DCT
1:21-cv-01594
Jazz Pharma Inc v. Avadel CNS Pharma LLC
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Jazz Pharmaceuticals, Inc. (Delaware) and Jazz Pharmaceuticals Ireland Limited (Ireland)
- Defendant: Avadel CNS Pharmaceuticals, LLC (Delaware)
- Plaintiff’s Counsel: Morris, Nichols, Arsht & Tunnell LLP
- Case Identification: 1:21-cv-01594, D. Del., 06/09/2023
- Venue Allegations: Venue is asserted based on Defendant being a limited liability company organized under the laws of Delaware.
- Core Dispute: Plaintiff alleges that Defendant’s once-nightly sodium oxybate drug product, LUMRYZ™, infringes a patent related to gamma-hydroxybutyrate (GHB) formulations.
- Technical Context: The technology concerns pharmaceutical formulations of sodium oxybate, a treatment for narcolepsy, designed to provide modified release characteristics that can enable once-nightly dosing.
- Key Procedural History: The action arises from Defendant's New Drug Application (NDA) filing with the FDA for its LUMRYZ™ product. The complaint notes that Defendant announced its NDA submission in December 2020 and received final FDA approval in May 2023, with an indicated intent to begin commercialization in June 2023.
Case Timeline
| Date | Event |
|---|---|
| 2015-02-18 | ’782 Patent Priority Date |
| 2020-12-16 | Avadel announces NDA submission for LUMRYZ™ |
| 2021-02-26 | FDA accepts Avadel's NDA for LUMRYZ™ |
| 2021-10-19 | U.S. Patent No. 11,147,782 Issues |
| 2023-05-01 | Avadel receives final FDA approval for LUMRYZ™ |
| 2023-06-01 | Avadel's indicated commercialization date for LUMRYZ™ |
| 2023-06-09 | Amended Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 11,147,782 - “GHB formulation and method for its manufacture,” issued October 19, 2021
The Invention Explained
- Problem Addressed: The patent's background describes the therapeutic agent gamma-hydroxybutyrate (GHB), or sodium oxybate, as having a short in-vivo half-life, which necessitates that patients take it in divided doses throughout the night (’782 Patent, col. 4:63-65). This dosing regimen can be disruptive to a patient's sleep. The patent also notes that GHB's high required dose, high water solubility, and ionic nature complicate the design of conventional modified-release formulations (’782 Patent, col. 5:44-61).
- The Patented Solution: The invention describes GHB formulations designed to provide a controlled or sustained release profile, with the object of maintaining therapeutic blood levels for a longer period, potentially up to eight hours (’782 Patent, col. 4:5-15). The specification discloses various approaches, including the use of ion-exchange resins and multi-particulate systems that can combine immediate- and controlled-release components to achieve a desired therapeutic effect from a single administration (’782 Patent, col. 4:46-62).
- Technical Importance: A formulation that successfully provides sustained GHB release could enable a once-nightly dosing regimen, improving patient convenience and therapeutic outcomes by avoiding the need for a middle-of-the-night dose required by existing treatments (’782 Patent, col. 4:5-15).
Key Claims at a Glance
- The complaint asserts infringement of one or more claims, including at least independent claim 1 (Compl. ¶30).
- Independent Claim 1 recites the following essential elements:
- A formulation of gamma-hydroxybutyrate comprising:
- a plurality of immediate release particles comprising gamma-hydroxybutyrate;
- a plurality of modified release particles comprising gamma-hydroxybutyrate;
- a viscosity enhancing agent; and
- an acid;
- wherein the viscosity enhancing agent and the acid are separate from the immediate release particles and the modified release particles.
- The complaint reserves the right to assert additional claims (Compl. ¶30).
III. The Accused Instrumentality
Product Identification
- The accused product is Defendant's sodium oxybate drug product, identified by the commercial name LUMRYZ™ and the code name FT218 (Compl. ¶14).
Functionality and Market Context
- LUMRYZ™ is described as a "once-nightly sodium oxybate formulation" for which Defendant has received FDA approval (Compl. p. 4, fn. 4; Compl. ¶23). The complaint alleges, on information and belief, that LUMRYZ™ is a formulation that "includes immediate release particles comprising GHB, modified release particles comprising GHB, a viscosity enhancing agent, and an acid" (Compl. ¶20). This positions LUMRYZ™ as a potential competitor to Plaintiff's own sodium oxybate product, XYREM®, which the complaint notes is a twice-nightly therapy (Compl. ¶¶11, 15).
