Moderna Beats Alnylam Appeal In COVID Vaccine Patent Case

The U.S. Court of Appeals for the Federal Circuit (CAFC) on Wednesday affirmed a district court’s finding of noninfringement in favor of Moderna, Inc. MRNA in its ongoing patent battle with Alnylam Pharmaceuticals Inc ALNY over mRNA-based COVID-19 vaccine technology, including its Spikevax COVID-19 vaccine.

The court held that Alnylam had acted as its lexicographer in defining the term “branched alkyl” in its patent specifications. That definition was included in Alnylam’s infringement allegations against Moderna’s Spikevax vaccine.

The case centered on whether Alnylam’s patents, U.S. Patent Nos. 11,246,933 and 11,382,979 were infringed by Moderna’s use of SM-102-a cationic lipid in Moderna’s COVID-19 vaccine formulations.

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Alnylam asserted that SM-102 fell within the scope of its claims, specifically limitations requiring a “branched alkyl” group in the hydrophobic tail of a cationic lipid. SM-102 enables intracellular delivery of mRNA in Moderna’s vaccine, making it central to Alnylam’s infringement theory.

In March 2022, Alnylam sued Moderna, alleging that Moderna infringed claim 18 and other claims of the '933 patent through activities involving the SM-102 lipid in its mRNA-based COVID-19 vaccine.

In July 2022, after the '979 patent was issued, Alnylam filed a similar suit against Moderna in the same forum, alleging infringement of claim 1 and other claims of the '979 patent. The two actions were consolidated.

In October 2024, Alnylam and Moderna reached a stipulation in their ongoing patent infringement litigation.

Based on the court’s claim construction, Alnylam acknowledged it couldn’t secure a favorable judgment regarding the accused products’ infringement of its patents.

The final stipulation allows for judgment in favor of Moderna, confirming that its currently formulated products do not infringe on Alnylam’s patents.

Both parties have agreed to dismiss the counterclaims and affirmative defenses raised by Moderna without prejudice, leaving the door open for further legal action if necessary in the future.

In October 2024, Northwestern University filed a patent infringement lawsuit against Moderna, alleging the pharmaceutical company used the university’s lipid nanoparticle (LNP) technology without permission to develop its COVID-19 vaccines.

According to the lawsuit, the development of Moderna’s COVID-19 vaccine, Spikevax, depended on key technological advancements made at Northwestern.

Recently, The U.S. Food and Drug Administration (FDA) approved Moderna’s mNexspike (mRNA-1283), a new vaccine against COVID-19, for all adults 65 and older and individuals aged 12-64 years with at least one or more underlying risk factors as defined by the Centers for Disease Control and Prevention (CDC).

Moderna shared Phase 3 immunogenicity data for its flu/COVID combination vaccine (mRNA-1083) for adults aged 50 and older at its 2024 R&D Day event. 

The company submitted mRNA-1083 for regulatory approval in older adults in 2024. Based on FDA feedback confirming the need for Phase 3 flu efficacy data, Moderna expects an extended review timeline and is now targeting approval in 2026.

Price Action: MRNA stock is down 1.32% at $26.91, and ALNY stock is up 0.69% at $307.43 at last check on Thursday.

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