DCT

1:24-cv-01135

GlaxoSmithKline Biologicals SA v. Moderna Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:24-cv-01135, D. Del., 09/04/2025
  • Venue Allegations: Plaintiff alleges that venue is proper in the District of Delaware because all Defendant entities are organized under the laws of Delaware and therefore reside in the district for venue purposes.
  • Core Dispute: Plaintiff alleges that Defendant’s Spikevax® and mNEXSPIKE® families of mRNA vaccines infringe seven U.S. patents related to messenger ribonucleic acid (mRNA) vaccine formulation and delivery technology.
  • Technical Context: The technology involves encapsulating mRNA in lipid-based particles to create vaccines, a platform that gained global market significance during the COVID-19 pandemic for its capacity for rapid development.
  • Key Procedural History: The complaint alleges that the foundational inventions were developed by a team at Novartis, which was later acquired by GSK. It further alleges that Moderna had knowledge of this technology long before commercializing its accused vaccines, citing Moderna’s own patent applications referencing the inventors' work since at least 2013 and its hiring of former Novartis and GSK employees. Plaintiff alleges it provided Defendant with specific notice of infringement on February 16, 2024.

Case Timeline

Date Event
2010-07-06 Earliest Patent Priority Date for all Patents-in-Suit
2020-12-18 FDA grants Emergency Use Authorization for Spikevax® (original monovalent)
2022-01-31 FDA grants full approval for Spikevax® (original monovalent)
2022-04-05 U.S. Patent No. 11,291,682 issues
2022-05-10 U.S. Patent No. 11,324,770 issues
2022-08-31 FDA grants EUA for Spikevax® (bivalent BA.4/5)
2023-03-07 U.S. Patent No. 11,596,645 issues
2023-06-06 U.S. Patent No. 11,666,534 issues
2023-07-04 U.S. Patent No. 11,690,862 issues
2023-07-25 U.S. Patent No. 11,707,482 issues
2023-09-11 FDA grants full approval for Spikevax® (monovalent XBB.1.5)
2023-10-17 U.S. Patent No. 11,786,467 issues
2024-02-16 Plaintiff alleges it provided Defendant with specific notice of infringement
2024-08-22 FDA grants full approval for Spikevax® (monovalent KP.2)
2025-05-30 FDA grants full approval for mNEXSPIKE® (monovalent JN.1)
2025-09-04 First Amended Complaint filed

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

U.S. Patent No. 11,291,682 - "Delivery of RNA to Trigger Multiple Immune Pathways"

The Invention Explained

  • Problem Addressed: The patent describes the historical challenges of using messenger RNA (mRNA) in vaccines, noting that mRNA is chemically fragile and prone to degradation, and that delivering it intact into a patient's cells for translation had been an "insurmountable" challenge (Compl. ¶24; ’682 Patent, col. 1:23-35).
  • The Patented Solution: The invention proposes a method where mRNA encoding an immunogen is delivered to trigger two distinct immune pathways simultaneously. It is delivered to non-immune cells (e.g., muscle cells) which translate the RNA to produce the immunogen, and also to infiltrating immune cells, which recognize the RNA itself via innate immune receptors (e.g., TLR7, RIG-I) to produce an adjuvant effect. This dual-action approach, using a single delivered RNA, aims to generate a strong and effective immune response ('682 Patent, Abstract; col. 2:4-37).
  • Technical Importance: This dual-pathway stimulation using a lipid-encapsulated RNA provided a platform for rapid and potent vaccine development without the need for traditional adjuvants or viral vectors (Compl. ¶¶3-4).

Key Claims at a Glance

  • The complaint asserts independent claims 1 and 11 ('682 Patent, Compl. ¶102).
  • Independent Claim 1 recites a method of raising an immune response in a vertebrate, comprising:
    • Administering a pharmaceutical composition comprising liposomes and messenger ribonucleic acid (mRNA) molecules;
    • Wherein the liposomes have specific physical characteristics: (i) at least 80% have a diameter in the range of 20-220 nm, (ii) a polydispersity index of less than 0.2, or both;
    • Wherein at least half of the mRNA molecules are encapsulated within the liposomes; and
    • Wherein the mRNA molecules encode an immunogen and comprise a specific 5' cap structure: a 7'-methylguanosine linked 5'-to-5' to a first 5' ribonucleotide which comprises a 2'-methylated ribose.
  • The complaint does not explicitly reserve the right to assert dependent claims for this patent.

