DCT

1:24-cv-01136

GlaxoSmithKline Biologicals SA v. Moderna Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:24-cv-01136, D. Del., 10/12/2024
  • Venue Allegations: Venue is based on the allegation that all Defendant entities are organized under the laws of the State of Delaware and therefore reside in the district for venue purposes.
  • Core Dispute: Plaintiff alleges that Defendant’s mRESVIA® respiratory syncytial virus (RSV) vaccine infringes six U.S. patents relating to foundational mRNA vaccine technology, including specific lipid formulations for encapsulating and delivering mRNA molecules that encode a viral immunogen.
  • Technical Context: The technology involves using lipid nanoparticles (LNPs) to deliver messenger RNA (mRNA) into human cells, which then produce viral proteins to trigger an immune response, a platform noted for enabling rapid vaccine development.
  • Key Procedural History: The complaint alleges that the inventions were developed by a team at Novartis, and that Plaintiff acquired the rights to the patents-in-suit as part of a 2015 acquisition of Novartis's global vaccines business. It further alleges that Defendant has been aware of the patented technology since at least 2013, having cited patent applications in the patents' family within its own patent filings. Plaintiff states it provided Defendant with specific notice of infringement on October 11, 2024, one day prior to filing this complaint.

Case Timeline

Date Event
2010-07-06 Earliest Priority Date for Patents-in-Suit
2015-03-02 GSK acquires Novartis's global vaccines business, including rights to the asserted inventions
2022-05-10 U.S. Patent No. 11,324,770 issues
2023-07-04 U.S. Patent No. 11,690,861 issues
2023-07-04 U.S. Patent No. 11,690,864 issues
2023-08-08 U.S. Patent No. 11,717,529 issues
2023-10-17 U.S. Patent No. 11,786,467 issues
2024-01-30 U.S. Patent No. 11,883,534 issues
2024-05-31 FDA approves Accused Product (mRESVIA®)
2024-06-26 CDC Advisory Committee on Immunization Practices (ACIP) recommends RSV vaccine use
2024-07-01 Accused Product (mRESVIA®) launches in the U.S. (approximate date)
2024-10-11 Plaintiff provides Defendant with notice of infringement
2024-10-12 Complaint filed

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

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

The Invention Explained

  • Problem Addressed: The patent background describes the long-standing technical hurdles of using mRNA for vaccines, namely that mRNA is chemically fragile and difficult to deliver intact into a patient's cells where it can be translated to produce an immune response (Compl. ¶24; ’770 Patent, col. 1:24-32).
  • The Patented Solution: The invention provides a composition that encapsulates immunogen-encoding mRNA within lipid particles. This formulation protects the mRNA and facilitates its delivery into cells. The patent describes how this co-delivery of the RNA payload and the lipid vehicle can trigger multiple innate immune pathways—both in the cytoplasm (via RLRs) and in endosomes (via TLRs)—creating a local adjuvant effect that enhances the overall immune response to the translated immunogen (’770 Patent, Abstract; col. 2:33-55).
  • Technical Importance: This technology provided a platform for rapidly developing new vaccine candidates simply by altering the mRNA sequence, a significant advance in vaccine technology (Compl. ¶3).

Key Claims at a Glance

  • The complaint asserts independent composition Claim 6 and dependent method Claim 24 (Compl. ¶67).
  • The essential elements of independent Claim 6 include:
    • An immunogenic composition comprising lipid particles and mRNA molecules;
    • The mRNA molecules comprising a 7'-methylguanosine, a first 5' ribonucleotide with a 2'-methylated ribose, and a sequence encoding an immunogen, with the components linked 5'-to-5';
    • 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 composition being immunogenic in vivo by eliciting an antibody or cell-mediated immune response.

U.S. Patent No. 11,690,861 - Delivery of RNA to Trigger Multiple Immune Pathways

The Invention Explained

  • Problem Addressed: The patent addresses the same fundamental challenges of mRNA vaccine delivery as the ’770 Patent: protecting fragile mRNA and ensuring its entry into cells to generate an immune response (Compl. ¶24; ’861 Patent, col. 1:24-32).
  • The Patented Solution: The invention claimed in the ’861 patent is a composition of lipid particles and mRNA molecules specifically directed to an RSV vaccine. The claims recite an mRNA sequence that encodes a respiratory syncytial virus (RSV) F-protein immunogen and detail the required 5' cap structure. The lipid particle formulation is also specified, requiring a PEG-ylated lipid, cholesterol, an anionic or zwitterionic phospholipid, and a cationic lipid with a tertiary amine to encapsulate the mRNA (’861 Patent, Abstract; col. 2:33-43).
  • Technical Importance: This patent applies the foundational lipid-mRNA platform technology to the specific, commercially significant target of RSV, a common respiratory virus (Compl. ¶5).

