DCT

2:25-cv-13201

Supernus Pharma Inc v. Creekwood Pharma LLC

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:25-cv-13201, D.N.J., 07/11/2025
  • Venue Allegations: Venue is based on Defendant's principal place of business being located in Parsippany, New Jersey, within the judicial district.
  • Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff's Qelbree® product constitutes an act of infringement of six patents related to viloxazine formulations and methods of treating Attention Deficit Hyperactivity Disorder (ADHD).
  • Technical Context: The technology concerns extended-release pharmaceutical formulations of viloxazine, a selective norepinephrine reuptake inhibitor, and its use in treating ADHD.
  • Key Procedural History: The litigation was initiated under the Hatch-Waxman Act following Defendant's June 4, 2025 notice letter, which contained a Paragraph IV certification against the patents-in-suit listed in the FDA's Orange Book for Qelbree®. The complaint notes other pending litigation involving the same patents against different generic drug manufacturers.

Case Timeline

Date Event
2008-09-05 Earliest Priority Date for ’753, ’143, and ’523 Patents
2012-02-08 Earliest Priority Date for ’204, ’853, and ’338 Patents
2016-06-07 U.S. Patent No. 9,358,204 Issues
2017-03-28 U.S. Patent No. 9,603,853 Issues
2017-05-30 U.S. Patent No. 9,662,338 Issues
2022-05-10 U.S. Patent No. 11,324,753 Issues
2022-10-04 U.S. Patent No. 11,458,143 Issues
2024-10-22 U.S. Patent No. 12,121,523 Issues
2025-06-04 Defendant sends Paragraph IV Notice Letter to Plaintiff
2025-07-11 Complaint Filed

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

U.S. Patent No. 9,358,204 - "Formulations of Viloxazine"

The Invention Explained

  • Problem Addressed: The patent describes challenges in creating an extended-release formulation of viloxazine due to its high therapeutic dose, weakly basic nature, and rapid in vivo clearance rate, which traditionally would require frequent dosing ('204 Patent, col. 1:41-47).
  • The Patented Solution: The invention provides a modified-release oral formulation that combines different release components to control the drug's delivery over an extended period. This is achieved by using specific pharmaceutical components, such as release-rate controlling compounds and pore formers, often structured as multiparticulates with distinct immediate-release and extended-release portions ('204 Patent, Abstract; col. 2:1-4). This design allows for once or twice-daily dosing while maintaining therapeutic drug levels.
  • Technical Importance: This formulation technology enables a less frequent dosing regimen for viloxazine, potentially improving patient adherence and providing more stable plasma concentrations compared to immediate-release versions. (Compl. ¶29; ’204 Patent, col. 3:12-21).

Key Claims at a Glance

  • The complaint asserts infringement of one or more unspecified claims of the patent (Compl. ¶56). Independent claim 1 is representative of the formulation technology.
  • Essential elements of Independent Claim 1 include:
    • A pharmaceutical formulation comprising two distinct components: an immediate release (IR) component and an extended release (XR) component.
    • The IR component comprises an inert core surrounded by a layer of viloxazine.
    • The XR component comprises an inert core, a first layer of viloxazine, and a second layer containing a "release rate controlling compound" and a "pore former" in a specific weight ratio (19:1 to 8.5:1.5).
    • The total formulation contains 25% to 75% (w/w) viloxazine.
    • The formulation provides both immediate and continuous release and releases at least 80% of the drug over at least 2 hours in vitro.
  • The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 9,603,853 - "Formulations of Viloxazine"

The Invention Explained

  • Problem Addressed: As with the related ’204 Patent, this patent addresses the need for an effective extended-release formulation of viloxazine to overcome its challenging pharmacokinetic properties and allow for less frequent dosing ('853 Patent, col. 1:43-49).
  • The Patented Solution: This patent claims methods of treating ADHD or major depressive disorder by administering a specific multi-component viloxazine formulation. The formulation itself contains both immediate-release and extended-release particles, with the extended-release portion being engineered with specific release-controlling compounds and pore formers to achieve a desired therapeutic effect over time ('853 Patent, Abstract; col. 2:1-4).
  • Technical Importance: By claiming the method of use for these advanced formulations, the patent protects not just the drug product but also its specific application in treating CNS disorders like ADHD, linking the formulation's technical design to a clinical outcome. (Compl. ¶30; '853 Patent, col. 3:12-21).

