DCT
1:18-cv-00505
Egalet US Inc v. Teva Pharma USA Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Egalet US, Inc. (Delaware) and Egalet Ltd. (United Kingdom)
- Defendant: Teva Pharmaceuticals USA, Inc. (Delaware)
- Plaintiff’s Counsel: Morris, Nichols, Arsht & Tunnell LLP
- Case Identification: 1:18-cv-00505, D. Del., 04/04/2018
- Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant is a corporation organized and existing under the laws of Delaware.
- Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) for generic morphine sulfate extended-release tablets constitutes an act of infringement of a patent directed to abuse-deterrent opioid formulations.
- Technical Context: The technology relates to controlled-release opioid compositions designed to be physically resistant to tampering, a key area of pharmaceutical development aimed at mitigating the risks of prescription drug abuse.
- Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendant’s submission of an ANDA with a Paragraph IV certification, which asserted that Plaintiff’s patent is invalid and/or not infringed by the proposed generic product. The complaint was filed within the 45-day statutory window, triggering an automatic 30-month stay of FDA approval for the Defendant's generic product.
Case Timeline
| Date | Event |
|---|---|
| 2012-07-06 | U.S. Patent No. 9,044,402 Priority Date |
| 2015-06-02 | U.S. Patent No. 9,044,402 Issue Date |
| 2017-01-09 | FDA Approval of Plaintiff's Arymo® ER |
| 2018-02-22 | Date of Defendant's ANDA Notice Letter |
| 2018-02-23 | Plaintiff receives Defendant's ANDA Notice Letter |
| 2018-04-04 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 9,044,402 - "Abuse-Deterrent Pharmaceutical Compositions for Controlled Release"
- Patent Identification: U.S. Patent No. 9,044,402, “Abuse-Deterrent Pharmaceutical Compositions for Controlled Release,” issued June 2, 2015.
The Invention Explained
- Problem Addressed: The patent describes the increasing problem of prescription drug abuse, particularly with opioids, through methods such as physical tampering (e.g., grinding or crushing tablets to enable snorting or injection) and alcohol-induced "dose dumping," where alcohol consumption causes a rapid, unintended release of the active ingredient (’402 Patent, col. 1:25-52).
- The Patented Solution: The invention is a tablet composition that uses a high-molecular-weight polyethylene oxide (PEO) matrix to create a formulation that is physically hard and, upon contact with a solvent, forms a viscous gel ('402 Patent, col. 29:1-14). This dual characteristic is intended to make the tablet difficult to crush into a powder for snorting and resistant to extraction of the active drug for injection, thereby maintaining its controlled-release properties even after tampering attempts ('402 Patent, col. 3:9-16).
- Technical Importance: The formulation represents an approach to creating safer opioid analgesics by building abuse-deterrent features directly into the physical structure of the dosage form, a significant goal in pain management pharmacology. ('402 Patent, col. 1:30-34).
Key Claims at a Glance
- The complaint asserts infringement of at least claim 1 ('402 Patent, Compl. ¶23).
- Independent Claim 1:
- An abuse-deterrent tablet for oral administration of an opioid.
- The tablet consists of a composition comprising about 1-30% w/w of the opioid and about 70-98% w/w of a polyethylene oxide (PEO) with an average molecular weight between 400,000 and 600,000 daltons.
- The composition does not provide immediate release of the opioid after physical tampering (crushing, grinding, etc.).
- The composition exhibits a viscosity of at least 170 mPa·s (measured by Viscosity Test #2) or at least 46 Pa·s (measured by Viscosity Test #1).
- The complaint does not explicitly reserve the right to assert dependent claims, but the allegation is for infringement of "at least one claim... including but not limited to claim 1" (Compl. ¶23).
III. The Accused Instrumentality
Product Identification
- Defendant’s generic Morphine Sulfate Extended-Release Tablets, 15 mg, 30 mg, and 60 mg, as described in ANDA No. 210533 (the "Teva's ANDA Product") (Compl. ¶18).
Functionality and Market Context
- The complaint alleges that Teva's ANDA Product is a generic version of Plaintiff's branded drug, Arymo® ER (Compl. ¶24). The core of the infringement allegation rests on Teva's representations to the FDA that its proposed generic product has the same active ingredient, dosage form, strength, is bioequivalent to, and has the "same abuse deterrent properties" as Arymo® ER (Compl. ¶24).
IV. Analysis of Infringement Allegations
No probative visual evidence provided in complaint.
The complaint provides a generalized theory of infringement under 35 U.S.C. § 271(e)(2), based on the submission of the ANDA, rather than a detailed element-by-element mapping. The allegations below are inferred from the complaint's assertion that Teva's ANDA Product is a generic equivalent of Plaintiff's Arymo® ER and possesses the same properties.
