Alnylam Pharmaceuticals, Inc. v. Moderna, Inc., et al., No. 2023-2357 (Fed. Cir. (D. Del.) June 4, 2025). Opinion by Taranto, joined by Chen and Hughes.
Alnylam sued Moderna for infringement of two patents directed to “biodegradable lipids and … their use for the delivery of active agents such as nucleic acids.”
During claim construction, the district court ruled that Alnylam had acted as its own lexicographer for the claim term “branched alkyl.” The patent specification states: “Unless otherwise specified, the term ‘branched alkyl’ … refers 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.” The district court ruled that this passage “is clear and unequivocal lexicography.”
Based on the district court’s claim construction, which tracked the specification’s passage, the parties stipulated to a judgment of noninfringement. Alnylam appealed.
On appeal, Alnylam argued that the district court erred in holding that Alnylam acted as a lexicographer because, according to Alnylam, the intrinsic record shows that it did not intend to limit the term and because the court’s construction excludes disclosed embodiments. The Federal Circuit disagreed and thus affirmed, concluding that “Alnylam acted as lexicographer in its requirement of a carbon bound to at least three other carbons ‘unless otherwise specified’ and that Alnylam did not otherwise specify for purposes of the asserted claims.”
In so ruling, the Federal Circuit summarized the “high threshold for lexicography,” noting that “the intrinsic evidence must ‘clearly set forth’ or ‘clearly redefine’ a claim term so as to put one reasonably skilled in the art on notice that the patentee intended to so redefine the claim term.” The court ruled that the specification’s passage was definitional because it appeared in a section titled “Definitions”; the term “branched alkyl” was set off in quotation marks; the sentence used “refer to,” which “generally conveys an intent for that sentence to be definitional”; Alnylam used non-limiting terms elsewhere in the Definitions section; and the sentence included the phrase “unless otherwise specified,” suggesting a generally applicable definition.
The Federal Circuit also determined that the “otherwise specified” clause did not support Alnylam’s proposed claim construction. “Nothing in the claims, specification, or prosecution history ‘specifies’ a different definition of a branched alkyl for purposes of the asserted claims.”
The Federal Circuit emphasized that, “as a general matter, once the high threshold for lexicography is met in a patent, it makes sense that a high threshold would have to be met before finding a departure from that controlling definition.” According to the court, there must be a “clear reason” to depart from the definition in the specification. The Federal Circuit found no such reason and therefore upheld the claim construction and, accordingly, the stipulated judgment of noninfringement.
Dolby Laboratories Licensing Corp. v. Unified Patents, LLC, No. 2023-2110 (Fed. Cir. (PTAB) June 5, 2025). Opinion by Moore, joined by Clevenger and Chen.
Unified filed an IPR petition challenging certain claims of a Dolby patent directed to a prediction method using an in-loop filter. In the petition, Unified certified it was the sole real party in interest (RPI). In response, Dolby identified nine other entities it believed should have been named as RPIs.
The Patent Trial and Appeal Board declined to adjudicate the RPI dispute, explaining that such a determination was unnecessary because there was no evidence any of the alleged RPIs were time-barred or estopped under 35 U.S.C. § 315 from bringing the IPR or that Unified purposefully omitted any of the alleged RPIs to gain an advantage. The Board then held that Unified failed to show any of the challenged claims were unpatentable.
Dolby appealed the Board’s refusal to adjudicate the RPI dispute. But the Federal Circuit held that Dolby failed to establish an injury in fact sufficient to confer standing and therefore dismissed the appeal.
Dolby raised three reasons why it had standing to appeal the Board’s refusal to adjudicate the RPI dispute: (1) the statutory right of a “dissatisfied” party under 35 U.S.C. § 319, (2) the violation of Dolby’s statutory right to information under 35 U.S.C. § 312(a)(2), and (3) various harms stemming from the Board’s refusal. The Federal Circuit concluded that Dolby failed to establish standing on any of these grounds.
First, the court disagreed that § 319 confers standing because “it is well established that a statutory right to appeal under the America Invents Act (AIA) does not obviate the requirement for Article III standing.” Second, the Federal Circuit explained that even if patent owners have a right under § 312(a)(2) to have RPI disputes adjudicated, “such a right only arises in the context of IPR proceedings; there is no freestanding right to that information.” Third, each of the various harms identified by Dolby—such as potential breach of license agreements by the alleged RPIs—were “too speculative to establish Article III standing.” The Federal Circuit therefore dismissed the appeal.