the relevant background of the case:
Alnylam Pharmaceuticals, Inc., brought two suits against Moderna, Inc., ModernaTX, Inc., and Moderna US, Inc. (collectively Moderna) in district court, alleging that Moderna’s activities involving its mRNA based COVID-19 vaccine SPIKEVAX® infringed U.S. Patent Nos. 11,246,933 (parent) and 11,382,979 (child), issued to Alnylam as both applicant and assignee. Specifically, Alnylam alleged that Moderna’s vaccine contains a cationic lipid, SM-102, that is claimed by the asserted patents. The appeal here turns on a single issue of claim construction. The district court concluded that Alnylam had acted as lexicographer regarding the claim term “branched alkyl” in the following portion of the specification:
“Unless otherwise specified, the term[] ‘branched alkyl’ . . . refer[s] to an alkyl . . . group in which one carbon atom in the group (1) is bound to at least three other carbon atoms and (2) is not a ring atom of a cyclic group.”
Turning to the merits, Judge Taranto provided a description of the relevant law. He noted that “[a] patentee ‘may choose to be his own lexicographer and use terms in a manner other than their ordinary meaning, as long as the special definition of the term is clearly stated in the patent specification or file history.'” Applied here, he pointed out that “the sentence in question appears under the title ‘Definitions’ [and] . . . the term to be defined, ‘branched alkyl,’ is set off in quotation marks.” This, he explained, supports the conclusion that “column 412 language at issue is definitional.” Moreover, he noted, “the sentence uses the term ‘refer to,’ . . . which generally ‘conveys an intent for [that sentence] to be definitional.'” He also noted that, “elsewhere in the Definitions section, Alnylam used non-limiting terms that contrast with the ‘refer to’ language at issue here.” Additionally, Judge Taranto continued, “the inclusion of the phrase ‘[u]nless otherwise specified’ within the potentially lexicographic sentence suggests that the rest of the sentence lays out a generally applicable rule or definition.”
Judge Taranto next explained that the panel concluded that the “otherwise specified” clause “does not support Alnylam’s bottom-line position that the claims at issue cover a secondary carbon at the alpha position.” As for why, he explained that “[n]othing in the claims, specification, or prosecution history ‘specifie[s]’ a different definition of a branched alkyl for purposes of the asserted claims.”
Before addressing the claims, specification, and prosecution history, Judge Taranto agreed with the district court that “clarity would be required to support a different conclusion.” He explained how “[i]t would be odd to conclude that ‘otherwise specified’ is a loose or lenient standard.” As a result, he said, the court would “look for whether there is a clear reason to conclude that ‘branched alkyl’ as it is used in the asserted claims encompasses a secondary carbon at the alpha position, in contradiction to the definition in the specification and despite a definition whose very point in the respect at issue is to address carbons in the alpha position.”
With regard to the asserted claims, Judge Taranto explained, the “do not on their face require the inclusion of a ‘branched alkyl’ having a secondary carbon at the alpha position.”
With regard to specification, he continued, it “fails to specify that the asserted claims cover a branched alkyl with a secondary carbon at the alpha position where the claimed branching occurs.” He explained that, “[i]n the single instance where ‘a branched alkyl’ is used to describe an embodiment in this section, there is no description of the degree of branching at the alpha position.”
Finally, he wrote, “[w]ith the express definition in the specification, and the need for specificity to establish an exception, we conclude that this prosecution history is not sufficient.” While “the prosecution history comes closest to suggesting that Alnylam understood a branched alkyl to include a secondary carbon,” he explained, “we conclude that it is not sufficiently decisive to override the definition set forth in column 412.”
As a result of Judge Taranto’s reasoning, the panel agreed with the district court’s construction and affirmed its judgment.