Key Claims at a Glance

  • The complaint asserts infringement of one or more unspecified claims of the patent (Compl. ¶75). Independent claim 1 is representative of the claimed method.
  • Essential elements of Independent Claim 1 include:
    • A method of treating ADHD or major depressive disorder.
    • The method consists of administering a formulation that includes both an immediate release (IR) component and an extended release (XR) component.
    • The IR component is an inert core layered with viloxazine.
    • The XR component is an inert core layered with viloxazine, which is then covered by a second layer containing a "release rate controlling compound" and a "pore former" in a specified ratio.
    • The formulation has a specific drug load (25% to 75% w/w viloxazine) and in vitro release profile.
  • The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 9,662,338 - "Formulations of Viloxazine"

  • Technology Synopsis: Belonging to the same family as the ’204 and ’853 patents, this patent claims a pharmaceutical formulation of viloxazine comprising an extended-release component with specific structural characteristics, including an inert core, a drug layer, and a release-controlling layer containing a pore former. The claims protect a specific embodiment of the extended-release technology designed to achieve a controlled therapeutic profile ('338 Patent, col. 25:64-26:41).
  • Asserted Claims: One or more unspecified claims (Compl. ¶94). Independent Claim 1 is representative.
  • Accused Features: The accused features are the formulation characteristics of Defendant's generic viloxazine extended-release capsules, which are alleged to meet the claim limitations (Compl. ¶¶ 40, 96).

U.S. Patent No. 11,324,753 - "Method of Treatment of Attention Deficit/Hyperactivity Disorder (ADHD)"

  • Technology Synopsis: This patent is directed to a method of treating ADHD predicated on the discovery that viloxazine exhibits antagonist activity at the 5-HT7 and 5HT1B serotonin receptors. The invention claims the act of antagonizing these specific receptors in an ADHD patient by administering viloxazine ('753 Patent, Background; Abstract).
  • Asserted Claims: One or more unspecified claims (Compl. ¶113). Independent Claim 1 is representative.
  • Accused Features: The accused feature is the act of administering Defendant’s product according to its proposed label, which instructs use for the treatment of ADHD and thereby allegedly induces infringement of the patented method (Compl. ¶¶ 44, 116-117).

U.S. Patent No. 11,458,143 - "Method of Treatment of Attention Deficit/Hyperactivity Disorder (ADHD)"

  • Technology Synopsis: This patent, from the same family as the ’753 patent, claims a method of treating ADHD by administering a therapeutically effective amount of viloxazine or a salt thereof in a formulation. It links the administration of the viloxazine formulation directly to the treatment of the ADHD condition ('143 Patent, Abstract; Claim 1).
  • Asserted Claims: One or more unspecified claims (Compl. ¶132). Independent Claim 1 is representative.
  • Accused Features: The accused feature is the administration of Defendant's product for ADHD as instructed by the proposed product label, which Plaintiff alleges will induce infringement (Compl. ¶¶ 44, 135-136).

U.S. Patent No. 12,121,523 - "Method of Treatment of Attention Deficit/Hyperactivity Disorder (ADHD)"

  • Technology Synopsis: From the same family as the '753 and '143 patents, this patent claims a method for treating mood or affective disorders (e.g., anxiety, depression) that are co-morbid with ADHD. The method involves administering a viloxazine formulation to a patient with such a co-morbid condition ('523 Patent, Abstract; Claim 15).
  • Asserted Claims: One or more unspecified claims (Compl. ¶151). Independent Claim 15 is representative.
  • Accused Features: The proposed label for Defendant’s product allegedly instructs patients to seek help for "new or worse depression" or "anxiety," which Plaintiff alleges encourages the product's use for treating these co-morbid conditions, thereby inducing infringement (Compl. ¶¶ 48, 154).

III. The Accused Instrumentality

Product Identification

  • Defendant’s generic viloxazine extended-release oral capsules, in 100 mg and 200 mg strengths, for which Defendant filed Abbreviated New Drug Application No. 220277 with the FDA (Compl. ¶¶ 7, 40).

Functionality and Market Context

  • The accused products are designed to be bioequivalent to Plaintiff's Qelbree® extended-release capsules (Compl. ¶41). Their proposed labeling indicates them for the treatment of ADHD in adults and pediatric patients aged six and older (Compl. ¶44). The labeling includes specific dosage and administration instructions for different patient populations, including starting doses and titration schedules to maximum recommended doses (Compl. ¶45).
  • As a generic equivalent to an Orange Book-listed drug, the product is intended to be a direct market competitor to Qelbree®, leveraging the same approved indication and dosing regimens (Compl. ¶¶ 32, 43).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

'204 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A pharmaceutical formulation, comprising: (a) an immediate release (IR) component... and (b) an extended release (XR) component... Defendant's ANDA Products are extended-release capsules alleged to contain the claimed multi-component formulation. ¶40 col. 27:26-34
The IR component comprising an inert core and a layer comprising viloxazine... surrounding the core... The complaint does not provide sufficient detail for analysis of this specific structural element. It alleges on information and belief that the ANDA product infringes. ¶56 col. 27:27-30
The XR component comprising: (i) an inert core, (ii) a first layer comprising viloxazine..., and (iii) a second layer comprising a release rate controlling compound and a pore former in a weight ratio of 19:1 to 8.5:1.5... The complaint does not provide sufficient detail for analysis of this specific structural element or its ratios. It alleges the product is an extended-release formulation that meets the claim limitations. ¶¶40, 56 col. 27:31-41
wherein the formulation comprises, as a percentage of the total formulation, 25% (w/w) to 75% (w/w) viloxazine... The complaint does not provide sufficient detail for analysis of the drug load percentage. ¶56 col. 27:48-50
wherein at least 80% of the viloxazine or salt thereof in the formulation is released from the formulation over a period of time of at least 2 hours in vitro. As an extended-release capsule intended to be bioequivalent to Qelbree®, the ANDA product is alleged to have a release profile meeting this limitation. ¶¶40, 41 col. 27:54-57

