DCT
1:19-cv-00876
Collegium Pharmaceutical Inc v. Teva Pharma USA Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Collegium Pharmaceutical, Inc. (Virginia)
- Defendant: Teva Pharmaceuticals USA, Inc. (Delaware)
- Plaintiff’s Counsel: Richards, Layton & Finger, P.A.
- Case Identification: 1:19-cv-00876, D. Del., 05/09/2019
- Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant Teva is a Delaware corporation.
- Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff's XTAMPZA® ER (oxycodone extended-release) capsules infringes a patent related to abuse-deterrent pharmaceutical formulations.
- Technical Context: The technology concerns abuse-deterrent formulations for opioids, designed to prevent the rapid release of the active drug when the product is physically manipulated (e.g., crushed or chewed) by abusers.
- Key Procedural History: The complaint notes that related cases are pending in the same court (Civil Action Nos. 18-300-LPS-CJB and 18-1900) in which Collegium has accused Teva of infringing parent patents to the patent-in-suit with the same ANDA submission.
Case Timeline
| Date | Event |
|---|---|
| 2016-06-23 | Priority Date for U.S. Patent No. 10,188,644 |
| 2019-01-29 | U.S. Patent No. 10,188,644 Issued |
| 2019-03-27 | Teva sends Paragraph IV Notice Letter to Collegium |
| 2019-05-09 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 10,188,644 - "Process of Making Stable Abuse-Deterrent Oral Formulations"
- Patent Identification: U.S. Patent No. 10,188,644, "Process of Making Stable Abuse-Deterrent Oral Formulations", issued January 29, 2019.
The Invention Explained
- Problem Addressed: The patent addresses the problem of opioid abuse, where individuals manipulate extended-release (ER) formulations by crushing or dissolving them to achieve a rapid, dangerous release of the drug, defeating the intended therapeutic effect and safety profile (’644 Patent, col. 1:33-44; Compl. ¶15). A related problem is that the dissolution characteristics of some formulations can change undesirably during storage, affecting stability and performance (’644 Patent, col. 2:15-27).
- The Patented Solution: The invention is a specific manufacturing process for creating abuse-deterrent formulations with improved dissolution stability. The process involves forming solid microparticles from a hot melt of an active drug (e.g., oxycodone), fatty acids, and waxes. A critical and inventive step is then "curing" these microparticles for a minimum period at a temperature within a specific range defined by an "inversion temperature." This curing process is asserted to unexpectedly stabilize the drug release profile over time, which would otherwise degrade (’644 Patent, Abstract; col. 2:27-42).
- Technical Importance: This process-based approach aims to produce a more reliable abuse-deterrent opioid formulation whose therapeutic properties are stable over its shelf life, addressing a key challenge in the field (Compl. ¶¶19, 23).
Key Claims at a Glance
- The complaint asserts independent claim 1 and dependent claims 7-28 (Compl. ¶33).
- Independent Claim 1 is a product-by-process claim for a pharmaceutical composition prepared by a process comprising the following essential elements:
- Preparing a substantially homogeneous melt of specific components (oxycodone, myristic acid, beeswax, and carnauba wax).
- Forming solid microparticles from the melt.
- Optionally formulating the microparticles with other excipients.
- Curing the microparticles for a minimum of 48 hours at a temperature within a specific range (25° C. up to the "inversion temperature").
- The curing step is further defined as a two-stage process: "wherein the solid microparticles... are cured at a first temperature above the inversion temperature and subsequently a second temperature below the inversion temperature."
III. The Accused Instrumentality
Product Identification
- The accused instrumentalities are Teva’s proposed Oxycodone Extended-Release Capsules in 9 mg, 13.5 mg, 18 mg, 27 mg, and 36 mg dosages, as described in ANDA No. 209431 ("the Teva ANDA Products") (Compl. ¶1).
Functionality and Market Context
- The complaint alleges that the Teva ANDA Products are generic versions of Collegium's own product, XTAMPZA® ER (Compl. ¶¶25-26). It is therefore alleged that Teva’s products are extended-release oxycodone formulations with abuse-deterrent properties. The complaint asserts that Teva's submission of the ANDA is an act of infringement under the Hatch-Waxman Act, as Teva seeks FDA approval to market its generic product before the expiration of the ’644 Patent (Compl. ¶¶1, 32). The complaint further alleges that Teva intends to launch "essentially a copy" of Collegium's product, which is described as the first single-entity oxycodone formulation recognized by the FDA to have abuse-deterrent properties for oral, nasal, and intravenous routes of abuse (Compl. ¶¶25, 30).
IV. Analysis of Infringement Allegations
The complaint does not provide a detailed claim chart or specific factual allegations mapping elements of Teva's product or manufacturing process to the patent claims. The infringement theory rests on the allegation that the Teva ANDA Products are copies of Collegium's XTAMPZA® ER product, which itself is alleged to be an embodiment of the patented invention (Compl. ¶¶25-26, 30).
No probative visual evidence provided in complaint.