'402 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| An abuse-deterrent tablet formulated for oral administration of an opioid... comprising: about 1-30% w/w of the opioid... | The accused product is a tablet containing morphine sulfate, an opioid, intended for oral administration. (Compl. ¶13, 18). | ¶18, ¶24 | col. 8:39-41 |
| ...and about 70-98% w/w of a polyethylene oxide (PEO) having an average molecular weight of from about 400,000 daltons to about 600,000 daltons... | The accused product is alleged to have the same formulation characteristics as Arymo® ER, which is covered by the patent claims. (Compl. ¶24). | ¶24 | col. 4:51-64 |
| ...wherein the tablet composition does not provide immediate release of the opioid even after the abuse-deterrent tablet is subjected to physical tampering... | The accused product is alleged to possess the "same abuse deterrent properties" as Arymo® ER, which includes resistance to tampering. (Compl. ¶24). | ¶24 | col. 3:9-16 |
| ...wherein the tablet composition exhibits a viscosity of at least 170 mPa·s when measured by Viscosity Test #2, or a viscosity of at least 46 Pa·s when measured by Viscosity Test #1. | The accused product is alleged to possess the "same abuse deterrent properties" as Arymo® ER, which are defined in the patent by specific viscosity thresholds. (Compl. ¶24). | ¶24 | col. 45:13-22 |
- Identified Points of Contention:
- Scope Questions: The central dispute will likely be whether Teva's representation of having the "same abuse deterrent properties" as Arymo® ER (Compl. ¶24) means its product meets the specific, quantitative limitations of Claim 1. A primary question for the court will be whether the physical characteristics of Teva's ANDA product, when tested, fall within the claimed ranges for PEO molecular weight, post-tampering release profile, and viscosity.
- Technical Questions: The case will likely depend on competing expert analyses of Teva's ANDA product. A key technical question is whether Teva's formulation, under the exact testing protocols defined in the '402 patent's specification for "Viscosity Test #1" and "Viscosity Test #2" (col. 31:10-23), actually produces a viscosity meeting the claimed thresholds.
V. Key Claim Terms for Construction
The Term: "does not provide immediate release of the opioid even after ... physical tampering"
Context and Importance: This functional, negative limitation is at the heart of the "abuse-deterrent" aspect of the invention. Its construction is critical because infringement depends on whether Teva's product avoids a rapid release of the opioid after being crushed or ground. Practitioners may focus on this term because its scope will determine the standard of proof for infringement.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent’s background and objectives emphasize the general goal of preventing abuse and avoiding dose-dumping, which may support an interpretation that covers any formulation that meaningfully resists rapid release after tampering, regardless of minor deviations from a specific test result. ('402 Patent, col. 1:30-34, col. 3:9-16).
- Evidence for a Narrower Interpretation: The specification provides a precise definition for "immediate release" as releasing 80% of the drug within 30 minutes under a specific dissolution test ('402 Patent, col. 4:22-26). A party could argue that this term must be strictly construed to mean failing to meet this exact 80%/30-minute threshold under the specified test conditions after tampering.
The Term: "about 400,000 daltons to about 600,000 daltons"
Context and Importance: The molecular weight of the PEO is a key parameter for achieving the desired viscosity and hardness. The scope of "about" will be critical, as a formulation falling just outside the numerical range could escape infringement.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification describes mixing different PEOs to achieve a "desirable average molecular weight," suggesting that the precise value is a target rather than an absolute requirement ('402 Patent, col. 5:46-53). This may support a construction where "about" provides reasonable flexibility.
- Evidence for a Narrower Interpretation: The claims and examples provide specific molecular weights and resulting properties, such as viscosity ('402 Patent, col. 32:4-30; col. 45:35-41). A party could argue these examples demonstrate the criticality of the recited range, thereby supporting a narrow reading of "about."
VI. Other Allegations
- Indirect Infringement: The complaint does not contain allegations of indirect infringement.
- Willful Infringement: The complaint alleges that Teva had "actual knowledge of the '402 patent" prior to filing its ANDA and "violated its duty of care to avoid the known patent rights" (Compl. ¶28-29). This allegation is based on the Hatch-Waxman framework, wherein an ANDA filer must certify its position regarding patents listed in the FDA's Orange Book.
VII. Analyst’s Conclusion: Key Questions for the Case
- A key evidentiary question will be one of technical performance: Does Teva’s proposed generic product, when physically tested according to the protocols detailed in the '402 patent, actually exhibit the specific viscosity and post-tampering release profiles required by the asserted claims? The dispute will center on the results of competing laboratory tests.
- A core issue will be one of functional scope: How will the court construe the phrase "does not provide immediate release" after tampering? The case may turn on whether this requires only a general resistance to dose-dumping or adherence to the precise 80%-in-30-minutes threshold defined in the patent's specification.
- The outcome will also likely depend on a question of equivalence: Given that this is a Hatch-Waxman action, a central question is whether Teva's assertion to the FDA that its product has the "same abuse deterrent properties" as Arymo® ER is legally and factually sufficient to establish that it meets the specific limitations of the patent claims that protect those properties.