DCT
1:18-cv-01895
Duchesnay Inc v. Actavis Laboratories FL Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Duchesnay Inc. (Canada)
- Defendant: Actavis Laboratories FL, Inc. (Florida); Teva Pharmaceuticals USA, Inc. (Delaware); Teva Pharmaceutical Industries Ltd. (Israel)
- Plaintiff’s Counsel: McCARTER & ENGLISH LLP; Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
- Case Identification: 1:18-cv-01895, D. Del., 11/29/2018
- Venue Allegations: Plaintiff alleges venue is proper in the District of Delaware because Defendant Teva USA is a Delaware corporation and because Defendants intend to market and sell the accused generic drug product in the district upon FDA approval.
- Core Dispute: Plaintiff alleges that Defendants' submission of an Abbreviated New Drug Application (ANDA) for a generic version of the drug Bonjesta® constitutes an act of infringement of four patents related to dual-release pharmaceutical formulations.
- Technical Context: The technology concerns oral drug delivery systems for doxylamine and pyridoxine, a combination used to treat nausea and vomiting in pregnancy (NVP).
- Key Procedural History: The litigation was initiated under the Hatch-Waxman Act following Defendants' submission of ANDA No. 212472 to the FDA. The ANDA included a Paragraph IV certification asserting that the patents-in-suit are invalid, unenforceable, and/or will not be infringed. Plaintiff received a formal Notice Letter from Defendants on October 16, 2018, triggering the period for filing suit.
Case Timeline
| Date | Event |
|---|---|
| 2012-02-22 | Earliest Priority Date for all Patents-in-Suit |
| 2015-07-28 | U.S. Patent No. 9,089,489 Issues |
| 2016-06-28 | U.S. Patent No. 9,375,404 Issues |
| 2016-11-07 | FDA approves New Drug Application for Bonjesta® |
| 2016-12-27 | U.S. Patent No. 9,526,703 Issues |
| 2018-04-10 | U.S. Patent No. 9,937,132 Issues |
| 2018-10-16 | Date of Defendants' Paragraph IV Notice Letter |
| 2018-11-29 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 9,089,489 - "Formulation of Doxylamine and Pyridoxine and/or Metabolites or Salts Thereof"
- Issued: July 28, 2015
The Invention Explained
- Problem Addressed: The patent describes Nausea and Vomiting of Pregnancy (NVP) as a common condition that can have serious adverse effects if not managed effectively (’489 Patent, col. 1:25-41). The patent notes a need for novel pharmaceutical dosage forms with improved pharmacokinetic profiles over existing delayed-release options ('489 Patent, col. 1:49-54).
- The Patented Solution: The invention is a "dual release oral dosage system" that combines an "immediate release component" and a "delayed release component" in a single dosage form ('489 Patent, Abstract). This structure is intended to provide a rapid onset of therapeutic effect from the immediate release portion to address acute symptoms, followed by a sustained effect from the delayed release portion, which releases its active ingredients later in the gastrointestinal tract ('489 Patent, col. 2:1-38).
- Technical Importance: This dual-release approach aims to offer patients both rapid symptom relief and prolonged therapeutic coverage from a single dose, addressing a perceived deficiency in purely delayed-release formulations ('489 Patent, col. 1:49-54).
Key Claims at a Glance
- The complaint asserts independent claim 1 and dependent claims 2-26 and 29-30 (Compl. ¶51).
- The essential elements of independent claim 1 are:
- A dual release oral dosage form comprising:
- (A) an immediate release composition containing specified amounts of doxylamine and pyridoxine;
- (B) a delayed release composition containing specified amounts of doxylamine and pyridoxine;
- Wherein the immediate release composition begins to release its contents prior to the delayed release composition.
U.S. Patent No. 9,375,404 - "Formulation of Doxylamine and Pyridoxine and/or Metabolites or Salts Thereof"
- Issued: June 28, 2016
The Invention Explained
- Problem Addressed: The patent addresses the same technical problem as the '489 Patent: the need for an improved pharmacokinetic profile for NVP treatments beyond what is offered by existing delayed-release formulations (’404 Patent, col. 1:25-54).
- The Patented Solution: The '404 Patent discloses a specific structural approach to achieving a dual-release profile. The invention is an oral dosage form built in layers: a central "core" containing the active ingredients, an "enteric coating" surrounding the core to delay its release, and one or more "outer coatings" containing active ingredients that surround the enteric coating for immediate release ('404 Patent, col. 4:50-58).
- Technical Importance: This layered structure provides a concrete physical means of separating the immediate- and delayed-release portions of the dose, ensuring the core remains intact through the stomach while the outer layers dissolve quickly upon ingestion ('404 Patent, col. 1:49-54).