U.S. Patent No. 11,324,770 - "Delivery of RNA to Trigger Multiple Immune Pathways"

The Invention Explained

  • Problem Addressed: The '770 Patent addresses the same technical challenge as the related '682 Patent: the inherent instability of mRNA and the difficulty of delivering it into cells to produce an immunogenic response ('770 Patent, col. 1:23-35).
  • The Patented Solution: This patent claims an immunogenic composition rather than a method. The solution is a specific formulation comprising mRNA molecules with a defined 5' cap structure encapsulated within lipid particles. The lipid particles themselves are defined by a specific combination of four lipid types: a PEGylated lipid, cholesterol, a phospholipid, and a cationic lipid that contains a tertiary amine ('770 Patent, Abstract; col. 4:1-12).
  • Technical Importance: This patent claims a specific chemical formulation that provides a stable and effective delivery vehicle for mRNA, enabling its use as a versatile vaccine platform technology (Compl. ¶¶3, 29).

Key Claims at a Glance

  • The complaint asserts independent claims 6 and 24 ('770 Patent, Compl. ¶133).
  • Independent Claim 6 recites an immunogenic composition, comprising:
    • Lipid particles and messenger ribonucleic acid (mRNA) molecules;
    • The mRNA molecules comprising a 7'-methylguanosine, a first 5' ribonucleotide with a 2'-methylated ribose (linked 5'-to-5'), and a sequence that encodes an immunogen;
    • The lipid particles comprising a PEGylated lipid, cholesterol, a first phospholipid (anionic or zwitterionic), and a cationic lipid comprising a tertiary amine;
    • The lipid particles encapsulating at least half of the mRNA molecules; and
    • The immunogenic composition being immunogenic in vivo (eliciting an antibody or cell-mediated immune response).
  • The complaint does not explicitly reserve the right to assert dependent claims for this patent.

U.S. Patent No. 11,596,645 - "Delivery of RNA to Trigger Multiple Immune Pathways"

  • Technology Synopsis: This patent claims a composition comprising lipid particles and mRNA, where the mRNA has a specific 5' cap structure and encodes an immunogen from a specific list of viruses, including a coronavirus spike polypeptide. The lipid particles are defined by a specific four-component formulation including a cationic lipid with a tertiary amine (Compl. ¶168; '645 Patent, col. 35:1-35).
  • Asserted Claims: Independent claims 1 and 24 (Compl. ¶168).
  • Accused Features: The accused products are alleged to be compositions comprising mRNA encoding a coronavirus spike polypeptide, encapsulated in lipid particles containing a PEGylated lipid, cholesterol, a zwitterionic phospholipid (DSPC), and a cationic lipid with a tertiary amine (SM-102) (Compl. ¶¶169-176).

U.S. Patent No. 11,690,862 - "Delivery of RNA to Trigger Multiple Immune Pathways"

  • Technology Synopsis: This patent claims a method of obtaining a composition. The claimed method involves specific steps for mixing lipids in ethanol with mRNA in an aqueous buffer to form an intermediate mixture, which is then purified. The resulting composition comprises liposomes encapsulating mRNA that has a specified 5' cap structure and encodes a coronavirus spike polypeptide immunogen (Compl. ¶202; '862 Patent, col. 35:60-36:26).
  • Asserted Claims: Independent claim 1 (Compl. ¶202).
  • Accused Features: The complaint alleges that the process by which Moderna manufactures the Accused Products infringes the claimed method steps, including mixing lipids with ethanol, mixing mRNA with an aqueous buffer, mixing the two resulting mixtures, and purifying the result (Compl. ¶209).

