DCT
2:25-cv-12184
Supernus Pharma Inc v. Apotex Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Supernus Pharmaceuticals, Inc. (Delaware)
- Defendant: Apotex Inc. (Canada)
- Plaintiff’s Counsel: Saul Ewing LLP; Haug Partners LLP
- Case Identification: 2:25-cv-12184, D.N.J., 06/26/2025
- Venue Allegations: Plaintiff alleges venue is proper in the District of New Jersey because Defendant places goods into the stream of commerce in the state, derives substantial revenue from New Jersey, and has previously consented to jurisdiction in the district in prior litigation.
- Core Dispute: Plaintiff alleges that Defendant's submission of an Abbreviated New Drug Application (ANDA) to the FDA for generic versions of Plaintiff's Qelbree® extended-release capsules constitutes an act of infringement of six patents covering formulations of the drug viloxazine and methods of its use for 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 drug with a relatively short elimination half-life, for the treatment of ADHD.
- Key Procedural History: This infringement action was initiated under the Hatch-Waxman Act following Defendant's filing of ANDA No. 220456 with a Paragraph IV certification against the patents-in-suit. Plaintiff alleges it received a notice letter from Defendant regarding this certification on or about May 22, 2025.
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 |
| 2025-05-22 | Defendant sends 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 describes viloxazine as a drug with a potentially high therapeutic dose and a relatively high in vivo clearance rate, which presents challenges for developing an extended-release formulation suitable for once- or twice-daily administration (Compl. ¶¶ 55-56; ’204 Patent, col. 1:41-47).
- The Patented Solution: The invention is a modified-release formulation comprising a combination of an immediate-release (IR) component and an extended-release (XR) component. The XR component is described as comprising an inert core, a first layer containing viloxazine, and a second layer with a release rate controlling compound and a pore former, designed to provide therapeutic drug levels for about 8 to 16 hours (’204 Patent, Abstract; col. 10:27-41).
- Technical Importance: This formulation technology enables less frequent dosing of a short-acting drug, which may improve patient compliance and therapeutic outcomes (Compl. ¶¶ 55-56).
Key Claims at a Glance
- The complaint asserts infringement of "one or more claims" without specifying which ones (Compl. ¶ 53). For analytical purposes, independent claim 1 is representative:
- A pharmaceutical formulation comprising:
- an immediate release (IR) component comprising an inert core and a layer comprising viloxazine; and
- an extended release (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 specific weight ratio.
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 challenge of creating a viable extended-release formulation for viloxazine, given its pharmacokinetic properties (’853 Patent, col. 1:41-47).
- The Patented Solution: The patent discloses a multiparticulate, modified-release formulation that also combines IR and XR components. The claims focus on the specific composition of the XR component, which includes a release rate controlling compound (e.g., ethylcellulose) and a pore former (e.g., povidone or hypromellose) at particular weight ratios to achieve a desired release profile over at least two hours (’853 Patent, Abstract; col. 26:1-32).
- Technical Importance: This technology provides a specific method for tuning the drug release rate from multiparticulates, allowing for tailored pharmacokinetic profiles suitable for once- or twice-daily dosing (Compl. ¶¶ 74-75).
Key Claims at a Glance
- The complaint asserts infringement of "one or more claims" without specification (Compl. ¶ 72). For analytical purposes, independent claim 1 is representative:
- A pharmaceutical formulation, comprising:
- an extended release (XR) component comprising an inert core, a viloxazine layer, and a second layer comprising a release rate controlling compound and a pore former;
- wherein the formulation comprises 25% to 75% (w/w) viloxazine; and
- at least 80% of the viloxazine is released over a period of at least 2 hours in vitro.
U.S. Patent No. 9,662,338 - "Formulations of Viloxazine"
- Issued: May 30, 2017
- Technology Synopsis: This patent, part of the same family as the ’204 and ’853 patents, also claims modified-release formulations of viloxazine. It is directed to compositions that combine IR and XR components to achieve specific pharmacokinetic profiles, such as a maximum plasma concentration (Cmax) and area under the curve (AUC) that are comparable to multiple daily doses of an immediate-release version (’338 Patent, col. 27:6-28:17).
- Asserted Claims: One or more claims are asserted (Compl. ¶ 91).
- Accused Features: The composition, release profile, and pharmacokinetic properties of Apotex's ANDA Products are alleged to infringe (Compl. ¶¶ 91, 98).
