DCT
1:17-cv-01793
Neos Therap Inc v. Teva Pharma USA Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Neos Therapeutics, Inc. and Neos Therapeutics, LP (Delaware/Texas)
- Defendant: Teva Pharmaceuticals USA, Inc. (Delaware/Pennsylvania)
- Plaintiff’s Counsel: Morris, Nichols, Arsht & Tunnell LLP
- Case Identification: 1:17-cv-01793, D. Del., 12/13/2017
- Venue Allegations: Venue is alleged to be proper in the District of Delaware as Defendant is a Delaware corporation.
- Core Dispute: Plaintiff alleges that Defendant’s Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Plaintiff’s ADHD drug, COTEMPLA XR-ODT™, constitutes an act of infringement of three patents related to extended-release, orally disintegrating pharmaceutical compositions.
- Technical Context: The technology concerns formulations for orally disintegrating tablets that use ion-exchange resin particles to provide controlled, extended release of methylphenidate for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
- Key Procedural History: The patents-in-suit are listed in the U.S. Food and Drug Administration's "Orange Book" for Plaintiff's New Drug Application (NDA) approved product, COTEMPLA XR-ODT™. Defendant submitted an ANDA with a Paragraph IV certification, asserting that the patents are invalid and/or not infringed by its proposed generic product, which under the Hatch-Waxman Act is a technical act of infringement that prompted this lawsuit.
Case Timeline
| Date | Event |
|---|---|
| 2005-10-21 | ’924 Patent Priority Date |
| 2011-06-28 | ’680 and ’496 Patents Priority Date |
| 2014-09-23 | ’924 Patent Issue Date |
| 2015-07-07 | ’680 Patent Issue Date |
| 2015-07-28 | ’496 Patent Issue Date |
| 2017-10-30 | ANDA No. 210924 Submitted (on or before this date) |
| 2017-10-31 | Plaintiff Received Notification of ANDA Filing (on or about this date) |
| 2017-12-13 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,840,924 - "Compositions And Methods Of Making Rapidly Dissolving Ionically Masked Formulations"
The Invention Explained
- Problem Addressed: The patent describes the difficulty certain patient populations, such as children and the elderly, have with swallowing traditional solid dosage forms like tablets and capsules. While orally disintegrating or liquid formulations can solve the swallowing issue, they often introduce problems with unpalatable taste or unpleasant mouth-feel, which can lead to non-compliance. (’924 Patent, col. 2:26-42).
- The Patented Solution: The invention claims to solve this by creating a compressed tablet from two key components: a drug that is ionically bound to a resin particle (a "drug-resin complex") to mask its taste, and a "highly compressible, free-flowing pharmaceutical excipient." This excipient allows the formulation to be pressed into a solid tablet that nevertheless disintegrates rapidly in the mouth, releasing the taste-masked drug-resin complex for ingestion. (’924 Patent, Abstract; col. 7:34-50).
- Technical Importance: This technology enables the creation of a patient-friendly, orally disintegrating dosage form that also effectively manages the taste of the active pharmaceutical ingredient, a critical factor for ensuring patient adherence to a dosing regimen. (’924 Patent, col. 2:53-56).
Key Claims at a Glance
- The complaint asserts independent claim 1.
- The essential elements of Claim 1 are:
- A compressed, orally disintegrating, controlled release taste-masked pharmaceutical composition
- comprising a coated drug-ion-exchange resin complex
- and a directly compressible, free-flowing pharmaceutical excipient
- wherein the composition effectively masks an unpalatable taste
- wherein the coated drug-ion-exchange resin complex is coated with a controlled release coating
- and wherein the excipient aids in the liberation of the coated drug-resin complex in the mouth through disintegration.
- The complaint explicitly reserves the right to assert dependent claims (Compl. ¶16).
U.S. Patent No. 9,072,680 - "Compositions Comprising Methylphenidate Complexed With Ion-Exchange Resin Particles"
The Invention Explained
- Problem Addressed: The patent notes that while once-a-day ADHD treatments exist (e.g., ADDERALL XR), they are typically available only in conventional solid dosage forms that are difficult for many patients, especially children, to swallow. Furthermore, existing formulations using drug-resin complexes had not achieved a pharmacokinetic profile comparable to these established once-a-day therapies. (’680 Patent, col. 2:6-12, col. 2:35-39).