Key Claims at a Glance
- The complaint asserts independent claim 1 and dependent claims 2-14, 16, and 18-19 (Compl. ¶59).
- The essential elements of independent claim 1 are:
- An oral dosage form comprising:
- (A) a core containing specified amounts of doxylamine and pyridoxine;
- (B) an enteric coating substantially surrounding the core; and
- (C) one or more outer coatings substantially surrounding the enteric coating, which also contain specified amounts of doxylamine and pyridoxine.
Multi-Patent Capsule: U.S. Patent No. 9,526,703
- Title: "Plurimodal Release Formulation of Doxylamine and Pyridoxine and/or Metabolites or Salts Thereof"
- Issued: December 27, 2016 (Compl. ¶38)
- Technology Synopsis: The ’703 Patent describes a solid oral dosage form with multiple distinct layers to achieve a "plurimodal" release profile. The claimed structure involves a core with active ingredients, an enteric coating, and multiple active-ingredient-containing outer coatings that are separated from each other by an intermediate coating, aiming to provide a sophisticated, multi-stage release of doxylamine and pyridoxine (Compl. ¶38; ’703 Patent, Abstract).
- Asserted Claims: Independent claim 1 and dependent claims 2-24, 28, and 30 (Compl. ¶67).
- Accused Features: The complaint alleges that the Defendants' generic extended-release tablets embody the "solid oral dosage form" recited in the claims (Compl. ¶67).
Multi-Patent Capsule: U.S. Patent No. 9,937,132
- Title: "Formulation of Doxylamine and Pyridoxine and/or Metabolites or Salts Thereof"
- Issued: April 10, 2018 (Compl. ¶39)
- Technology Synopsis: The ’132 Patent claims a method for alleviating the symptoms of NVP. The claimed method consists of administering a dual release oral dosage form that contains both an immediate release component and a delayed release component of doxylamine and pyridoxine, thereby achieving a specific therapeutic effect (Compl. ¶39; ’132 Patent, Abstract).
- Asserted Claims: Independent claim 1 and dependent claims 2-12, 14, and 16-21 (Compl. ¶75).
- Accused Features: The complaint alleges that Defendants' future sale of their generic product will induce infringement of the method claims by instructing physicians and patients to use the product in a manner that practices the claimed method (Compl. ¶¶76, 78).
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is Defendants' generic doxylamine succinate and pyridoxine hydrochloride extended-release tablets, for which Defendants submitted ANDA No. 212472 to the FDA (Compl. ¶¶1, 42).
Functionality and Market Context
- The complaint identifies the accused product as a generic version of Plaintiff's Bonjesta®, an extended-release tablet formulation for treating NVP (Compl. ¶1). The complaint alleges, on information and belief, that the product is a "dual release oral dosage form" that satisfies the limitations of the asserted claims (Compl. ¶¶51, 59). No specific details regarding the generic product's formulation, structure, or dissolution profile are provided in the complaint. No probative visual evidence provided in complaint.
Commercial Importance
- The filing of an ANDA for a generic version of a branded drug indicates Defendants' intent to compete directly with the Plaintiff in the U.S. market for NVP treatments upon receiving FDA approval (Compl. ¶43, 46).
IV. Analysis of Infringement Allegations
The complaint does not contain a detailed element-by-element infringement analysis. It alleges that because Defendants' Paragraph IV Notice Letter did not contest infringement of certain claims, infringement is therefore admitted, and further alleges on information and belief that the ANDA product meets all limitations of the asserted claims.
'489 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A dual release oral dosage form comprising... | The complaint alleges the ANDA product is a "dual release oral dosage form." | ¶51 | col. 2:1-4 |
| (A) an immediate release composition comprising: (a) from about 5 mg to about 20 mg of doxylamine... and (b) from about 5 mg to about 20 mg of pyridoxine... | The complaint alleges the ANDA product contains an immediate release composition with the claimed active ingredients. | ¶51 | col. 2:10-17 |
| (B) a delayed release composition comprising: (a) from about 5 mg to about 20 mg of doxylamine... and (b) from about 5 mg to about 20 mg of pyridoxine... | The complaint alleges the ANDA product contains a delayed release composition with the claimed active ingredients. | ¶51 | col. 2:18-24 |
| wherein said immediate release composition is for effecting release... which begins prior to release... from the delayed release component... | The complaint alleges the ANDA product functions such that its immediate release portion acts before its delayed release portion. | ¶51 | col. 2:25-38 |
- Identified Points of Contention:
- Scope Questions: A central issue may be the construction of the functional terms "immediate release composition" and "delayed release composition." The analysis will question whether Defendants' product, potentially a single integrated extended-release matrix, contains two distinct "compositions" as required by the claim, or if the claim can read on a single formulation that exhibits a biphasic release profile.