U.S. Patent No. 11,324,753 - "Method of Treatment of Attention Deficit/Hyperactivity Disorder (ADHD)"
- Issued: May 10, 2022
- Technology Synopsis: This patent claims a method of treating ADHD by administering viloxazine. The invention is based on the discovery that viloxazine antagonizes both 5-HT7 and 5HT1B serotonin receptors, in addition to its known activity as a norepinephrine reuptake inhibitor (’753 Patent, Abstract; col. 1:27-32, col. 8:13-18).
- Asserted Claims: One or more claims are asserted (Compl. ¶ 110).
- Accused Features: Apotex's ANDA product is accused of infringing because its proposed label allegedly instructs for the administration of viloxazine to treat ADHD, thereby inducing performance of the patented method (Compl. ¶¶ 113, 115).
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 of treating ADHD by administering viloxazine. The claims focus on the administration of a formulation providing a specific therapeutic effect for treating ADHD (’143 Patent, Abstract, claim 1).
- Asserted Claims: The complaint alleges infringement of claims 1-5 and 7 (Compl. ¶ 24), though the infringement count itself refers more generally to "one or more claims" (Compl. ¶ 129).
- Accused Features: The proposed labeling for Apotex's ANDA Products, which allegedly directs use for ADHD, is the basis for the infringement allegation (Compl. ¶¶ 132, 134).
U.S. Patent No. 12,121,523 - "Method of Treatment of Attention Deficit/Hyperactivity Disorder (ADHD)"
- Issued: October 22, 2024
- Technology Synopsis: This patent is also part of the method-of-treatment family. It claims methods for treating mood or affective disorders that are co-morbid with ADHD by administering a viloxazine formulation (’523 Patent, claim 15).
- Asserted Claims: One or more claims are asserted (Compl. ¶ 148).
- Accused Features: Infringement is alleged based on the proposed labeling for Apotex's ANDA Products, which allegedly instructs users to take the drug for its approved indications, thereby inducing infringement of the claimed methods (Compl. ¶¶ 151, 153).
III. The Accused Instrumentality
- Product Identification: Defendant Apotex's viloxazine extended-release capsules, in 100 mg, 150 mg, and 200 mg dosage strengths, for which Apotex filed ANDA No. 220456 (the "ANDA Products") (Compl. ¶¶ 3, 37).
- Functionality and Market Context:
- The complaint alleges that the ANDA Products are generic versions of Plaintiff's Qelbree® product and have been represented to the FDA as bioequivalent (Compl. ¶¶ 36, 38).
- The proposed prescribing information for the ANDA Products allegedly includes an indication for the "treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older" (Compl. ¶ 41).
- The complaint further alleges that the proposed label for the ANDA Products recommends dosages and administration schedules that are the same as those for Qelbree®, and that the label will substantially copy the Qelbree® label (Compl. ¶¶ 42, 55).
- No probative visual evidence provided in complaint.
IV. Analysis of Infringement 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 comprising an inert core and a layer comprising viloxazine... and (b) an extended release (XR) component... | Apotex's ANDA Products are alleged to be extended-release capsule formulations containing viloxazine that are bioequivalent to Qelbree® and necessarily contain both IR and XR components to achieve the required therapeutic profile. | ¶¶ 37, 38, 53 | col. 10:27-41 |
| the (XR) component comprising: (i) an inert core, (ii) a first layer comprising viloxazine... surrounding the core, and (iii) a second layer comprising a release rate controlling compound... surrounding the first layer | The ANDA Products allegedly replicate the structure and function of Qelbree®, which is covered by the patent, thereby incorporating a multi-layer XR component to control drug release. | ¶¶ 38, 53, 55 | col. 7:5-12 |
| a pore former in a weight ratio of from 19:1 to 8.5:1.5, respectively, surrounding the first layer | As a bioequivalent generic, Apotex's ANDA Products are alleged to contain the necessary excipients, including a pore former, in the claimed ratios to achieve the same extended-release profile as the branded drug. | ¶¶ 38, 53, 60 | col. 10:35-41 |
'853 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A pharmaceutical formulation, comprising... an extended release (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... | Apotex's ANDA Products are alleged to be extended-release capsule formulations that are bioequivalent to Qelbree® and therefore contain an XR component with the claimed layered structure. | ¶¶ 37, 38, 72 | col. 26:1-12 |
| wherein the formulation comprises, as a percentage of the total formulation, from 25% (w/w) to 75% (w/w) viloxazine | The ANDA Products are alleged to be high-drug-load formulations that meet this weight percentage limitation, consistent with the formulation of the reference listed drug, Qelbree®. | ¶¶ 37, 72 | col. 2:5-8 |
| 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 | The ANDA Products, in order to be bioequivalent to Qelbree®, must allegedly exhibit an in vitro dissolution profile that meets this extended-release criterion. | ¶¶ 38, 72 | col. 5:35-40 |
- Identified Points of Contention:
- Scope Questions: A central question will be whether the specific excipients, polymers, and manufacturing methods used in Apotex's ANDA Products fall within the literal scope of claim terms such as "release rate controlling compound" and "pore former." Given that the ANDA itself has not yet been produced to the Plaintiff, the precise nature of Apotex's formulation remains a point of discovery (Compl. ¶ 15).
