DCT

1:25-cv-00009

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-00009, D. Del., 01/03/2025
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant Jazz Pharmaceuticals, Inc. is a Delaware corporation and Defendant Jazz Pharmaceuticals Ireland Limited is not a U.S. resident and may be sued in any district.
  • Core Dispute: Plaintiff alleges that Defendant's XYWAV® product, used to treat sleep disorders, infringes a patent directed to methods of treatment using specific multi-salt compositions of gamma-hydroxybutyrate.
  • Technical Context: The technology concerns pharmaceutical formulations of gamma-hydroxybutyrate (GHB) salts designed to treat conditions like narcolepsy and idiopathic hypersomnia, a significant market for central nervous system therapies.
  • Key Procedural History: The complaint alleges a history of intellectual property disputes between the parties, citing prior litigation. It asserts that Defendant has closely monitored Plaintiff's patent portfolio, referencing deposition testimony and multiple Information Disclosure Statements (IDS) filed during Defendant's own patent prosecution that cited Plaintiff's related patents. Plaintiff also sent a formal notice letter to Defendant on the day the patent-in-suit issued.

Case Timeline

Date Event
2019-03-01 Earliest Priority Date for ’991 Patent
2020-12-21 Defendant allegedly disclosed related Avadel patents in an IDS
2021-08-12 Defendant receives FDA approval for XYWAV for Idiopathic Hypersomnia
2024-10-24 Application for ’991 Patent became public
2024-10-31 Issue fee paid for ’991 Patent; alleged date of knowledge
2024-12-17 U.S. Patent No. 12,167,991 Issues
2024-12-17 Plaintiff sends notice letter to Defendant
2025-01-03 Complaint Filed

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

U.S. Patent No. 12,167,991 - "Gamma-Hydroxybutyrate Compositions Having Improved Pharmacokinetics in the Fed State"

  • Patent Identification: U.S. Patent No. 12,167,991, "Gamma-Hydroxybutyrate Compositions Having Improved Pharmacokinetics in the Fed State," issued December 17, 2024.

The Invention Explained

  • Problem Addressed: The patent’s background section identifies a "deleterious food effect on the absorption of GHB" associated with existing treatments like Xyrem®, which requires patients to take the first dose "at least 2 hours after eating" to ensure bioavailability ('991 Patent, col. 1:63-col. 2:5). This requirement is described as a practical obstacle for patients that can reduce compliance and efficacy ('991 Patent, col. 2:11-17).
  • The Patented Solution: The patent describes developing an oral pharmaceutical composition of gamma-hydroxybutyrate that can be administered less than two hours after eating "without compromising safety or efficacy" ('991 Patent, col. 2:36-40). The invention is described as a modified-release formulation that mitigates the food effect, thereby providing more consistent pharmacokinetic properties regardless of when a patient has eaten ('991 Patent, Abstract; col. 2:43-54).
  • Technical Importance: A GHB formulation that is not significantly impacted by food intake could improve patient convenience and ensure more consistent therapeutic effects for individuals being treated for chronic sleep disorders like narcolepsy ('991 Patent, col. 2:11-17).

Key Claims at a Glance

  • The complaint asserts infringement of at least independent Claim 1 of the ’991 Patent (Compl. ¶¶ 3, 38).
  • The essential elements of Claim 1 are:
    • A method of decreasing excessive daytime sleepiness in a human subject.
    • The method comprises orally administering a pharmaceutical composition.
    • The composition comprises calcium oxybate, magnesium oxybate, and potassium oxybate.
    • The administration occurs only once nightly.
    • The administration occurs at least two hours after eating.
  • The complaint’s general allegation of infringing "at least one claim" suggests a reservation of the right to assert other claims, including dependent claims (Compl. ¶3).

III. The Accused Instrumentality

Product Identification

  • The accused product is XYWAV®, an oral solution (Compl. ¶¶ 2, 16).

Functionality and Market Context

  • The complaint alleges, by quoting the product's approved labeling, that XYWAV is a "mixture of calcium oxybate, magnesium oxybate, potassium oxybate, and sodium oxybate" (Compl. ¶17).
  • XYWAV is FDA-approved for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy and for the treatment of idiopathic hypersomnia (IH) (Compl. ¶¶ 18-19).
  • The complaint alleges that Jazz’s marketing and the XYWAV Prescribing Information instruct and encourage a method of use that corresponds to the asserted patent claim (Compl. ¶¶ 23-26, 30).
  • No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