Key Claims at a Glance

  • The complaint asserts independent composition Claim 1 and dependent method Claim 14 (Compl. ¶100).
  • The essential elements of independent Claim 1 include:
    • A composition comprising lipid particles and mRNA molecules;
    • The mRNA molecules comprising a 5' cap nucleoside, a first 5' ribonucleoside with a 2'-methylated ribose, a triphosphate bridge, and a sequence encoding an RSV F-protein immunogen, with the cap structure linked 5'-to-5';
    • The lipid particles comprising a polyethylene glycol-ylated lipid, cholesterol, an anionic or zwitterionic phospholipid, and a cationic lipid comprising a tertiary amine; and
    • The lipid particles encapsulating at least half of the mRNA molecules.

U.S. Patent No. 11,690,864 - Delivery of RNA to Trigger Multiple Immune Pathways

  • Technology Synopsis: The ’864 Patent addresses the same technical problem of mRNA delivery. Its claims are directed to a composition comprising "liposomes" (rather than "lipid particles") and mRNA molecules encoding an RSV immunogen, specifying the mRNA structure (including a 5' cap and a 3' polyadenosine monophosphate tail) and a liposome composition comprising cholesterol and a cationic lipid with a tertiary amine (Compl. ¶132).
  • Asserted Claims: Independent Claim 1 (Compl. ¶132).
  • Accused Features: The mRESVIA® product is accused of being a "composition comprising liposomes and messenger ribonucleic acid" containing the claimed mRNA structure and lipid components (Compl. ¶¶133-138).

U.S. Patent No. 11,717,529 - Delivery of RNA to Trigger Multiple Immune Pathways

  • Technology Synopsis: The ’529 Patent claims a method of obtaining an mRNA-liposome composition. The patented method involves the steps of preparing an ethanolic lipid mixture and an aqueous RNA mixture, mixing the two to form an intermediate mixture, and purifying that mixture to obtain the final composition (Compl. ¶162).
  • Asserted Claims: Independent Claim 1 (Compl. ¶162).
  • Accused Features: The complaint alleges that the process used by Defendant to manufacture mRESVIA® infringes the claimed method, citing regulatory filings and public statements describing a manufacturing process that involves mixing lipids in ethanol with an aqueous mRNA solution (Compl. ¶¶44, 169).

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

  • Technology Synopsis: The ’467 Patent claims a formulation comprising RNA encoding an immunogen and a specific combination of lipids: a tertiary amine cationic lipid, a polyethylene glycol-conjugated (PEG-conjugated) lipid, and cholesterol. The claims require the formulation to be immunogenic in vivo and to encapsulate at least half of the RNA molecules (Compl. ¶187).
  • Asserted Claims: Independent Claim 1 (Compl. ¶187).
  • Accused Features: The mRESVIA® vaccine is accused of infringing by containing the specific combination of lipids recited in the claims: SM-102 (tertiary amine cationic lipid), PEG2000-DMG (PEG-conjugated lipid), and cholesterol (Compl. ¶¶190-192).

U.S. Patent No. 11,883,534 - Immunisation with Lipid Formulations with RNA Encoding Immunogens

  • Technology Synopsis: The ’534 Patent is a method-of-use patent claiming a method for eliciting an antibody response. The method comprises intramuscularly administering a composition of RNA and lipid particles, where the claims specify the type of immunogen (including RSV), the composition of the lipid particles by mole percentages of cationic lipid, PEG-conjugated lipid, and cholesterol, and a required particle diameter range (Compl. ¶215).
  • Asserted Claims: Independent Claim 1 (Compl. ¶215).
  • Accused Features: The FDA-approved use of mRESVIA® is accused of infringing, as its administration to humans for immunization against RSV allegedly meets all steps and compositional requirements of the claim, including the mole % ratios of its constituent lipids (Compl. ¶¶216-223).

III. The Accused Instrumentality

Product Identification

  • Moderna, Inc.’s mRESVIA® RSV F mRNA vaccine product (the “Accused Product”) (Compl. ¶7).

Functionality and Market Context

  • The Accused Product is a sterile, single-dose injectable suspension containing lipid nanoparticles (LNPs) that encapsulate a linear messenger RNA (mRNA) molecule (Compl. ¶36). The mRNA is engineered to encode the F glycoprotein of the respiratory syncytial virus (RSV), stabilized in its prefusion conformation, which acts as the immunogen (Compl. ¶42). The complaint provides a diagram illustrating the alleged structure of the mRNA, which includes a 5' cap, untranslated regions (UTRs), an open reading frame (ORF), and a 3' poly(A) tail (Compl. p. 13). The LNPs are alleged to be composed of four specific lipids: the ionizable cationic lipid SM-102, the phospholipid DSPC, cholesterol, and the PEGylated lipid PEG2000-DMG (Compl. ¶43). When administered, the product is designed to induce an immune response that protects against lower respiratory tract disease caused by RSV in older adults (Compl. ¶49, 56). The complaint positions the Accused Product in a "highly competitive" and potentially multi-billion dollar market for RSV vaccines (Compl. ¶¶59-60).

