DCT
2:20-cv-05212
Tris Pharma Inc v. Teva Pharma USA Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Tris Pharma, Inc. (New Jersey)
- Defendant: Teva Pharmaceuticals USA, Inc. (Delaware)
- Plaintiff’s Counsel: McCarter & English, LLP; Milbank LLP
- Case Identification: 2:20-cv-05212, D.N.J., 09/16/2021
- Venue Allegations: Plaintiff Tris Pharma, Inc. alleges venue is proper in the District of New Jersey because Defendant Teva Pharmaceuticals USA, Inc. maintains a regular and established place of business in the district, a substantial part of the events giving rise to the action occurred there, and Teva intends to market and sell the accused product in New Jersey.
- Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) for a generic version of QuilliChew ER® constitutes an act of infringement of five U.S. patents directed to extended-release chewable methylphenidate tablet formulations.
- Technical Context: The technology concerns oral pharmaceutical formulations for methylphenidate, a central nervous system stimulant widely prescribed for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD), particularly in children.
- Key Procedural History: The action was precipitated by Teva’s March 16, 2020 notification letter to Tris, which declared its intent to market a generic drug prior to the expiration of the patents-in-suit. The complaint alleges that Tris provided Teva with notice of the allowed applications that would issue as the ’545, ’494, and ’495 patents before they were granted. The complaint also references a prior, administratively closed litigation against Actavis Elizabeth LLC (a Teva subsidiary) involving the ’399, ’544, and ’545 patents over a different ANDA.
Case Timeline
| Date | Event |
|---|---|
| 2012-08-15 | Earliest Priority Date for all Patents-in-Suit |
| 2017-01-17 | U.S. Patent No. 9,545,399 Issues |
| 2017-11-02 | Tris notifies Teva subsidiary Actavis that the future '545 patent is allowed |
| 2017-12-19 | U.S. Patent No. 9,844,544 Issues |
| 2017-12-19 | U.S. Patent No. 9,844,545 Issues |
| 2020-03-16 | Teva sends Tris a "Notification of Certification" letter regarding its ANDA filing |
| 2021-07-29 | Tris notifies Teva that the future '494 and '495 patents are allowed |
| 2021-08-31 | U.S. Patent No. 11,103,494 Issues |
| 2021-08-31 | U.S. Patent No. 11,103,495 Issues |
| 2021-09-16 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 11,103,494 - “Methylphenidate Extended Release Chewable Tablet”
The Invention Explained
- Problem Addressed: The patent addresses the need for a methylphenidate formulation that is quick-acting, provides extended release over a long duration (e.g., 12 hours), and is suitable for patients, such as young children, who have difficulty swallowing solid tablets or capsules ( Compl. ¶4; ’494 Patent, col. 1:39-44). Existing extended-release products often must be swallowed whole, precluding their use by certain patient populations (’494 Patent, col. 1:29-32).
- The Patented Solution: The invention is an oral chewable tablet that combines three different forms of methylphenidate to achieve both a rapid onset of therapeutic effect and a 12-hour extended-release profile (’494 Patent, Abstract). The formulation includes an uncomplexed methylphenidate for fast release, an uncoated methylphenidate-ion exchange resin complex for a slower immediate release, and a barrier-coated methylphenidate-ion exchange resin complex for sustained release (’494 Patent, col. 2:15-21). The tablet is designed to be scored, allowing it to be split without significantly modifying its release characteristics (’494 Patent, col. 2:9-14).
- Technical Importance: This approach combines the convenience of a once-daily ADHD medication with a dosage form suitable for pediatric patients and allows for dose titration by splitting the tablet.
Key Claims at a Glance
- The complaint alleges infringement of one or more claims without specifying which are asserted (Compl. ¶71). Independent claim 1 is representative.
- Claim 1 of the ’494 Patent includes these essential elements:
- An extended release racemic methylphenidate tablet, wherein the tablet is a solid dispersion.
- A component (a) comprising a water-insoluble, water-permeable, pH-independent barrier coated, racemic methylphenidate-cation exchange resin complex.
- This component (a) provides about 50% to about 90% w/w of the total racemic methylphenidate in the tablet.
