DCT

1:25-cv-00003

Acuitas Therap Inc v. GlaxoSmithKline Biologicals SA

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-00003, D. Del., 04/17/2025
  • Venue Allegations: Venue is asserted in the District of Delaware because Defendants previously filed a lawsuit in the same district asserting the same patents against Plaintiff's partners (Pfizer and BioNTech) concerning the same accused product. Additionally, Defendant GSK LLC is incorporated in Delaware.
  • Core Dispute: Plaintiff seeks a declaratory judgment that the Comirnaty® COVID-19 vaccine, which utilizes its lipid nanoparticle (LNP) delivery technology, does not infringe eight of Defendant’s patents and that those patents are invalid.
  • Technical Context: The technology involves lipid nanoparticle (LNP) formulations used to encapsulate and deliver messenger RNA (mRNA), a critical platform for modern vaccines, most notably for COVID-19.
  • Key Procedural History: This declaratory judgment action was filed by Acuitas in response to an underlying patent infringement lawsuit brought by GSK against Acuitas's partners, Pfizer and BioNTech, over their sales of the Comirnaty® vaccine. Acuitas states it faces a threat of indemnity obligations to its partners. The complaint alleges that GSK's patents-in-suit, which claim priority to 2010 applications, were amended with the benefit of hindsight after the composition of Comirnaty® became public in late 2020, in order to craft claims that would read on the successful vaccine.

Case Timeline

Date Event
2010-07-06 Earliest Priority Date for ’693, ’694, ’534, ’401, ’467, ’475, ’422, ’660 Patents
2019-10-18 GSK files patent application that leads to ’475 Patent
2020-04-01 GSK files patent application that leads to ’422 Patent
2020-12-10 FDA grants first Emergency Use Authorization for Comirnaty®
2021-08-23 FDA grants full approval for Comirnaty®
2021-12-22 GSK files patent applications that lead to ’534, ’401, and ’467 Patents
2022-06-23 GSK files patent applications that lead to ’693 and ’694 Patents
2022-12-13 GSK files patent application that leads to ’660 Patent
2023-05-02 ’693 Patent Issued
2023-05-02 ’694 Patent Issued
2023-05-23 ’475 Patent Issued
2023-06-06 ’534 Patent Issued
2023-09-19 ’422 Patent Issued
2023-09-26 ’401 Patent Issued
2023-10-17 ’467 Patent Issued
2023-12-26 ’660 Patent Issued
2025-04-17 Acuitas files First Amended Complaint for Declaratory Judgment

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

U.S. Patent No. 11,638,693 - “Vaccine for Eliciting Immune Response Comprising RNA Encoding an Immunogen and Lipid Formulations Comprising Mole Percentage of Lipids,” Issued May 2, 2023 (’693 Patent)

The Invention Explained

  • Problem Addressed: The patent background section notes a continuing need for "further and improved nucleic acid vaccines," addressing the general challenge of effectively delivering nucleic acids like RNA for immunization purposes (’693 Patent, col. 1:33-35).
  • The Patented Solution: The invention describes a liposome-based vaccine formulation for delivering RNA that encodes an immunogen. The core of the solution is the use of a specific lipid composition, including a cationic lipid with a tertiary amine and a pKa (a measure of acidity) within a defined range of 5.0 to 7.6, which allows the liposome to have a neutral or reduced surface charge at physiological pH (’693 Patent, Abstract; col. 1:40-52). This composition is designed to effectively encapsulate and deliver the RNA to elicit an immune response (’693 Patent, Abstract).
  • Technical Importance: Formulating RNA delivery vehicles that are stable and effective in vivo, while avoiding the strong positive charge typical of early cationic lipids (which can cause toxicity), was a key technical hurdle in the field.

Key Claims at a Glance

  • The complaint asserts non-infringement of at least independent claim 1 (Compl. ¶ 61).
  • Essential elements of Claim 1 include:
    • A formulation comprising: ribonucleic acid (RNA) molecules encoding an immunogen.
    • Lipids comprising specific mole percentages of: (a) a cationic lipid, (b) an anionic or zwitterionic lipid, (c) a polyethylene glycol-conjugated (PEG-conjugated) lipid, and (d) cholesterol.
    • The lipids must encapsulate at least half of the RNA molecules.
    • The formulation must be immunogenic in vivo.
    • The cationic lipid must comprise a tertiary amine and have a pKa from 6.07 to 7.6.
    • The pKa is defined as being determined by a specific, recited 14-step laboratory procedure involving a fluorescent probe and multiple buffered solutions (’693 Patent, col. 41:5-43:30).

U.S. Patent No. 11,638,694 - “Vaccine for Eliciting Immune Response Comprising Lipid Formulations and RNA encoding multiple immunogens,” Issued May 2, 2023 (’694 Patent)

The Invention Explained

  • Problem Addressed: Similar to the ’693 Patent, this patent addresses the general need for improved nucleic acid vaccine delivery systems (’694 Patent, col. 1:33-35).
  • The Patented Solution: The technology is nearly identical to that of the ’693 Patent, but is directed to a formulation containing at least two different species of RNA molecules, encoding a first and a second immunogen. The patented solution remains a liposome formulation with a specific lipid composition, including a cationic lipid with a tertiary amine and a pKa within a defined range, determined by the same 14-step process recited in the ’693 Patent (’694 Patent, Abstract; col. 1:40-54).
  • Technical Importance: This approach extends the LNP delivery platform to multivalent vaccines, which can provide protection against multiple pathogens or different strains of a single pathogen in a single formulation.

