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Alnylam v. Moderna: Federal Circuit Affirms LNP Patent Ruling | PatSnap
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Case ID23-2357
FiledSep 2023
ClosedJun 2025
Patent Litigation

Alnylam v. Moderna: Federal Circuit Affirms LNP Patent Decision (Case 23-2357)

Alnylam Pharmaceuticals challenged Moderna’s SPIKEVAX® COVID-19 vaccine across two lipid nanoparticle delivery patents (US11246933B1 and US11382979B2). The Federal Circuit found no reversible error and affirmed the district court’s decision in full — closing a 636-day appellate contest over foundational mRNA delivery IP.

Resolution time
636days
636 days at the Federal Circuit — longer than the median LNP patent appeal
Patents asserted
2
US11246933B1 and US11382979B2 — lipid nanoparticle mRNA delivery technology
Outcome
Appeal Dismissed
Federal Circuit found no reversible error; district court decision stands in full
Cost ruling
Each party bears own
No cost award specified in Federal Circuit disposition; standard appellate practice applies
Published by PatSnap Insights Team · Verified by PatSnap Eureka Data
Case overview

Federal Circuit closes Alnylam’s LNP challenge against Moderna’s SPIKEVAX®

Alnylam Pharmaceuticals, Inc. filed this appeal at the Court of Appeals for the Federal Circuit on 7 September 2023, targeting Moderna, Inc. and its affiliates Moderna US, Inc. and ModernaTX, Inc. The dispute centres on two patents — US11246933B1 and US11382979B2 — which cover lipid nanoparticle (LNP) compositions and delivery methods central to mRNA-based therapeutics, and which Alnylam asserted were infringed by Moderna’s COVID-19 vaccine, SPIKEVAX®. The case represents one of a series of high-stakes IP battles in the mRNA delivery space following the commercial explosion of COVID-19 vaccines.

The Federal Circuit issued its affirmance on 4 June 2025, adopting the district court’s outcome in full. The panel considered Alnylam’s remaining arguments and found them unpersuasive, affirming without remand. For Moderna, the ruling means the district court’s original disposition remains intact and SPIKEVAX® continues to operate under whatever legal status the lower court established. Alnylam’s infringement claims on these two LNP patents have now been resolved adversely at both the trial and appellate levels.

A 636-day appellate duration suggests substantive briefing and deliberation rather than a rapid procedural dismissal, consistent with the technical complexity of LNP claim construction arguments. The public record does not disclose whether any licensing discussions ran parallel to the appeal, nor whether Alnylam intends to seek en banc rehearing or certiorari — options that remain theoretically available but face a high bar following a unanimous affirmance.

Case at a glance
Case no.23-2357
DefendantMODERNA, INC.
CourtCourt of Appeals for the Federal Circuit
JudgeN/A
FiledSeptember 7, 2023
ClosedJune 4, 2025
Duration636 days
OutcomeAppeal Dismissed
Verdict causeInfringement Action
BasisAppeal Dismissed
Prior Art Intelligence
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Case data sourced from PACER / Court of Appeals for the Federal Circuit via PatSnap Eureka Litigation Intelligence Explore similar cases ↗
Case timeline

Filing to Appeal Dismissed in 636 days

636 days at the Federal Circuit — longer than the median LNP patent appeal

Case timeline: Appeal filed SEP 7 2023, JUL–AUG — 636 days total Horizontal timeline showing the three key events in Alnylam Pharmaceuticals, Inc. v MODERNA, INC. from filing to resolution. Source: PACER, Court of Appeals for the Federal Circuit. SEP 7 2023 Appeal filed Pre-trial proceedings JUN 4 2025 Appeal Dismissed 636 DAYS TOTAL
Court ruling

Federal Circuit affirms: what the ruling means for both parties

Legal mechanism

What ‘AFFIRMED’ means at the Federal Circuit

An affirmance by the Federal Circuit means the appellate panel found no reversible error in the district court’s legal reasoning or factual findings. The lower court’s decision is left fully intact. The court explicitly noted it considered all of Alnylam’s remaining arguments and found them unpersuasive — signalling a substantive, not merely procedural, endorsement of the result below. No remand was ordered.

No reversible error found
Patent holder outcome

Alnylam’s LNP patents fail to overcome Federal Circuit review

For Alnylam, the affirmance represents the exhaustion of appeal-level options on US11246933B1 and US11382979B2 as asserted against SPIKEVAX®. The patents themselves remain in force but their enforceability against Moderna’s specific vaccine is now resolved adversely at two court levels. Alnylam may theoretically seek en banc rehearing or Supreme Court certiorari, though the bar for both is exceptionally high following a clear Federal Circuit affirmance.

