DCT

2:25-cv-12183

Supernus Pharma Inc v. Appco Pharma LLC

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:25-cv-12183, D.N.J., 06/26/2025
  • Venue Allegations: Plaintiff alleges venue is proper in the District of New Jersey because both Defendants maintain principal places of business in the state and conduct continuous and systematic business there, including the development and manufacturing of generic pharmaceuticals. The complaint further alleges that upon approval, the accused generic products will be marketed, distributed, prescribed, and used within New Jersey.
  • Core Dispute: Plaintiff alleges that Defendants' submission of an Abbreviated New Drug Application (ANDA) to the FDA seeking approval to market generic viloxazine extended-release capsules constitutes an act of infringement of six patents listed in the FDA's Orange Book for Plaintiff's branded drug, Qelbree®.
  • Technical Context: The technology concerns pharmaceutical formulations and methods of use for viloxazine, an active ingredient approved for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD).
  • Key Procedural History: This litigation was initiated under the Hatch-Waxman Act following Defendants' notification to Plaintiff of their ANDA filing, which included a "paragraph IV certification" challenging the patents-in-suit. The complaint notes that Defendants' notification letters allegedly did not provide invalidity contentions for three of the six asserted patents.

Case Timeline

Date Event
2008-09-05 Earliest Priority Date ('753, '143, '523 Patents)
2012-02-08 Earliest Priority Date ('204, '853, '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
2025-05-21 Defendants send first Paragraph IV Notice Letter to Plaintiff
2025-06-09 Defendants send second Paragraph IV Notice Letter to Plaintiff
2025-06-26 Complaint Filed

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

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

  • Issued: June 7, 2016

The Invention Explained

  • Problem Addressed: The patent addresses challenges in developing an extended-release formulation for viloxazine, a drug which has a potentially high therapeutic dose and a relatively short elimination half-life in humans, characteristics that would otherwise necessitate multiple daily doses (ʼ204 Patent, col. 1:41-47).
  • The Patented Solution: The invention provides modified-release formulations that control the release of viloxazine over an extended period. This is achieved through various formulation strategies, including matrix systems where the drug is mixed with release-controlling compounds, or systems with drug-layered beads that are coated with release-controlling polymers ('204 Patent, col. 2:1-4; col. 7:1-42). These formulations can combine immediate, extended, and delayed-release components to achieve a desired therapeutic profile with less frequent dosing ('204 Patent, col. 2:1-4).
  • Technical Importance: These extended-release formulations are designed to improve patient compliance by allowing for once or twice-daily administration, which is particularly beneficial for treating chronic CNS disorders (ʼ204 Patent, col. 3:11-20).

Key Claims at a Glance

  • The complaint does not identify any specific claims of the ’204 Patent that are asserted, stating only that Defendants’ products infringe "one or more claims" (Compl. ¶68).

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

  • Issued: May 10, 2022

The Invention Explained

  • Problem Addressed: The patent is based on the "unexpected discovery that viloxazine may be effective in the treatment of ADHD in humans with nominal, if any, significant side effects" (’753 Patent, col. 1:29-32).
  • The Patented Solution: The invention describes a method for treating ADHD by administering viloxazine. The patent discloses that, in addition to its known activity as a noradrenergic reuptake inhibitor, viloxazine also functions as an antagonist at the 5-HT1B and 5-HT7 serotonin receptors (’753 Patent, col. 2:56-61). The claims are directed to the method of treating ADHD by administering viloxazine to achieve this multi-receptor antagonistic activity (’753 Patent, col. 7:13-18).
  • Technical Importance: This disclosed dual-mechanism of action provides a novel pharmacological basis for using viloxazine to treat ADHD, potentially offering a distinct therapeutic profile from other available treatments (’753 Patent, col. 6:30-44).

Key Claims at a Glance

  • The complaint does not identify any specific claims of the ’753 Patent that are asserted, alleging infringement of "one or more of the methods claimed" (Compl. ¶137). Independent claim 1 is representative of the invention:
    • A method of antagonizing 5-HT7 and 5HT1B receptor activity
    • in a patient suffering from ADHD,
    • consisting of administering to the patient...a therapeutically effective amount of viloxazine,
    • wherein the administration antagonizes both receptors.

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

  • Issued: March 28, 2017 (Compl. ¶41)
  • Technology Synopsis: This patent, like the ’204 Patent, is directed to modified-release pharmaceutical formulations of viloxazine. It addresses the technical challenge of formulating a drug with a short half-life into a dosage form suitable for once or twice-daily administration for treating CNS disorders (’853 Patent, col. 1:43-49).
  • Asserted Claims: The complaint alleges infringement of "one or more claims" without specification (Compl. ¶90).
  • Accused Features: The accused features are Defendants' viloxazine extended-release capsules and their commercial manufacture, use, or sale (Compl. ¶90).

