DCT

2:25-cv-12186

Supernus Pharma Inc v. Aurobindo Pharma Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:25-cv-12186, D.N.J., 06/26/2025
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey based on Defendant Aurobindo USA maintaining its principal place of business in the district, operating a distribution center there, and systematically placing goods into the stream of commerce in the state.
  • Core Dispute: Plaintiff alleges that Defendants’ filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff’s Qelbree® (viloxazine) product constitutes an act of infringement of six patents covering drug formulations and methods of treatment.
  • Technical Context: The patents relate to extended-release formulations of viloxazine and methods of using it to treat Attention Deficit/Hyperactivity Disorder (ADHD), a common neurodevelopmental disorder.
  • Key Procedural History: The complaint notes that Defendant Aurobindo has consented to jurisdiction in the District of New Jersey in prior civil actions. It also alleges that Defendants' Paragraph IV Notice Letter did not disclose invalidity or unenforceability contentions for most of the asserted patents and claims, which Plaintiff frames as an acknowledgment of their validity.

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 Issue Date (U.S. Patent No. 9,358,204)
2017-03-28 Issue Date (U.S. Patent No. 9,603,853)
2017-05-30 Issue Date (U.S. Patent No. 9,662,338)
2022-05-10 Issue Date (U.S. Patent No. 11,324,753)
2022-10-04 Issue Date (U.S. Patent No. 11,458,143)
2024-10-22 Issue Date (U.S. Patent No. 12,121,523)
2025-05-29 Defendants sent Paragraph IV Notice Letter to Plaintiff
2025-06-26 Complaint Filing Date

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 describes challenges in creating an extended-release formulation of viloxazine suitable for once- or twice-daily dosing, citing the drug's high therapeutic dose, weakly basic nature, and high rate of in vivo clearance, which traditionally required multiple daily doses (’204 Patent, col. 1:41-49).
  • The Patented Solution: The invention provides modified-release formulations that combine different release components, such as immediate-release (IR), extended-release (XR), and delayed-release (DR) components, to achieve a therapeutic effect over a prolonged period (’204 Patent, col. 2:1-4). This approach aims to create a "pulsatile release" profile, allowing for less frequent dosing than was possible with immediate-release versions (’204 Patent, col. 1:63-65).
  • Technical Importance: Developing an effective extended-release formulation can improve patient compliance and provide more stable plasma concentrations of a drug, which is particularly relevant for managing chronic conditions like ADHD (’204 Patent, col. 3:11-20).

Key Claims at a Glance

The complaint alleges infringement of "one or more claims" of the '204 patent but does not identify any specific claims, independent or dependent (Compl. ¶66). As such, a breakdown of asserted claim elements is not possible based on the complaint.

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

  • Issued: March 28, 2017

The Invention Explained

  • Problem Addressed: Similar to the '204 Patent, this patent addresses the technical difficulties of formulating viloxazine for extended release given its physicochemical and pharmacokinetic properties (’853 Patent, col. 1:41-49).
  • The Patented Solution: The invention discloses modified-release formulations, including high-drug-load compositions, that achieve specific release profiles through the use of release-rate-controlling compounds and excipients (’853 Patent, Abstract; col. 2:1-4). The patent describes formulations comprising an extended-release component, and optionally immediate-release or delayed-release components, to control the drug's release over time.
  • Technical Importance: By enabling high-drug-load formulations, the invention allows for higher doses of viloxazine to be delivered in a single, manageable dosage form, which is critical for a drug with a high therapeutic dose requirement (’853 Patent, col. 2:5-8).

Key Claims at a Glance

The complaint alleges infringement of "one or more claims" of the '853 patent but does not identify specific claims (Compl. ¶88). Analysis of specific claim elements is therefore not possible based on the complaint.

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

  • Issued: May 30, 2017

Technology Synopsis

This patent, related to the '204 and '853 patents, also discloses modified-release formulations of viloxazine designed to overcome challenges associated with its high dose and rapid clearance (’338 Patent, col. 1:41-49). The solution involves combinations of immediate, extended, and delayed-release components to achieve specific therapeutic plasma profiles with less frequent dosing (’338 Patent, col. 2:1-4).

Asserted Claims

The complaint asserts infringement of "one or more claims" (Compl. ¶110).

Accused Features

The accused features are Defendants' generic viloxazine extended-release oral capsules as described in their ANDA filing (Compl. ¶12).

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

  • Issued: May 10, 2022

Technology Synopsis

This patent is directed to a method of treating ADHD. It is based on the discovery that viloxazine exhibits antagonist activity at the 5-HT1B and/or 5-HT7 serotonin receptors, in addition to its known noradrenergic reuptake inhibition (’753 Patent, col. 2:20-33, col. 2:56-62). The patent claims methods of treating ADHD by administering a pharmaceutical agent with this combined activity profile.

Asserted Claims

The complaint asserts infringement of "one or more claims" (Compl. ¶132).

Accused Features

Infringement is alleged based on Defendants' intent to market their generic product for the treatment of ADHD, with a label that will instruct this use (Compl. ¶¶142-143).

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

  • Issued: October 4, 2022

Technology Synopsis

This patent is part of the same family as the '753 patent and covers methods of treating ADHD by administering viloxazine. The invention is predicated on the discovery of viloxazine’s specific antagonist activity at certain serotonin receptors, which contributes to its efficacy in treating ADHD (’143 Patent, col. 2:20-33, col. 2:56-62).