- Technical Questions: For the method of treatment patents (e.g., the ’753 Patent), a potential issue is whether the administration of Apotex's product according to its proposed label inherently results in the functional outcome required by the claims, such as "antagonizing 5-HT7 and 5HT1B receptor activity." Defendant may argue that this functional result is not a guaranteed outcome of administration or may challenge the validity of such a functional claim limitation.
V. Key Claim Terms for Construction
The Term: "release rate controlling compound" (appearing in claims of the ’204 and ’853 patents)
Context and Importance: The definition of this term is central to the scope of the formulation patents. Defendant's primary non-infringement defense will likely be that the specific polymer or substance it uses to control drug release in its ANDA Product is not a "release rate controlling compound" as that term is used and defined in the patents.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specifications provide a list of suitable compounds, including both hydrophilic and hydrophobic examples, and use open-ended language such as "may be selected from" and "combinations thereof," which may support a broad, functional definition covering any compound that performs the stated function of controlling the release rate (’204 Patent, col. 6:15-52).
- Evidence for a Narrower Interpretation: The specifications provide specific examples and embodiments that use particular compounds (e.g., ethylcellulose). A defendant may argue that the term should be limited to the classes of compounds or specific examples disclosed, particularly if the prosecution history contains any disclaimers related to other types of polymers (’204 Patent, col. 16:32-44).
The Term: "antagonizing 5-HT7 and 5HT1B receptor activity" (appearing in claim 1 of the ’753 patent)
Context and Importance: This is a functional limitation that defines the patented method of treatment. Practitioners may focus on this term because infringement depends on whether the administration of the accused product necessarily performs this specific biological function. The dispute could center on what level of receptor antagonism is required to meet the claim limitation.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent describes the "unexpected discovery that viloxazine may be effective in the treatment of ADHD" and links this to its antagonist activity at these receptors, suggesting that administering an effective dose of viloxazine for ADHD inherently involves this mechanism (’753 Patent, col. 1:27-32).
- Evidence for a Narrower Interpretation: The detailed description provides specific in vitro assay results for viloxazine's antagonist activity. A defendant could argue that the term requires a specific, quantifiable level of antagonism as demonstrated in those assays, and that the administration of its generic product does not necessarily achieve that level in a patient (’753 Patent, col. 3:30-col. 5:12).
VI. Other Allegations
- Indirect Infringement: The complaint alleges both induced and contributory infringement for all asserted patents. The factual basis is the allegation that Apotex's proposed product labeling will instruct physicians to prescribe and patients to use the ANDA Products for the patented indication of treating ADHD, which will directly infringe the method claims and encourage the use of the infringing formulations (Compl. ¶¶ 58, 77, 96, 115, 134, 153). The complaint also alleges the ANDA Products are not staple articles of commerce suitable for substantial noninfringing uses (Compl. ¶ 60).
- Willful Infringement: Willfulness is alleged for all patents based on Defendant’s pre-suit knowledge. The complaint asserts that Defendant knew of the patents-in-suit, as evidenced by its filing of a Paragraph IV certification that specifically identified each patent, yet continued to pursue its infringing ANDA (Compl. ¶¶ 61, 80, 99, 118, 137, 156).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of technical and compositional equivalence: As the details of Apotex's formulation are not yet public, the case will likely turn on whether the specific combination of excipients, polymers, and structural design used in its ANDA product falls within the literal scope of the asserted formulation claims in the '204, '853, and '338 patents, or if Plaintiff must rely on the doctrine of equivalents.
- A second key question will be one of induced infringement for the method claims: The dispute will likely focus on whether Apotex’s proposed label, by instructing the use of its product for treating ADHD, actively encourages medical professionals and patients to perform the steps of the patented methods, including the functional outcome of antagonizing specific serotonin receptors as claimed in the '753 patent family.