DCT
2:25-cv-13204
Supernus Pharma Inc v. MSN Pharma Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Supernus Pharmaceuticals, Inc. (Delaware)
- Defendant: MSN Pharmaceuticals Inc. (Delaware)
- Plaintiff’s Counsel: Saul Ewing LLP; Haug Partners LLP
- Case Identification: 2:25-cv-13204, D.N.J., 07/11/2025
- Venue Allegations: Plaintiff alleges venue is proper in the District of New Jersey because Defendant maintains its principal place of business in Piscataway, New Jersey, operates a 225,000 square foot facility there, and has purposefully availed itself of the district by placing goods into the stream of commerce.
- Core Dispute: Plaintiff alleges that Defendant's submission of an Abbreviated New Drug Application (ANDA) to the FDA seeking to market generic viloxazine extended-release capsules constitutes an act of infringement of six patents related to formulations of viloxazine and its use in treating Attention Deficit/Hyperactivity Disorder (ADHD).
- Technical Context: The technology concerns extended-release pharmaceutical formulations designed to provide once or twice-daily dosing for viloxazine, a norepinephrine reuptake inhibitor used to treat ADHD, thereby improving patient compliance and managing therapeutic effect.
- Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendant's Paragraph IV certification notice letter, which signaled its intent to market a generic version of Plaintiff's Qelbree® product before the expiration of the patents-in-suit. The complaint notes that Defendant has consented to jurisdiction in New Jersey in prior, unrelated actions and that Supernus is engaged in parallel litigation against other generic manufacturers over the same drug product and patents.
Case Timeline
| Date | Event |
|---|---|
| 2008-09-05 | Priority Date for ’753, ’143, ’523 Patents |
| 2012-02-08 | Priority Date for ’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 |
| 2025-06-05 | Defendant sends Paragraph IV Notice Letter |
| 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’s background section notes that viloxazine presents challenges for developing an extended-release formulation due to its potentially high therapeutic dose, weakly basic nature, and relatively high in vivo clearance rate in humans, which would typically necessitate frequent dosing (U.S. Patent No. 9,358,204, col. 1:41-47).
- The Patented Solution: The invention is a modified-release formulation of viloxazine that combines different release profiles, such as an immediate-release (IR) component with an extended-release (XR) component, to achieve a therapeutic effect over a longer period. This approach allows for less frequent administration and can support high drug loads, with viloxazine comprising 25% to 75% of the formulation by weight (’204 Patent, col. 2:1-8).
- Technical Importance: This formulation technology enables a drug with a short physiological half-life to be administered once or twice daily, which can improve patient adherence to the treatment regimen (Compl. ¶¶ 56, 61).
Key Claims at a Glance
- The complaint asserts infringement of one or more claims without specifying which ones (Compl. ¶57). Independent claim 1 is representative of the formulation claims and requires:
- An immediate release (IR) component comprising an inert core and a layer of viloxazine surrounding the core.
- An extended release (XR) component comprising an inert core, a first layer of viloxazine, and a second layer with a release rate controlling compound and a pore former.
- The total formulation comprises 25% (w/w) to 75% (w/w) viloxazine.
- The formulation provides immediate and continuous release upon administration, with at least 80% released 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: This patent, a divisional of the application leading to the ’204 Patent, addresses the same challenges of formulating viloxazine for extended release (U.S. Patent No. 9,603,853, col. 1:46-52).
- The Patented Solution: The patent claims a method of treating ADHD or major depressive disorder by administering the specific modified-release formulation described in the ’204 Patent family, which combines immediate and extended-release components to achieve a prolonged therapeutic effect (’853 Patent, Claim 1).
- Technical Importance: By claiming the method of using the specific formulation, the patent provides an additional layer of protection covering the therapeutic application of the novel dosage form (Compl. ¶¶ 79-80).
Key Claims at a Glance
- The complaint asserts infringement of one or more claims without specifying them (Compl. ¶76). Independent claim 1 is a method of treatment claim requiring:
- Administering a formulation to a subject with ADHD or major depressive disorder.
- The formulation comprises the same IR and XR components with the same structural and compositional limitations as recited in claim 1 of the ’204 Patent.
- The complaint does not explicitly reserve the right to assert dependent claims.
U.S. Patent No. 9,662,338 - "Formulations of Viloxazine"
- Patent Identification: 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, claims extended-release pharmaceutical formulations of viloxazine. The technology enables less frequent dosing for a high-dose drug with a short half-life by using multiparticulates with release-controlling coatings (’338 Patent, col. 1:41-47; Claim 1).
- Asserted Claims: The complaint does not specify which claims are asserted (Compl. ¶95).
- Accused Features: Defendant’s generic viloxazine extended-release capsules are accused of infringing the claimed formulations (Compl. ¶96).