Asserted Claims

The complaint asserts infringement of "one or more claims" (Compl. ¶154).

Accused Features

The accused activity is the future marketing of Defendants' generic product with labeling that will induce physicians and patients to use it for treating ADHD (Compl. ¶¶164-165).

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

  • Issued: October 22, 2024

Technology Synopsis

This patent, also in the family of the '753 patent, claims methods of treating ADHD and related disorders by administering viloxazine. The invention is based on viloxazine's newly discovered multi-modal mechanism of action, including its antagonist activity at 5-HT1B and/or 5-HT7 receptors (’523 Patent, col. 2:20-33, col. 2:56-62).

Asserted Claims

The complaint asserts infringement of "one or more claims" (Compl. ¶176).

Accused Features

Infringement allegations are based on Defendants' ANDA filing and proposed labeling, which will direct the use of the generic product for treating ADHD (Compl. ¶¶186-187).

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 filed Abbreviated New Drug Application (ANDA) No. 220487 with the U.S. Food and Drug Administration (FDA) (Compl. ¶12).

Functionality and Market Context

The complaint alleges that the Defendants' ANDA Products are generic versions of Plaintiff's Qelbree® extended-release capsules and are bioequivalent to that product (Compl. ¶¶50, 52). The proposed prescribing information allegedly states that the products are "indicated for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older" (Compl. ¶55). The proposed label also allegedly recommends specific dosing regimens for different patient age groups, mirroring the label for Qelbree® (Compl. ¶56).

IV. Analysis of Infringement Allegations

The complaint does not assert infringement of any specific claims from the patents-in-suit, nor does it provide a claim chart or detailed element-by-element infringement analysis. Instead, it advances infringement theories based on the statutory framework governing generic drug approvals.

For the formulation patents ('204, '853, '338), the primary allegation is that the very act of submitting the ANDA to the FDA seeking approval to manufacture and sell the generic products before the patents' expiration constitutes an act of infringement under 35 U.S.C. § 271(e)(2)(A) (Compl. ¶¶70, 92, 114). The complaint alleges that upon approval, the commercial manufacture, use, and sale of the Defendants' ANDA Products would directly infringe one or more claims of these patents (Compl. ¶¶72, 94, 116).

For the method of treatment patents ('753, '143, '523), the infringement theory is based on induced infringement under 35 U.S.C. § 271(b). The complaint alleges that Defendants' proposed product labeling will instruct and encourage physicians and patients to administer the generic capsules for the treatment of ADHD, thereby inducing infringement of the patented methods (Compl. ¶¶143, 165, 187). The complaint states that the proposed labeling "substantially copies the labeling for Qelbree®" and contains sections on "Indication and Usage" and "Dosage and Administration" that will direct infringing use (Compl. ¶¶74, 96, 118, 140, 162, 184).

No probative visual evidence provided in complaint.

V. Key Claim Terms for Construction

The complaint does not assert specific claims or provide infringement contentions that highlight particular claim terms for construction. Analysis of key terms is not possible based on the provided document.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement. Induced infringement is alleged for all patents based on Defendants' knowledge of the patents and their intent for third parties (e.g., doctors, patients) to infringe by following the instructions on the proposed product label (Compl. ¶¶77, 99, 121, 143, 165, 187). Contributory infringement is alleged for the formulation patents on the basis that Defendants' ANDA Products constitute a material part of the patented formulations and are not staple articles of commerce suitable for substantial noninfringing uses (Compl. ¶¶79, 101, 123). For the method patents, contributory infringement is similarly alleged on the basis that the products are a material part of the claimed methods (Compl. ¶¶145, 167, 189).
  • Willful Infringement: The complaint alleges that Defendants have acted with full knowledge of the patents-in-suit, as evidenced by their filing of a Paragraph IV certification with the FDA that specifically references each patent (Compl. ¶¶80, 102, 124, 146, 168, 190). It is alleged that Defendants acted "without a reasonable basis for believing that [they] would not be liable for infringement," thereby supporting a claim for willful infringement (Compl. ¶80).

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

This action, initiated under the Hatch-Waxman Act, is at a very early stage. The complaint serves primarily to meet the statutory deadline for filing suit following receipt of a Paragraph IV notice. The central legal and factual questions that will define the litigation will emerge after the Defendants answer and provide their detailed invalidity and non-infringement contentions. Based on the complaint, the case will likely turn on the following core issues:

  • Claim Scope and Formulation: For the formulation patents ('204, '853, '338), a primary issue will be one of technical scope: does the specific composition of Defendants' proposed generic product—including its active ingredient, excipients, and release-controlling mechanisms as detailed in the confidential ANDA—fall within the scope of the asserted patent claims?
  • Infringement by Label: For the method of treatment patents ('753, '143, '523), the case will present a question of induced infringement: does the language of Defendants' proposed product label actively instruct or encourage physicians and patients to administer the generic drug in a manner that practices all steps of the patented methods for treating ADHD?
  • Patent Validity: A central defense in ANDA litigation is the assertion that the patents-in-suit are invalid. A key question for the court will be whether Defendants can prove by clear and convincing evidence that the asserted claims are invalid as anticipated, obvious, or otherwise failing to meet the requirements for patentability.