DCT

1:22-cv-00487

Avadel CNS Pharma LLC v. Jazz Pharma Inc

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:22-cv-00487, D. Del., 04/28/2022
  • Venue Allegations: Venue is alleged to be proper as Defendants transact business within the district and have consented to venue, at least in part by filing prior lawsuits in the jurisdiction.
  • Core Dispute: Plaintiff seeks correction of inventorship on several of Defendant’s patents related to sodium oxybate formulations, alleging they were derived from Plaintiff’s misappropriated trade secrets and confidential information.
  • Technical Context: The technology concerns controlled-release formulations of sodium oxybate, a treatment for narcolepsy, designed to provide therapeutic effects throughout the night with a single evening dose.
  • Key Procedural History: The complaint alleges that Defendant Jazz Pharmaceuticals, Inc. previously filed three patent infringement lawsuits against Plaintiff Avadel's once-nightly product, FT218, asserting the same patents for which Avadel now seeks correction of inventorship. Avadel alleges that during prosecution of its patents, Jazz distinguished its claims over prior art by characterizing its invention as a "sustained release" composition, distinct from a "delayed release" composition.

Case Timeline

Date Event
2010-03-24 Priority Date for Jazz '488, '885, '956, '931 Patents
2010-05-26 Avadel allegedly discloses confidential information to Jazz under a 2010 CDA
2014-04-XX Avadel announces completion of a proof-of-concept study for its microparticle technology
2015-02-18 Priority Date for Jazz '079 and '782 Patents
2015-04-01 Avadel allegedly sends Jazz a confidential clinical study report under a 2015 CDA
2018-01-25 Avadel's '062 patent application is published
2019-06-20 Avadel's '866 patent application is published
2019-09-12 Avadel's '986 patent application is published
2020-09-01 U.S. Patent 10,758,488 Issues
2020-10-27 U.S. Patent 10,813,885 Issues
2021-03-30 U.S. Patent 10,959,956 Issues
2021-04-06 U.S. Patent 10,966,931 Issues
2021-08-03 U.S. Patent 11,077,079 Issues
2021-10-19 U.S. Patent 11,147,782 Issues
2022-04-28 Complaint Filing Date

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

U.S. Patent No. 10,758,488 - "Controlled Release Dosage Forms for High Dose, Water Soluble and Hygroscopic Drug Substances"

  • Issued: September 1, 2020

The Invention Explained

  • Problem Addressed: The patent describes the difficulty in creating controlled-release oral dosage forms for drugs like sodium gamma-hydroxybutyrate (GHB) that require a high dose, have high water solubility, and are hygroscopic (tend to absorb moisture) ('488 Patent, col. 1:19-44). Existing twice-nightly dosing regimens for narcolepsy are disruptive to patients' sleep ('488 Patent, col. 2:56-65).
  • The Patented Solution: The invention is a pharmaceutical formulation that combines an immediate-release portion of GHB with a sustained-release portion in a single dosage form ('488 Patent, Abstract). The sustained-release portion comprises a core containing the drug, which is covered by a functional coating made of specific polymers (methacrylic acid-methyl methacrylate co-polymers) that controls the drug's release over time, aiming to maintain therapeutic plasma levels from a single administration ('488 Patent, col. 27:24-36; col. 28:28-44). This is intended to provide a quick onset of action followed by a prolonged therapeutic effect ('488 Patent, col. 4:24-29).
  • Technical Importance: This approach aims to consolidate a multi-dose, sleep-interrupting regimen into a single, once-nightly dosage form, which could improve patient compliance and quality of life ('488 Patent, col. 8:2-10).

Key Claims at a Glance

  • The complaint seeks correction of inventorship for all claims of the '488 Patent, with a focus on the subject matter introduced into the asserted claims (Compl. ¶¶182-188). Independent claim 1 is representative.
  • Independent Claim 1:
    • A formulation with immediate release and sustained release portions, each containing GHB or its salts.
    • The sustained release portion has a functional coating over a core.
    • The core contains GHB or its salts.
    • The functional coating comprises one or more methacrylic acid-methyl methacrylate co-polymers, which make up 20% to 50% by weight of the coating.
    • The sustained release portion releases over 40% of its GHB between 4 to 6 hours when tested under specific dissolution conditions (USP apparatus 2, 37° C, 50 rpm).
    • The immediate release portion contains 10% to 50% of the total GHB in the formulation.
    • The total formulation releases at least 30% of its GHB by one hour and over 90% by 8 hours under the same test conditions.

