DCT

8:23-cv-01758

Alpha O'Peptides AG v. Regents Of University Of California On behalf Of University Of California

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 8:23-cv-01758, C.D. Cal., 09/19/23
  • Venue Allegations: Plaintiffs allege venue is proper because a substantial part of the events giving rise to the claims occurred in the district and the primary corporate and individual defendants reside or maintain principal places of business within the district.
  • Core Dispute: Plaintiffs allege that Defendants engaged in a fraudulent scheme to misappropriate trade secrets and patented technology related to self-assembling protein nanoparticles (SAPNs) for vaccines, and that Defendant UCI infringed three patents by making and using this technology in connection with unauthorized federal grant proposals.
  • Technical Context: The technology involves self-assembling protein nanoparticles, a platform technology for the rational design of potent vaccines by displaying viral or disease-related markers (epitopes) in a highly organized and repetitive manner to stimulate a strong immune response.
  • Key Procedural History: The complaint alleges that the parties entered into a series of licensing agreements, including a Materials Transfer Agreement, which strictly limited Defendants' rights to use Plaintiffs' proprietary SAPN technology to specific, authorized research projects. The dispute centers on allegations that Defendants breached these agreements and used the technology for at least three unauthorized NIH grant proposals, misrepresented inventorship on a subsequent patent application that disclosed Plaintiffs' trade secrets, and falsely claimed ownership of the technology.

Case Timeline

Date Event
2003-02-17 Earliest Priority Date for ’110 Patent
2008-02-01 Earliest Priority Date for ’337 Patent
2013-10-01 ’337 Patent Issued
2013-11-05 ’110 Patent Issued
2014-01-09 Earliest Priority Date for ’318 Patent
2016-09-20 Confidentiality Disclosure Agreement between AOP and Sunomix
2016-11-16 Materials Transfer Agreement between AOP, Sunomix, and UCI
2017-03-21 2017 Licensing Agreement between AOP and Sunomix
2018-09-07 2018 Licensing Agreement between AOP and Sunomix
2018-12-19 Alleged submission of NIH Grant Proposal 5R21AI147499
2019-04-02 ’318 Patent Issued
2019-04-11 Alleged submission of NIH Grant Proposal 1R01AI150091
2019-08-08 UCI allegedly files U.S. Patent Application 16/535,534
2020-04-11 4/11/20 Agreement between AOP and Sunomix
2020-04-22 4/22/20 Agreement between AOP and Sunomix
2020-05-22 Alleged submission of NIH Grant Proposal 1R01AI158060
2023-09-19 Complaint Filed

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

U.S. Patent No. 8,575,110: "Peptidic Nanoparticles as Drug Delivery and Antigen Display Systems" (Issued November 5, 2013)

The Invention Explained

  • Problem Addressed: The patent's background section describes the limitations of existing particulate systems for drug delivery, such as liposomes, which can be mechanically unstable and have limited loading capacity. It further notes the challenges in developing effective peptide-based vaccines, which often require strong adjuvants and face issues of genetic heterogeneity in human immune responses (’110 Patent, col. 1:12-col. 2:32).
  • The Patented Solution: The invention claims a new type of nanoparticle formed by the 'self-organization of a single continuous chain' of peptides (’110 Patent, Abstract). Each peptide chain is composed of two distinct 'oligomerization domains' connected by a linker. These domains have a tendency to self-associate into structures of a specific number (e.g., a trimer and a pentamer). The geometric and mathematical constraints imposed by linking two domains with different, non-multiple oligomerization states (e.g., a 3-mer and a 5-mer) forces a multitude of these peptide chains to self-assemble into a closed, spherical nanoparticle of a predictable size and structure (’110 Patent, col. 3:4-10; Fig. 3).
  • Technical Importance: This self-assembly method provides a modular and robust platform for creating uniform, stable nanoparticles that can be precisely engineered for applications in drug delivery and as platforms for vaccine development (Compl. ¶¶ 2, 5).

Key Claims at a Glance

The complaint alleges infringement of "at least one claim" without specifying which ones (Compl. ¶178). Independent claim 1 is representative of the core technology.

  • Independent Claim 1:
    • A peptidic nanoparticle consisting of an assembly of 10 or more peptides.
    • Each peptide consists of a continuous chain comprising a peptidic oligomerization domain D1, a linker L, and a peptidic oligomerization domain D2.
    • D1 forms oligomers of 'm' subunits, and D2 forms oligomers of 'n' subunits.
    • The combination of 'm' and 'n' is restricted to specific pairs where m and n are not equal or multiples of each other (e.g., 2 and 5; 3 and 4; 3 and 5; 4 and 5).
    • At least one of the D1 or D2 domains is a coiled-coil peptide sequence.

