DCT

1:25-cv-00021

Avadel CNS Pharma LLC v. Jazz Pharma Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-00021, D. Del., 01/07/2025
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant Jazz Pharmaceuticals, Inc. is a Delaware corporation and therefore resides in the district.
  • Core Dispute: Plaintiff alleges that Defendant’s marketing and sale of its XYWAV® oral solution, when used according to its labeling for a once-nightly regimen, infringes a patent related to methods of treating certain disorders with gamma-hydroxybutyrate compositions.
  • Technical Context: The technology concerns pharmaceutical formulations of gamma-hydroxybutyrate (GHB), a compound used to treat narcolepsy and other sleep disorders, focusing on dosing regimens that improve patient convenience and sleep quality.
  • Key Procedural History: The complaint alleges that Defendant has actively monitored Plaintiff's patent portfolio, citing testimony from prior litigation between the parties and Defendant's submission of related patents from Plaintiff’s portfolio in Information Disclosure Statements during the prosecution of its own patents. These allegations form the basis for the claims of pre-suit knowledge and willful infringement.

Case Timeline

Date Event
2016-07-22 ’298 Patent Priority Date
2021-08-12 FDA approval for Defendant's XYWAV product
2024-10-31 Application for ’298 Patent became public
2024-11-20 Issue fee for ’298 Patent paid
2025-01-07 ’298 Patent Issued
2025-01-07 Complaint Filed

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

U.S. Patent No. 12,186,298 - "Modified Release Gamma-Hydroxybutyrate Formulations Having Improved Pharmacokinetics"

The patent-in-suit is U.S. Patent No. 12,186,298, issued January 7, 2025 (’298 Patent).

The Invention Explained

  • Problem Addressed: The patent describes the primary treatment for narcolepsy, sodium oxybate (marketed as Xyrem®), as requiring a burdensome twice-nightly dosing regimen where the patient must wake up 2.5 to 4 hours after the first dose to take a second dose. This requirement is described as a "substantial inconvenience" that can "interrupt ongoing productive sleep" (’298 Patent, col. 2:37-41). The patent further notes that previous attempts to create a once-nightly, modified-release version suffered from significantly reduced bioavailability compared to the immediate-release, twice-nightly product (’298 Patent, col. 2:42-51).
  • The Patented Solution: The invention claims to provide modified-release formulations of gamma-hydroxybutyrate that can be administered once per night while achieving a pharmacokinetic profile and bioavailability comparable to the twice-nightly regimen (’298 Patent, col. 6:49-59). This is achieved through formulations that combine immediate-release and modified-release components, designed to release the drug rapidly under different conditions within the gastrointestinal tract, thereby optimizing absorption over the course of the night from a single dose (’298 Patent, Abstract; col. 6:59-65).
  • Technical Importance: The described solution addresses a significant patient compliance and quality-of-life issue in narcolepsy treatment by aiming to eliminate the need for sleep-interrupting nocturnal dosing while maintaining therapeutic efficacy (’298 Patent, col. 2:37-41).

Key Claims at a Glance

  • The complaint asserts independent claim 1 (Compl. ¶15).
  • The essential elements of Claim 1 are:
    • A method of treating a disorder treatable with gamma-hydroxybutyrate in a human subject.
    • The method comprises orally administering a pharmaceutical composition.
    • The composition comprises a first and a second salt of gamma-hydroxybutyrate, where the salts are different from each other.
    • The first and second salts are selected from the group of sodium oxybate, calcium oxybate, magnesium oxybate, and potassium oxybate.
    • The composition comprises an amount of salts equivalent to 1.5 g, 3.0 g, 4.5 g, 6.0 g, 7.5 g, or 9.0 g of sodium oxybate.
    • The oral administration occurs only once daily at bedtime.
    • The oral administration occurs at least 2 hours after eating.
  • The complaint does not explicitly reserve the right to assert dependent claims.

III. The Accused Instrumentality

Product Identification

Defendant’s XYWAV® oral solution (Compl. ¶2).

Functionality and Market Context

  • XYWAV is described as an oral solution containing a mixture of four salts of gamma-hydroxybutyrate: calcium oxybate, magnesium oxybate, potassium oxybate, and sodium oxybate (Compl. ¶17).
  • The product is approved by the FDA for the treatment of idiopathic hypersomnia in adults and for cataplexy or excessive daytime sleepiness in narcolepsy patients aged seven and older (Compl. ¶19, ¶20).
  • The complaint alleges that XYWAV’s approved labeling and prescribing information instruct on dosing equivalencies to sodium oxybate and provide instructions for a "once nightly regimen in adults" (Compl. ¶18, ¶26).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