U.S. Patent No. 10,813,885 - "Controlled Release Dosage Forms for High Dose, Water Soluble and Hygroscopic Drug Substances"

  • Issued: October 27, 2020

The Invention Explained

  • Problem Addressed: This patent addresses the same technical challenges as the '488 Patent: formulating a high-dose, highly soluble, and hygroscopic drug like GHB into a once-nightly controlled-release dosage form to avoid disruptive twice-nightly dosing ('885 Patent, col. 1:15-44).
  • The Patented Solution: The '885 Patent claims a sustained-release formulation of GHB, without an explicit immediate-release component in its independent claims. The core technology is a dosage form with a core containing GHB and a functional coating that controls its release ('885 Patent, col. 26:54-61). The coating is comprised of methacrylic acid-methyl methacrylate co-polymers and is designed to release over 40% of the drug between 4 to 6 hours under specified dissolution test conditions ('885 Patent, col. 27:1-6). This design provides a prolonged delivery of the therapeutic agent from a single dosage unit ('885 Patent, Abstract).
  • Technical Importance: The technology provides a method for achieving a specific, prolonged drug release profile for GHB, potentially enabling a once-nightly treatment option for narcolepsy.

Key Claims at a Glance

  • The complaint seeks correction of inventorship for all claims of the '885 Patent (Compl. ¶¶190-196). Independent claim 1 is representative.
  • Independent Claim 1:
    • A sustained release formulation comprising 500 mg to 12 g of GHB or its salts.
    • The formulation includes a functional coating and a core.
    • The core contains the GHB or its salt.
    • The functional coating is deposited over the core and comprises one or more methacrylic acid-methyl methacrylate co-polymers, making up 20% to 50% of the coating's weight.
    • The formulation releases over 40% of its GHB between 4 to 6 hours when tested under specific dissolution conditions.

U.S. Patent No. 10,959,956 - "Controlled Release Dosage Forms for High Dose, Water Soluble and Hygroscopic Drug Substances"

  • Issued: March 30, 2021
  • Technology Synopsis: Similar to the '488 and '885 patents, this patent describes controlled-release formulations for high-dose, water-soluble drugs like GHB. The claims are directed to a method of treating narcolepsy by administering a formulation with both immediate and sustained release portions, characterized by specific dissolution profiles and polymer coatings ('956 Patent, col. 27:26-51).
  • Asserted Claims: All claims; correction of inventorship sought (Compl. ¶¶197-204).
  • Alleged Derivation: The complaint alleges the claimed dissolution profiles and use of methacrylic acid-methyl methacrylate co-polymers were copied from Avadel's public patent applications and confidential information (Compl. ¶¶111, 113).

U.S. Patent No. 10,966,931 - "Controlled Release Dosage Forms for High Dose, Water Soluble and Hygroscopic Drug Substances"

  • Issued: April 6, 2021
  • Technology Synopsis: This patent claims methods of treating narcolepsy by administering a sustained-release GHB formulation. The formulation is defined by a core, a functional coating containing methacrylic acid-methyl methacrylate co-polymers, and a specific dissolution profile where over 40% of the drug is released between 4 to 6 hours ('931 Patent, col. 27:52-col. 28:8).
  • Asserted Claims: All claims; correction of inventorship sought (Compl. ¶¶205-212).
  • Alleged Derivation: The complaint alleges the claimed subject matter was not supported by Jazz's original specification but was instead derived from Avadel's disclosures (Compl. ¶¶112-113).

U.S. Patent No. 11,077,079 - "GHB Formulation and Method for its Manufacture"

  • Issued: August 3, 2021
  • Technology Synopsis: This patent, which the complaint calls one of the "Resinate Patents," describes GHB formulations using ion-exchange resin beads to achieve controlled release. The claims are directed to methods of treating narcolepsy by administering a solid oral formulation containing immediate and controlled-release components in a single daily dose ('079 Patent, col. 25:22-col. 26:10).
  • Asserted Claims: All claims; correction of inventorship sought (Compl. ¶¶213-220).
  • Alleged Derivation: The complaint alleges Jazz drafted these claims based on Avadel's confidential information and '986 patent publication, despite Jazz's own specification focusing on ion-exchange resins, a technology not used by Avadel (Compl. ¶¶117-118).