U.S. Patent No. 8,546,337: "Self-Assembling Peptide Nanoparticles Useful as Vaccines" (Issued October 1, 2013)

The Invention Explained

  • Problem Addressed: The patent's background section highlights the difficulty in designing vaccines that induce a strong and durable immune response, particularly the cell-mediated immunity driven by cytotoxic T-lymphocytes (CTLs), which is critical for clearing viral infections (’337 Patent, col. 1:12-28). Presenting peptide epitopes in a way that effectively stimulates these responses is a central challenge in vaccinology.
  • The Patented Solution: The invention leverages the self-assembling nanoparticle platform described in related patents and adapts it specifically for vaccines. It claims nanoparticles where T-cell epitopes (recognized by T-cells) and/or B-cell epitopes (recognized by antibodies) are incorporated directly into the structure of the self-assembling peptide chains (’337 Patent, Abstract). This creates a nanoparticle surface with a highly dense and repetitive display of the target antigen, a structure known to be highly effective at stimulating the immune system.
  • Technical Importance: This technology allows for the rational design of vaccine candidates that can present specific, crucial fragments of a pathogen in a multivalent format, potentially leading to a more potent and targeted immune response than traditional vaccine approaches (Compl. ¶¶ 2, 27).

Key Claims at a Glance

The complaint alleges infringement of "at least one claim" without specifying which ones (Compl. ¶176). Independent claim 1 is representative.

  • Independent Claim 1:
    • A self-assembling peptide nanoparticle made of building blocks with a D1-L-D2 structure.
    • D1 and D2 are peptide domains with tendencies to form oligomers of 'm' and 'n' subunits, respectively, where 'm' and 'n' are different, non-multiple integers between 2 and 10.
    • At least one of the D1 or D2 domains is a coiled-coil that "incorporates one or more T- and/or B-cell epitopes."

U.S. Patent No. 10,245,318: "Flagellin-Containing Protein Nanoparticles as a Vaccine Platform" (Issued April 2, 2019)

  • Technology Synopsis: This patent addresses the need for safe and effective vaccine adjuvants, which are components that boost the immune response. The invention describes a self-assembling nanoparticle that incorporates the bacterial protein flagellin, or a derivative thereof, into its structure. Flagellin acts as a natural adjuvant by activating Toll-like receptor 5 (TLR5) on immune cells, thereby enhancing the vaccine's overall potency (’318 Patent, Abstract; col. 2:24-34).
  • Asserted Claims: The complaint alleges infringement of "at least one claim" (Compl. ¶180). Independent claim 1 is representative of the core technology.
  • Accused Features: The complaint alleges that Defendant UCI made and/or used SAPNs in connection with NIH Grant Proposals 5R21AI147499, 1R01AI150091, and 1R01AI158060, thereby infringing the patent (Compl. ¶180).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are not commercial products but rather Self-Assembling Protein Nanoparticles (SAPNs) allegedly made and/or used by Defendant UCI in connection with three NIH grant proposals: 5R21AI147499, 1R01AI150091, and 1R01AI158060 (Compl. ¶¶176, 178, 180).

Functionality and Market Context

  • The complaint alleges that Defendants used Plaintiffs’ proprietary and patented SAPN technology as a platform to develop vaccines, specifically for Herpes Simplex Virus (HSV) and COVID-19, for the research purposes outlined in the grant proposals (Compl. ¶¶38, 53, 63). These actions are framed not in a commercial sales context but as part of an alleged scheme to obtain federal research funding through the unauthorized use of Plaintiffs' intellectual property (Compl. ¶¶63, 192). No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not provide specific technical details or claim charts mapping elements to the accused instrumentalities. The infringement theory is based on the overarching allegation that UCI used Plaintiffs' own SAPN technology, implying a direct correspondence.

U.S. Patent No. 8,575,110 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A peptidic nanoparticle consisting of an assembly of 10 or more peptides... The nanoparticles allegedly made and used by UCI for NIH grant proposals are based on Plaintiffs’ SAPN technology, which forms nanoparticles from multiple peptide chains. ¶¶178, 3 col. 4:2-3
...each peptide is consisting of a continuous chain of a peptidic oligomerization domain D1, a linker segment L, and a peptidic oligomerization domain D2... The allegedly used SAPN technology is described as being based on the self-organization of a single continuous chain comprising oligomerization domains. ¶29 col. 3:4-10
...the peptidic nanoparticle contains: (a) one of m or n is 2 forming a dimer protein oligomer assembly, and the other of m or n is 5 forming a pentamer protein oligomer assembly; or (b) one of m or n is 3 forming a trimer...and the other...is 4 or 5...; or (c)... The complaint alleges use of Plaintiffs' patented SAPN technology, which relies on this principle of combining domains with different, non-multiple oligomerization states to drive self-assembly. ¶29 col. 4:18-24
...at least one D1 or D2 is a coiled-coil peptide sequence... The complaint does not provide sufficient detail for analysis of this specific element. col. 4:29-30

