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.”

The Court’s opinion can be found here.

By Jeff Liao

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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.

The opinion can be found here.

By Jason A. Wrubleski

This article summarizes aspects of the law and does not constitute legal advice. For legal advice with regard to your situation, you should contact an attorney.