- The Patented Solution: The invention discloses a composition containing two distinct populations of drug-resin particles. The first population is uncoated to provide an immediate release of the drug. The second population is coated with a delayed-release coating, which may include a pH-triggered layer and a diffusion barrier. This combination is designed to create a specific biphasic or "escalating" drug release profile over a prolonged period from a single, easily ingested dose. (’680 Patent, Abstract; col. 4:50-60).
- Technical Importance: This approach provides a once-daily, orally disintegrating ADHD medication designed to offer therapeutic effectiveness throughout the day, thereby improving patient compliance by eliminating the need for mid-day dosing and addressing difficulties with swallowing pills. (’680 Patent, col. 2:50-54).
Key Claims at a Glance
- The complaint asserts independent claims 1 and 19.
- The essential elements of Claim 1 are:
- A pharmaceutical composition comprising an ADHD effective agent (methylphenidate) complexed with ion-exchange resin particles.
- The composition includes a first plurality of drug-resin particles for immediate release.
- The composition also includes a second plurality of drug-resin particles coated with a triggered-release coating (triggered by a pH change) and a diffusion barrier coating.
- The essential elements of Claim 19 are:
- A pharmaceutical composition comprising an ADHD effective agent (methylphenidate) complexed with ion-exchange resin particles.
- The composition produces a mean plasma concentration profile for d-methylphenidate in human subjects with one or more pharmacokinetic parameters (e.g., AUC, Cmax) that are substantially similar to reference profiles shown in a patent figure.
- The complaint asserts claims 1-28, which includes dependent claims (Compl. ¶16).
U.S. Patent No. 9,089,496 - "Compositions Comprising Methylphenidate Complexed With Ion-Exchange Resin Particles"
- Technology Synopsis: Similar to the ’680 Patent, this patent addresses the need for an easily ingested, once-daily oral composition for ADHD treatment. The disclosed solution involves a composition with a first plurality of uncoated, immediate-release drug-resin particles and a second plurality of coated, delayed-release drug-resin particles to achieve a prolonged and effective therapeutic profile from a single dose. (’496 Patent, Abstract; col. 2:5-17).
- Asserted Claims: Independent claims 1 and 12 are asserted among claims 1-22 (Compl. ¶16).
- Accused Features: The complaint alleges that Defendant’s proposed generic drug product, as a whole, infringes the asserted claims (Compl. ¶16).
III. The Accused Instrumentality
Product Identification
The accused instrumentalities are Defendant Teva's proposed "Generic Products"—extended-release orally disintegrating tablets containing methylphenidate—as described in ANDA No. 210924 (Compl. ¶14).
Functionality and Market Context
The complaint describes the accused products as "extended-release orally disintegrating tablets containing 8.6 mg, 17.3 mg, or 25.9 mg of methylphenidate as the active ingredient" (Compl. ¶14). The filing of the ANDA indicates that the Generic Products are intended to be bioequivalent to Plaintiff's COTEMPLA XR-ODT™ product (Compl. ¶14). The complaint does not provide further technical details regarding the formulation or mechanism of action of the accused Generic Products.
Plaintiff's COTEMPLA XR-ODT™ is described as the "first and only FDA-approved methylphenidate extended-release orally disintegrating tablet for the treatment of ADHD," positioning the accused Generic Products to compete directly in this market segment (Compl. ¶12).
No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint does not contain a claim chart or provide specific factual allegations mapping claim elements to features of the accused product. The following summaries are based on the general description of the accused product and the allegation of infringement.
’924 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A compressed, orally disintegrating, controlled release taste-masked pharmaceutical composition... | The complaint alleges Teva's product is an extended-release orally disintegrating tablet. | ¶14 | col. 29:61-63 |
| ...comprising: a coated drug-ion-exchange resin complex... | The complaint alleges infringement, suggesting the product contains this structure. | ¶16 | col. 29:64-65 |
| ...and a directly compressible, free-flowing pharmaceutical excipient... | The complaint alleges infringement, suggesting the product contains this excipient. | ¶16 | col. 29:66-67 |
| ...wherein the coated drug-ion-exchange resin complex is coated with a controlled release coating... | The complaint alleges infringement, suggesting the presence of such a coating. | ¶16 | col. 30:1-3 |
| ...wherein the directly compressible, free-flowing pharmaceutical excipient aids in the liberation of the coated drug-resin complex in the mouth through disintegration. | This is a functional limitation; infringement is alleged without specifying the mechanism. | ¶16 | col. 30:4-7 |
’680 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A pharmaceutical composition comprising an ADHD effective agent complexed with ion-exchange resin particles to form drug-resin particles... | Teva's product is alleged to be a composition containing methylphenidate, an ADHD agent. | ¶14 | col. 81:53-56 |
| ...wherein said composition comprises a first plurality of drug-resin particles that provide for immediate release of said ADHD effective agent... | The complaint alleges infringement, suggesting the product contains an immediate-release component. | ¶16 | col. 81:57-60 |
| ...and a second plurality of drug-resin particles that are coated with a triggered-release coating triggered by a pH change and a diffusion barrier coating. | The complaint alleges infringement, suggesting the product contains a delayed-release component with this specific dual-coating structure. | ¶16 | col. 81:61-65 |
Identified Points of Contention
- Structural Questions: A primary issue will be factual and evidentiary: does the formulation described in Teva’s confidential ANDA actually contain the specific structures claimed in the patents? For example, with respect to the ’680 Patent, does the accused product utilize two distinct populations of drug-resin particles, one of which has the claimed dual-layer coating of a pH-triggered layer over a diffusion barrier?
