DCT

1:21-cv-01138

Jazz Pharma Inc v. Avadel CNS Pharma LLC

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:21-cv-01138, D. Del., 06/09/2023
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant is a limited liability company organized under Delaware law, is registered to do business in the state, and has engaged in systematic and continuous business contacts within the state.
  • Core Dispute: Plaintiff alleges that Defendant's submission of a New Drug Application (NDA) for, and subsequent commercialization of, its LUMRYZ™ sodium oxybate product constitutes infringement of a patent covering formulations and methods for treating narcolepsy.
  • Technical Context: The technology relates to pharmaceutical formulations of gamma-hydroxybutyrate (GHB), marketed as sodium oxybate, a compound used to treat narcolepsy and characterized by a short in-vivo half-life.
  • Key Procedural History: This action arises under the Hatch-Waxman Act, triggered by Defendant’s filing of an NDA for its LUMRYZ™ product. The complaint notes that the FDA granted final approval for Defendant's NDA on May 1, 2023.

Case Timeline

Date Event
2015-02-18 ’079 Patent Priority Date
2020-12-16 Avadel announces submission of its NDA to the FDA
2021-02-26 FDA notifies Avadel of formal acceptance of its NDA
2021-08-03 ’079 Patent Issue Date
2023-05-01 Avadel receives final approval of its NDA from the FDA
2023-06-01 Avadel's indicated date for commercialization of its product
2023-06-09 Amended Complaint Filing Date

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

U.S. Patent No. 11,077,079 - "GHB FORMULATION AND METHOD FOR ITS MANUFACTURE"

  • Patent Identification: U.S. Patent No. 11,077,079, “GHB FORMULATION AND METHOD FOR ITS MANUFACTURE,” issued August 3, 2021.

The Invention Explained

  • Problem Addressed: The patent’s background section explains that gamma-hydroxybutyrate (GHB) has a short in-vivo half-life, which requires patients with narcolepsy to take multiple doses per night, disrupting sleep (Compl. ¶11; ’079 Patent, col. 1:53-54, col. 7:6-9). Furthermore, the high dose and high water solubility of GHB, combined with its potential to raise gastric pH, complicates the development of conventional oral modified-release dosage forms, particularly those relying on pH-sensitive enteric coatings (’079 Patent, col. 5:36-50).
  • The Patented Solution: The invention proposes formulating GHB using drug-ion exchange resin complexes to achieve sustained release (’079 Patent, Abstract, col. 2:49-54). In this system, the charged GHB molecule is bound to an insoluble resin particle. Drug release is not governed by simple dissolution but by the exchange of GHB with other anions (such as chloride) present in the gastrointestinal tract, a process which can be rate-limited by physiological anion secretion (’079 Patent, col. 15:58-65). This approach allows for a controlled-release profile intended to last for a longer duration, potentially enabling once-nightly dosing (’079 Patent, col. 4:4-15).
  • Technical Importance: This technology provides a method for creating a sustained-release formulation of a high-dose, highly soluble drug, aiming to reduce dosing frequency and improve patient convenience and compliance in the treatment of narcolepsy (’079 Patent, col. 6:1-11).

Key Claims at a Glance

  • The complaint asserts infringement of at least independent claim 1 (’079 Patent, col. 23:56-24:12; Compl. ¶31).
  • The essential elements of independent claim 1 are:
    • A method of treating narcolepsy in a patient in need thereof.
    • Administering a single daily dose comprising an amount of oxybate equivalent to from 4.0 g to 12.0 g of sodium oxybate.
    • The administration comprises the steps of: (1) opening a sachet containing a solid oxybate formulation, (2) mixing the formulation with water, and (3) orally administering the mixture.
    • The oxybate formulation comprises an immediate release component and a controlled release component.
  • The complaint reserves the right to assert other claims, stating infringement of "one or more claims" (Compl. ¶31).

III. The Accused Instrumentality

Product Identification

  • The accused product is Defendant Avadel’s sodium oxybate drug product, identified by the commercial name LUMRYZ™ and the code name FT218 (Compl. ¶14).

