DCT

2:25-cv-13207

Supernus Pharma Inc v. Zenara Pharma Pvt Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:25-cv-13207, D.N.J., 07/11/2025
  • Venue Allegations: Venue is alleged in the District of New Jersey based on Defendant Biophore Pharma Inc. being a New Jersey corporation and acting as the U.S. agent for Defendant Zenara Pharma Private Limited. The complaint further alleges that both defendants conduct business in the district and that the notice letter for the underlying drug application designated a New Jersey address for service of process.
  • Core Dispute: Plaintiff alleges that Defendants' filing of an Abbreviated New Drug Application (ANDA) to market generic extended-release viloxazine capsules constitutes an act of infringement of six U.S. patents covering Plaintiff's commercial product, Qelbree®.
  • Technical Context: The dispute centers on pharmaceutical formulations for viloxazine, an active ingredient used to treat Attention Deficit Hyperactivity Disorder (ADHD), and methods of using those formulations.
  • Key Procedural History: The litigation was triggered by Defendants' submission of ANDA No. 220376 to the U.S. Food and Drug Administration (FDA) and their subsequent issuance of a Paragraph IV certification notice letter to Plaintiff on or about June 9, 2025, asserting that the patents-in-suit are invalid or will not be infringed by the proposed generic product.

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
2025-06-09 Defendants send 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 effective extended-release formulation for viloxazine, citing its potentially high therapeutic dose, weakly basic nature, and high in vivo clearance rate in humans as obstacles to achieving prolonged therapeutic effects with conventional dosing. (’204 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 pulsatile release systems that may combine immediate-release, extended-release, and/or delayed-release components, often in the form of coated pellets or matrix tablets, to maintain therapeutic drug levels with once- or twice-daily administration. (’204 Patent, col. 2:1-4, col. 7:4-8:67).
  • Technical Importance: These extended-release formulations are intended to improve patient compliance by reducing dosing frequency and to potentially mitigate side effects associated with the fluctuating plasma concentrations of immediate-release versions. (’204 Patent, col. 3:18-24).

Key Claims at a Glance

The complaint does not identify the specific independent claims of the ’204 patent that are asserted against the Defendants, alleging infringement of “one or more claims” generally (Compl. ¶ 74).

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

The Invention Explained

  • Problem Addressed: The patent addresses the same technical challenges as the ’204 Patent regarding the development of a stable, effective extended-release viloxazine product suitable for once- or twice-daily dosing. (’853 Patent, col. 1:41-47).
  • The Patented Solution: The invention, as described in the specification, discloses modified-release pharmaceutical compositions of viloxazine. The disclosed solutions involve formulations comprising components with different release profiles, such as an immediate-release component combined with one or more extended-release components, to achieve a desired therapeutic effect over a prolonged duration. (’853 Patent, col. 2:1-4, col. 7:4-8:67).
  • Technical Importance: As with the ’204 Patent, the technical approach aims to provide a more convenient dosing regimen and a more stable pharmacokinetic profile compared to immediate-release alternatives. (’853 Patent, col. 3:18-24).

Key Claims at a Glance

The complaint does not identify the specific independent claims of the ’853 patent that are asserted against the Defendants, alleging infringement of “one or more claims” generally (Compl. ¶ 96).

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

Technology Synopsis

This patent, part of the same family as the ’204 and ’853 patents, also relates to modified-release pharmaceutical formulations of viloxazine designed to provide extended therapeutic activity and allow for less frequent dosing (Compl. ¶ 48).

Asserted Claims

The complaint does not identify specific asserted claims (Compl. ¶ 112).

Accused Features

The accused features are the formulation characteristics of Defendants' proposed generic viloxazine extended-release capsules (Compl. ¶ 118).

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

Technology Synopsis

This patent describes a method of treating ADHD by administering viloxazine. The invention is based on the discovery that viloxazine exhibits antagonist activity at specific serotonin receptors (5-HT7 and 5HT1B), in addition to its known activity as a norepinephrine reuptake inhibitor, which contributes to its therapeutic effect in ADHD. (’753 Patent, Abstract; col. 2:20-32).

Asserted Claims

The complaint does not identify specific asserted claims (Compl. ¶ 134).

Accused Features

Defendants are accused of inducing infringement through the proposed product labeling, which allegedly instructs physicians and patients to administer the generic product for the treatment of ADHD (Compl. ¶¶ 143, 144).

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

Technology Synopsis

This patent is from the same family as the ’753 patent and similarly relates to methods of treating ADHD by administering viloxazine, based on its combined activity as a norepinephrine reuptake inhibitor and antagonist at certain serotonin receptors (Compl. ¶ 50; ’143 Patent, Abstract).

Asserted Claims

The complaint does not identify specific asserted claims (Compl. ¶ 156).

Accused Features

Infringement allegations are based on the instructions for use for treating ADHD that will allegedly be included in the labeling for Defendants' generic product (Compl. ¶¶ 165, 166).

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

Technology Synopsis

This patent is from the same family as the ’753 and ’143 patents and also claims methods for treating ADHD through the administration of viloxazine, leveraging its multi-modal mechanism of action (Compl. ¶ 51; ’523 Patent, Abstract).