IV. Analysis of Infringement Allegations

’770 Patent Infringement Allegations

Claim Element (from Independent Claim 6) Alleged Infringing Functionality Complaint Citation Patent Citation
An immunogenic composition comprising lipid particles and mRNA molecules The Accused Product is a vaccine described as an "immunogenic composition comprising lipid particles and messenger ribonucleic acid (mRNA) molecules." ¶68 col. 2:33-35
the mRNA molecules comprising a 7'-methylguanosine, a first 5' ribonucleotide, and a sequence that encodes an immunogen The mRNA in the Accused Product allegedly has a 5' cap structure containing 7'-methylguanosine and encodes the RSV F protein immunogen. ¶¶69-70 col. 12:1-5
the first 5' ribonucleotide comprising a 2'-methylated ribose; the 7' methylguanosine linked 5'-to-5' to the first 5' ribonucleotide The complaint points to disclosures for Moderna's COVID-19 vaccine products, which allegedly use the same manufacturing process and have a cap structure ("m7G-5'-ppp-5'-Gm") that meets this limitation. ¶70 col. 12:1-5
the lipid particles comprising a PEGylated lipid, cholesterol, a first phospholipid, and a cationic lipid The Accused Product's lipid particles are alleged to contain PEG2000-DMG (a PEGylated lipid), cholesterol, DSPC (a phospholipid), and SM-102 (a cationic lipid). ¶71 col. 3:56-58
the cationic lipid comprising a tertiary amine The cationic lipid used, SM-102, is alleged to be a molecule comprising a tertiary amine. ¶72 col. 4:1-3
the first phospholipid comprising an anionic phospholipid or a zwitterionic phospholipid The phospholipid used, DSPC (1,2-distearoyl-sn-glycero-3-phosphocholine), is alleged to be a zwitterionic phospholipid. ¶74 col. 4:4-6
the lipid particles encapsulating at least half of the mRNA molecules The Accused Product is described as consisting of LNPs that encapsulate mRNA, with data from similar formulations allegedly showing encapsulation efficiencies of >90%. ¶75 col. 3:53-55
the immunogenic composition being immunogenic in vivo by eliciting at least: (i) an antibody response..., (ii) a cell-mediated immune response..., or (iii) both Clinical trial data and the product's package insert allegedly demonstrate that administration of the Accused Product elicits an immune response, including neutralizing antibodies, against the RSV immunogen. ¶76 col. 2:39-43

’861 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A composition comprising lipid particles and messenger ribonucleic acid (mRNA) molecules The Accused Product is described as a "composition comprising lipid particles and messenger ribonucleic acid (mRNA) molecules." ¶101 col. 2:33-35
the mRNA molecules comprising: (i) a 5' cap nucleoside, (ii) a first 5' ribonucleoside, (iii) a triphosphate bridge, and (iv) a sequence that encodes a respiratory syncytial virus (RSV) surface fusion glycoprotein (F-protein) immunogen The mRNA in the Accused Product is alleged to have a 5' cap structure and to encode the RSV F-protein immunogen. ¶¶102-103 col. 13:23-28
the first 5' ribonucleotide comprising a 2'-methylated ribose; the 5' cap nucleoside linked 5'-to-5' to the first 5' ribonucleoside by the triphosphate bridge Allegations rely on disclosures for Moderna's similar COVID-19 products, which allegedly use a cap structure consistent with this limitation. ¶103 col. 12:1-5
the lipid particles comprising: (a) a polyethylene glycol-ylated lipid, (b) cholesterol, (c) an anionic phospholipid or a zwitterionic phospholipid, and (d) a cationic lipid comprising a tertiary amine The lipid particles are alleged to contain PEG2000-DMG, cholesterol, DSPC (a zwitterionic phospholipid), and SM-102 (a cationic lipid with a tertiary amine). ¶¶104-107 col. 3:56-61
the lipid particles encapsulating at least half of the mRNA molecules The Accused Product is described as consisting of LNPs that encapsulate mRNA, with data from similar formulations allegedly showing encapsulation efficiencies typically >90%. ¶108 col. 3:53-55
  • Identified Points of Contention:
    • Scope Questions: Several asserted patents claim compositions comprising "liposomes" (e.g., ’864 Patent), while others claim "lipid particles" (e.g., ’770, ’861 Patents). The complaint appears to treat these terms as interchangeable, citing a source that considers liposomes an early generation of lipid nanoparticles (Compl. ¶133). A potential point of contention may be whether the Accused Product's LNPs fall within the legal scope of the term "liposome" as understood in the art and defined by the patent specifications.
    • Technical Questions: The complaint's allegations regarding the specific 5' cap structure of the mRNA and the high encapsulation efficiency (>90%) in the Accused Product rely on evidence from Moderna's separate COVID-19 vaccine products or general scientific literature (Compl. ¶¶70, 75, 103, 108). This raises the evidentiary question of whether GSK can prove that the mRESVIA® product, as sold, actually possesses these precise technical features, or if Moderna will be able to demonstrate material differences in its structure or manufacturing process.