U.S. Patent No. 8,546,337 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A self-assembling peptide nanoparticle consisting of aggregates of a multitude of building blocks... The nanoparticles allegedly made and used by UCI for NIH grant proposals are based on Plaintiffs’ SAPN technology. ¶¶176, 32 col. 3:44-46
...a continuous chain comprising a peptidic oligomerization domain D1, a linker segment L, and a peptidic oligomerization domain D2... The allegedly used SAPN technology is based on the D1-L-D2 architecture for self-assembly. ¶32 col. 4:3-6
...wherein at least one of the D1 or D2 is a coiled-coil that incorporates one or more T- and/or B-cell epitopes... The complaint alleges Defendants used the technology to engineer specific HSV and COVID-19 epitopes (which function as B-cell and T-cell epitopes) into the SAPNs for vaccine development. ¶38 col. 4:30-33

Identified Points of Contention

  • Evidentiary Question: The complaint's infringement allegations are conclusory and lack technical evidence detailing the specific structure and composition of the nanoparticles UCI allegedly created. A central question for the court will be an evidentiary one: what proof can Plaintiffs provide from discovery to demonstrate that the nanoparticles actually made and used by UCI in its grant-related research meet every limitation of the asserted claims?
  • Technical Question: The infringement analysis will depend on the precise nature of the protein constructs used by UCI. The complaint does not provide sufficient detail for analysis of whether those constructs meet specific claim limitations, such as the requirement for a "coiled-coil peptide sequence" or the precise manner in which epitopes were "incorporated."

V. Key Claim Terms for Construction

The Term: "peptidic oligomerization domain"

  • Context and Importance: This term is the fundamental building block of the claimed invention in both the ’110 and ’337 patents. The entire self-assembly concept relies on linking two such domains with different and specific oligomerization states (e.g., a trimer and a pentamer). Practitioners may focus on this term because the infringement case depends on whether the protein segments used by UCI qualify as such domains, both structurally and functionally.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patents provide a functional definition, stating D1 is "a peptide having a tendency to form oligomers (D1)m of m subunits" (’337 Patent, col. 4:40-42). This language could support a construction covering any peptide that exhibits the required oligomerization behavior.
    • Evidence for a Narrower Interpretation: The specifications heavily emphasize "coiled-coil" domains as the preferred embodiment and provide specific examples, such as domains from the COMP protein or the T4 fibritin foldon (’337 Patent, col. 5:60-65; col. 9:23-30). This may support an argument that the term should be construed more narrowly to encompass only structures with similar characteristics to those explicitly disclosed.

The Term: "incorporates one or more T- and/or B-cell epitopes" (’337 Patent)

  • Context and Importance: This limitation distinguishes the vaccine-specific ’337 patent from the more general platform technology of the ’110 patent. The case may turn on how an epitope is considered "incorporated." Practitioners may focus on this term because a dispute could arise over whether merely including an epitope sequence somewhere in the peptide chain is sufficient, or if the claim requires a more specific structural integration into the coiled-coil domain.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The claim language states the epitope is "within the...oligomerization domain," which could be read broadly to mean it is part of the amino acid sequence that makes up the domain (’337 Patent, col. 4:30-33).
    • Evidence for a Narrower Interpretation: The detailed description discusses specific methods for "engineering" epitopes into the coiled-coil structure, suggesting a deliberate and structurally significant integration is contemplated, rather than a simple fusion (’337 Patent, col. 11:34-45).

VI. Other Allegations

Willful Infringement

  • The complaint does not explicitly use the term "willful infringement" in the patent counts. However, it alleges facts that may support a future claim for willfulness. The complaint asserts that Defendants were aware of Plaintiffs' patents through multiple licensing agreements that specifically identified the patent numbers and that Defendants' use of the technology in the grant proposals was outside the scope of those licenses (Compl. ¶¶53, 58, 63).

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

  • A central issue will be one of evidentiary proof: As the alleged infringement relates to non-public research activities rather than a commercial product, the case will likely depend on what evidence emerges during discovery to prove the precise technical specifications of the nanoparticles UCI made and used, and whether those specifications meet every element of the asserted claims.
  • A key legal and factual question will be one of damages: Given that the alleged infringement is based on making and using nanoparticles for federal grant proposals, not commercial sales, the case raises the question of the appropriate theory for calculating damages. The analysis may involve assessing the value of the grant money obtained or the value of the research enabled by the alleged infringement, intertwined with the broader allegations of fraud and contract breach.