U.S. Patent No. 11,707,482 - "Delivery of RNA to Trigger Multiple Immune Pathways"

  • Technology Synopsis: This patent claims a composition comprising liposomes and mRNA molecules. The claims require the mRNA to have a specific 5' cap structure and a 3' polyadenosine tail, and to encode a coronavirus spike polypeptide immunogen. The liposomes are required to comprise cholesterol and a cationic lipid with a tertiary amine (Compl. ¶227; '482 Patent, col. 35:60-36:13).
  • Asserted Claims: Independent claims 1 and 14 (Compl. ¶227).
  • Accused Features: The Accused Products are alleged to be compositions comprising mRNA with the claimed cap structure and poly(A) tail, encoding a coronavirus spike polypeptide, encapsulated in liposomes containing cholesterol and the cationic lipid SM-102, which allegedly has a tertiary amine (Compl. ¶¶228-233).

U.S. Patent No. 11,666,534 - "Methods of Administering Lipid Formulations with Viral Immunogens"

  • Technology Synopsis: This patent claims a method of eliciting an immune response by administering a formulation of RNA and lipids. The RNA must encode an immunogen from a specific list, including a coronavirus spike polypeptide. The lipids must comprise a tertiary amine cationic lipid, a PEG-conjugated lipid, and cholesterol (Compl. ¶259; '534 Patent, col. 37:37-58).
  • Asserted Claims: Independent claim 1 (Compl. ¶259).
  • Accused Features: The administration of the Accused Products to patients is alleged to meet the method limitations, as the products are formulations of RNA encoding a coronavirus spike polypeptide with lipids including the alleged tertiary amine cationic lipid SM-102, PEG2000-DMG, and cholesterol (Compl. ¶¶260-266).

U.S. Patent No. 11,786,467 - "Lipid Formulations With Immunogens"

  • Technology Synopsis: This patent claims a formulation comprising RNA molecules that encode an immunogen and lipids that include a tertiary amine cationic lipid, a PEG-conjugated lipid, and cholesterol. The formulation is required to be immunogenic in vivo and to encapsulate at least half of the RNA molecules (Compl. ¶282; '467 Patent, col. 37:50-65).
  • Asserted Claims: Independent claim 1 (Compl. ¶282).
  • Accused Features: The Accused Products are alleged to be immunogenic formulations containing RNA encoding an immunogen, encapsulated by lipids including the alleged tertiary amine cationic lipid SM-102, PEG2000-DMG, and cholesterol (Compl. ¶¶283-289).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are Defendant’s Spikevax® and mNEXSPIKE® families of SARS-CoV-2 S protein mRNA vaccines (collectively, "Accused Products") (Compl. ¶7). This includes multiple versions targeting different viral strains, such as the original monovalent, bivalent BA.4/5, monovalent XBB.1.5, monovalent KP.2, and monovalent JN.1 vaccines (Compl. ¶38).

Functionality and Market Context

  • The Accused Products are described as suspensions of mRNA "encapsulated in lipid particles" and are supplied in multi-dose vials (Compl. ¶39). The encapsulated mRNA molecules encode various versions of the SARS-CoV-2 spike (S) protein, which acts as the immunogen (Compl. ¶¶43, 49, 51, 55, 59). The lipid particles are composed of four specific lipid ingredients: the ionizable lipid SM-102, the PEGylated lipid PEG2000-DMG, the phospholipid DSPC, and cholesterol (Compl. ¶67). The complaint provides a table itemizing these four lipids. (Compl. ¶67, p. 20). When administered to a person, the Accused Products are designed to cause the person's own cells to produce the viral spike protein, thereby eliciting an immune response that protects against COVID-19 (Compl. ¶¶89-93). The complaint alleges that Moderna has earned billions of dollars in revenue from these products (Compl. ¶¶6, 95).