V. Key Claim Terms for Construction

  • The Term: "cationic lipid comprising a tertiary amine"

  • Context and Importance: This term is a critical limitation in the independent claims of both the ’770 and ’861 patents and is central to defining the claimed lipid composition. The infringement theory hinges on the allegation that the SM-102 lipid used in the Accused Product has a chemical structure that meets this definition. Practitioners may focus on this term because the specific chemical nature of the cationic lipid is fundamental to the function and novelty of LNP delivery systems.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specifications provide various examples of suitable lipids without narrowly defining the term "tertiary amine" itself, suggesting the term should be given its plain and ordinary meaning in chemistry. The patents teach that the goal is to use lipids that can be positively charged to facilitate RNA encapsulation but are less charged at physiological pH, a function enabled by tertiary amines (’861 Patent, col. 17:44-50; '770 Patent, col. 17:44-50 from a related patent in the family).
    • Evidence for a Narrower Interpretation: The specifications list specific examples of cationic lipids with tertiary amines, such as DSDMA, DODMA, DLinDMA, and DLenDMA (’770 Patent, col. 3:56-61). A party might argue that the term should be construed in light of these specific disclosed embodiments, potentially limiting its scope.

  • The Term: "lipid particles" / "liposomes"

  • Context and Importance: These terms appear in the independent claims of different patents-in-suit (’770 and ’861 use "lipid particles"; ’864 and ’529 use "liposomes"). The distinction, or lack thereof, will be critical to whether the accused LNP product infringes claims reciting "liposomes." Practitioners may focus on this distinction as it could create a non-infringement argument based on structural differences between the accused product and the patent claims.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The ’770 Patent, in its detailed description, introduces "liposomes" as a preferred delivery system immediately before the claims recite "lipid particles," suggesting the patentee may have viewed the terms as largely synonymous in this context (’770 Patent, col. 3:40-43).
    • Evidence for a Narrower Interpretation: The term "liposome" traditionally implies a structure with an aqueous core surrounded by one or more lipid bilayers. A party could argue that if the accused LNPs have a different internal structure (e.g., a solid lipid core), they would not meet the definition of a "liposome," even if they are a "lipid particle." The patents do not provide explicit definitions to resolve this potential ambiguity.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges inducement of infringement against healthcare practitioners by providing labeling and prescribing information that instructs them to administer the Accused Product, thereby practicing the patented methods of eliciting an immune response (Compl. ¶¶88, 120, 150). It further alleges contributory infringement on the basis that the Accused Product is a material component of the patented methods, is not a staple article of commerce, and is especially adapted for infringing use (Compl. ¶¶89, 121, 151).
  • Willful Infringement: The complaint alleges that Defendant's infringement has been willful and deliberate at least since receiving specific notice from Plaintiff on October 11, 2024 (Compl. ¶¶93, 125, 155). The allegations are further supported by claims that Defendant knew of the underlying patented technology as early as 2013 by citing the patent family in its own patent applications (Compl. ¶32).

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

  • A core issue will be one of evidentiary proof: can Plaintiff demonstrate that the precise chemical structure, composition, and manufacturing process of the accused mRESVIA® vaccine match the infringement theories, which appear to rely in part on technical disclosures related to Defendant's different COVID-19 vaccine? The case may depend on whether discovery confirms that the technology platforms are as interchangeable as the complaint alleges.
  • A key legal question will be one of definitional scope: how will the court construe the terms "lipid particles" and "liposomes" as used across the asserted patents? The resolution of whether Defendant's LNPs fall within the scope of both terms will be critical for determining infringement of several key claims.
  • A fundamental challenge for the litigation will be patent validity: given the highly competitive and rapidly evolving field of mRNA vaccine technology, the novelty and non-obviousness of the asserted claims, which have a 2010 priority date, will almost certainly be a central point of contention, raising the question of what the state of the art was at the time of the invention.