DCT

2:26-cv-08697

Translate Bio Inc v. Pfizer Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:26-cv-08697, D.N.J., 07/14/2026
  • Venue Allegations: Venue is alleged to be proper based on Defendant Pfizer Inc. maintaining at least two regularly established places of business in the District of New Jersey, and Defendant Pharmacia & Upjohn Co. LLC residing in the district.
  • Core Dispute: Plaintiff alleges that Defendant's COMIRNATY® COVID-19 vaccine infringes eight patents relating to messenger RNA (mRNA) delivery compositions, methods for achieving sustained in vivo protein expression from mRNA, and methods for mRNA purification.
  • Technical Context: The technology at issue involves the delivery of mRNA using lipid nanoparticles (LNPs) to induce protein expression in vivo and the purification of synthesized mRNA, a foundational technology for a class of modern vaccines and therapeutics.
  • Key Procedural History: The complaint notes that Plaintiff Translate Bio was acquired by Plaintiff Sanofi in 2021 to support Sanofi's mRNA vaccine development work. Translate Bio and Sanofi had an existing collaboration on mRNA vaccines beginning in 2018.

Case Timeline

Date Event
2011-06-08 Priority Date for '754, '618, '734, '044, '764 Patents
2013-03-14 Priority Date for '554 Patent
2014-04-25 Priority Date for '269, '841 Patents
2017-12-26 '269 Patent Issued
2019-03-26 '754 Patent Issued
2019-09-17 '618 Patent Issued
2020-03-17 Pfizer and BioNTech announce joint COVID-19 vaccine development
2020-12-11 FDA grants Emergency Use Authorization (EUA) for Pfizer-BioNTech vaccine
2021-07-13 '841 Patent Issued
2021-08-23 FDA grants full approval for COMIRNATY®
2022-04-05 '734 Patent Issued
2022-05-24 '044 Patent Issued
2023-01-10 '764 Patent Issued
2026-03-17 '554 Patent Issued
2026-07-14 Complaint Filing Date

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 10,238,754 - "Lipid Nanoparticle Compositions and Methods for mRNA Delivery"

  • Patent Identification: U.S. Patent No. 10,238,754, "Lipid Nanoparticle Compositions and Methods for mRNA Delivery," issued March 26, 2019 Compl. ¶34

The Invention Explained

  • Problem Addressed: The patent's background section describes the difficulty in achieving significant and sustained levels of a desired protein in the bloodstream using prior nucleic acid delivery methods, as well as the inherent instability of mRNA, which makes it prone to degradation and limits its therapeutic utility Compl. ¶23 Compl. ¶26 '754 Patent, col. 2:1-64
  • The Patented Solution: The invention provides a method for delivering mRNA encapsulated in a lipid nanoparticle (LNP) to a human, which results in the sustained in vivo production of the encoded protein. This creates a "depot effect," where target cells continuously produce and secrete the protein, allowing it to be detectable in the serum for an extended period of at least 72 hours after administration '754 Patent, abstract '754 Patent, col. 3:1-10 '754 Patent, col. 4:26-48
  • Technical Importance: This approach provided a method to overcome the short half-life of mRNA, enabling its use for therapies requiring sustained protein levels, a significant advance beyond applications like vaccines that only require transient expression '754 Patent, col. 2:51-64

Key Claims at a Glance

  • The complaint asserts independent claim 1 Compl. ¶36
  • Claim 1 of the '754 Patent includes the following essential elements:
    • A method for delivery of messenger RNA (mRNA) for in vivo production of a protein or a peptide,
    • comprising administering to a human, a composition comprising an mRNA that encodes a protein or a peptide,
    • wherein the mRNA is encapsulated within a lipid nanoparticle,
    • and wherein the administering of the composition results in expression of the protein or peptide encoded by the mRNA that is detectable in serum at least 72 hours after administration,
    • wherein the lipid nanoparticle comprises one or more PEG-modified lipids.