- Technical Questions: The complaint does not provide dissolution data or structural details for the accused product. A key question for the court will be what evidence supports the allegation that the accused product achieves the claimed dual-release functionality.
'404 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| An oral dosage form comprising: (A) a core comprising... doxylamine... and... pyridoxine... | The complaint alleges the ANDA product is an "oral dosage form" that has the claimed core structure. | ¶59 | col. 4:50-58 |
| (B) an enteric coating substantially surrounding the core; and | The complaint alleges the ANDA product possesses an enteric coating around the core. | ¶59 | col. 4:50-58 |
| (C) one or more outer coatings substantially surrounding the enteric coating, the one or more outer coatings comprising... doxylamine... and... pyridoxine... | The complaint alleges the ANDA product has one or more outer coatings containing active ingredients over the enteric coating. | ¶59 | col. 4:50-58 |
- Identified Points of Contention:
- Scope Questions: The dispute for the ’404 Patent may center on the structural definitions of "core," "enteric coating," and "outer coatings." It raises the question of whether the physical layers of the accused product, once revealed in discovery, correspond to the specific architecture required by the claim language.
- Technical Questions: What is the physical structure of the accused generic tablet? The infringement analysis will depend entirely on evidence establishing whether it is a multi-layer tablet with the specific arrangement of a drug-containing core, an intermediate enteric layer, and a drug-containing outer layer.
V. Key Claim Terms for Construction
Term ('489 Patent): "immediate release composition" and "delayed release composition"
- Context and Importance: These terms define the fundamental nature of the '489 Patent's invention. The infringement case hinges on whether the accused product contains two structurally or functionally distinct "compositions." Practitioners may focus on this term because a defendant could argue its product is a single, monolithic extended-release formulation that does not have two separate compositions, even if it produces a biphasic release curve.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification defines these components functionally, stating that an "immediate release composition is for effecting release substantially within the stomach" ('489 Patent, col. 5:18-20). This language could support an interpretation where any formulation that releases a drug portion quickly in the stomach meets the "immediate" limitation, regardless of physical form.
- Evidence for a Narrower Interpretation: The specification describes embodiments where the compositions are physically distinct, such as a "core comprising the delayed release composition and... one or more coats... comprising the immediate release composition" ('489 Patent, col. 4:60-64). This could support a narrower construction requiring physically separate components.
Term ('404 Patent): "core"
- Context and Importance: This term establishes the foundational layer of the claimed structure in the '404 Patent. The definition of "core" will be critical to determining if the accused product's structure maps onto the claim. A defendant might argue that its formulation does not have a discernible "core" in the manner claimed.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claims do not define the "core" by its manufacturing method or specific excipients, only by its contents (doxylamine and pyridoxine) and its position relative to the enteric coating ('404 Patent, col. 41:1-12). This may support a broad reading on any central drug-containing portion of a layered tablet.
- Evidence for a Narrower Interpretation: Embodiments in the specification link the "core" to the delayed-release function, as it is the component protected by the enteric coating ('404 Patent, col. 4:60-64). This could support an interpretation requiring the "core" to be specifically formulated for delayed release, not just any central mass.
VI. Other Allegations
- Indirect Infringement: The complaint alleges both induced and contributory infringement for all four patents. The allegations are based on Defendants having knowledge of the patents and intending for physicians and patients to use the accused product according to its label, which will allegedly result in direct infringement (Compl. ¶¶53-55, 61-63, 69-71, 77-79). The complaint further alleges the product is not a staple article of commerce suitable for substantial noninfringing use (Compl. ¶55).
- Willful Infringement: The complaint does not include an explicit allegation of willful infringement or a request for enhanced damages under 35 U.S.C. § 284.
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of claim construction and scope: For the '489 patent, can the functional term "composition" be construed to read on a single, integrated extended-release matrix, or does it require two physically distinct components? For the '404 and '703 patents, how narrowly will the court define the structural terms "core," "enteric coating," and "outer coatings," and will the accused product's physical architecture fall within those definitions?
- A key evidentiary question will be one of technical proof: The complaint relies on conclusory allegations and a purported "admission by omission" from a notice letter. The case will likely turn on what discovery reveals about the actual formulation, physical structure, and dissolution profile of the Defendants' ANDA product and how that evidence aligns with the court's construction of the key claim terms.
- A central legal question will be the effect of the Paragraph IV notice: The complaint repeatedly asserts that Defendants' failure to address certain claims in their notice letter constitutes an admission of infringement. The court will need to determine the legal weight, if any, of this alleged admission by omission, which is a frequently contested issue in ANDA litigation.