Adverse outcome at two levels
Challenger outcome

Moderna secures appellate confirmation for SPIKEVAX® freedom

Moderna and its affiliates emerge from this appeal with the district court’s ruling affirmed, providing greater legal certainty for SPIKEVAX® commercialisation with respect to the two Alnylam LNP patents in suit. The Federal Circuit’s unequivocal affirmance strengthens Moderna’s position in any related licensing negotiations and raises the evidentiary bar should Alnylam attempt to assert closely related LNP claims through continuation patents or parallel proceedings.

SPIKEVAX® LNP position confirmed
Commercial implications

mRNA sector IP landscape shifts as foundational LNP claims are tested

The affirmance contributes to a growing body of Federal Circuit precedent on LNP patent scope — a technology area that underpins not only COVID-19 vaccines but a broad pipeline of mRNA therapeutics. Competitors, licensees, and FTO analysts should note that the specific claim constructions or validity findings upheld here may inform how courts treat overlapping LNP patent families across the sector. The ruling suggests courts are scrutinising broad LNP infringement theories with rigour.

LNP patent scope precedent set
Legal analysis based on PACER docket records for case 23-2357 and PatSnap Eureka litigation intelligence Search PatSnap Eureka ↗
Parties and representation

Full party and counsel information

RoleNameTypeDetail
PlaintiffAlnylam Pharmaceuticals, Inc.CompanyBiopharmaceutical company — holder of US11246933B1 and US11382979B2, LNP mRNA delivery patentsSearch in Eureka ↗
DefendantMODERNA, INC.CompanyModerna, Inc. and affiliates — developer and marketer of SPIKEVAX® mRNA COVID-19 vaccineSearch in Eureka ↗
Co-DefendantModerna US, Inc.CompanySearch in Eureka ↗
Co-DefendantModernaTX, Inc.CompanySearch in Eureka ↗
Plaintiff counselBhanu Sadasivan Ph.D.AttorneyCounsel for Alnylam Pharmaceuticals, Inc.Search in Eureka ↗
Plaintiff counselIan Barnett BrooksAttorneyCounsel for Alnylam Pharmaceuticals, Inc.Search in Eureka ↗
Plaintiff counselPaul Whitfield Hughes, IIIAttorneyCounsel for Alnylam Pharmaceuticals, Inc.Search in Eureka ↗
Plaintiff counselSarah Chapin ColumbiaAttorneyCounsel for Alnylam Pharmaceuticals, Inc.Search in Eureka ↗
Plaintiff counselSarah J. FischerAttorneyCounsel for Alnylam Pharmaceuticals, Inc.Search in Eureka ↗
Plaintiff counselWilliam G. Gaede IIIAttorneyCounsel for Alnylam Pharmaceuticals, Inc.Search in Eureka ↗
Plaintiff law firmMcDermott Will & Emery LLPLaw FirmRepresenting Alnylam Pharmaceuticals, Inc.Search in Eureka ↗
Defendant counselElizabeth M. FlanaganAttorneyCounsel for MODERNA, INC.Search in Eureka ↗
Defendant counselGeoffrey Donovan BieglerAttorneyCounsel for MODERNA, INC.Search in Eureka ↗
Defendant counselJeffrey A. LamkenAttorneyCounsel for MODERNA, INC.Search in Eureka ↗
Defendant counselSara MargolisAttorneyCounsel for MODERNA, INC.Search in Eureka ↗
Defendant counselSara TofighbakhshAttorneyCounsel for MODERNA, INC.Search in Eureka ↗
Defendant counselW. Chad ShearAttorneyCounsel for MODERNA, INC.Search in Eureka ↗
Defendant law firmCooley LLPLaw FirmRepresenting MODERNA, INC.Search in Eureka ↗
Defendant law firmMoloLamken LLPLaw FirmRepresenting MODERNA, INC.Search in Eureka ↗
Presiding judgeJudge N/AJudgeCourt of Appeals for the Federal CircuitSearch in Eureka ↗
Official verdict

Official order — verbatim text

“We have considered Alnylam’s remaining arguments and find them unpersuasive. We affirm the decision of the district court. AFFIRMED”
Source: PACER Docket, Case 23-2357, Court of Appeals for the Federal Circuit

The Federal Circuit’s disposition — ‘We have considered Alnylam’s remaining arguments and find them unpersuasive. We affirm the decision of the district court’ — is notable for its directness. At the appellate level, the court applies a deferential standard to factual findings (clear error) while reviewing claim construction and legal conclusions de novo. The panel’s categorical dismissal of all remaining arguments, without remand or qualification, suggests Alnylam’s positions failed under both standards. The word ‘remaining’ implies earlier arguments were addressed in the body of the opinion, reinforcing the substantive depth of the court’s analysis.

