DCT
1:25-cv-00057
Avadel CNS Pharma LLC v. Jazz Pharma Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Avadel CNS Pharmaceuticals, LLC (Delaware) and Flamel Ireland Limited (Ireland)
- Defendant: Jazz Pharmaceuticals, Inc. (Delaware) and Jazz Pharmaceuticals Ireland Limited (Ireland)
- Plaintiff’s Counsel: McCarter & English, LLP; Latham & Watkins LLP
- Case Identification: 1:25-cv-00057, D. Del., 01/14/2025
- 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. Venue over Jazz Pharmaceuticals Ireland Limited is asserted on the basis that it is not a resident of the United States and may be sued in any judicial district.
- Core Dispute: Plaintiff alleges that Defendant’s marketing and sale of its XYWAV® product induces infringement of a patent related to a once-daily method of administering gamma-hydroxybutyrate salts for treating sleep disorders.
- Technical Context: The technology concerns modified-release pharmaceutical formulations designed to treat narcolepsy and other sleep disorders, aiming to improve patient convenience and outcomes by enabling a single dose at bedtime rather than multiple doses during the night.
- Key Procedural History: The complaint alleges that Defendant has a pattern of closely monitoring Plaintiff’s patent portfolio, referencing testimony from prior litigation between the parties and Defendant’s citation of Plaintiff’s related patents in Information Disclosure Statements filed during its own patent prosecutions. Plaintiff also sent a notice letter to Defendant on the day the patent-in-suit issued.
Case Timeline
| Date | Event |
|---|---|
| 2016-07-22 | U.S. Patent No. 12,186,298 Priority Date |
| 2021-08-12 | FDA approved XYWAV for treatment of Idiopathic Hypersomnia |
| 2025-01-07 | U.S. Patent No. 12,186,298 Issued |
| 2025-01-14 | 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"
- Patent Identification: U.S. Patent No. 12,186,298, “Modified Release Gamma-Hydroxybutyrate Formulations Having Improved Pharmacokinetics,” issued January 7, 2025 (’298 Patent).
The Invention Explained
- Problem Addressed: The patent’s background describes the existing commercial treatment for narcolepsy, sodium oxybate (Xyrem®), as requiring two separate doses per night, which is a “substantial inconvenience” that can interrupt a patient’s sleep (’298 Patent, col. 2:36-41). It further notes that previous attempts to create a once-nightly formulation suffered from a significant “reduction in bioavailability” compared to the immediate-release, twice-nightly product (’298 Patent, col. 2:48-55). The high sodium content of existing treatments is also identified as a drawback (’298 Patent, col. 5:48-56).
- The Patented Solution: The invention is a method of treatment using a modified-release formulation of gamma-hydroxybutyrate that is administered once per night. The formulation is designed to approximate the bioavailability of the twice-nightly immediate-release product across a range of therapeutic doses, thereby solving the prior art’s bioavailability problem while improving patient convenience (’298 Patent, col. 6:27-41; Abstract).
- Technical Importance: This approach aims to provide a full night of therapeutic effect from a single dose, addressing a significant patient compliance and quality-of-life issue associated with the standard twice-nightly treatment regimen for narcolepsy (’298 Patent, col. 2:36-41).
Key Claims at a Glance
- The complaint asserts at least Claim 1 (Compl. ¶39).
- The essential elements of independent claim 1 are:
- A method of treating a disorder treatable with gamma-hydroxybutyrate in a human subject.
- Orally administering a pharmaceutical composition comprising first and second salts of gamma-hydroxybutyrate.
- The first salt is selected from a group including sodium, calcium, magnesium, and potassium oxybate.
- The second salt differs from the first and is selected from the same group.
- 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 administration occurs only once daily at bedtime.
- The 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 an oral solution that contains a mixture of four different salts of gamma-hydroxybutyrate: calcium oxybate, magnesium oxybate, potassium oxybate, and sodium oxybate (Compl. ¶17). It is approved by the FDA for the treatment of idiopathic hypersomnia in adults and for cataplexy or excessive daytime sleepiness (EDS) in patients with narcolepsy (Compl. ¶19-20). The complaint alleges that the prescribing information for XYWAV® recommends that it can be administered as a “once nightly regimen” for adult patients with idiopathic hypersomnia, with recommended dosages that are equivalent to 3.0 g, 4.5 g, or 6.0 g of sodium oxybate (Compl. ¶18, 26).
