Fresh From the Bench Cases

Alnylam Pharmaceuticals, Inc. v. Moderna, Inc., Appeal No. 2023-2357 (Fed. Cir. June 4, 2025)‎

In this week’s Case of the Week, the Federal Circuit affirmed a final judgment that Moderna’s mRNA-‎based COVID-19 vaccine did not infringe Alnylam Pharmaceuticals’ U.S. Patent Nos. 11,246,933 and ‎‎11,382,979.  The parties had stipulated to non-infringement under the district court’s claim construction, ‎and in its precedential opinion, the Federal Circuit agreed with the lower court that Alnylam acted as its ‎own lexicographer in defining the claim term “branched alkyl.”‎

The patents-at-issue are directed to “biodegradable lipids and . . . their use for the delivery of active ‎agents such as nucleic acids.”  The patents explain that “lipid nanoparticles used to deliver nucleic acids ‎can be formed from cationic lipids,” and claim lipids which includes a “head group,” a “central moiety,” ‎and “hydrophobic tails” including at least one “branched alkyl, where the branching occurs at the α-‎position… .”  With respect to the “branched alkyl,” the parties disagreed over “the degree of branching” ‎required.  While Moderna and the district court relied on a definition set forth in the patents’ specification ‎to construe a “branched alkyl” as requiring one carbon atom that “is bound to at least three other carbon ‎atoms;” Alnylam argued that its claims required only a carbon atom bound to  “at least two other carbon ‎atoms.”  Alnylam’s broader proposed construction was consistent with the ordinary meaning of a ‎‎“branched alkyl,” i.e. “a saturated hydrocarbon moiety that is not a straight chain … [with] a branched ‎C10-C20 alkyl [that] contains 10 to 20 carbon atoms.”‎

On appeal, Alnylam argued that the district court erred in holding that Alnylam acted as its own ‎lexicographer.  The Court disagreed, relying on four indicators from the patents’ specification: section ‎title, quotation marks, reference terms, and consistency.  The Court found that Alnylam placed the ‎purported definition under a section titled “Definitions;” used quotation marks to prime the reader that ‎the words within were going to be defined; used the term “refer to,” which conveys an intent for the ‎sentence to be definitional; used the phrase “unless otherwise specified,” which suggests a definition to ‎follow; and consistently used other “non-limiting terms” that contrasted with the term “refer to.”‎

In reaching its conclusion, the Court rejected Alnylam’s argument that the patent “otherwise specified” ‎an alternative definition.  For example, Alnylam argued that a dependent claim requiring the branched ‎alkyl group to have one carbon atom bound to three other carbon atoms implied that the independent ‎claim is broader in scope, and so should cover a carbon atom bound to “two other carbon ‎atoms.”  However, the Court first reasoned that the claims read in light of the definition “do[] not show ‎that the claims make no sense.”  Moreover, the Court disagreed that the dependent claim necessarily ‎implied that the independent claim includes the “at least two” interpretation, noting that during ‎prosecution the applicant had distinguished prior art by stating the prior art requires “three carbon atoms ‎which are bound to three other carbon atoms,” whereas the claim at issue required “only one carbon ‎atom which is bound to three other carbon atoms.”  The Court further noted that although the patents ‎disclosed an example with the α-position carbon bound to only two other carbon atoms, Alnylam itself ‎had initially argued that the example fell outside the asserted claims, and the Court agreed the claims ‎did not direct a POSITA to that example.  The Court considered Alnylam’s various other arguments, but ‎concluded that cited examples lacked the required “specificity to establish an exception” given the ‎‎“express definition in the specification.”‎

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Dolby Laboratories Licensing Corporation v. Unified Patents, LLC, Appeal No. 2023-2110 (Fed. Cir. June 5, ‎‎2025)‎

Following an inter partes review in which all challenged claims of its own patent were upheld, prevailing ‎patentee Dolby sought to appeal the Patent Trial and Appeal Board’s declination to adjudicate whether ‎multiple entities identified by Dolby were “real parties in interest” (RPIs) to the proceeding.  While Dolby ‎sought to confirm the membership of petitioner Unified Patents, the Board had followed its practice of ‎only adjudicating RPI disputes when the result would be material to the proceeding.  The Federal Circuit ‎dismissed Dolby’s appeal for failure to establish an injury-in-fact sufficient to confer Article III ‎standing.  Among other things, the Court held that 35 U.S.C. § 312(a)(2) does not create a free-standing ‎‎“informational right” to know the identities of all RPIs, and found that Dolby’s asserted injuries—such as ‎the possibility that the alleged RPIs may be breaching license agreements—too speculative to confer ‎standing to appeal.

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Editors:

Nika Aldrich, IP Litigation Group Leader, Schwabe

Jason A. Wrubleski, Shareholder

Contributor:

Jeff Liao, Associate