DCT

1:26-cv-01160

Tris Pharma Inc v. Granules Pharma Inc

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Complaint
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I. Executive Summary and Procedural Information

  • Parties & Counsel:

  • Case Identification: 1:26-cv-01160, D. Del., 09/15/2026

  • Venue Allegations: Venue is alleged to be proper based on the Defendant being a Delaware corporation and therefore subject to personal jurisdiction in the district.

  • Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff's DYANAVEL® XR extended-release tablets constitutes an act of infringement of a patent covering the drug’s formulation.

  • Technical Context: The technology relates to extended-release oral amphetamine formulations used for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD).

  • Key Procedural History: This is a patent infringement action filed under the Hatch-Waxman Act. The complaint notes that the patent-in-suit issued after the Defendant’s ANDA was filed, but asserts that this does not preclude infringement liability. The complaint also references other pending patent litigation between the parties involving the same ANDA.

Case Timeline

Date Event
2017-09-24 '132 Patent Priority Date
2025-03-11 Defendant's "Notice Letter" regarding ANDA filing
2026-09-15 '132 Patent Issue Date
2026-09-15 Complaint Filing Date

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

U.S. Patent No. 12,734,132 - "Extended release amphetamine tablets"

  • Patent Identification: U.S. Patent No. 12,734,132, issued September 15, 2026.

The Invention Explained

  • Problem Addressed: The patent background describes the need for an amphetamine formulation that provides both a rapid onset of therapeutic effect and an extended duration of action to allow for once-daily dosing, which is particularly beneficial for treating ADHD Compl., Exhibit A, ’132 Patent, col. 1:17-19 Compl., Exhibit A, ’132 Patent, col. 3:28-34 The patent also notes issues with existing formulations, such as the "binge and crash" cycle and the potential for "dose dumping" when taken with ethanol Compl., Exhibit A, ’132 Patent, col. 1:52-54 Compl., Exhibit A, ’132 Patent, col. 2:59-62
  • The Patented Solution: The invention is an oral solid dose formulation, such as a chewable tablet, that combines three distinct amphetamine components to achieve a specific release profile: (1) an uncomplexed amphetamine for fast onset; (2) an uncoated amphetamine-cation exchange resin complex for a second, slightly slower immediate release; and (3) a barrier-coated amphetamine-cation exchange resin complex for modified, extended release Compl., Exhibit A, ’132 Patent, abstract Compl., Exhibit A, ’132 Patent, col. 3:44-col. 4:35 This combination is designed to achieve a therapeutic effect by about one hour that lasts for at least thirteen hours, and to be chewable without disrupting the extended-release mechanism Compl., Exhibit A, ’132 Patent, abstract Compl., Exhibit A, ’132 Patent, col. 3:34-43
  • Technical Importance: This technology offers a single, once-daily dosage form with both immediate and long-lasting effects, which can improve patient compliance, particularly for pediatric and geriatric patients who may have difficulty swallowing pills Compl., Exhibit A, ’132 Patent, col. 3:28-34

Key Claims at a Glance

  • The complaint alleges infringement of "one or more claims" without specifying particular claims Compl. ¶27 Independent claim 1 is representative of the asserted technology.
  • Essential elements of independent claim 1 include:
    • A method for treating attention deficit hyperactivity disorder in a subject not younger than 6 years of age.
    • Comprising providing to the subject a dose of one or more oral amphetamine solid dosage forms once daily in the morning.
    • Wherein each solid dosage form comprises: (A) amphetamine complexed with a cation exchange resin in a 3.2 to 1 ratio of d- to l-amphetamine; (B) amphetamine aspartate; and (C) dextroamphetamine sulfate.
    • Wherein the dosage forms comprise about 60% w/w to about 80% w/w immediate release amphetamines and about 20% w/w to 40% w/w modified release amphetamines.
    • Wherein the friability of the dosage form is less than about 1%.
  • The complaint does not explicitly reserve the right to assert dependent claims but makes a general allegation against "one or more claims" Compl. ¶27

III. The Accused Instrumentality

Product Identification

The accused instrumentality is Defendant Granules’ proposed generic versions of DYANAVEL® XR (amphetamine) in 5 mg, 10 mg, 15 mg, and 20 mg extended-release tablets, which are the subject of ANDA No. 220284 (the "Proposed ANDA Product") Compl. ¶1