- At least one immediate release methylphenidate component (b) which provides a release of the drug in less than about 30 minutes in an in vitro dissolution assay.
- The tablet is capable of being divided or chewed and provides a specific pharmacokinetic profile (AUC, Cmax, and Tmax) following a single oral administration.
- The complaint does not explicitly reserve the right to assert dependent claims for this patent.
U.S. Patent No. 11,103,495 - “Methylphenidate Extended Release Chewable Tablet”
The Invention Explained
- Problem Addressed: The patent addresses the same technical problem as the ’494 Patent: the need for a quick-acting, extended-release methylphenidate formulation in a dosage form, such as a chewable tablet, that is easy for pediatric patients to administer (’495 Patent, col. 1:39-44).
- The Patented Solution: The patented solution is a chewable tablet providing a 12-hour release profile and a fast onset of action by combining sustained-release and immediate-release methylphenidate components (’495 Patent, Abstract). The formulation uses a barrier-coated drug-ion exchange resin for sustained release and an uncoated drug-ion exchange resin complex and an uncomplexed drug salt for two different immediate-release profiles (’495 Patent, col. 2:15-21). The tablet can be scored and split while retaining its pharmacokinetic properties (’495 Patent, Abstract).
- Technical Importance: The formulation provides a long-acting, once-daily ADHD treatment in a chewable form that facilitates administration to children and allows for dose splitting.
Key Claims at a Glance
- The complaint alleges infringement of one or more claims without specifying which are asserted (Compl. ¶84). Independent claims 1, 21, and 26 are representative.
- Claim 26 of the ’495 Patent includes these essential elements:
- A racemic methylphenidate tablet, wherein the tablet is a uniform solid dispersion.
- A component (a) comprising a water-insoluble, water-permeable, pH-independent barrier coated, racemic methylphenidate-cation exchange resin complex.
- A first immediate release component (b) comprising an uncoated racemic methylphenidate-ion exchange resin complex, providing about 5% to about 20% w/w of the total drug.
- A second immediate release component (c) comprising an uncomplexed racemic methylphenidate, providing about 5% w/w to about 20% w/w of the total drug.
- The tablet provides a specific pharmacokinetic profile (AUC and/or Cmax and Tmax).
- The complaint does not explicitly reserve the right to assert dependent claims for this patent.
U.S. Patent No. 9,545,399 - “Methylphenidate Extended Release Chewable Tablet”
- Technology Synopsis: This patent describes a chewable, extended-release methylphenidate tablet that combines uncoated, barrier-coated, and uncomplexed drug forms to achieve both rapid onset and a 12-hour therapeutic effect. The technology is designed to be administrable to patients who cannot swallow whole tablets and to be divisible without losing its extended-release properties.
- Asserted Claims: The complaint notes that Defendant’s notice letter did not assert non-infringement of claims 1–9, 17–20, and 22–27 (Compl. ¶30).
- Accused Features: The accused features are the formulation and pharmacokinetic profile of Teva’s ANDA Product, which is alleged to be a generic version of Tris’s QuilliChew ER® product (Compl. ¶31).
U.S. Patent No. 9,844,544 - “Methylphenidate Extended Release Chewable Tablet”
- Technology Synopsis: The patent relates to a divisible, chewable tablet for extended release of methylphenidate. The formulation combines different release mechanisms, including a barrier-coated drug-ion exchange resin, to provide a rapid onset of action and a therapeutic effect lasting approximately 12 hours.
- Asserted Claims: The complaint notes that Defendant’s notice letter did not assert non-infringement of claims 28–38 and 40 (Compl. ¶45).
- Accused Features: The complaint alleges that Teva’s ANDA product infringes by embodying the claimed chewable tablet formulation (Compl. ¶46).
U.S. Patent No. 9,844,545 - “Methylphenidate Extended Release Chewable Tablet”
- Technology Synopsis: This patent describes a chewable, extended-release methylphenidate tablet containing a barrier coating comprising cellulose acetate. The formulation is designed for once-daily administration and can be divided while maintaining its extended-release characteristics.
- Asserted Claims: The complaint specifically alleges infringement of at least claim 1 (Compl. ¶58).