- Scope Questions: The dispute may raise questions about the scope of claim terms. For the ’924 Patent, the analysis may focus on whether the excipients used in Teva's product meet the functional requirement of being a "directly compressible, free-flowing pharmaceutical excipient" that "aids in the liberation" of the drug-resin complex as defined by the patent.
V. Key Claim Terms for Construction
The complaint does not provide sufficient detail for analysis of specific terms. However, based on the technology, the following terms may become central to the dispute.
Term: "aids in the liberation of the coated drug-resin complex in the mouth through disintegration" (’924 Patent, Claim 1)
- Context and Importance: This functional language describes the role of the excipient. The dispute will likely center on what level of activity constitutes "aiding" liberation and whether the accused product's excipients perform this specific function in the claimed manner. Practitioners may focus on this term because the mechanism of disintegration is a key inventive concept for achieving a compressed yet rapidly dissolving tablet.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification describes the excipient in general terms as causing "disintegration of the tablet and liberation of the drug-resin complex in the mouth" (e.g., ’924 Patent, col. 7:61-63), which may support a construction covering any excipient that contributes to this result.
- Evidence for a Narrower Interpretation: The abstract states the excipient "causes release of the drug-resin complex in the mouth," suggesting a more active and primary role. (’924 Patent, Abstract). A defendant may argue the term is limited to the specific types of excipients disclosed, such as "amorphous sugars." (’924 Patent, col. 7:45-47).
Term: "triggered-release coating triggered by a pH change" (’680 Patent, Claim 1)
- Context and Importance: This term defines a specific mechanism for delayed drug release. Infringement will depend on whether the coating on Teva's delayed-release particles, if any, operates based on a pH trigger. Practitioners may focus on this term as it distinguishes the invention from other delayed-release mechanisms like simple erosion or diffusion over time.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification lists several examples of pH-dependent coatings, such as "co-polymerized methacrylic acid/acrylic acid ethyl esters," suggesting the term is not limited to a single polymer. (’680 Patent, col. 15:50-55).
- Evidence for a Narrower Interpretation: A defendant may argue that the term should be limited by the specific examples provided in the patent, such as EUDRAGIT L100, or by the specific pH values at which those examples are known to dissolve. (’680 Patent, col. 4:54-57).
VI. Other Allegations
- Indirect Infringement: The complaint alleges inducement of infringement on the basis that Teva’s prescribing information for its generic product, if approved, will instruct physicians and patients to use the product in an infringing manner (Compl. ¶18). Contributory infringement is also alleged, based on the assertion that the Generic Products are not staple articles of commerce and are especially made for use in an infringing way (Compl. ¶19).
- Willful Infringement: The complaint does not use the word "willful," but it alleges that Teva was aware of the patents-in-suit prior to filing its ANDA (Compl. ¶17). It further alleges that Teva's actions render this an "exceptional case" under 35 U.S.C. § 285, which forms the basis for a request for attorney fees (Compl. ¶20).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of structural and mechanistic identity: What are the specific formulation and release mechanisms of Teva's proposed generic product as detailed in its ANDA, and do they incorporate the two-part, coated/uncoated ion-exchange resin systems required by the asserted claims?
- A key legal question will be one of definitional scope: How will the court construe functional claim language related to the properties of excipients (e.g., "aids in the liberation") and the specific mechanism of coatings (e.g., "triggered by a pH change"), and does the accused product's actual operation fall within that construed scope?