’991 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of decreasing excessive daytime sleepiness in a human subject, the method comprising: Jazz markets XYWAV for use in treating symptoms including "excessive daytime sleepiness" and promotes its use in a "method of decreasing excessive daytime sleepiness." ¶26 col. 54:10-11
orally administering a pharmaceutical composition comprising calcium oxybate, magnesium oxybate, and potassium oxybate, XYWAV is an oral solution that its approved labeling describes as a mixture containing calcium oxybate, magnesium oxybate, and potassium oxybate (in addition to sodium oxybate). ¶¶ 16, 17 col. 54:12-15
wherein the orally administering occurs only once nightly at least two hours after eating. The XYWAV Prescribing Information allegedly recommends a "once nightly regimen" for IH and instructs that XYWAV "should be administered 'at least 2 hours after eating.'" ¶¶ 25, 30 col. 54:16-18
  • Identified Points of Contention:
    • Scope Questions: Claim 1 recites a composition "comprising" three specific oxybate salts. A central issue may be whether this claim reads on the accused XYWAV product, which the complaint states contains a fourth salt, sodium oxybate. The outcome may depend on the construction of the open-ended term "comprising."
    • Technical Questions: A significant question arises from the apparent contradiction between the patent’s claims and its specification. The specification repeatedly touts the invention's ability to be administered less than two hours after eating, yet Claim 1 explicitly requires administration at least two hours after eating. This raises the question of whether the claim is supported by the written description as required by 35 U.S.C. § 112.

V. Key Claim Terms for Construction

  • The Term: "at least two hours after eating"

  • Context and Importance: This term's construction and validity will likely be a primary focus of the litigation. The asserted claim requires waiting at least two hours, which appears to be the very problem the patent's specification claims to solve. Practitioners may focus on this term because it creates a potential vulnerability for the patent under 35 U.S.C. § 112, as a defendant could argue the specification lacks written description for a method that runs counter to the stated invention.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation (Upholding the Claim): A plaintiff may argue that the claim language is plain and unambiguous and should be enforced as written. They might suggest the invention is a robust formulation that works well under various conditions, and the patentees simply chose to claim this specific, narrower method of use.
    • Evidence for a Narrower Interpretation (Challenging the Claim): A defendant may point to the patent’s repeated statements that the invention’s purpose is to enable administration "less than two hours after eating" ('991 Patent, col. 2:36-40) and to overcome the "food effect obstacle" ('991 Patent, col. 2:11-17). This evidence could support an argument that the specification does not describe or enable the method literally recited in Claim 1, potentially rendering it invalid.

  • The Term: "comprising"

  • Context and Importance: This term is critical because the accused product contains an additional ingredient (sodium oxybate) not listed in Claim 1. The infringement case hinges on this term being interpreted in its conventional, open-ended sense ("including, but not limited to").

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The use of "comprising" in the claim itself is strong evidence for an open-ended meaning, a standard convention in patent law ('991 Patent, col. 54:12). Further, dependent Claim 2 adds sodium oxybate to the composition of Claim 1, which suggests that the drafters understood Claim 1 to be broad enough to permit, but not require, additional ingredients.
    • Evidence for a Narrower Interpretation: A defendant might argue that the patent, by framing itself as an alternative to the sodium-based Xyrem® product, implicitly disclaimed compositions containing sodium oxybate. However, this argument may be difficult to sustain against the strong presumption that "comprising" is open-ended.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Defendant actively induces infringement by healthcare providers and patients (Compl. ¶¶ 39-40). This allegation is based on the XYWAV Prescribing Information, Medication Guide, marketing websites, and other materials that allegedly instruct users to perform the patented method, including the specific composition, "once nightly" administration, and timing relative to meals (Compl. ¶¶ 23-30).
  • Willful Infringement: The complaint alleges willful infringement based on both pre- and post-suit knowledge (Compl. ¶43). Pre-suit knowledge is alleged based on Defendant's purported practice of monitoring Plaintiff’s patent filings, prior litigation between the parties, and the publication of the patent application on October 24, 2024 (Compl. ¶¶ 31-34). Willfulness is further supported by Plaintiff’s act of sending a formal notice letter on December 17, 2024, the day the patent issued, and Defendant's alleged continuation of infringing activities thereafter (Compl. ¶35).

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

  • A central issue will be one of validity and written description: Can Claim 1's requirement to administer the drug "at least two hours after eating" survive a validity challenge under 35 U.S.C. § 112, given that the patent's specification consistently frames the invention as a solution that enables administration less than two hours after eating?
  • A key question will be one of claim scope: Assuming the claim is valid, will the term "comprising" be interpreted to allow the three-salt composition of Claim 1 to read on the accused four-salt XYWAV product, or can the defendant successfully argue for a narrower construction?
  • A dispositive issue for indirect infringement will be intent and causation: Can Plaintiff provide sufficient evidence that Defendant's instructions and marketing for XYWAV, which mention both "once" and "twice" nightly dosing options, specifically intended to, and in fact did, cause users to adopt the "only once nightly" method required by the claim?