Key Claims at a Glance

  • The complaint asserts non-infringement of at least independent claim 1 (Compl. ¶ 81).
  • Essential elements of Claim 1 include:
    • A formulation comprising: a first species of RNA molecules encoding a first immunogen and a second species of RNA molecules encoding a second immunogen.
    • Lipids comprising: (a) a cationic lipid, (b) an anionic or zwitterionic lipid, (c) a PEG-conjugated lipid, and (d) cholesterol.
    • The lipids must encapsulate at least half of both the first and second species of RNA molecules.
    • The cationic lipid must comprise a tertiary amine and have a pKa from 6.07 to 7.6.
    • The pKa is defined as being determined by the identical 14-step laboratory procedure recited in the ’693 Patent (’694 Patent, col. 41:48-43:16).

Multi-Patent Capsule: U.S. Patent No. 11,666,534 (’534 Patent)

  • Patent Identification: U.S. Patent No. 11,666,534, "Methods of Administering Lipid Formulations with Viral Immunogens," Issued June 6, 2023.
  • Technology Synopsis: This patent claims methods of eliciting an immune response by administering a formulation comprising RNA encoding a specific viral immunogen (e.g., coronavirus spike polypeptide) and lipids including a tertiary amine cationic lipid (Compl. ¶ 47).
  • Asserted Claims: Independent claims 1 and 37 (Compl. ¶ 47).
  • Accused Features: The administration of the Comirnaty® mRNA-LNP vaccine (Compl. ¶¶ 99, 101).

Multi-Patent Capsule: U.S. Patent No. 11,766,401 (’401 Patent)

  • Patent Identification: U.S. Patent No. 11,766,401, "Methods of Administering Lipid Formulations with Immunogens," Issued September 26, 2023.
  • Technology Synopsis: This patent claims methods of eliciting an immune response in a human or cow by administering a formulation comprising RNA and lipids including a tertiary amine cationic lipid (Compl. ¶ 49).
  • Asserted Claims: Independent claim 1 (Compl. ¶ 49).
  • Accused Features: The administration of the Comirnaty® mRNA-LNP vaccine (Compl. ¶¶ 119, 121).

Multi-Patent Capsule: U.S. Patent No. 11,786,467 (’467 Patent)

  • Patent Identification: U.S. Patent No. 11,786,467, "Lipid Formulations with Immunogens," Issued October 17, 2023.
  • Technology Synopsis: This patent claims a formulation comprising RNA encoding an immunogen and lipids including a tertiary amine cationic lipid, where the formulation is immunogenic in vivo (Compl. ¶ 51).
  • Asserted Claims: Independent claim 1 (Compl. ¶ 51).
  • Accused Features: The Comirnaty® mRNA-LNP formulation (Compl. ¶¶ 139, 141).

Multi-Patent Capsule: U.S. Patent No. 11,655,475 (’475 Patent)

  • Patent Identification: U.S. Patent No. 11,655,475, "Immunisation of large mammals with low doses of RNA," Issued May 23, 2023.
  • Technology Synopsis: This patent claims a method of eliciting an antibody response in a large mammal by administering at least two unit doses of a composition comprising liposomes and mRNA encoding a specific viral immunogen, with specific dosage ranges (Compl. ¶ 53).
  • Asserted Claims: Independent claims 1 and 35 (Compl. ¶ 53).
  • Accused Features: The administration of the Comirnaty® mRNA-LNP vaccine (Compl. ¶¶ 159, 161).

Multi-Patent Capsule: U.S. Patent No. 11,759,422 (’422 Patent)

  • Patent Identification: U.S. Patent No. 11,759,422, "Pegylated liposomes for delivery of immunogen-encoding RNA," Issued September 19, 2023.
  • Technology Synopsis: This patent claims a method for raising a protective immune response by administering a liposome containing RNA, where the liposome comprises a lipid with a polyethylene glycol (PEG) moiety of a specific molecular mass range (Compl. ¶ 55).
  • Asserted Claims: Independent claims 1, 8, and 9 (Compl. ¶ 55).
  • Accused Features: The Comirnaty® mRNA-LNP formulation (Compl. ¶¶ 179, 181).

Multi-Patent Capsule: U.S. Patent No. 11,851,660 (’660 Patent)

  • Patent Identification: U.S. Patent No. 11,851,660, "Immunisation of large mammals with low doses of RNA," Issued December 26, 2023.
  • Technology Synopsis: This patent claims a method of eliciting an antibody response against a coronavirus spike polypeptide by administering at least two unit doses of a composition comprising lipid particles and mRNA, with specific dosage ranges (Compl. ¶ 57).
  • Asserted Claims: Independent claims 1 and 16 (Compl. ¶ 57).
  • Accused Features: The administration of the Comirnaty® mRNA-LNP vaccine (Compl. ¶¶ 199, 201).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is the Comirnaty® COVID-19 vaccine (Compl. ¶ 1).