No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
’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: | Jazz promotes XYWAV® for treating idiopathic hypersomnia, a disorder treatable with gamma-hydroxybutyrate. | ¶25 | col. 7:32-38 |
| orally administering a pharmaceutical composition comprising first and second salts of gamma-hydroxybutyrate to said human subject, wherein | XYWAV® is an oral solution containing a mixture of four different salts of gamma-hydroxybutyrate. | ¶16, 17 | col. 18:27-40 |
| said first salt is selected from the group consisting of sodium oxybate, calcium oxybate, magnesium oxybate, and potassium oxybate, | XYWAV® is a mixture of calcium oxybate, magnesium oxybate, potassium oxybate, and sodium oxybate, all of which are in the claimed group. | ¶17 | col. 18:27-40 |
| 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 at least two different salts from the claimed group (e.g., calcium oxybate and magnesium oxybate). | ¶17 | col. 18:27-40 |
| 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, | Jazz’s labeling allegedly equates XYWAV® doses of 3.0 g, 4.5 g, or 6.0 g to the same amount of sodium oxybate, which are dosages recited in the claim. | ¶18 | col. 7:26-31 |
| the orally administering occurs only once daily at bedtime, and | The XYWAV® Prescribing Information allegedly recommends a "once nightly regimen" for adult patients with idiopathic hypersomnia, instructing patients to "Take your XYWAV dose at bedtime." | ¶26, 30 | col. 5:61-63 |
| the orally administering occurs at least 2 hours after eating. | The XYWAV® Prescribing Information and Medication Guide allegedly instruct patients and caregivers to administer the product "at least 2 hours after eating." | ¶31 | col. 7:8-14 |
Identified Points of Contention
- Scope Questions: The infringement theory is one of inducement, as the patent claims a method of use. A central question may be whether Jazz’s marketing and labeling, which allegedly present a once-nightly regimen as one of two options (“twice or once nightly”), are sufficient to establish the specific intent required to induce infringement of a claim that requires administration "only once daily."
- Technical Questions: What evidence does the complaint provide that the instructions for use for idiopathic hypersomnia, which is the context for the once-nightly dosing allegation, are followed by a sufficient number of users to support a claim of widespread direct infringement by third parties, a prerequisite for an inducement claim?
V. Key Claim Terms for Construction
- The Term: “only once daily at bedtime”
- Context and Importance: This term is critical because the infringement theory depends on Jazz inducing a specific dosing frequency. The inclusion of the word "only" may become a focal point of dispute. Practitioners may focus on this term because Jazz could argue that its product labeling, by presenting a once-nightly regimen as an option alongside a twice-nightly regimen, does not induce a method that must be performed "only" once daily.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent specification repeatedly frames the invention as a solution to the problem of twice-nightly dosing, suggesting the primary purpose is to enable a single administration event per day (’298 Patent, col. 2:36-41, col. 5:61-63). Plaintiff may argue "only once daily" refers to the patient's action on any given day, not that the drug label must forbid any other possibility.
- Evidence for a Narrower Interpretation: Defendant may argue that the plain meaning of "only" requires exclusivity. Since the accused product’s label allegedly offers a "twice or once nightly regimen," it does not instruct a method that is only once-daily, thereby avoiding infringement (Compl. ¶26).
VI. Other Allegations
- Indirect Infringement: The complaint alleges active inducement of infringement under 35 U.S.C. § 271(b) (Compl. ¶41). The factual basis is Defendant’s alleged promotion of XYWAV® for once-nightly use through its Prescribing Information, Medication Guide, marketing materials, and website, which allegedly instruct and encourage healthcare providers and patients to perform the patented method (Compl. ¶25, 26, 30, 31, 38).
- Willful Infringement: Willfulness is alleged based on Defendant’s purported knowledge of the ’298 Patent (Compl. ¶44). This knowledge is allegedly based on: (1) Defendant’s alleged pre-suit pattern of closely monitoring Plaintiff’s patent portfolio and citing related patents during its own patent prosecution (Compl. ¶32-35); and (2) Plaintiff sending a formal notice letter to Defendant on the day the ’298 Patent issued (Compl. ¶36).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of inducement: does promoting a drug for an optional once-nightly use, when a twice-nightly use is also permitted on the label, constitute the specific intent required to induce infringement of a method claim requiring administration "only once daily"?
- A key evidentiary question will be one of pre-suit knowledge: what level of constructive or actual knowledge can be established from Defendant's alleged monitoring of Plaintiff's patent portfolio prior to the patent's issuance, and how will that affect the analysis of willfulness, particularly for infringing acts that occurred before the formal notice letter was sent?