DCT

3:23-cv-00764

Acuitas Therap Inc v. CureVac Se

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:23-cv-00764, E.D. Va., 11/13/2023
  • Venue Allegations: Plaintiffs allege venue is proper under federal statutes governing patent cases and actions against foreign defendants.
  • Core Dispute: Plaintiffs seek to correct inventorship under 35 U.S.C. § 256, alleging their scientists should be added as co-inventors to four of Defendant’s patents covering mRNA-based coronavirus vaccines, based on their alleged conception and development of the claimed lipid nanoparticle (LNP) delivery technology.
  • Technical Context: The dispute concerns foundational technology for mRNA vaccines, where an mRNA payload encoding a viral protein is encapsulated in an LNP for safe and effective delivery into human cells.
  • Key Procedural History: The complaint alleges a long-standing collaboration between the parties, including a prior joint patent application (WO 2018/078053) that lists scientists from both companies as co-inventors on related mRNA-LNP technology. This history of joint work is presented to support the claim that the patents-in-suit also result from a joint inventive effort.

Case Timeline

Date Event
2014-01-01 Alleged start of collaboration between Acuitas and CureVac
2017-10-26 Filing date of joint patent application WO 2018/078053
2020-01-22 Acuitas allegedly approaches CureVac to collaborate on a COVID-19 vaccine
2020-02-04 Earliest Priority Date for ’493, ’966, and ’686 Patents
2020-11-10 Earliest Priority Date for ’525 Patent
2022-02-08 U.S. Patent No. 11,241,493 Issues
2022-10-18 U.S. Patent No. 11,471,525 Issues
2023-02-14 U.S. Patent No. 11,576,966 Issues
2023-03-07 U.S. Patent No. 11,596,686 Issues
2023-11-13 Complaint Filing Date

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

U.S. Patent No. 11,241,493

  • Patent Identification: U.S. Patent No. 11,241,493, "Coronavirus Vaccine," issued February 8, 2022 (the "’493 Patent").

The Invention Explained

  • Problem Addressed: The patent addresses the urgent global need for a safe and effective vaccine to prevent infection by SARS-CoV-2, the virus that causes COVID-19. (Compl. ¶24; ’493 Patent, col. 2:1-20).
  • The Patented Solution: The invention is a vaccine composition comprising two key components: a messenger RNA (mRNA) sequence that instructs human cells to produce a stabilized version of the SARS-CoV-2 spike protein, and a lipid nanoparticle (LNP) that acts as a delivery vehicle to protect the fragile mRNA and transport it into cells. (’493 Patent, Abstract; col. 10:50-67). The specific combination of the mRNA payload and the four-part LNP formulation is claimed to produce a protective immune response. (’493 Patent, Abstract).
  • Technical Importance: This approach combines the rapid development potential of mRNA technology with an LNP delivery system designed to ensure the stability and cellular uptake of the vaccine's active ingredient. (Compl. ¶3).

Key Claims at a Glance

  • The complaint bases its inventorship claim on independent claim 1. (Compl. ¶34).
  • The essential elements of claim 1 are:
    • An mRNA component with a coding sequence for a specific, pre-fusion stabilized SARS-CoV-2 spike protein.
    • A lipid nanoparticle (LNP) component that complexes with the mRNA.
    • The LNP is specifically defined as comprising four lipid types: (i) a specific cationic lipid (formula III-3), (ii) a neutral lipid (DSPC), (iii) a steroid (cholesterol), and (iv) a specific PEG-lipid (formula IVa).
    • The LNP components are further defined by specific molar ratios.
  • The complaint also alleges contribution to dependent claims 15-16 and 19-22. (Compl. ¶38).

U.S. Patent No. 11,471,525

  • Patent Identification: U.S. Patent No. 11,471,525, "Coronavirus Vaccine," issued October 18, 2022 (the "’525 Patent").

The Invention Explained

  • Problem Addressed: The patent addresses the same problem as the ’493 Patent: the need for an effective vaccine against SARS-CoV-2. (’525 Patent, col. 2:1-20).
  • The Patented Solution: Rather than claiming the composition itself, this patent claims a method of stimulating an immune response in a subject. The method consists of administering an effective amount of a composition that, like the invention of the ’493 Patent, comprises a specific mRNA sequence complexed with a specific four-component LNP. (’525 Patent, Abstract). The claim specifies that the composition is administered by intramuscular injection. (’525 Patent, col. 280:45-47).
  • Technical Importance: This patent protects the therapeutic application and administration of the vaccine composition, extending protection beyond the product itself to its medical use. (Compl. ¶51).

