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.
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.
Filing to Appeal Dismissed in 636 days
636 days at the Federal Circuit — longer than the median LNP patent appeal
Federal Circuit affirms: what the ruling means for both parties
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 foundAlnylam’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 levelsModerna 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 confirmedmRNA 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 setFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Alnylam Pharmaceuticals, Inc. | Company | Biopharmaceutical company — holder of US11246933B1 and US11382979B2, LNP mRNA delivery patentsSearch in Eureka ↗ |
| Defendant | MODERNA, INC. | Company | Moderna, Inc. and affiliates — developer and marketer of SPIKEVAX® mRNA COVID-19 vaccineSearch in Eureka ↗ |
| Co-Defendant | Moderna US, Inc. | Company | Search in Eureka ↗ |
| Co-Defendant | ModernaTX, Inc. | Company | Search in Eureka ↗ |
| Plaintiff counsel | Bhanu Sadasivan Ph.D. | Attorney | Counsel for Alnylam Pharmaceuticals, Inc.Search in Eureka ↗ |
| Plaintiff counsel | Ian Barnett Brooks | Attorney | Counsel for Alnylam Pharmaceuticals, Inc.Search in Eureka ↗ |
| Plaintiff counsel | Paul Whitfield Hughes, III | Attorney | Counsel for Alnylam Pharmaceuticals, Inc.Search in Eureka ↗ |
| Plaintiff counsel | Sarah Chapin Columbia | Attorney | Counsel for Alnylam Pharmaceuticals, Inc.Search in Eureka ↗ |
| Plaintiff counsel | Sarah J. Fischer | Attorney | Counsel for Alnylam Pharmaceuticals, Inc.Search in Eureka ↗ |
| Plaintiff counsel | William G. Gaede III | Attorney | Counsel for Alnylam Pharmaceuticals, Inc.Search in Eureka ↗ |
| Plaintiff law firm | McDermott Will & Emery LLP | Law Firm | Representing Alnylam Pharmaceuticals, Inc.Search in Eureka ↗ |
| Defendant counsel | Elizabeth M. Flanagan | Attorney | Counsel for MODERNA, INC.Search in Eureka ↗ |
| Defendant counsel | Geoffrey Donovan Biegler | Attorney | Counsel for MODERNA, INC.Search in Eureka ↗ |
| Defendant counsel | Jeffrey A. Lamken | Attorney | Counsel for MODERNA, INC.Search in Eureka ↗ |
| Defendant counsel | Sara Margolis | Attorney | Counsel for MODERNA, INC.Search in Eureka ↗ |
| Defendant counsel | Sara Tofighbakhsh | Attorney | Counsel for MODERNA, INC.Search in Eureka ↗ |
| Defendant counsel | W. Chad Shear | Attorney | Counsel for MODERNA, INC.Search in Eureka ↗ |
| Defendant law firm | Cooley LLP | Law Firm | Representing MODERNA, INC.Search in Eureka ↗ |
| Defendant law firm | MoloLamken LLP | Law Firm | Representing MODERNA, INC.Search in Eureka ↗ |
| Presiding judge | Judge N/A | Judge | Court of Appeals for the Federal CircuitSearch in Eureka ↗ |
Official order — verbatim text
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.
US11246933B1 & US11382979B2 — lipid nanoparticle mRNA delivery technology
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.
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.
Run a freedom-to-operate analysis on US11246933B1 to assess your product’s exposure
Run FTO in Eureka →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.
Related patent case — similar technology
Comparable case in the same technology domain. Patent holder and defendant reached resolution after proceedings.
SettledRelated infringement action — same court
Comparable mRNA-based COVID-19 vaccine SPIKEVAX®-adjacent infringement action. Patent enforcement dynamics analysed in depth.
Active · District CourtRelated invalidity challenge — appellate outcome
Combined invalidity and infringement action in the same technology space. Decided after substantive proceedings.
DecidedAlnylam Pharmaceuticals, Inc.’s broader IP enforcement history
Alnylam Pharmaceuticals, Inc.’s full litigation history covering prior enforcement, licensing activity, and inter partes review proceedings.
Portfolio viewWhat 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.
How Moderna’s dual-firm defence strategy shaped the appellate outcome
Moderna deployed both Cooley LLP and MoloLamken LLP — a pairing that combines deep biotech patent expertise with elite appellate litigation capability. This dual-firm structure is increasingly common in high-stakes Federal Circuit matters and may have contributed to the panel’s finding that Alnylam’s arguments were unpersuasive across the board.
Which other LNP patent families carry similar infringement exposure for mRNA vaccine makers
Beyond Alnylam’s US11246933B1 and US11382979B2, related LNP patent families from Arbutus, Acuitas, and MIT-licensed portfolios may carry comparable claim scope against SPIKEVAX® and competing mRNA platforms. FTO teams should map these families against current formulation parameters before the next product generation launches.
Alnylam v MODERNA — key questions answered
The Federal Circuit affirmed the district court’s decision in full on 4 June 2025. The panel considered all remaining arguments raised by Alnylam Pharmaceuticals and found them unpersuasive, issuing a clean affirmance with no remand. The case concerned alleged infringement of US11246933B1 and US11382979B2 by Moderna’s SPIKEVAX® COVID-19 vaccine.
Alnylam asserted two patents: US11246933B1 (application 17/302311) and US11382979B2 (application 17/644907). Both patents relate to lipid nanoparticle (LNP) compositions and delivery methods for mRNA — the core delivery technology enabling SPIKEVAX® and other mRNA-based vaccines and therapeutics.
The affirmance leaves the district court’s ruling intact, providing Moderna with greater legal certainty regarding SPIKEVAX® and the two Alnylam LNP patents in suit. Moderna successfully defended at both trial and appellate levels. The decision may also strengthen Moderna’s position in related licensing negotiations involving Alnylam’s broader LNP portfolio.
Alnylam’s options at this stage are limited but not entirely exhausted. It could seek en banc rehearing at the Federal Circuit or petition the Supreme Court for certiorari — both face very high bars following a clear affirmance. Alnylam may also pursue Moderna through related continuation patents or divisional applications covering differentiated LNP claim scope, though those would require fresh litigation.
Alnylam was represented by McDermott Will & Emery LLP, with counsel including Paul Whitfield Hughes III, Sarah Chapin Columbia, William G. Gaede III, and others. Moderna deployed a dual-firm structure: Cooley LLP and MoloLamken LLP, with Jeffrey A. Lamken, W. Chad Shear, Geoffrey Donovan Biegler, and others serving as counsel.
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.
PatSnap Eureka searches patents and litigation data to answer instantly.