Functionality and Market Context

  • The complaint alleges that the Proposed ANDA Product uses an extended-release formulation and that its ANDA filing contains data demonstrating bioequivalence to Plaintiff's DYANAVEL® XR tablets Compl. ¶22 Compl. ¶23
  • The complaint asserts that the Proposed ANDA Product is intended for the same therapeutic use as DYANAVEL® XR, which is the treatment of ADHD Compl. ¶16 Compl. ¶24 As a generic equivalent, the product is positioned to compete directly with Plaintiff’s branded product upon receiving final FDA approval Compl. ¶5

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not provide a claim chart or specific factual allegations mapping elements of the Proposed ANDA Product to the patent's claim limitations. The infringement allegation is a statutory one under 35 U.S.C. § 271(e)(2)(A), where the filing of an ANDA for a drug claimed in a patent is an act of infringement Compl. ¶20 Compl. ¶28 The substantive theory is that because the Proposed ANDA Product is intended to be a bioequivalent generic version of DYANAVEL® XR—a product Plaintiff asserts is covered by the '132 Patent—the Proposed ANDA Product will necessarily contain the claimed formulation Compl. ¶18 Compl. ¶22 Compl. ¶23 The complaint alleges infringement either literally or under the doctrine of equivalents Compl. ¶27 Due to the lack of specific infringement contentions, a detailed claim chart analysis is not possible based on the complaint alone.

V. Key Claim Terms for Construction

  • The Term: "complexed with a cation exchange resin"

  • Context and Importance: This term is fundamental to the invention's release mechanism. The claims require specific components to be "complexed" to achieve the desired dual immediate and modified release profiles. The nature of this complexation will be a critical point in the infringement analysis, as any material difference in the Defendant’s binding method or the resulting chemical structure could support a non-infringement argument. Practitioners may focus on this term because the distinction between a simple mixture and a true "complex" can be a dispositive technical issue.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification discusses the complexation process broadly as an "exchange" in an "aqueous medium" between the drug salt and the resin Compl., Exhibit A, ’132 Patent, col. 9:60-col. 10:4 This general description could support an interpretation covering a wide range of binding interactions between an amphetamine and a resin.
    • Evidence for a Narrower Interpretation: The patent provides specific examples of cation exchange resins, such as "Amberlite® IRP69," a "sulfonated copolymer of styrene and divinylbenzene" Compl., Exhibit A, ’132 Patent, col. 13:10-13 A party could argue that the term should be construed more narrowly to reflect the specific types of resins and complexation conditions disclosed in the embodiments, rather than any generic association.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement, stating that the Defendant's proposed product label "will instruct healthcare providers to prescribe its Proposed ANDA Product" in an infringing manner Compl. ¶24 Compl. ¶29 It also makes a general allegation of contributory infringement Compl. ¶30

  • Willful Infringement: The complaint does not contain an explicit allegation of willful infringement. It does, however, request a declaration that the case is "exceptional" under 35 U.S.C. § 285 Compl., prayer e The complaint notes that the patent-in-suit issued on the same day the complaint was filed, suggesting that any basis for enhanced damages would likely arise from post-suit conduct Compl. p. 1 Compl. ¶15

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

  1. Evidentiary Proof of Infringement: The central question will be whether discovery reveals that the formulation detailed in Granules' confidential ANDA submission falls within the scope of the '132 Patent's claims. The case will likely depend on a technical comparison of the proposed generic product’s composition—including its specific components, ratios, and release mechanisms—against the limitations of the asserted claims.

  2. Claim Construction and Scope: A key legal battle will likely focus on the definition of claim terms, such as the required characteristics of the "amphetamine... complexed with a cation exchange resin" and the precise boundaries of the "immediate release" and "modified release" components, which are defined by specific weight percentages in the claims. The court's interpretation of these terms may be determinative of infringement.

  3. Timing of the Patent Grant: The patent-in-suit issued on the same day the lawsuit was filed and after the Defendant's ANDA submission Compl. p. 1 Compl. ¶19-20 While the complaint correctly cites precedent that this does not bar an infringement action, the unique timing may raise procedural questions regarding pre-suit notice and the basis for any potential damages or willfulness claims.