Key Claims at a Glance

  • The complaint bases its inventorship claim on independent claims 1 and 25. (Compl. ¶51).
  • The essential elements of claim 1 are:
    • A method of stimulating an immune response by administering a composition.
    • The composition contains an mRNA component encoding a specific SARS-CoV-2 spike protein with particular mutations.
    • The mRNA is complexed with an LNP comprising the same four lipid types recited in the ’493 patent: (i) a specific cationic lipid (formula III-3), (ii) a neutral lipid (DSPC), (iii) cholesterol, and (iv) a specific PEG-lipid (formula IVa).
    • The LNP components are defined by specific molar ratios.
    • The method requires administration by intramuscular injection.
  • The complaint also alleges contribution to dependent claims 15-23 and 28-29. (Compl. ¶54).

U.S. Patent No. 11,576,966

  • Patent Identification: U.S. Patent No. 11,576,966, "Coronavirus Vaccine," issued February 14, 2023 (the "’966 Patent").
  • Technology Synopsis: This patent claims a composition comprising an mRNA encoding a SARS-CoV-2 spike protein with a different, more extensive set of stabilizing mutations and amino acid substitutions compared to the ’493 Patent. (Compl. ¶64). The claimed LNP formulation is defined more generically by lipid class (cationic, neutral, steroid, PEG-lipid) and molar ratios, without reference to the specific chemical formulas recited in the ’493 and ’525 patents. (Compl. ¶64).
  • Asserted Claims: Independent claims 1 and 26. (Compl. ¶64).
  • Alleged Contributions: Plaintiffs allege they conceived of and formulated the LNP compositions with the claimed relative proportions of lipids. (Compl. ¶¶65-66).

U.S. Patent No. 11,596,686

  • Patent Identification: U.S. Patent No. 11,596,686, "Coronavirus Vaccine," issued March 7, 2023 (the "’686 Patent").
  • Technology Synopsis: This patent claims a purified mRNA and compositions thereof, where the mRNA has a specific 5' cap structure and encodes a stabilized SARS-CoV-2 spike protein. (Compl. ¶77). The patent also claims compositions where this purified mRNA is complexed with an LNP, which is defined generically by lipid class and molar ratios, similar to the ’966 Patent. (Compl. ¶¶77-78).
  • Asserted Claims: Independent claims 1 and 26, as well as dependent claims 19 and 27 which add the LNP limitations. (Compl. ¶¶77-78).
  • Alleged Contributions: Plaintiffs allege they significantly contributed to the conception of the claimed LNP compositions. (Compl. ¶¶79-80).

III. Subject Matter of Inventorship Dispute

Product Identification

The subject matter of the dispute is the claimed invention in each of the four patents-in-suit: compositions and methods for an mRNA-LNP coronavirus vaccine. (Compl. ¶1).

Functionality and Context

The complaint alleges that the claimed inventions are the result of a collaboration combining two distinct technologies. (Compl. ¶35). Defendant CureVac allegedly provided the mRNA component, which carries the genetic instructions for the SARS-CoV-2 spike protein. (Compl. ¶21, 35). Plaintiffs Acuitas and its scientists allegedly conceived, designed, and formulated the LNP technology, which serves as the essential delivery vehicle. (Compl. ¶21, 37). The complaint asserts that Acuitas’s contribution included the specific lipids used, the molar ratios of those lipids, the non-mRNA components of the formulation, and key characteristics of the final mRNA-LNP particle, such as its size. (Compl. ¶26). These LNP formulations are alleged to be necessary to protect the fragile mRNA and deliver it effectively into cells to produce an immune response. (Compl. ¶3). The experimental data in the patents, which allegedly provides the basis for the claims, is described as having been jointly generated by both parties using Acuitas's LNP technology to encapsulate CureVac's mRNA. (Compl. ¶¶6, 11, 26).

IV. Analysis of Inventorship Contribution Allegations

The core of the complaint is that Plaintiffs conceived of the LNP portion of the claimed inventions. The allegations of contribution are summarized below for the lead patents.