- Accused Features: The complaint alleges, on information and belief, that the barrier coating in Teva’s ANDA Product contains cellulose acetate, thereby meeting a limitation of claim 1 of the ’545 patent (Compl. ¶58).
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is Defendant Teva’s proposed generic drug product, identified as “Methylphenidate Hydrochloride Extended-Release Chewable Tablets, 20 mg, 30 mg and 40 mg” (the “ANDA Product”) (Compl. ¶3). The infringement action is based on Teva’s submission of Abbreviated New Drug Application (ANDA) No. 214202 to the U.S. Food and Drug Administration (FDA) (Compl. ¶3).
Functionality and Market Context
- The ANDA Product is a generic version of Tris’s QuilliChew ER®, which is a once-daily, long-lasting chewable methylphenidate tablet for the treatment of ADHD in children (Compl. ¶¶3-4). As an ANDA product, its formulation and bioequivalence are intended to correspond to the reference listed drug, QuilliChew ER®. The complaint alleges that upon FDA approval, Teva will manufacture, market, and sell the ANDA Product in the United States (Compl. ¶20).
No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint does not contain a detailed claim chart. The infringement allegations are based on the act of filing the ANDA, which asserts that the proposed generic product will not infringe or that the patents are invalid, and on Plaintiff's information and belief that the ANDA Product meets the limitations of the asserted claims.
’494 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| An extended release racemic methylphenidate tablet, wherein the tablet is a solid dispersion | On information and belief, the ANDA Product is an extended release chewable tablet formulated as a solid dispersion. | ¶71 | col. 31:7-9 |
| (a) a racemic methylphenidate component comprising a water-insoluble, water-permeable, pH-independent barrier coated, racemic methylphenidate-cation exchange resin complex | On information and belief, the ANDA Product contains a sustained-release component comprising a barrier-coated drug-ion exchange resin complex. | ¶71 | col. 31:10-16 |
| (b) at least one immediate release methylphenidate component which provides a release of the racemic methylphenidate in less than about 30 minutes | On information and belief, the ANDA Product contains at least one immediate-release component that provides rapid drug release. | ¶71 | col. 31:24-28 |
| wherein the tablet...provides a pharmacokinetic profile for racemic methylphenidate comprising a geometric mean area under the curve (AUC)0-∞ of about 110 ng-hr/mL to about 140 ng-hr/mL | On information and belief, the ANDA Product is bioequivalent to QuilliChew ER® and will exhibit the claimed pharmacokinetic profile. | ¶3, ¶71 | col. 31:32-36 |
’495 Patent Infringement Allegations
| Claim Element (from Independent Claim 26) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A racemic methylphenidate tablet, wherein the tablet is a uniform solid dispersion | On information and belief, the ANDA Product is a chewable tablet formulated as a uniform solid dispersion. | ¶84 | col. 35:5-7 |
| (a) a...barrier coated, racemic methylphenidate-cation exchange resin complex | On information and belief, the ANDA Product contains a sustained-release component comprising a barrier-coated drug-ion exchange resin complex. | ¶84 | col. 35:8-14 |
| (b) a first immediate release component which comprises an immediate release uncoated racemic methylphenidate-ion exchange resin complex | On information and belief, the ANDA Product contains a first immediate-release component comprising an uncoated drug-ion exchange resin complex. | ¶84 | col. 35:20-23 |
| (c) a second immediate release racemic methylphenidate component which comprises an uncomplexed racemic methylphenidate | On information and belief, the ANDA Product contains a second immediate-release component comprising an uncomplexed form of the drug. | ¶84 | col. 35:27-30 |
- Identified Points of Contention:
- Evidentiary Questions: As this is an ANDA action filed on "information and belief," a primary point of contention will be evidentiary. The case will depend on the actual contents of Teva’s confidential ANDA submission. Key questions include: Does Teva’s formulation contain the specific three-component system (coated complex, uncoated complex, uncomplexed drug) recited in claims like Claim 26 of the ’495 Patent? Does the ANDA Product’s coating material meet the structural and functional limitations of a "barrier coat" as claimed?