Functionality and Market Context

  • The complaint describes Comirnaty® as an mRNA-based vaccine developed jointly by BioNTech, Pfizer, and Acuitas (Compl. ¶ 3). Its relevant functionality is the use of a lipid nanoparticle (LNP) delivery system to encapsulate, protect, and deliver BioNTech's mRNA payload into cells to prompt an immune response (Compl. ¶ 3).
  • The complaint alleges that this LNP technology was invented by Acuitas and includes specific components such as a PEG-conjugated lipid (ALC-159) and an ionizable lipid (ALC-0315) (Compl. ¶ 3).
  • The complaint characterizes Comirnaty® as the "leading COVID-19 vaccine" and alleges that its sales have generated "billions of dollars in revenue" (Compl. ¶¶ 1, 19).
  • No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint seeks a declaratory judgment of non-infringement and does not contain a claim chart exhibit. Instead, it presents a narrative theory of non-infringement.

  • ’693 and ’694 Patent Non-Infringement Theory: The central theory of non-infringement is that the LNP formulation in Comirnaty® does not meet the definition of a "cationic lipid" as required by the claims of the patents-in-suit (Compl. ¶¶ 64, 84). Acuitas alleges that its ionizable lipid, ALC-0315, does not fall within the scope of the term "cationic lipid" as that term is "described in the specification and set forth by the claims" of the patents (Compl. ¶¶ 64, 84). This suggests the dispute centers on the specific properties of the lipid, particularly whether its pKa falls within the claimed range of 6.07 to 7.6 when measured by the highly detailed, 14-step process explicitly recited in the independent claims of both patents.

  • Identified Points of Contention:

    • Scope Questions: A primary question for the court will be whether the term "cationic lipid" is strictly limited by the 14-step pKa determination method recited in the claim language. The complaint's focus on the lipid "as described in the specification and set forth by the claims" suggests that Acuitas will argue for this narrow, method-dependent construction (Compl. ¶¶ 64, 84).
    • Technical Questions: A dispositive factual question will be what the pKa of Acuitas's ALC-0315 lipid is when subjected to the exact 14-step analytical method defined in claim 1 of the ’693 and ’694 Patents. The complaint does not provide the results of such a test, but its assertion of non-infringement implies that the result would be outside the claimed 6.07 to 7.6 range.

V. Key Claim Terms for Construction

  • The Term: "the cationic lipid comprises a tertiary amine and has a pKa from 6.07 to 7.6; and whereby the pKa is determined at standard temperature and pressure by the following: [14-step process]" (’693 Patent, Claim 1; ’694 Patent, Claim 1).
  • Context and Importance: The construction of this term is central to the infringement dispute. Acuitas's declaratory judgment action is predicated on its contention that the ionizable lipid in Comirnaty® is not a "cationic lipid" as defined by the patent claims (Compl. ¶¶ 64, 84). Practitioners may focus on whether this functional language, which defines a required property by reciting a specific measurement process, limits the claim scope to only those lipids that satisfy the pKa range when tested by that exact process.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent specification describes useful lipids for the invention more generally as those "having a pKa in the range of 5.0 to 7.6, and preferred lipids with a pKa in this range have a tertiary amine" (’693 Patent, col. 2:15-18). A party might argue this broader description informs the claim language.
    • Evidence for a Narrower Interpretation: The claim language itself is exceptionally specific, stating "whereby the pKa is determined by the following:" before reciting a detailed, multi-step laboratory protocol (’693 Patent, col. 41:48-43:30). This explicit recitation of a measurement methodology provides strong intrinsic evidence that the claim scope is limited to pKa values obtained only through this precise method, potentially excluding lipids that might fall in the range if measured differently. This is a form of lexicography where the patentee acts as its own dictionary.

VI. Other Allegations

This section is not applicable as the complaint is for a declaratory judgment of non-infringement and invalidity and does not contain allegations of indirect or willful infringement.

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

  • A core issue will be one of claim construction and scope: Is the term "cationic lipid" defined exclusively by the elaborate 14-step pKa measurement protocol recited in the claims? The case may turn on whether this detailed procedure acts as a hard limit on the claim's reach, a question that will require careful analysis of the patent's intrinsic evidence.
  • A key evidentiary question will be one of technical fact-finding: Assuming the claim is construed to require the recited measurement protocol, what is the actual, measured pKa of the ALC-0315 lipid used in Comirnaty® when subjected to that exact protocol? The outcome of this highly technical test could be dispositive for the infringement analysis.
  • A central validity question will be one of written description and enablement: The complaint alleges that GSK amended its claims years after the 2010 priority date using "hindsight and public information about Comirnaty® to craft the claims" (Compl. ¶ 29). This raises the question of whether the original 2010 patent applications contained adequate written description to support the specific lipid mole percentages and pKa measurement methods that now appear in the issued claims, or if this constitutes invalidating new matter.