’493 Patent Contribution Allegations

Claim Element (from Independent Claim 1) Plaintiff's Alleged Contribution Complaint Citation Patent Citation
(a) at least one coding sequence encoding a SARS-CoV-2 spike protein ... (b) at least one heterologous untranslated region (UTR) CureVac is alleged to have conceived the mRNA component. ¶35 col. 286:39-46
(c) at least one pharmaceutically acceptable carrier, wherein the mRNA is complexed or associated with lipid nanoparticles (LNP) The resulting mRNA-LNP composition is alleged to be a joint conception. ¶35 col. 286:47-50
and wherein the LNP comprises: (i) at least one cationic lipid according to formula III-3 Acuitas alleges it conceived of this specific cationic lipid. ¶37 col. 286:50-61
(ii) at least one neutral lipid, comprising 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC); (iii) at least one steroid, comprising cholesterol Acuitas alleges it conceived of and formulated the complete LNP, including the selection and proportion of these components. ¶37 col. 286:62-65
(iv) at least one PEG-lipid according to formula IVa: Acuitas alleges it conceived of this specific PEG-lipid. ¶37 col. 287:1-8
wherein (i) to (iv) are in a molar ratio of about 20-60% cationic lipid, 5-25% neutral lipid, 25-55% sterol, and 0.5-15% PEG-lipid. Acuitas alleges it conceived of and formulated the LNP compositions with these specific relative lipid proportions. ¶37 col. 287:9-12
  • Identified Points of Contention:
    • Conception vs. Routine Formulation: A central question will be whether Acuitas's work on the LNP constitutes conception of a novel element of the claimed invention or was instead the application of known techniques or a pre-existing proprietary technology at the direction of CureVac. The complaint alleges Acuitas "conceived of and formulated" the LNP compositions, suggesting inventive contribution beyond routine work. (Compl. ¶37).
    • Contribution to the Combination: The dispute may turn on whether providing one essential component (the LNP) for combination with another (the mRNA) constitutes co-inventorship of the final claimed composition. Plaintiffs allege joint conception of the final mRNA-LNP composition. (Compl. ¶35).

V. Key Claim Terms for Construction

In an inventorship dispute, the focus is less on claim construction for infringement and more on what the claim elements mean in the context of who conceived them.

  • The Term: "complexed or associated with lipid nanoparticles (LNP)"

  • Context and Importance: This phrase links CureVac's alleged contribution (the mRNA) with Acuitas's (the LNP). The legal dispute will center on who conceived of this specific combination. Practitioners may focus on whether the act of combining a known mRNA with a known LNP formulation constitutes an inventive conception, and if so, whether that conception was solely CureVac's or a joint effort as alleged by Plaintiffs.

  • Intrinsic Evidence for Interpretation:

    • Evidence for Joint Conception: The complaint points to a prior, joint patent application (WO 2018/078053) between the parties for similar mRNA-LNP technology, which may suggest a pattern of joint inventive work in combining these two elements. (Compl. ¶22).
    • Evidence for Separate Conception: The patent specification describes the two components—the nucleic acid and the LNP—in separate, extensive sections, which may support an argument that the conception of each part was distinct before they were combined. (’493 Patent, col. 10:50-67, col. 89:26-90:19).

  • The Term: "cationic lipid according to formula III-3" and "PEG-lipid according to formula IVa"

  • Context and Importance: These terms define the specific, proprietary molecules that form the basis of Acuitas’s inventorship claim. Their novelty and origin are central to whether Acuitas contributed to the conception of the claimed invention.

  • Intrinsic Evidence for Interpretation:

    • Evidence for Acuitas's Contribution: The specification of the ’493 Patent explicitly states that suitable cationic and PEG-lipids can be derived from PCT application WO2018/078053A1. (’493 Patent, col. 93:59-62; col. 96:26-32). The complaint identifies this PCT application as the prior joint invention of Acuitas and CureVac. (Compl. ¶22). This direct reference in the patent to a prior joint work may provide strong evidence supporting Acuitas’s contribution to these elements.
    • Evidence for Pre-existence/Obviousness: A defendant in such a case would typically argue that such lipids were already in the public domain or that their selection for this application was obvious. However, the patent's own citation to the joint application may complicate such an argument.

VI. Other Allegations

  • Circumstances of Filing: The complaint alleges that CureVac "surreptitiously filed the applications" for the patents-in-suit "without Plaintiffs' knowledge" and "deliberately" omitted the Acuitas scientists as inventors. (Compl. ¶¶2, 6). While the modern standard for correcting inventorship focuses on "error" rather than deceptive intent, these allegations speak to the context of the dispute and may be relevant to related claims or remedies, such as the request for attorneys' fees. (Compl. p. 25, ¶ I).

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

  • The Standard for Co-Inventorship: A core legal issue will be whether providing and formulating a specific, proprietary LNP delivery system for another party's mRNA payload meets the standard for joint inventorship. The court will have to determine if this contribution was merely supplying a known component or performing a service, or if it rose to the level of contributing to the "definite and permanent idea of the complete and operative invention," i.e., the conception of the final claimed vaccine composition.
  • The Role of Prior Collaboration: A key evidentiary question will be how the parties' history of collaboration, particularly the joint inventorship on the WO'053 patent application for related technology, informs the assessment of conception for the patents-in-suit. The direct citation to that joint application within the patents themselves will likely be a central piece of evidence in determining whether the LNP components were a recognized contribution from the Acuitas team.