U.S. Patent No. 11,324,753 - "Method of Treatment of Attention Deficit/Hyperactivity Disorder (ADHD)"
- Patent Identification: 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 based on the discovery that viloxazine exhibits antagonist activity at specific serotonin receptors (5-HT7 and 5HT1B) in addition to its known noradrenergic reuptake inhibition. The invention claims a method of treating ADHD by administering viloxazine to achieve this dual receptor antagonism (’753 Patent, col. 1:26-33, col. 2:56-62).
- Asserted Claims: The complaint does not specify which claims are asserted (Compl. ¶114).
- Accused Features: The proposed labeling for Defendant’s generic product, which allegedly instructs for its use in treating ADHD, is accused of inducing infringement of the claimed method (Compl. ¶¶ 117-119).
U.S. Patent No. 11,458,143 - "Method of Treatment of Attention Deficit/Hyperactivity Disorder (ADHD)"
- Patent Identification: U.S. Patent No. 11,458,143, “Method of Treatment of Attention Deficit/Hyperactivity Disorder (ADHD),” issued October 4, 2022.
- Technology Synopsis: This patent, related to the ’753 patent, claims a method for treating ADHD by administering a therapeutically effective amount of a viloxazine formulation. The invention leverages viloxazine's combined activity on noradrenergic and serotonergic pathways (’143 Patent, Abstract).
- Asserted Claims: The complaint does not specify which claims are asserted (Compl. ¶133).
- Accused Features: Defendant’s proposed product labeling, which indicates the product for the treatment of ADHD, is accused of inducing infringement (Compl. ¶¶ 136-138).
U.S. Patent No. 12,121,523 - "Method of Treatment of Attention Deficit/Hyperactivity Disorder (ADHD)"
- Patent Identification: U.S. Patent No. 12,121,523, “Method of Treatment of Attention Deficit/Hyperactivity Disorder (ADHD),” issued October 22, 2024.
- Technology Synopsis: This patent, related to the ’753 and ’143 patents, claims a method of treating mood or affective disorders that are co-morbid with ADHD by administering viloxazine. This patent extends the therapeutic application to related psychological conditions (’523 Patent, Claim 15).
- Asserted Claims: The complaint does not specify which claims are asserted (Compl. ¶152).
- Accused Features: Defendant’s proposed product labeling, which indicates the product for ADHD and may include information on co-morbid conditions like anxiety or depression, is accused of inducing infringement (Compl. ¶¶ 49, 155-157).
III. The Accused Instrumentality
Product Identification
The accused instrumentalities are Defendant’s generic viloxazine extended-release capsules in 100 mg, 150 mg, and 200 mg dosage strengths, for which Defendant has filed ANDA No. 220551 with the FDA (Compl. ¶7).
Functionality and Market Context
The complaint alleges that the ANDA Products are bioequivalent to Plaintiff's branded product, Qelbree®, and will be marketed with substantially the same labeling (Compl. ¶¶ 42, 44). The proposed label allegedly indicates the product for the treatment of ADHD in adults and pediatric patients and recommends specific once-daily dosage and administration schedules (Compl. ¶¶ 45-46). The act of infringement is the statutory act of filing the ANDA to obtain approval for commercial manufacture, use, or sale before the expiration of the patents-in-suit (Compl. ¶55).
No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint does not contain a claim chart or plead infringement on an element-by-element basis. The following tables summarize the infringement theory for representative independent claims based on the complaint's narrative allegations.
'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 described as "viloxazine extended-release capsules" that are bioequivalent to Qelbree®, which may imply a formulation designed with multiple release profiles to achieve the overall pharmacokinetic effect. | ¶¶ 7, 41, 42 | col. 2:1-4 |
| 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 this element. | col. 2:5-8 | |
| wherein the viloxazine is released immediately and continuously upon administration | The product's characterization as an extended-release formulation bioequivalent to Qelbree® suggests a release profile that begins promptly and continues over a prolonged period. | ¶¶ 41, 42 | col. 25:65-67 |
'853 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method of treating ADHD... comprising administration to the subject... | Defendant's proposed product labeling allegedly includes an "Indication and Usage" section stating the product is for the "treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older." | ¶45 | col. 1:46-52 |
| a formulation comprising: (a) an immediate release (IR) component... and (b) an extended release (XR) component... | The proposed labeling allegedly contains a "Dosage and Administration" section with instructions for once-daily dosing of the extended-release capsules. This instruction to administer the formulation is alleged to induce infringement. | ¶46 | col. 2:1-4 |
Identified Points of Contention
- Technical Questions: For the formulation patents (’204, ’853, ’338), a central dispute will likely be whether Defendant's ANDA product meets the specific structural limitations of the asserted claims. For example, does the generic formulation contain physically distinct "immediate release" and "extended release" multiparticulates as claimed, or does it achieve an extended-release profile through a different, non-infringing mechanism such as a monolithic matrix tablet? The complaint's allegations are based on bioequivalence, not a direct structural analysis of the ANDA product.