Functionality and Market Context

  • The complaint alleges LUMRYZ™ is a "once-nightly" sodium oxybate formulation for treating narcolepsy, positioning it as a direct competitor to Plaintiff's "twice-nightly" XYREM® product (Compl. ¶11, ¶15). LUMRYZ™ is allegedly supplied in "unit dose-sachets" containing 4.5, 6, 7.5, and 9 gram doses, which are intended to be opened and mixed with water for oral administration (Compl. ¶20, ¶21). The complaint further alleges that LUMRYZ™ is a "Modified Release" formulation, corresponding to examples in Avadel's own U.S. Patent No. 10,272,062 (Compl. ¶16, ¶17). No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

’079 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of treating narcolepsy in a patient in need thereof, the method comprising: administering a single daily dose to the patient, the single daily dose comprising an amount of oxybate equivalent to from 4.0 g to 12.0 g of sodium oxybate... Defendant’s LUMRYZ™ is a "once-nightly" sodium oxybate formulation for treating narcolepsy, available in unit doses of 4.5 g, 6 g, 7.5 g, and 9 g. ¶14, ¶15, ¶20 col. 23:56-60
...wherein the administering comprises: opening a sachet containing a solid oxybate formulation, LUMRYZ™ is allegedly supplied in "unit dose-sachets" that are meant to be opened by the user. ¶20, ¶21 col. 6:8-10
mixing the formulation with water, and The contents of the LUMRYZ™ sachets are allegedly intended to be mixed with water to create a dose for administration. ¶21 col. 6:8-10
orally administering the mixture to the patient, wherein the oxybate formulation comprises an immediate release component and a controlled release component. LUMRYZ™ is an oral, "Modified Release" formulation, which the complaint alleges is covered by the patent claims requiring both immediate and controlled release components. ¶16, ¶18, ¶21, ¶22 col. 4:46-55
  • Identified Points of Contention:
    • Technical Questions: The complaint alleges that LUMRYZ™ is "covered by" the ’079 patent but provides no specific factual allegations about the technical mechanism used by LUMRYZ™ to achieve its modified-release profile (Compl. ¶22). The ’079 patent specification is heavily focused on ion-exchange resin technology. A central question for discovery will be whether LUMRYZ™ employs this specific technology or achieves its once-nightly profile via an alternative, potentially non-infringing, technical pathway.
    • Scope Questions: The infringement analysis may turn on the construction of "controlled release component." A key legal question will be whether this term should be interpreted broadly to cover any mechanism that results in sustained release, or construed more narrowly to be limited to the ion-exchange resin embodiments that are described in detail throughout the ’079 patent specification.

V. Key Claim Terms for Construction

  • The Term: "controlled release component"
  • Context and Importance: This term is central to the infringement analysis, as it defines the core technical feature of the invention. The case may depend on whether the specific technology used in Defendant's LUMRYZ™ product falls within the scope of this term. Practitioners may focus on this term because the complaint lacks allegations detailing the specific controlled-release mechanism of the accused product, making the term's breadth a dispositive issue.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent defines "controlled release" functionally as a composition having a release over a period of "at least about 2 to about 8 hours" (’079 Patent, col. 6:55-63). Plaintiff may argue that the claim term is not explicitly limited to a particular technology and should be read to cover any component that performs this specified function.
    • Evidence for a Narrower Interpretation: The specification's detailed description and examples almost exclusively describe the "controlled release component" as an ion-exchange resin system (’079 Patent, col. 2:49-65; col. 8:11-20; Examples 1-7). Defendant may argue that the patent teaches and enables only this resin-based technology, and the claims should therefore be limited to this disclosed embodiment, effectively excluding other modified-release technologies.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement. The inducement theory is based on Avadel allegedly encouraging direct infringement by end-users (patients) who follow product instructions to open the sachet and mix the contents with water, with Avadel having knowledge of the ’079 patent (Compl. ¶32). The contributory infringement allegation posits that LUMRYZ™ is especially adapted for this infringing use and has no substantial non-infringing use (Compl. ¶33).
  • Willful Infringement: The complaint does not use the term "willful," but it does allege that the case is "exceptional" under 35 U.S.C. § 285 and pleads that Defendant acted with "knowledge of the '079 patent" (Compl. ¶32, ¶37). This suggests an allegation of knowing infringement, which could support a future claim for enhanced damages.

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

  1. A central evidentiary question will be one of technological mechanism: Does Defendant’s LUMRYZ™ product achieve its modified-release characteristics using the ion-exchange resin technology that forms the basis of the ’079 patent’s disclosure, or does it employ a different, potentially non-infringing, formulation technology?
  2. The case will likely involve a core issue of claim construction: Should the term "controlled release component," as used in Claim 1, be defined by its functional outcome (release over time), or should its scope be limited to the ion-exchange resin embodiments repeatedly described as the invention in the patent’s specification? The answer will determine whether the patent can be asserted against a wider range of modified-release technologies.