U.S. Patent No. 11,147,782 - "GHB Formulation and Method for its Manufacture"

  • Issued: October 19, 2021
  • Technology Synopsis: A child patent of the '079 patent, this patent also describes GHB formulations using ion-exchange resins. The claims cover methods of treating narcolepsy by administering a single daily dose of a solid formulation with immediate and controlled-release components ('782 Patent, col. 25:1-col. 26:10).
  • Asserted Claims: All claims; correction of inventorship sought (Compl. ¶¶221-228).
  • Alleged Derivation: The complaint alleges the claims were drafted based on Avadel's confidential information and '866 patent publication, rather than on any disclosure in Jazz's underlying applications (Compl. ¶122).

III. The Accused Instrumentality

No probative visual evidence provided in complaint.

Product Identification

The "instrumentalities" at issue are not commercial products but rather the claimed inventions of U.S. Patent Nos. 10,758,488; 10,813,885; 10,959,956; 10,966,931; 11,077,079; and 11,147,782 (the "Jazz Patents") (Compl. ¶¶181-228).

Functionality and Market Context

The Jazz Patents claim pharmaceutical formulations and methods for controlled, once-nightly delivery of sodium oxybate (GHB) (Compl. ¶¶108, 110, 111, 112, 118, 122). The complaint alleges that these patents were asserted by Jazz in prior litigation to block Avadel's FT218 product from entering the market (Compl. ¶¶1, 6). Avadel alleges that the claimed subject matter—specifically, formulations comprising methacrylic acid-methyl methacrylate co-polymers and achieving certain dissolution profiles, as well as formulations in sachet or suspension form—was not invented by Jazz (Compl. ¶¶109, 118). Instead, Avadel alleges Jazz copied these features from confidential information disclosed by Avadel under CDAs in 2010 and 2015 and from Avadel's own subsequent patent publications (Compl. ¶¶7, 85, 101). The complaint alleges that Jazz's parent application was directed to a "compressed tablet controlled release core," but that Jazz later amended the claims to cover different technology after seeing Avadel's publications (Compl. ¶102, 108).

IV. Analysis of Infringement Allegations

The complaint does not allege patent infringement. Instead, it alleges that the inventors of the Jazz Patents are incorrect and seeks to add Avadel inventors under 35 U.S.C. § 256, asserting that the claimed subject matter was derived from Avadel's confidential information and public disclosures. The tables below summarize Avadel's allegations mapping its disclosures to the elements of Jazz's patent claims.

10,758,488 Patent Inventorship Allegations

Claim Element (from Independent Claim 1) Alleged Source of Conception/Invention (per Avadel) Complaint Citation Patent Citation
a formulation comprising immediate release and sustained release portions Avadel's 2010 Micropump® Deck allegedly disclosed using a "combination of immediate release AND delayed release in a single administration." ¶84 col. 27:24-26
the sustained release portion comprises a functional coating and a core The concept of using microparticulate beads with a controlled-release coating was allegedly disclosed in Avadel's 2010 Micropump® Deck. ¶33 col. 27:28-30
the functional coating comprises one or more methacrylic acid-methyl methacrylate co-polymers Avadel's '062 patent publication, published January 25, 2018, allegedly disclosed modified release formulations of GHB containing these specific co-polymers. ¶96 col. 27:34-36
the sustained release portion releases greater than about 40% of its gamma-hydroxybutyrate by about 4 to about 6 hours when tested in a dissolution apparatus 2 Avadel's '062 patent publication allegedly disclosed formulations with specific dissolution profiles tested under identical conditions (USP apparatus 2, 37°C, 50 rpm). ¶¶96, 108 col. 27:40-45
the formulation releases greater than about 90% of its gamma-hydroxybutyrate by 8 hours Avadel's '062 patent publication allegedly disclosed this dissolution profile feature. Jazz is alleged to have drafted claims to match. ¶¶108-109 col. 27:58-62

10,813,885 Patent Inventorship Allegations

Claim Element (from Independent Claim 1) Alleged Source of Conception/Invention (per Avadel) Complaint Citation Patent Citation
A sustained release formulation ... comprising a functional coating and a core Avadel's '062 patent application publication allegedly disclosed the core concepts of a multiparticulate approach for modified release. ¶¶109, 110 col. 26:54-56
the functional coating ... comprises one or more methacrylic acid-methyl methacrylate co-polymers This specific polymer was allegedly disclosed in Avadel's '062 patent publication and not in Jazz's original specification. ¶¶96, 110 col. 26:62-65
the formulation releases greater than about 40% of its gamma-hydroxybutyrate by about 4 to about 6 hours when tested in a dissolution apparatus 2 This specific dissolution profile and the testing conditions were allegedly copied by Jazz from Avadel's '062 patent publication. ¶¶96, 110 col. 27:1-6