U.S. Patent No. 10,413,618 - "Lipid Nanoparticle Compositions and Methods for mRNA Delivery"

  • Patent Identification: U.S. Patent No. 10,413,618, "Lipid Nanoparticle Compositions and Methods for mRNA Delivery," issued September 17, 2019 Compl. ¶38

The Invention Explained

  • Problem Addressed: Similar to the '754 Patent, the '618 Patent addresses the challenge of using historically unstable mRNA to achieve sustained, therapeutic levels of protein production in vivo '618 Patent, col. 2:1-64
  • The Patented Solution: The patented method involves administering an LNP-encapsulated mRNA to a human, which results in the detectable expression of the encoded protein in the serum for at least 72 hours. This sustained expression is described as a "depot effect," where transfected cells serve as a source for continuous protein production into the circulatory system '618 Patent, abstract '618 Patent, col. 3:1-10
  • Technical Importance: The invention provided a method for achieving prolonged in vivo protein expression from an mRNA therapeutic, a significant hurdle that had previously limited mRNA's application to diseases requiring more than transient protein presence '618 Patent, col. 2:51-64

Key Claims at a Glance

  • The complaint asserts independent claim 1 Compl. ¶40
  • Claim 1 of the '618 Patent includes the following essential elements:
    • A method for delivery of messenger RNA (mRNA) for in vivo production of a protein,
    • comprising administering, to a human, a composition comprising an mRNA that encodes the protein,
    • wherein the mRNA is encapsulated within a lipid nanoparticle,
    • wherein the administering of the composition results in expression of the protein encoded by the mRNA that is detectable in serum at least 72 hours after administration,
    • and wherein the lipid nanoparticle comprises one or more PEG-modified lipids.

U.S. Patent No. 11,291,734 ('734 Patent) - "Lipid Nanoparticle Compositions and Methods for mRNA Delivery"

  • Patent Identification: "Lipid Nanoparticle Compositions and Methods for mRNA Delivery," issued April 5, 2022 Compl. ¶42
  • Technology Synopsis: The patent claims methods for delivering LNP-encapsulated mRNA to produce a protein. It is distinguished by the functional outcome that the protein is detectable in a target tissue for at least 48 hours after administration Compl. ¶43
  • Asserted Claims: The complaint asserts independent claim 1 Compl. ¶44
  • Accused Features: The administration of the COMIRNATY® vaccine is alleged to result in the expression of the spike protein in a target tissue for at least 48 hours Compl. ¶75 Compl. ¶80

U.S. Patent No. 11,338,044 ('044 Patent) - "Lipid Nanoparticle Compositions and Methods for mRNA Delivery"

  • Patent Identification: "Lipid Nanoparticle Compositions and Methods for mRNA Delivery," issued May 24, 2022 Compl. ¶46
  • Technology Synopsis: The patent claims a method of delivering mRNA encapsulated in an LNP, where the LNP has specific molar ratios of its lipid components: greater than 1% PEG-modified lipid, greater than 10% cationic lipid, greater than 5% non-cationic lipid (DOPE or DSPC), and greater than 10% cholesterol Compl. ¶47 Compl. ¶48
  • Asserted Claims: The complaint asserts independent claim 1 Compl. ¶48
  • Accused Features: The LNP in the COMIRNATY® vaccine is alleged, on information and belief, to have the claimed molar ratios of lipids Compl. ¶85

U.S. Patent No. 11,547,764 ('764 Patent) - "Lipid Nanoparticle Compositions and Methods for mRNA Delivery"

  • Patent Identification: "Lipid Nanoparticle Compositions and Methods for mRNA Delivery," issued January 10, 2023 Compl. ¶50
  • Technology Synopsis: The patent claims a composition comprising an mRNA encapsulated in an LNP of a specific size (<150 nm) and with specific lipid ratios. The claim also requires the mRNA itself to have certain structural attributes: a 5'-UTR, a 3'-UTR, a 5' cap, and a poly A tail Compl. ¶51 Compl. ¶52
  • Asserted Claims: The complaint asserts independent claim 1 Compl. ¶52
  • Accused Features: The COMIRNATY® vaccine is alleged to be a composition that meets the LNP size, lipid ratio, and mRNA structure limitations of the claim Compl. ¶¶82-86

U.S. Patent No. 9,850,269 ('269 Patent) - "Methods for Purification of Messenger RNA"

  • Patent Identification: "Methods for Purification of Messenger RNA," issued December 26, 2017 Compl. ¶54
  • Technology Synopsis: The patent claims a composition of in vitro synthesized mRNA that is highly purified, containing less than 1% of prematurely aborted RNA sequences and/or enzyme reagents from the synthesis process Compl. ¶55
  • Asserted Claims: The complaint asserts independent claim 14 Compl. ¶56
  • Accused Features: The COMIRNATY® vaccine is alleged to contain mRNA purified to a level that meets the "less than 1%" impurity limitation Compl. ¶87 Compl. ¶90