- Technical Questions: A central technical dispute may involve the claimed pharmacokinetic profiles. The independent claims of the ’494 and ’495 patents recite specific numerical ranges for pharmacokinetic parameters like AUC, Cmax, and Tmax. A key question for the court will be whether Teva's bioequivalence data demonstrates that its ANDA Product literally meets these claimed PK limitations or, alternatively, infringes under the doctrine of equivalents.
V. Key Claim Terms for Construction
The complaint does not provide sufficient detail for a full analysis of likely claim construction disputes. However, based on the patent specifications and the nature of the technology, certain terms may become central to the infringement analysis.
The Term: "barrier coated"
Context and Importance: This term defines the sustained-release mechanism, which is a core element of the invention. The properties of the coating (e.g., pH-independence, water-permeability, tensile strength) are critical for achieving the 12-hour release profile while allowing the tablet to be chewed or split. Practitioners may focus on this term because the infringement analysis will likely turn on whether Teva's coating technology falls within the scope of this limitation.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification discloses a wide range of potential coating materials, including polyvinylacetate, ethylcellulose, and various acrylic polymers, suggesting the term is not limited to a single specific material (’494 Patent, col. 10:40-14:65).
- Evidence for a Narrower Interpretation: The specification emphasizes specific functional properties, such as an "elongation factor of at least about 150% to about 400%" (’494 Patent, col. 11:59-65). The detailed examples also focus on specific commercial polymers like Kollicoat® SR 30 D (’494 Patent, col. 24:50-53). A defendant could argue that these specific disclosures and functional requirements narrow the scope of a qualifying "barrier coat."
The Term: "uncomplexed racemic methylphenidate"
Context and Importance: This term, appearing in claims like Claim 26 of the ’495 Patent, distinguishes one of the immediate-release components from the other drug-ion resin complexes. This three-part system is a key feature. The definition of "uncomplexed" will be critical to determining whether a generic product that contains the active drug and various excipients truly has an "uncomplexed" component.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification defines the term functionally as the "faster onset immediate release component" and structurally as a methylphenidate salt "which is not complexed with or bound to an ion exchange resin" (’495 Patent, col. 2:1-5). This suggests any form of the drug not bound to an ion-exchange resin could qualify.
- Evidence for a Narrower Interpretation: The detailed examples use methylphenidate HCl specifically for this component (’495 Patent, col. 27, Table B). A defendant might argue that interactions between the methylphenidate salt and other excipients in the tablet matrix (e.g., gums, binders) constitute a form of complexation, even if not with an ion-exchange resin, thereby placing its formulation outside the literal scope of "uncomplexed."
VI. Other Allegations
- Indirect Infringement: The complaint alleges induced infringement against Teva. It asserts that Teva, upon receiving FDA approval, will actively and intentionally encourage infringement by others (including distributors, prescribers, and consumers) through its product labeling, which will instruct on the use of the ANDA Product (Compl. ¶¶33-34, 48-49, 61-62, 74-75, 87-88).
- Willful Infringement: The complaint does not use the word "willful" but alleges facts that may support such a claim. It asserts that Teva had "full knowledge" of the patents, alleging that Tris provided pre-issuance notice of the allowed applications for the ’545, ’494, and ’495 patents (Compl. ¶¶7-8, 57, 70, 83). The complaint also pleads that the case is "exceptional" and seeks attorney's fees under 35 U.S.C. § 285, which is often associated with findings of willful infringement or litigation misconduct (Compl. ¶¶38, 53, 66, 79, 92).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of structural and functional correspondence: As an ANDA case based on "information and belief," the dispute will turn on evidence from Teva's confidential ANDA submission. The central question for the court will be whether Teva's formulation contains the specific three-part drug delivery system (a barrier-coated complex, an uncoated complex, and an uncomplexed drug salt) that is a basis for patentability in patents like the ’495 Patent.
- A key evidentiary question will be one of pharmacokinetic identity: The asserted patents claim specific numerical ranges for pharmacokinetic parameters such as AUC, Cmax, and Tmax. A dispositive issue will be whether Teva’s bioequivalence data demonstrates that its ANDA Product's performance profile falls within the literal scope of these claimed pharmacokinetic limitations, or is otherwise equivalent.