’298 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of treating a disorder treatable with gamma-hydroxybutyrate in a human subject in need thereof, the method comprising: Defendant markets and promotes XYWAV for treating idiopathic hypersomnia and narcolepsy, which are alleged to be disorders treatable with gamma-hydroxybutyrate. ¶25, ¶27 col. 221:50-53
orally administering a pharmaceutical composition comprising first and second salts of gamma-hydroxybutyrate to said human subject, wherein XYWAV is an oral solution containing salts of gamma-hydroxybutyrate, and its prescribing information provides instructions for oral administration. ¶16, ¶24 col. 222:1-12
said first salt is selected from the group consisting of sodium oxybate, calcium oxybate, magnesium oxybate, and potassium oxybate, XYWAV's approved labeling states it is a mixture of calcium oxybate, magnesium oxybate, potassium oxybate, and sodium oxybate. ¶17 col. 222:1-12
said second salt differs from said first salt and is selected from the group consisting of sodium oxybate, calcium oxybate, magnesium oxybate, and potassium oxybate, XYWAV contains four distinct salts, all of which are members of the claimed group. ¶17 col. 222:1-12
the pharmaceutical composition comprises an amount of salts of gamma-hydroxybutyric acid equivalent to 1.5 g, 3.0 g, 4.5 g, 6.0 g, 7.5 g, or 9.0 g of sodium oxybate, XYWAV's labeling allegedly states that doses of 3.0 g, 4.5 g, or 6.0 g are equivalent to the same gram-for-gram dose of sodium oxybate, and prescribing information recommends titrating up to a 6.0 g nightly dose. ¶18, ¶26 col. 222:1-12
the orally administering occurs only once daily at bedtime, and Defendant's prescribing information and medication guide allegedly instruct patients on a "once nightly regimen" and to take the dose "at bedtime." ¶26, ¶30 col. 222:1-12
the orally administering occurs at least 2 hours after eating. Defendant's prescribing information and medication guide allegedly instruct patients and caregivers to administer XYWAV "at least 2 hours after eating." ¶31 col. 222:1-12

Identified Points of Contention

  • Scope Questions: A central issue may be the scope of the term "pharmaceutical composition." The complaint alleges that XYWAV, an oral solution, infringes a claim from a patent titled "Modified Release... Formulations" and whose specification exclusively discusses modified-release solid particulate formulations. This raises the question of whether the claim term, which does not explicitly recite a "modified release" property, should be limited by the patent's title and specification to exclude immediate-release liquid solutions.
  • Technical Questions: While the complaint maps the elements of the method claim to Defendant's product labeling, a factual question for the court will be the extent to which healthcare providers and patients actually perform the claimed method of "treating a disorder" by administering XYWAV according to the once-nightly instructions for the specified indications.

V. Key Claim Terms for Construction

  • The Term: "pharmaceutical composition"
  • Context and Importance: The definition of this term is critical to the dispute. The accused product is an oral solution, whereas the ’298 Patent specification focuses entirely on solving bioavailability problems inherent to solid, modified-release formulations. Practitioners may focus on this term because its construction could determine whether the claim can read on a liquid formulation that may not possess the modified-release characteristics that are the stated object of the invention.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: Claim 1 itself does not contain any limitations regarding the formulation's physical form (e.g., solid or liquid) or its release profile (e.g., modified or immediate). It only specifies the active ingredients (first and second salts) and their amounts. This may support an argument that the claim term should be given its plain and ordinary meaning, covering any mixture of the claimed salts suitable for administration.
    • Evidence for a Narrower Interpretation: The patent is titled "Modified Release... Formulations" (’298 Patent, Title). The abstract states the invention relates to "Modified release formulations," and the "Background" and "Summary of Invention" sections exclusively discuss solving problems associated with creating a once-nightly, modified-release dosage form (’298 Patent, Abstract; col. 2:42-51; col. 6:49-59). This evidence may support an argument that the term "pharmaceutical composition" should be construed as being limited to the modified-release formulations that constitute the invention described in the specification.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Defendant actively induces infringement by third parties (healthcare providers and patients) (Compl. ¶39-40). The basis for this allegation is Defendant's dissemination of the XYWAV Prescribing Information, Medication Guide, marketing materials, and website, which allegedly instruct and encourage users to administer XYWAV in a manner that directly infringes at least Claim 1 of the ’298 Patent (Compl. ¶25-31, ¶37).
  • Willful Infringement: The complaint alleges that Defendant’s infringement is willful (Compl. ¶43). This is based on allegations of pre-suit knowledge of the ’298 Patent, stemming from Defendant’s alleged "pattern and practice of closely monitoring Avadel's patent application publications" (Compl. ¶35). The complaint cites testimony from prior litigation where Defendant's employees admitted to monitoring Plaintiff's patent filings and notes that Defendant cited related Avadel patents in its own patent prosecution filings (Compl. ¶32-33). Knowledge of the patent's specific claims is alleged since at least November 20, 2024, the date the issue fee was paid and its allowance became public (Compl. ¶35).

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

  • A core issue will be one of definitional scope: can the term "pharmaceutical composition" in Claim 1 be construed to cover a liquid oral solution, given that the patent's specification is replete with disclosures and objectives tied exclusively to solving problems of solid, modified-release formulations? The outcome of this claim construction dispute may be dispositive.
  • A key evidentiary question will be one of knowledge and intent: assuming infringement is found, the complaint presents detailed allegations that Defendant closely monitored Plaintiff's patent portfolio. The court will examine what evidence supports the assertion that this monitoring provided Defendant with pre-suit knowledge of the infringing nature of its activities, which is central to the claim for willful infringement.