U.S. Patent No. 11,059,841 ('841 Patent) - "Methods for Purification of Messenger RNA"

  • Patent Identification: "Methods for Purification of Messenger RNA," issued July 13, 2021 Compl. ¶58
  • Technology Synopsis: The patent claims a composition of in vitro synthesized mRNA containing less than 5% of prematurely aborted RNA sequences and/or enzyme reagents from the synthesis process Compl. ¶59 This impurity threshold is less stringent than that of the '269 Patent.
  • Asserted Claims: The complaint asserts independent claim 18 Compl. ¶60
  • Accused Features: The COMIRNATY® vaccine is alleged to contain mRNA purified to a level that meets the "less than 5%" impurity limitation Compl. ¶87 Compl. ¶90

U.S. Patent No. 12,577,554 ('554 Patent) - "Methods for Purification of Messenger RNA"

  • Patent Identification: "Methods for Purification of Messenger RNA," issued March 17, 2026 Compl. ¶62
  • Technology Synopsis: The patent claims a pharmaceutically acceptable composition containing purified mRNA that (a) is substantially free of prematurely aborted RNA sequences less than 15 bases long, (b) comprises one or more 1-methylpseudouracil nucleosides, and (c) is suitable for human administration Compl. ¶63 Compl. ¶64
  • Asserted Claims: The complaint asserts independent claim 1 Compl. ¶64
  • Accused Features: The COMIRNATY® vaccine is alleged to be a composition that meets these purification, modification, and suitability requirements Compl. ¶¶88-93

III. The Accused Instrumentality

Product Identification

The accused instrumentality is Defendant's COMIRNATY® COVID-19 vaccine Compl. ¶2

Functionality and Market Context

  • The complaint alleges that COMIRNATY® is an mRNA vaccine that contains a nucleoside-modified messenger RNA (modRNA) encoding the spike glycoprotein of SARS-CoV-2 Compl. ¶77 Compl. ¶92 This mRNA is formulated in lipid nanoparticles (LNPs) to enable its delivery into host cells, where it is expressed to elicit a protective immune response Compl. ¶78 The LNPs are described as containing four lipids, including the ionizable cationic lipid ALC-0315 Compl. ¶2 Compl. ¶72
  • The complaint alleges that COMIRNATY® has been highly successful, with Pfizer enjoying revenue of over $1.6 billion nationally in 2025 alone Compl. ¶73 The prescribing information for COMIRNATY® instructs healthcare professionals on its administration to humans Compl. ¶76 The complaint includes a screenshot of the "INDICATIONS AND USAGE" section from the prescribing information, which states the vaccine is for active immunization to prevent COVID-19 Compl. ¶76

IV. Analysis of Infringement Allegations

'754 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for delivery of messenger RNA (mRNA) for in vivo production of a protein or a peptide, comprising administering to a human, a composition comprising an mRNA that encodes a protein or a peptide, Healthcare professionals administer COMIRNATY® to humans, which is a composition containing mRNA encoding the COVID-19 spike glycoprotein, as instructed by Pfizer's prescribing information. ¶76; ¶77 col. 3:11-16
wherein the mRNA is encapsulated within a lipid nanoparticle The mRNA in COMIRNATY® is formulated in lipid particles, which enables its delivery into host cells. A screenshot from the "Mechanism of Action" section of the prescribing information is provided. ¶78 col. 3:16-18
and wherein the administering of the composition results in expression of the protein or peptide encoded by the mRNA that is detectable in serum at least 72 hours after administration, On information and belief, the administration of COMIRNATY® results in the expression of the spike protein being detectable in serum for at least 72 hours. ¶79 col. 4:45-48
wherein the lipid nanoparticle comprises one or more PEG-modified lipids. The COMIRNATY® vaccine is alleged to contain PEG-modified lipids, specifically ALC-0159. A screenshot of the vaccine's ingredients is provided. ¶81 col. 4:22-25