’644 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A pharmaceutical composition comprising solid microparticles or formulated microparticles prepared by: a. preparing a mixture comprising: (i) oxycodone, myristic acid, beeswax and carnauba wax, or (ii) oxycodone in the form of a fatty acid salt, beeswax and carnauba wax at a temperature sufficient to form a substantially homogeneous melt; | The complaint alleges on information and belief that the Teva ANDA Products infringe, and are "essentially a copy" of Collegium's patented abuse-deterrent oxycodone product, which is made from these or equivalent components (Compl. ¶¶25, 30). | ¶¶30, 33 | col. 20:11-16 |
| b. forming solid microparticles from the substantially homogeneous melt; | The complaint does not provide sufficient detail for analysis of this element. | ¶33 | col. 20:17-18 |
| d. curing the solid microparticles or the formulated microparticles at a temperature within the range of 25° C. up to and including the inversion temperature, for a minimum of about 48 hours to provide cured solid microparticles or cured formulated microparticles; wherein the solid microparticles or the formulated microparticles are cured at a first temperature above the inversion temperature and subsequently a second temperature below the inversion temperature. | The complaint does not provide specific factual allegations regarding Teva's manufacturing process, but infringement of this process step is implied by the allegation that Teva's product is a "copy" of Collegium's patented product (Compl. ¶30). | ¶¶30, 33 | col. 20:22-col. 21:2 |
- Identified Points of Contention:
- Process vs. Product Evidence: Claim 1 is a product-by-process claim. Infringement will depend on whether Teva’s manufacturing process, as detailed in its confidential ANDA, utilizes the specific steps recited in the claim. A central question for the court will be what evidence Collegium can obtain and present to show that Teva’s process includes the claimed two-stage curing step relative to an "inversion temperature."
- Technical Questions: The core of the patented process is the specific two-stage curing step. The complaint does not allege any facts about the thermal processing or curing steps Teva uses to manufacture its generic product. It raises the question of whether any heat treatment used by Teva meets the specific limitations of being a two-stage process performed above and then below the "inversion temperature."
V. Key Claim Terms for Construction
The Term: "inversion temperature"
- Context and Importance: This term is the lynchpin of the claimed curing process, as it defines the boundary for the required two-stage curing temperatures. The patent defines it as "the temperature at or below which a composition... is cured to result in improved dissolution stability" and notes it can be "determined empirically" (’644 Patent, col. 6:8-13). Practitioners may focus on this term because its definition and method of determination will be critical to proving infringement. Whether a given temperature is "above" or "below" the inversion temperature is a factual question that depends on how this term is construed.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent describes the term functionally, tying it to an observable outcome ("improved dissolution stability"), which may support an argument that any empirically determined temperature that achieves this result for a given formulation qualifies (’644 Patent, col. 6:8-12).
- Evidence for a Narrower Interpretation: The patent provides specific examples where the inversion temperature for an oxycodone/myristic acid formulation is found to be "around approximately 36° C." and for a stearic acid formulation to be "between 50° C. and 55° C." (’644 Patent, col. 18:26, col. 19:57-59). A party could argue these examples limit the term to a narrow, experimentally verified temperature range for similar compositions.
The Term: "curing"
- Context and Importance: The claim requires a specific two-stage "curing" process. The patent defines "curing" as a process "to stabilize excipients, intermediates and finished products over shorter time frames than would otherwise be realized at room temperature" (’644 Patent, col. 5:62-col. 6:2). Practitioners may focus on this term because Teva may argue that its manufacturing process involves simple heating or drying steps that do not rise to the level of the specific, stability-imparting "curing" process claimed.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The general definition focuses on accelerated stabilization, which could be argued to encompass a wide range of thermal treatments that achieve this functional goal (’644 Patent, col. 5:62-col. 6:2).
- Evidence for a Narrower Interpretation: The claim itself recites a highly specific two-stage curing process relative to the inversion temperature. This context suggests "curing" is not just any heating, but this particular, structured thermal process designed to achieve the invention's objective of improved stability (’644 Patent, col. 20:25-col. 21:2).
VI. Other Allegations
- Indirect Infringement: The complaint alleges that Teva will induce infringement by third parties, such as patients and manufacturers (Compl. ¶¶36, 38). The basis for this allegation is that "Teva, through at least its labeling, will intentionally induce infringement" (Compl. ¶38).
- Willful Infringement: While not pleaded as a separate count, the complaint alleges that Teva provided a Paragraph IV notice letter on March 27, 2019, which establishes pre-suit knowledge of the patent (Compl. ¶29). The prayer for relief seeks a declaration of an exceptional case and an award of attorneys' fees, which is often associated with findings of willful infringement (Compl., Prayer for Relief ¶D).
VII. Analyst’s Conclusion: Key Questions for the Case
- A primary issue will be one of process evidence: As Claim 1 is a product-by-process claim, can Collegium demonstrate through discovery that the confidential manufacturing process described in Teva's ANDA includes the specific, two-stage curing process—performed at temperatures both above and below an "inversion temperature"—as recited in the claim?
- The case will also turn on a question of definitional scope: How will the court construe the term "inversion temperature"? The resolution of whether this term defines a precise, empirically fixed point or a broader functional range will be fundamental to determining the scope of the claims and whether Teva's process infringes.