IV. Analysis of Infringement Allegations

11,291,682 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of raising an immune response in a vertebrate, the method comprising administering to the vertebrate an effective amount...of a pharmaceutical composition Each approved use of the Accused Products involves administering an effective amount of the vaccine to raise an immune response in a vertebrate (human). ¶108 col. 2:4-6
comprising liposomes and messenger ribonucleic acid (mRNA) molecules The Accused Products are pharmaceutical compositions comprising mRNA molecules encapsulated in lipid particles, which the complaint alleges are liposomes. ¶103 col. 3:45-50
(a) (i) at least 80% of the liposomes have a diameter in the range of 20-220 nm, (ii) a polydispersity index of less than 0.2, (iii) or both The lipid nanoparticles in the Accused Products are alleged to have a particle size of approximately 80-160 nm and a polydispersity index of less than 0.2. ¶104 col. 3:36-42
(b) at least half of the mRNA molecules are encapsulated within the liposomes The Accused Products are alleged to have encapsulation efficiencies of greater than 90%. ¶105 col. 4:56-59
(c) the mRNA molecules encode an immunogen and comprise a 7'-methylguanosine and a first 5' ribonucleotide, the 7'-methylguanosine being linked 5'-to-5' to the first 5' ribonucleotide, and the first 5' ribonucleotide comprising a 2'-methylated ribose. The mRNA in the Accused Products encodes the SARS-CoV-2 spike protein immunogen and allegedly includes the claimed 5'-cap structure, identified as "m7G-5'-ppp-5'-Gm." ¶¶106-107 col. 11:47-51
  • Identified Points of Contention:
    • Scope Questions: A primary question may be whether the accused "lipid nanoparticles" (LNPs) fall within the scope of the claim term "liposomes". The complaint alleges they are equivalent, but the defense may argue that LNPs, particularly with a potentially complex, non-aqueous core, are structurally distinct from the claimed "liposomes", which are typically understood to possess an aqueous core.
    • Technical Questions: The method claim requires "administering" the composition. While Moderna sells the product with instructions for administration, the direct act of administration is performed by third-party healthcare providers, which raises questions about the evidence needed to prove direct infringement by Moderna versus indirect infringement theories.

11,324,770 Patent Infringement Allegations

Claim Element (from Independent Claim 6) Alleged Infringing Functionality Complaint Citation Patent Citation
An immunogenic composition comprising lipid particles and messenger ribonucleic acid (mRNA) molecules The Accused Products are alleged to be immunogenic compositions comprising mRNA molecules encapsulated in lipid particles. ¶134 col. 4:1-3
the mRNA molecules comprising a 7'-methylguanosine, a first 5' ribonucleotide...the first 5' ribonucleotide comprising a 2'-methylated ribose; the 7' methylguanosine linked 5'-to-5' to the first 5' ribonucleotide The mRNA molecules in the Accused Products allegedly comprise the claimed 5'-cap structure ("m7G-5'-ppp-5'-Gm"), which includes a 2'-methylated ribose. ¶136 col. 35:49-56
and a sequence that encodes an immunogen The mRNA sequence in the Accused Products encodes the SARS-CoV-2 spike protein, which is an immunogen. ¶135 col. 35:45-48
the lipid particles comprising a PEGylated lipid, cholesterol, a first phospholipid, and a cationic lipid; the cationic lipid comprising a tertiary amine The lipid particles in the Accused Products allegedly comprise PEG2000-DMG (PEGylated lipid), cholesterol, DSPC (a zwitterionic phospholipid), and SM-102, which is alleged to be a cationic lipid comprising a tertiary amine. ¶¶137-140 col. 3:57-67
the lipid particles encapsulating at least half of the mRNA molecules The Accused Products are alleged to have mRNA encapsulation efficiencies greater than 90%. ¶141 col. 4:54-57
the immunogenic composition being immunogenic in vivo by eliciting at least: (i) an antibody response..., (ii) a cell-mediated immune response..., or (iii) both The Accused Products are alleged to elicit adaptive humoral (antibody) and cellular (T-cell and B-cell) immune responses against the S antigen. ¶142 col. 2:4-9
  • Identified Points of Contention:
    • Scope Questions: As with the ’682 patent, the construction of "lipid particles" relative to the term "liposomes" used in the shared specification could be a point of dispute.
    • Technical Questions: A central technical question will be whether the SM-102 lipid used in the Accused Products is properly characterized as a "cationic lipid comprising a tertiary amine" as required by the claim. The defense may argue that the chemical properties and ionization state of SM-102 at physiological pH do not meet the claim limitation as it would have been understood by a person of ordinary skill in the art.

V. Key Claim Terms for Construction

The Term: "liposome" ('682 Patent, Claim 1)

Context and Importance

This term is foundational to the asserted composition and method claims. Defendant’s products are marketed and described in regulatory filings as containing "lipid nanoparticles" (LNPs). The outcome of the case may depend significantly on whether the specific LNP structure used by Moderna is construed to be a "liposome" as the term is used in the patent.