IV. Analysis of Infringement Allegations
No probative visual evidence provided in complaint.
’782 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A formulation of gamma-hydroxybutyrate comprising: a plurality of immediate release particles comprising gamma-hydroxybutyrate; a plurality of modified release particles comprising gamma-hydroxybutyrate; a viscosity enhancing agent; and an acid; | The complaint alleges that LUMRYZ™ includes immediate release particles with GHB, modified release particles with GHB, a viscosity enhancing agent, and an acid. This allegation is based on "information and belief" and references Avadel's own '866 patent. | ¶20 | col. 25:10-18 |
| wherein the viscosity enhancing agent and the acid are separate from the immediate release particles and the modified release particles. | The complaint alleges that in the LUMRYZ™ formulation, the viscosity enhancing agent and the acid are separate from the GHB-containing particles. | ¶20 | col. 25:19-22 |
- Identified Points of Contention:
- Scope Questions: The infringement analysis may focus on the construction of the final "wherein" clause of claim 1. A central question for the court will be defining the term "separate from" in the context of the claim. Does this require the viscosity agent and acid to be in a distinct physical phase from the GHB particles (e.g., as part of a liquid vehicle or dry powder blend in which the particles are suspended), or could it be construed to cover other formulation arrangements?
- Technical Questions: A key evidentiary issue will be whether the commercial LUMRYZ™ product is, in fact, formulated as alleged. The complaint's allegations regarding the product's composition are made "on information and belief" and appear to be derived from Defendant's own patent documents (Compl. ¶¶19-20). The case may turn on what factual evidence Plaintiff can produce through discovery and analysis to demonstrate that the accused product meets every limitation of the asserted claim, particularly the "separate from" requirement.
V. Key Claim Terms for Construction
- The Term: "separate from the immediate release particles and the modified release particles"
- Context and Importance: This limitation, which qualifies the location of the viscosity agent and the acid relative to the GHB-containing particles, appears to be a critical element of the claimed invention. Its interpretation will be central to the infringement analysis, as the dispute may focus on whether the specific formulation architecture of LUMRYZ™ falls within the scope of this term. Practitioners may focus on this term because the complaint's infringement theory relies on interpreting Defendant's formulation as having this specific structural arrangement.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent does not appear to provide an explicit definition of "separate from." A party could argue for the term's plain and ordinary meaning, which might encompass any formulation where the acid and viscosity agent are not incorporated into the physical structure of the immediate and modified release particles themselves.
- Evidence for a Narrower Interpretation: A party could argue that the term should be limited by the embodiments described in the specification. For example, the patent describes liquid suspensions where particles are suspended in a vehicle (’782 Patent, col. 13:60-66). This could support a construction where "separate from" requires the acid and viscosity agent to be components of a liquid or powder vehicle in which distinct GHB-containing particles are suspended, rather than simply being unmixed in a single-phase solid.
VI. Other Allegations
- Indirect Infringement: The complaint alleges both induced infringement under 35 U.S.C. § 271(b) and contributory infringement under § 271(c) (Compl. ¶¶31-32). The inducement allegation is based on the assertion that Defendant acts with knowledge of the ’782 patent and with specific intent to encourage infringing acts (Compl. ¶31). The contributory infringement allegation is based on the assertion that Defendant has knowledge that its product is especially adapted for an infringing use and has no substantial non-infringing use (Compl. ¶32).
- Willful Infringement: The complaint alleges that Defendant infringes with knowledge of the ’782 patent and states that the case is "exceptional" under 35 U.S.C. § 285, which is the basis for seeking attorneys' fees (Compl. ¶¶31, 36, Prayer ¶H). This pleading structure supports a claim for enhanced damages, although the term "willful" is not explicitly used.
VII. Analyst’s Conclusion: Key Questions for the Case
- A primary issue will be one of claim construction: how will the court define the limitation "separate from" as it relates to the components of the claimed formulation? The outcome of this construction will likely define the scope of the patent and be dispositive of infringement.
- A key evidentiary question will be one of factual proof: what is the precise physical architecture and composition of the commercial LUMRYZ™ product? The case will likely depend on whether the evidence adduced during discovery shows that the accused product's structure meets the "separate from" limitation as construed by the court, moving the infringement allegation from "information and belief" to established fact.