- Scope Questions: For the method-of-use patents related to serotonin receptor activity (’753, ’143, ’523), a key question will be whether Defendant's proposed label induces infringement of claims requiring "antagonizing" specific receptors. The complaint alleges the label will state the mechanism of action is "unclear" but thought to be related to norepinephrine reuptake, while also noting the drug exhibits "partial agonist activity at the serotonin 5-HT2C receptor" (Compl. ¶¶ 47, 48). This raises the question of whether a label describing an unclear mechanism and partial agonist activity at a different receptor can induce infringement of a claim requiring antagonist activity at the specific 5-HT7 and 5HT1B receptors.
V. Key Claim Terms for Construction
"immediate release (IR) component" (from the ’204, ’853, and ’338 Patents)
Context and Importance
The asserted claims in the formulation patent family require a combination of distinct components, including an "IR component." The definition of this term is critical because if Defendant’s formulation achieves its release profile through a single, monolithic system without a structurally separate IR component, it may fall outside the scope of the claims.
Intrinsic Evidence for Interpretation
- Evidence for a Broader Interpretation: The specification defines an "immediate release formulation" functionally as one that releases "greater than or equal to 80% by weight of the active pharmaceutical agent in less than or equal to 1 hour" (’204 Patent, col. 5:21-24). A party could argue that any part of a formulation that meets this functional definition constitutes an "IR component," regardless of its physical structure.
- Evidence for a Narrower Interpretation: Claim 1 of the ’204 patent defines the IR component structurally as "comprising an inert core and a layer comprising viloxazine and, optionally, a pharmaceutically acceptable excipient, surrounding the core" (’204 Patent, col. 25:61-64). This language may support a narrower construction requiring a distinct, multi-layered particle structure, not just a rapid initial release from a blended matrix.
"antagonizing" (from the ’753 Patent)
Context and Importance
Claim 1 of the ’753 patent requires "antagonizing 5-HT7 and 5HT1B receptor activity." The viability of this claim depends on whether the administration of viloxazine, as instructed by Defendant's proposed label, results in this specific pharmacological action. Practitioners may focus on this term because the complaint alleges the label will refer to "partial agonist activity," a distinct pharmacological effect, at a different serotonin receptor (Compl. ¶48).
Intrinsic Evidence for Interpretation
- Evidence for a Broader Interpretation: The complaint does not provide sufficient detail for analysis of a broader interpretation.
- Evidence for a Narrower Interpretation: The patent specification predicates the invention on the "unexpected discovery" that viloxazine "exhibits specific antagonist activity at the 6-HT7 (serotonin 7) and 5HT1B receptors" (’753 Patent, col. 2:58-61). The detailed description includes antagonist functional assays (FIGS. 3 and 6) and distinguishes this from agonist effects (FIGS. 2 and 5), suggesting the patent uses the term "antagonizing" in its specific pharmacological sense, which is contrary to agonist or partial agonist activity.
VI. Other Allegations
Indirect Infringement
The complaint alleges induced infringement for all asserted patents. For the method of treatment patents, it alleges that Defendant’s proposed labeling, which will contain instructions on dosage and administration for ADHD, will knowingly encourage and instruct physicians and patients to perform the steps of the claimed methods (Compl. ¶¶ 119, 138, 157). For the formulation patents, it alleges inducement by distributing the corresponding labeling which will instruct users on how to use the allegedly infringing product (Compl. ¶62).
Willful Infringement
Willfulness is alleged for all six patents based on Defendant’s pre-suit knowledge. The complaint asserts that Defendant knew of the patents-in-suit, as evidenced by its Paragraph IV certification letter that specifically identified each patent, and nonetheless proceeded with acts of infringement by filing its ANDA (Compl. ¶¶ 65, 84, 103, 122, 141, 160).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central technical question will be one of structural equivalence: Does MSN’s generic formulation, despite being bioequivalent to Qelbree®, contain the specific combination of structurally defined "immediate release" and "extended release" multiparticulates required by the asserted formulation claims, or does it achieve its release profile through a non-infringing design?
- A core issue of claim scope and inducement will be dispositive for the method-of-use patents: Can a product label that allegedly describes viloxazine’s mechanism of action as "unclear" and notes "partial agonist activity" at a different serotonin receptor be found to actively encourage infringement of claims that explicitly require "antagonizing" the 5-HT7 and 5HT1B receptors?
- An underlying evidentiary challenge for the Plaintiff will be to prove its infringement allegations, which are currently based on information and belief about the contents of a confidential ANDA filing and a proposed product label, without the benefit of full discovery.