Asserted Claims

The complaint does not identify specific asserted claims (Compl. ¶ 178).

Accused Features

The infringement allegations target the instructions in the proposed label for Defendants' product, which are alleged to encourage the administration of the drug for the treatment of ADHD (Compl. ¶¶ 187, 188).

III. The Accused Instrumentality

Product Identification

  • The accused products are Defendants' generic viloxazine extended-release oral capsules in 100 mg, 150 mg, and 200 mg strengths, for which Defendants seek FDA approval via ANDA No. 220376 (Compl. ¶¶ 13, 53).

Functionality and Market Context

  • The complaint alleges that Defendants' ANDA Products are bioequivalent to Plaintiff's Qelbree® extended-release capsules and are intended for the same medical indication: the treatment of ADHD in adults and pediatric patients 6 years and older (Compl. ¶¶ 54, 57). The proposed prescribing information for the ANDA Products is alleged to contain the same dosage and administration recommendations as the Qelbree® label, and to describe a mechanism of action involving inhibition of norepinephrine reuptake and interaction with serotonin receptors (Compl. ¶¶ 58-60).

IV. Analysis of Infringement Allegations

The complaint does not assert specific claims for any of the patents-in-suit, instead alleging infringement of “one or more claims” for each patent (Compl. ¶¶ 74, 96, 118, 140, 162, 184). Consequently, a detailed claim chart analysis is not possible based on the provided complaint. The infringement theories are summarized below.

Formulation Patents (’204, ’853, ’338 Patents)
The complaint alleges that the submission of the ANDA itself constitutes an act of infringement under 35 U.S.C. § 271(e)(2)(A) (Compl. ¶¶ 72, 94, 116). Upon information and belief, the complaint alleges that the future commercial manufacture, use, or sale of Defendants' ANDA Products would directly infringe the claims of the formulation patents because the products allegedly embody the claimed extended-release formulations (Compl. ¶¶ 74, 96, 118).

Method of Treatment Patents (’753, ’143, ’523 Patents)
The complaint alleges that Defendants will indirectly infringe the method-of-use patents. The theory of induced infringement is based on the allegation that Defendants' proposed product labeling will instruct and encourage physicians to prescribe and patients to use the ANDA Products for the treatment of ADHD, which is the patented method (Compl. ¶¶ 143-145, 165-167, 187-189). This inducement is predicated on the proposed label being a substantial copy of the label for Qelbree® (Compl. ¶¶ 142, 164, 186).

  • Identified Points of Contention:
    • Scope Questions (Formulation Patents): A primary issue will be whether the specific formulation characteristics of Defendants' ANDA product, once revealed in discovery, fall within the scope of the yet-to-be-asserted patent claims. The dispute may focus on elements such as the release-controlling polymers, the drug load, the physical structure of the capsules or pellets, and the resulting in vitro dissolution profiles.
    • Technical Questions (Method Patents): A key question for the method patents will be whether the act of administering the ANDA product as instructed by its label meets every step of an asserted method claim. For example, claim 1 of the ’753 patent recites a method of "antagonizing 5-HT7 and 5HT1B receptor activity." A potential dispute is whether a product label that instructs treatment of a condition (ADHD) is sufficient to induce infringement of a claim that recites a specific biological mechanism of action.

No probative visual evidence provided in complaint.

V. Key Claim Terms for Construction

As the complaint does not identify the specific claims asserted from any of the patents-in-suit, an analysis of key claim terms for construction is not possible.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement for all six patents-in-suit.
    • Inducement: The allegations are based on Defendants' proposed product labeling, which allegedly instructs and encourages medical professionals and patients to use the ANDA products in a manner that directly infringes the asserted patents (Compl. ¶¶ 79, 101, 123, 145, 167, 189).
    • Contributory Infringement: The complaint alleges that Defendants' ANDA Products are a material part of the patented inventions, are not staple articles of commerce suitable for substantial noninfringing uses, and that Defendants know their products are specially adapted for an infringing use (Compl. ¶¶ 81, 103, 125, 147, 169, 191).
  • Willful Infringement: The complaint alleges that Defendants acted with full knowledge of the patents-in-suit, as evidenced by their filing of an ANDA with a Paragraph IV certification that specifically references each asserted patent, and that this knowledge supports a claim for willful infringement (Compl. ¶¶ 82, 104, 126, 148, 170, 192).

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

  • A central issue will be one of factual comparison: does the specific composition of matter disclosed in Defendants' confidential ANDA—including its excipients, structure, and dissolution profile—fall within the literal scope of the claims that Supernus will ultimately assert from its formulation patents? The outcome of this question will depend entirely on evidence obtained during discovery.
  • A key legal question will be one of induced infringement scope: for the method-of-use patents, is a product label that instructs the treatment of ADHD sufficient to demonstrate the specific intent required to induce infringement of claims that recite not only the treatment but also the underlying biological mechanism of action?
  • A final question will be one of validity: while the complaint alleges Defendants admitted the validity of the ’204 and ’338 patents by not raising invalidity contentions in the Notice Letter, validity of all asserted claims will likely be a core battleground, with Defendants expected to challenge the patents based on prior art or other statutory requirements (Compl. ¶ 39).