'853 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of treating ADHD... comprising administration... of a formulation... Defendant's proposed product label instructs physicians and patients to administer the generic product for the treatment of ADHD. ¶¶44, 45, 78 col. 27:21-24
said formulation comprising: (a) an immediate release (IR) component... and (b) an extended release (XR) component... Defendant's product is an extended-release capsule alleged to be formulated with the claimed IR and XR components. Inducement is alleged based on the product being supplied with instructions for the infringing use. ¶¶40, 78 col. 27:25-47
the XR component... comprising a release rate controlling compound and a pore former in a weight ratio of 19:1 to 8.5:1.5... The complaint does not provide sufficient detail for analysis of this specific structural element in the accused product. It alleges on information and belief that the product supplied for the infringing method contains this feature. ¶75 col. 27:34-40

Identified Points of Contention

  • Scope Questions: The primary dispute for the formulation patents ('204, '853, '338) will concern the scope of terms defining the product's physical structure, such as "immediate release (IR) component" and "extended release (XR) component." A question for the court will be whether these terms require physically distinct, multi-layered particles as described in the specification, or if they could be construed more broadly to cover other types of formulations (e.g., a monolithic matrix) that achieve a similar release profile.
  • Technical Questions: A key evidentiary question will be whether Defendant’s ANDA product, the formulation of which is confidential, actually incorporates the specific multi-layered particulate structure with the claimed ratios of "release rate controlling compound" to "pore former." The complaint lacks specific factual allegations on this point, which will be a focus of discovery. For the method-of-use patents ('753, '143, '523), a question may arise as to whether the product label's language rises to the level of specific encouragement required to prove the intent element for induced infringement.

V. Key Claim Terms for Construction

  • The Term: "an immediate release (IR) component" and "an extended release (XR) component" (from claims of the '204, '853, and '338 patents).
  • Context and Importance: These terms are foundational to the formulation patents. The claims define a product containing physically distinct IR and XR parts. The infringement analysis will depend entirely on whether the accused generic product is found to contain both of these structurally defined components, as opposed to a single, uniform component that provides an extended-release profile.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification describes the overall goal as achieving a certain pharmacokinetic profile, stating formulations can be in the form of "tablets, capsules, beads, granules," etc. ('204 Patent, col. 2:9-12). A party might argue that "component" should be interpreted functionally to mean any portion of the dose that provides either an immediate or extended release, regardless of its specific physical structure.
    • Evidence for a Narrower Interpretation: The claims themselves provide detailed structural definitions for each component (e.g., "comprising an inert core and a layer comprising viloxazine" for the IR component; a multi-layered structure for the XR component) ('204 Patent, claim 1). The detailed description and figures also depict multi-particulate systems. A party could argue this intrinsic evidence limits the term "component" to these specific disclosed physical structures.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Defendant will induce infringement of the method-of-treatment patents ('853, '338, '753, '143, '523) by marketing its product with a proposed label that instructs physicians and patients to administer it for the treatment of ADHD (Compl. ¶¶ 78, 118, 137, 156). Contributory infringement is also alleged on the basis that the accused product is a material part of the patented methods and is not a staple article of commerce suitable for substantial non-infringing uses (Compl. ¶¶ 82, 120, 139, 158).
  • Willful Infringement: Willfulness is alleged based on Defendant’s pre-suit knowledge of the patents-in-suit, as evidenced by its filing of an ANDA containing a Paragraph IV certification that specifically identified each patent (Compl. ¶¶ 64, 83, 102, 121, 140, 159).

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

  • A core issue will be one of structural correspondence: Does Creekwood’s generic formulation, as confidentially described in its ANDA, contain the specific multi-component, layered particulate structure required by the asserted claims of the formulation patents, or does it achieve an extended-release profile through a structurally different design (e.g., a monolithic matrix tablet)? The answer to this technical question, which depends on evidence not yet public, will be central to the infringement analysis for a significant portion of the asserted patent portfolio.
  • A second key issue will be one of induced infringement: For the method-of-treatment patents, the central question will be whether Creekwood’s proposed product label—by indicating the drug for ADHD and providing specific dosing instructions—demonstrates the specific intent required to encourage or promote the infringing acts of administration by physicians and patients.