DCT
1:25-cv-00498
Tris Pharma Inc v. Granules Pharma Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Tris Pharma, Inc. (New Jersey)
- Defendant: Granules Pharmaceuticals, Inc. (Delaware)
- Plaintiff’s Counsel: McCarter & English, LLP
- Case Identification: 1:25-cv-00498, D. Del., 04/24/2025
- Venue Allegations: Venue is asserted on the basis that Defendant is a Delaware corporation and is therefore subject to personal jurisdiction in the District of Delaware.
- 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 lawsuit concerns extended-release oral drug delivery technology within the significant market for Attention-Deficit/Hyperactivity Disorder (ADHD) therapeutics.
- Key Procedural History: This action arises under the Hatch-Waxman Act, triggered by Defendant’s filing of ANDA No. 220284 with a Paragraph IV certification. This certification asserts that U.S. Patent No. 11,590,081 is invalid, unenforceable, and/or will not be infringed by Defendant’s proposed generic product. The complaint was filed within the 45-day statutory window following receipt of Defendant’s March 11, 2025 notice letter, triggering a potential 30-month stay of FDA approval for the generic. The complaint also notes a pre-suit dispute regarding Plaintiff's access to Defendant's confidential ANDA information.
Case Timeline
| Date | Event |
|---|---|
| 2017-09-24 | ’081 Patent Priority Date |
| 2023-02-28 | ’081 Patent Issue Date |
| 2025-03-11 | Defendant sends Paragraph IV Notice Letter |
| 2025-04-24 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 11,590,081 - "Extended Release Amphetamine Tablets," issued February 28, 2023 (’081 Patent)
- The Invention Explained:
- Problem Addressed: The patent describes a need for an amphetamine-based ADHD treatment that offers both a rapid onset of therapeutic effect and a long duration of action, thereby avoiding the "rebound effects" associated with some long-acting medications. It also identifies a need for a dosage form that is easy to administer for patients who have difficulty swallowing pills, such as pediatric and geriatric populations (’081 Patent, col. 3:6-10, col. 2:58-62).
- The Patented Solution: The invention is a solid oral dosage form, such as a chewable tablet, that combines three distinct amphetamine-containing components to achieve a specific pharmacokinetic profile from a single dose. These components are: (1) an uncomplexed amphetamine for fast, immediate release; (2) an uncoated amphetamine complexed with a cation exchange resin for a second, slightly slower immediate release; and (3) a barrier-coated amphetamine-cation exchange resin complex that provides modified, extended release. This tri-component system is designed to provide a therapeutic effect for at least 13 hours after a single administration (’081 Patent, Abstract; col. 3:11-34).
- Technical Importance: The formulation aims to improve both therapeutic outcomes and patient compliance by combining a rapid-onset, long-duration pharmacokinetic profile into a single, patient-friendly (chewable) daily dose (’081 Patent, col. 3:25-34).
- Key Claims at a Glance:
- The complaint asserts infringement of one or more claims of the ’081 Patent, with Independent Claim 1 being representative.
- Essential elements of Independent Claim 1 include:
- An extended release amphetamine tablet that provides a single plasma concentration peak and lacks a pH-dependent delayed-release coating.
- (A) A modified release component comprising a barrier-coated amphetamine-cation exchange resin complex.
- (B) Immediate release components comprising over 70% of the total amphetamine, which are further divided into:
- (i) A first immediate release component of uncomplexed amphetamine.
- (ii) A second immediate release component of an uncoated amphetamine-cation exchange resin complex.
- The complaint reserves the right to assert additional claims, including dependent claims (Compl. ¶31).
III. The Accused Instrumentality
- Product Identification: Defendant’s "Proposed ANDA Product," identified as a generic version of DYANAVEL® XR (amphetamine) extended-release tablets in 5 mg, 10 mg, 15 mg, and 20 mg strengths (Compl. ¶1).
- Functionality and Market Context: The complaint alleges that the Proposed ANDA Product is a generic drug for which Defendant is seeking FDA approval by relying on the safety and efficacy data of Plaintiff's branded DYANAVEL® XR (Compl. ¶1, ¶22). As part of its ANDA, Defendant must demonstrate that its product is bioequivalent to the branded drug, meaning it is expected to have the same therapeutic effect (Compl. ¶22). The product is intended to compete directly with DYANAVEL® XR in the ADHD market upon receiving regulatory approval (Compl. ¶5, ¶6).
IV. Analysis of Infringement Allegations
No probative visual evidence provided in complaint.
The complaint does not contain a detailed claim chart. The infringement theory is predicated on the allegation that for Defendant’s Proposed ANDA Product to be bioequivalent to Plaintiff's DYANAVEL® XR, it must necessarily use the formulation claimed in the ’081 Patent, which is listed in the FDA's Orange Book for that drug (Compl. ¶18, ¶21, ¶22).