Intrinsic Evidence for Interpretation

  • Evidence for a Broader Interpretation: The specification describes liposomes as being formed from various mixtures of lipids including cationic lipids, zwitterionic lipids, and cholesterol ('682 Patent, col. 3:5-14), which mirrors the general composition of the accused LNPs. The complaint itself cites scientific literature suggesting liposomes are considered the "earliest generation of lipid nanoparticles," which may support an interpretation that LNP is a species within the genus of liposome (Compl. ¶103).
  • Evidence for a Narrower Interpretation: The specification describes liposomes as having a "single bilayer encapsulating an aqueous core" ('682 Patent, col. 3:33-34). A defendant may argue that its LNPs do not have a simple aqueous core but rather a more complex or solid core matrix of lipids and nucleic acids, distinguishing them from the structures explicitly described in the patent.

The Term: "cationic lipid comprising a tertiary amine" ('770 Patent, Claim 6)

Context and Importance

This term defines a specific chemical feature of one of the four required lipid components. Infringement of the asserted composition claims in the ’770 patent (and several other patents-in-suit) hinges on whether Moderna's SM-102 lipid meets this structural requirement. Practitioners may focus on this term because SM-102 is an ionizable lipid, meaning its charge is pH-dependent, which could be a basis for arguing it is not "cationic" in the manner contemplated by the patent under physiological conditions.

Intrinsic Evidence for Interpretation

  • Evidence for a Broader Interpretation: The specification does not provide an explicit definition of the term or link it to a specific pKa range in the claims themselves. Plaintiff may argue for a plain and ordinary meaning, where any lipid that is cationic under some relevant condition (e.g., the acidic conditions used during formulation) and possesses a tertiary amine group in its chemical structure would satisfy the limitation.
  • Evidence for a Narrower Interpretation: A defendant may argue that, in the context of the invention (in vivo delivery), a "cationic lipid" must be cationic at physiological pH. Since ionizable lipids like SM-102 are designed to be largely neutral at physiological pH to reduce toxicity, the defense could argue it does not function as a "cationic lipid" in the manner required by the claim for in vivo immunogenicity, even though it contains a tertiary amine.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges inducement of infringement based on Defendant's product labeling, package inserts, and other promotional materials that instruct healthcare practitioners to administer the Accused Products, thereby practicing the patented methods (Compl. ¶¶87, 115, 150). Contributory infringement is alleged on the basis that Defendant sells the Accused Products, which constitute a material part of the inventions and are not staple articles of commerce suitable for substantial non-infringing use (Compl. ¶¶116, 151).
  • Willful Infringement: The complaint alleges willful infringement based on Defendant's continued infringement at least since receiving specific notice from GSK on February 16, 2024 (Compl. ¶¶126, 161). It also alleges pre-suit knowledge dating back to at least 2013, based on Moderna’s own patent filings that cite the patents and publications of the GSK inventors, as well as Moderna's hiring of former Novartis/GSK employees familiar with the technology (Compl. ¶¶33-35).

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

  • A core issue will be one of definitional scope: can the term "liposome," as used in the patents and understood in the context of early 2010s technology, be construed to cover the specific, highly engineered structure of the "lipid nanoparticles" (LNPs) used in Moderna's 2020s-era COVID-19 vaccines? The case may require a deep technical inquiry into whether Moderna's LNPs possess the fundamental structural characteristics of the claimed liposomes.
  • A second dispositive issue will be one of chemical identity and function: does the accused SM-102 lipid, which is an ionizable lipid designed to be near-neutral at physiological pH, meet the claim requirement of a "cationic lipid comprising a tertiary amine"? This question will likely involve expert testimony on the chemical properties of SM-102 and how a person of ordinary skill in the art would have understood the claim term at the time of the invention.
  • Should infringement be established, a critical question for damages will center on willfulness and pre-suit knowledge: does the evidence that Moderna cited the inventors' foundational work in its own patents and hired their former colleagues, years before launching its accused products, demonstrate the "objectively high likelihood" of infringement necessary to support a finding of willful infringement from the onset of commercial sales?