'618 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for delivery of messenger RNA (mRNA) for in vivo production of a protein, comprising administering, to a human, a composition comprising an mRNA that encodes the protein Healthcare professionals administer COMIRNATY® to humans, which is a composition containing mRNA encoding the COVID-19 spike glycoprotein, as instructed by Pfizer's prescribing information. ¶76; ¶77 col. 3:11-16
wherein the mRNA is encapsulated within a lipid nanoparticle, The mRNA in COMIRNATY® is formulated in lipid particles, enabling its delivery into host cells. ¶78 col. 3:16-18
wherein the administering of the composition results in expression of the protein encoded by the mRNA that is detectable in serum at least 72 hours after administration, On information and belief, the administration of COMIRNATY® results in the expression of the spike protein being detectable in serum for at least 72 hours. ¶79 col. 4:45-48
and wherein the lipid nanoparticle comprises one or more PEG-modified lipids. The COMIRNATY® vaccine is alleged to contain PEG-modified lipids, specifically ALC-0159. ¶81 col. 4:22-25
  • Identified Points of Contention:
    • Evidentiary Question: A central point of contention for the '754 and '618 patents will be the functional limitation requiring the encoded protein to be "detectable in serum at least 72 hours after administration." The complaint makes this allegation on "information and belief" Compl. ¶79 The case may turn on what factual evidence (e.g., from clinical trial data, post-market surveillance, or new experiments) Plaintiffs can produce to prove that the spike protein produced by COMIRNATY® circulates in the serum at detectable levels for the claimed duration.
    • Scope Question: Does the transient expression of an antigen for a vaccine, which is designed to be recognized and cleared by the immune system, meet the patent's described "depot effect" for sustained protein levels, which is framed in the context of treating protein or enzyme deficiencies? A court will have to determine whether the claim language, read in light of the specification, covers the specific pharmacokinetics of a vaccine antigen as opposed to a therapeutic replacement protein.

V. Key Claim Terms for Construction

  • The Term: "detectable in serum at least 72 hours after administration"
  • Context and Importance: This term, appearing in independent claim 1 of both the '754 and '618 patents, is the core functional limitation that defines the invention's purported novelty. The entire infringement analysis for these two patents hinges on whether the protein expression resulting from the COMIRNATY® vaccine meets this durational requirement. Practitioners may focus on this term because it is a results-oriented limitation whose satisfaction is not apparent from the composition of the accused product itself but depends on its in vivo functional effect.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification states that the methods lead to production of protein for "sustained amounts of time," including "more than 72 hours after administration" ('754 Patent, col. 4:30-41). Plaintiffs may argue that any scientifically valid method of detection (e.g., ELISA, as used in the patent's own examples) showing the protein's presence at the 72-hour mark satisfies the plain meaning of "detectable."
    • Evidence for a Narrower Interpretation: The patents' background and detailed description repeatedly frame the invention as a solution for diseases requiring "therapeutic levels of secreted functional protein" and creating a "depot source" '754 Patent, col. 3:1-10 Defendants may argue that "detectable" should be construed to mean detectable at a sustained, therapeutically-relevant level consistent with the patent's stated goal of treating protein deficiencies, not merely trace amounts of a vaccine antigen that may be transiently present in serum.

VI. Other Allegations

  • Indirect Infringement: Plaintiffs allege that Pfizer actively induces infringement of the method claims of the '754, '618, '734, and '044 patents under 35 U.S.C. § 271(b) Compl. ¶¶95, 99, 103, 107 The basis for this allegation is that Pfizer's prescribing information and advertisements for COMIRNATY® instruct healthcare professionals to perform the patented method of delivering the mRNA by administering the vaccine to humans Compl. ¶75 The complaint also alleges contributory infringement under 35 U.S.C. § 271(c) for these patents, asserting that COMIRNATY® can only be used in a manner that infringes Compl. ¶¶96, 100, 104, 108
  • Willful Infringement: The complaint does not contain an explicit count for willful infringement or a request for enhanced damages.

VII. Analyst's Conclusion: Key Questions for the Case

  • A primary issue will be one of evidentiary proof for a functional claim limitation: Can Plaintiffs demonstrate through factual evidence that the administration of COMIRNATY® results in the spike protein being "detectable in serum at least 72 hours after administration," as required by the '754 and '618 patents? The resolution of this question will likely depend on expert testimony and analysis of clinical data regarding the vaccine's pharmacokinetics.
  • A second core issue will be one of compositional identity: Does the COMIRNATY® product, as manufactured and sold, possess the specific LNP lipid molar ratios, mRNA purity levels, and mRNA structural features (e.g., 1-methylpseudouracil) required by the composition claims of the '044, '764, '269, '841, and '554 patents? This will be a fact-intensive inquiry comparing the accused product's precise characteristics against the parameters set forth in the claims.
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