’081 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| An extended release amphetamine tablet... [that] provides a single plasma concentration peak for d-amphetamine and for l-amphetamine... | The complaint alleges that the Proposed ANDA Product is an extended-release amphetamine tablet that, by virtue of being bioequivalent to DYANAVEL® XR, will produce a corresponding single plasma concentration peak. | ¶21, ¶22 | col. 3:42-44 |
| (A) a modified release amphetamine component which comprises at least one modified release barrier coated amphetamine-cation exchange resin complex... | To achieve the extended-release profile required for bioequivalence, the Proposed ANDA Product is alleged to contain a modified release component that corresponds to the claimed barrier-coated drug-resin complex. | ¶21, ¶31 | col. 17:47-53 |
| (B) immediate release amphetamine components which comprise greater than 70% w/w of the total amphetamines... | To match the rapid onset of the branded drug, the Proposed ANDA Product is alleged to contain immediate release components that meet this quantitative threshold. | ¶21, ¶31 | col. 3:44-46 |
| (i) a first immediate release amphetamine component which comprises d-amphetamine or a pharmaceutically acceptable salt thereof... | The complaint's bioequivalence theory implies the Proposed ANDA Product contains a component corresponding to the claimed uncomplexed "fast onset" amphetamine to match the initial phase of the branded drug's PK profile. | ¶21, ¶31 | col. 5:17-29 |
| (ii) a second immediate release component which comprises an amphetamine cation exchange resin complex... | The complaint's theory implies the Proposed ANDA Product also contains a component corresponding to the claimed uncoated drug-resin complex to match the subsequent phase of the branded drug's immediate-release profile. | ¶21, ¶31 | col. 5:30-50 |
- Identified Points of Contention:
- Scope Questions: The central dispute may concern whether achieving bioequivalence necessarily requires use of the claimed invention. This raises the question: can the defendant's product achieve the same pharmacokinetic result through a different, non-infringing formulation, or is the specific three-part structure of Claim 1 essential to replicating the branded drug's performance?
- Technical Questions: The case will depend on the actual, undisclosed formulation of the Proposed ANDA Product. A key technical question for discovery is: does the defendant’s ANDA product actually contain three distinct components—a barrier-coated modified release complex, an uncomplexed immediate release drug, and an uncoated immediate release drug-resin complex—as mandated by the claim structure?
V. Key Claim Terms for Construction
The Term: "immediate release amphetamine components which comprise... (i) a first... component... and (ii) a second... component"
- Context and Importance: This limitation requires the presence of two structurally distinct immediate-release components: an uncomplexed drug and a drug-ion exchange resin complex. Infringement requires the accused product to possess both. Practitioners may focus on this term because a defendant could argue its product achieves a similar release profile using only a single type of immediate release component, or a different combination of components, thereby designing around this specific claim language.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party might argue that any formulation resulting in two distinct phases of immediate release meets this limitation, regardless of the precise physical forms of the components.
- Evidence for a Narrower Interpretation: The claim language explicitly separates the "first" and "second" components and defines their structures differently (one as uncomplexed, the other as a resin complex) (’081 Patent, Claim 1). The specification reinforces this distinction by describing the "faster onset immediate release uncomplexed amphetamine" and the "slower onset immediate release uncoated amphetamine-cation exchange resin complex" as separate elements of the formulation (’081 Patent, col. 8:17-24, col. 8:55-64).
The Term: "a modified release barrier coated amphetamine-cation exchange resin complex"
- Context and Importance: The definition of this term is critical for determining the scope of the extended-release element. A defendant may argue that its extended-release technology (e.g., a hydrophilic matrix system) is different from the claimed "barrier coated" particle system.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification discusses a variety of potential barrier coating materials, including polyvinylacetate, ethylcellulose, and acrylic polymers, suggesting the term is not limited to a single type of coating (’081 Patent, col. 17:47-21:12).
- Evidence for a Narrower Interpretation: The patent consistently describes the modified release mechanism as a distinct "barrier coat" applied over a drug-resin complex, often in an optional matrix (’081 Patent, col. 3:49-54, Abstract). This could support an interpretation that limits the claim to coated particle technologies and excludes other monolithic extended-release systems.
VI. Other Allegations
- Indirect Infringement: The complaint alleges inducement of infringement, stating that Defendant’s proposed product label will instruct healthcare providers and patients to administer the drug in a manner that directly infringes the ’081 Patent (Compl. ¶23, ¶34). It alleges the requisite intent is established by Defendant's knowledge of the patent at the time of its ANDA submission (Compl. ¶35).
- Willful Infringement: While the complaint does not use the term "willful," it alleges that Defendant had knowledge of the ’081 Patent when it filed its ANDA and seeks a declaration that the case is "exceptional" under 35 U.S.C. § 285, which forms the basis for a potential award of attorneys' fees (Compl. ¶20, ¶35, p. 8 ¶(e)).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central evidentiary question will be one of technical composition: Does discovery on Granules's confidential ANDA reveal a formulation that literally embodies the specific three-part structure of Claim 1—a coated modified-release drug-resin complex, an uncomplexed immediate-release drug, and an uncoated immediate-release drug-resin complex—or does it utilize a different technology?
- The case may also turn on a question of infringement by equivalence: If the ANDA product does not literally infringe, can Tris prove that achieving bioequivalence to its DYANAVEL® XR product is impossible without using a formulation that is legally equivalent to the one claimed in the ’081 patent, or will Granules succeed in arguing it has "designed around" the patent?