PACER case 23-2357 · Public docket record Explore in Eureka ↗
Patent at issue

US11246933B1 & US11382979B2 — lipid nanoparticle mRNA delivery technology

Publication No.US11246933B1
Application No.US17/302311
Patent details
ProductLipid nanoparticle compositions for mRNA delivery
Cited in actionSeptember 7, 2023

Publication No.US11382979B2
Application No.US17/644907
Patent details
ProductLipid nanoparticle formulations and methods of use in mRNA therapeutics
Cited in actionSeptember 7, 2023

US11246933B1 (application 17/302311) and US11382979B2 (application 17/644907) both relate to lipid nanoparticle (LNP) technology — the delivery system that encapsulates mRNA molecules and enables their uptake by human cells. LNPs are the critical enabling layer of mRNA therapeutics: without effective delivery, mRNA degrades before reaching its target. These patents protect specific compositions and methods within this delivery framework, and their application filing dates place them in the intense innovation period surrounding the development of mRNA COVID-19 vaccines.

LNP delivery patents sit at the nexus of some of the most commercially significant IP disputes in modern biopharmaceutical history. Alnylam, as a pioneer in RNA interference therapeutics, holds a substantial LNP portfolio that it has actively licensed and enforced. The assertion of these patents against SPIKEVAX® — one of the highest-revenue pharmaceutical products globally — illustrates the enormous commercial stakes attached to foundational LNP IP. Any company developing mRNA vaccines, therapeutics, or gene editing products that rely on LNP delivery should treat this patent family as a priority for FTO analysis.

Patent data sourced from USPTO via PatSnap Eureka patent database Search patent records in Eureka ↗
Freedom to operate

Should your mRNA platform team run an FTO against US11246933B1 and US11382979B2?

Any organisation developing or commercialising mRNA-based products — including vaccines, oncology therapeutics, rare disease treatments, or gene editing platforms — that uses lipid nanoparticle delivery systems should assess exposure to Alnylam’s LNP portfolio. While the Federal Circuit’s affirmance resolves these patents as applied to SPIKEVAX®, the patents remain in force and may be asserted against different product formulations or distinct mRNA applications. The district court’s claim constructions are now reinforced by the appellate decision, making this a critical moment to map your LNP formulations against upheld claim scope.

PatSnap Eureka’s FTO Search Agent can map US11246933B1 and US11382979B2 against your specific LNP formulation parameters, identify claim elements most likely to read on your platform, and surface related Alnylam continuation filings that may present future risk. Eureka also tracks prosecution history and file wrapper data for both application numbers — 17/302311 and 17/644907 — providing the granular claim-level insight that product and IP teams need before advancing to clinical or commercial stage.

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Run a freedom-to-operate analysis on US11246933B1 to assess your product’s exposure

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Related litigation

Similar Federal Circuit LNP and mRNA patent infringement appeals

Cases involving lipid nanoparticle and mRNA delivery patent disputes before the Federal Circuit, including related Alnylam enforcement actions and COVID-19 vaccine IP litigation.

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Alnylam Pharmaceuticals, Inc. patent enforcement history, Court of Appeals for the Federal Circuit case history, Alnylam Pharmaceuticals, Inc.’s full IP portfolio, and comparable case analysis
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Strategic implications

What this case signals for the mRNA therapeutics IP landscape

Two Federal Circuit-tested LNP patents, a failed affirmance challenge, and a sector watching closely: here is what practitioners need to act on.

LNP patent assertions face a high bar at the Federal Circuit

The Federal Circuit’s unequivocal affirmance — dismissing all remaining Alnylam arguments as unpersuasive — signals that broadly asserted LNP infringement theories will be scrutinised carefully at every level. Patent holders in the mRNA delivery space should ensure claim construction positions are airtight before pursuing high-profile enforcement actions.

Continuation strategies remain Alnylam’s most plausible next move

With US11246933B1 and US11382979B2 now resolved adversely against Moderna at appeal level, Alnylam’s most commercially relevant path likely involves continuation patents or divisional applications with narrowed or differentiated claims. Practitioners monitoring this space should track new Alnylam LNP filings originating from applications 17/302311 and 17/644907.

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Full strategic analysis in PatSnap Eureka
Unlock gated insights on LNP patent strategy and Federal Circuit appellate risk for the mRNA therapeutics sector.
Continuation patent riskCompeting LNP portfoliosLicensing leverage shift
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Frequently asked questions

Alnylam v MODERNA — key questions answered

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Track the mRNA LNP patent landscape before your next programme advances

The Federal Circuit’s affirmance in Alnylam v. Moderna makes LNP claim scope a live risk for any mRNA platform. Use PatSnap Eureka to run real-time FTO analysis on US11246933B1 and US11382979B2 and monitor related Alnylam filings.

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