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

  • Issued: May 30, 2017 (Compl. ¶42)
  • Technology Synopsis: This patent is also part of the family directed to modified-release formulations of viloxazine. It aims to provide extended therapeutic coverage from a single dose by controlling the drug's release profile, thereby overcoming the limitations of its short intrinsic half-life (’338 Patent, col. 1:43-49).
  • Asserted Claims: The complaint alleges infringement of "one or more claims" without specification (Compl. ¶112).
  • Accused Features: The accused features are Defendants' viloxazine extended-release capsules submitted for approval under ANDA No. 220326 (Compl. ¶112).

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

  • Issued: October 4, 2022 (Compl. ¶44)
  • Technology Synopsis: This patent, similar to the ’753 Patent, covers methods of treating ADHD by administering viloxazine. The invention is based on the discovery that viloxazine has antagonist activity at specific serotonin receptors in addition to its known noradrenergic activity, providing a novel method of action for treating ADHD (’143 Patent, col. 1:25-34, col. 2:53-65).
  • Asserted Claims: The complaint alleges infringement of "one or more of the methods claimed" without specification (Compl. ¶159).
  • Accused Features: Infringement is based on the intended use of Defendants' ANDA products, as will be directed by the proposed product labeling for the treatment of ADHD (Compl. ¶¶158, 160).

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

  • Issued: October 22, 2024 (Compl. ¶45)
  • Technology Synopsis: This patent is also directed to methods of treating ADHD by administering viloxazine. The claimed method relies on the compound's discovered multi-modal activity, including antagonism of 5-HT1B and/or 5-HT7 receptors, to achieve a therapeutic effect in patients with ADHD (’523 Patent, col. 1:40-44, col. 2:34-47).
  • Asserted Claims: The complaint alleges infringement of "one or more of the methods claimed" without specification (Compl. ¶181).
  • Accused Features: The accused acts include the future, intended use of Defendants' generic product for treating ADHD, which would be performed by patients and physicians following the instructions on the product's FDA-approved label (Compl. ¶¶180, 182).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are Defendants' viloxazine extended-release capsules in 100 mg, 150 mg, and 200 mg strengths, for which Defendants submitted ANDA No. 220326 to the FDA (Compl. ¶¶7, 47).

Functionality and Market Context

  • The complaint alleges that Defendants' ANDA Products are generic versions of Plaintiff's Qelbree® and have been represented to the FDA as bioequivalent (Compl. ¶48). The proposed prescribing information for the ANDA Products indicates their use for the "treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older" (Compl. ¶51). The proposed labeling is alleged to recommend dosage and titration schedules similar to those for Qelbree® and to describe viloxazine's mechanism of action as inhibiting the reuptake of norepinephrine (Compl. ¶¶52, 53). Defendants are described as New Jersey-based generic drug development and manufacturing companies that intend to market the ANDA Products throughout the United States upon receiving final FDA approval (Compl. ¶¶7, 27, 31).

IV. Analysis of Infringement Allegations

The complaint makes general allegations of infringement for each patent-in-suit but does not provide a claim-by-claim or element-by-element analysis mapping the accused product to any specific asserted claims. Therefore, a claim chart summary cannot be constructed from the provided complaint.

No probative visual evidence provided in complaint.

V. Key Claim Terms for Construction

The complaint does not identify specific asserted claims or articulate a detailed infringement theory, which prevents the identification of key claim terms that are likely to be in dispute.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement for all six patents-in-suit. The inducement allegations are based on the assertion that Defendants, by creating and seeking approval for product labeling that instructs physicians and patients to use the generic product, will knowingly encourage acts that directly infringe the asserted patents (e.g., Compl. ¶¶73-74, 139-140). The contributory infringement allegations are based on the assertion that Defendants' ANDA Products are a material part of the patented formulations and methods, are not staple articles of commerce, and are sold with knowledge that they will be used in an infringing manner (e.g., Compl. ¶¶75, 97).
  • Willful Infringement: Willfulness is alleged for all six patents. The complaint alleges that Defendants had full knowledge of the patents-in-suit, as evidenced by their filing of a Paragraph IV certification with the FDA that specifically referenced each patent, and that they continued to seek approval to market their products without a reasonable basis for believing they would not be liable for infringement (e.g., Compl. ¶¶76, 98, 120, 142, 164, 186). This alleges pre-suit knowledge of the patents and infringing conduct.

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

  • A foundational issue will be one of pleading sufficiency: given that the complaint asserts infringement of six patents without identifying a single claim or providing a detailed factual basis for how the accused generic product infringes, a primary question is whether the allegations meet the plausibility standard required to proceed to discovery.
  • For the method patents (e.g., ’753, ’143, ’523), a core question will be one of infringement and validity: assuming specific claims are later identified, the dispute may focus on whether administering the accused product for ADHD as directed by its label necessarily results in the claimed "antagonizing" of specific serotonin receptors, and whether this newly claimed therapeutic mechanism was non-obvious over the prior art for the known compound viloxazine.
  • For the formulation patents (e.g., ’204, ’853, ’338), a key evidentiary question will be one of technical comparison: once the details of the ANDA are produced in discovery, the case will likely turn on whether the specific excipients, drug load, and resulting in vitro and in vivo release profiles of Defendants' product fall within the scope of the asserted patent claims as construed by the court.