Identified Points of Contention

  • Derivation vs. Independent Invention: A central question will be whether Avadel can provide sufficient evidence to demonstrate that the named Jazz inventors derived the claimed subject matter from Avadel's confidential disclosures, as opposed to developing it independently. The complaint points to the timing of Jazz's patent application amendments relative to Avadel's disclosures as evidence of copying (Compl. ¶¶101, 105, 124).
  • Scope and Written Description: The complaint raises the question of whether Jazz's original patent specification provides adequate written description support for the later-added claims reciting methacrylic acid-methyl methacrylate co-polymers and specific dissolution profiles. Avadel alleges it does not, which could impact the validity of the claims and their priority date (Compl. ¶¶109, 113).

V. Key Claim Terms for Construction

The Term: "sustained release"

  • Context and Importance: Avadel alleges that during prosecution, Jazz distinguished its "sustained release" invention from a prior art "delayed release" composition to secure the patents (Compl. ¶115). The definition of this term will be critical in determining whether the claims, as understood during prosecution, are adequately supported by the specification, and whether they cover technology Avadel claims to have invented. Practitioners may focus on this term because its construction could be central to both the inventorship and written description challenges.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The '488 patent specification describes sustained release in general terms as releasing a drug "over a prolonged period of time" (e.g., '488 Patent, col. 5:29-32).
    • Evidence for a Narrower Interpretation: The specific embodiments and dissolution data provided in the specification primarily describe tablet and capsule formulations (e.g., '488 Patent, col. 32:9-11), which Avadel alleges is narrower than the scope Jazz later claimed to cover microparticulate suspensions (Compl. ¶109).

The Term: "formulation"

  • Context and Importance: The complaint alleges Jazz's original application disclosed only "tablets and capsules," but the claims were later amended to cover a broader "formulation" or "composition" after Jazz allegedly learned of Avadel's sachet-based microparticle technology (Compl. ¶¶82, 109). The construction of "formulation" will determine if the claims are limited to the solid dosage forms originally disclosed or can be read to encompass the liquid suspensions and sachets Avadel claims as its own invention.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: Claim 1 of the '488 patent uses the general term "formulation" without limitation to a specific dosage form like a tablet.
    • Evidence for a Narrower Interpretation: The detailed description of the '488 patent repeatedly refers to dosage forms as "coated tablet" or "capsule" and its examples focus on these solid forms ('488 Patent, col. 4:12, col. 10:45-56, Examples 1-2). This may suggest that the inventors' possession was limited to these embodiments.

VI. Other Allegations

  • Breach of Contract: The complaint alleges that Jazz breached at least two Confidential Disclosure Agreements (CDAs) from 2010 and 2015 (Compl. ¶¶126-139). Avadel alleges it provided confidential technical and clinical data regarding its once-nightly sodium oxybate program to Jazz for the purpose of evaluating a potential partnership, and that Jazz misused this information to file patent applications on Avadel's technology (Compl. ¶¶7, 131, 139).
  • Misappropriation of Trade Secrets: Avadel alleges that its confidential disclosures, including the "2010 Micropump® Deck" and the "2015 Study Report," constituted trade secrets (Compl. ¶151). The complaint alleges Jazz misappropriated these trade secrets under both federal and California law by using the information to guide its own patent prosecution and drug development efforts (Compl. ¶¶7, 149-180). Avadel alleges its actions were willful, fraudulent, and malicious (Compl. ¶180).

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

  • A key evidentiary question will be one of derivation: can Avadel produce sufficient corroborating evidence to prove that the conception of the claimed subject matter in Jazz's patents originated from specific confidential disclosures made by Avadel, as opposed to being the product of Jazz's independent invention?
  • A central validity issue will be one of written description: does the specification of Jazz's original 2011 application provide adequate written description and enablement for the later-filed claims reciting methacrylic acid-methyl methacrylate co-polymers and specific dissolution profiles, or were these concepts, as Avadel alleges, new matter improperly added after viewing Avadel's own technology?
  • A core issue will be one of contractual and trade secret breach: assuming Avadel's confidential information was used by Jazz, the court will need to determine whether that information rises to the level of a trade secret and whether its use constituted a breach of the specific terms of the 2010 and 2015 CDAs.