DCT

2:21-cv-12794

TherapeuticsMD Inc v. Teva Pharma USA Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:21-cv-12794, D.N.J., 06/21/2021
  • Venue Allegations: Plaintiff alleges venue is proper in the District of New Jersey because Defendant Teva USA maintains a principal place of business in the district, is registered to do business in the state, and has previously consented to jurisdiction and venue in the district in four related patent infringement actions.
  • Core Dispute: Plaintiff alleges that Defendants' submission of an Abbreviated New Drug Application (ANDA) to the FDA, seeking approval to market a generic version of Plaintiff's Imvexxy® product, constitutes an act of infringement of a patent related to a soluble estradiol capsule for vaginal insertion.
  • Technical Context: The technology relates to pharmaceutical formulations for hormone replacement therapy, specifically for treating symptoms of vulvovaginal atrophy in postmenopausal women.
  • Key Procedural History: This action arises under the Hatch-Waxman Act, triggered by Defendants' filing of ANDA No. 214137 with a Paragraph IV certification, asserting that U.S. Patent No. 10,888,516 is invalid, unenforceable, or will not be infringed by the proposed generic product. The complaint notes this is the fifth lawsuit filed by TherapeuticsMD against Teva concerning patents listed in the FDA's Orange Book for the Imvexxy® product, with the prior four actions having been consolidated.

Case Timeline

Date Event
2012-12-21 U.S. Patent No. 10,888,516 Earliest Priority Date
2018-05-29 FDA approval of Plaintiff's Imvexxy® New Drug Application
2020-04-01 Plaintiff files first related complaint against Defendants
2020-07-13 Plaintiff files second related complaint against Defendants
2020-08-21 Plaintiff files third related complaint against Defendants
2020-11-30 Plaintiff files fourth related complaint against Defendants
2021-01-12 U.S. Patent No. 10,888,516 Issues
2021-05-13 Defendants send Notice Letter regarding ANDA No. 214137
2021-06-21 Complaint Filing Date

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 10,888,516 - Soluble Estradiol Capsule For Vaginal Insertion

  • Patent Identification: U.S. Patent No. 10,888,516, issued January 12, 2021.

The Invention Explained

  • Problem Addressed: The patent’s background section describes deficiencies with existing treatments for vulvovaginal atrophy. It notes that conventional creams and gels can be messy, rub off, contain irritating alcohols, and rely on reusable applicators that pose hygiene and trauma risks (’516 Patent, col. 1:59-2:6). Vaginal tablets may not dissolve completely, leading to reduced efficacy and unwanted discharge, while a prior art capsule required the presence of vaginal secretions to activate its formulation—a practical issue for patients whose condition is characterized by vaginal dryness (’516 Patent, col. 2:7-14, 2:25-32).
  • The Patented Solution: The invention is a pharmaceutical formulation comprising estradiol that is already solubilized within a liquid fill material, which is then encapsulated in a soft capsule for vaginal insertion (’516 Patent, Abstract). This design aims to provide a stable, easy-to-administer dosage form that releases the active ingredient upon dissolution of the capsule, without depending on the patient's own vaginal secretions to activate the formulation, thereby improving patient comfort, hygiene, and compliance (’516 Patent, col. 2:33-39).
  • Technical Importance: The patented approach seeks to improve the reliability and user experience of locally administered hormone therapy, potentially increasing patient adherence to treatment for a common menopausal condition (Compl. ¶26).

Key Claims at a Glance

The complaint does not identify specific claims asserted against the Defendants. However, the first independent claim, Claim 1, is representative of the patented method.

  • Independent Claim 1: A method of treating a symptom of vulvovaginal atrophy by administering an estradiol-containing soft gelatin capsule, with key elements including:
    • A method of treating a symptom of vulvovaginal atrophy in a female human patient.
    • The method comprises administering an estradiol-containing soft gelatin capsule intravaginally on a specified dosing schedule.
    • The capsule contains a liquid fill material comprising "one or more C6 to C14 fatty acid mono-, di-, or triesters of glycerol" and "1 to 10 mcg of estradiol."
    • The liquid fill material has a specified viscosity of "between 50 to 1000 cP as measured at 25° C."
    • Administering the capsule provides an estradiol AUC (Area Under the Curve) and Cmax (Maximum Concentration) that are 80% to 125% of the values obtained from administering a "reference soft gelatin capsule," which is itself defined by a specific formulation.

III. The Accused Instrumentality

Product Identification

  • Defendants’ proposed "Estradiol Vaginal Insert 4 mcg and 10 mcg," which is the subject of Abbreviated New Drug Application (ANDA) No. 214137 (Compl. ¶19, ¶46).

Functionality and Market Context

  • The complaint alleges that Defendants' ANDA Product is a generic version of Plaintiff’s Imvexxy® product and relies on it as the reference listed drug (Compl. ¶45).
  • Based on the proposed prescribing information, the ANDA Product is indicated for the "treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause" (Compl. ¶35).
  • The proposed instructions for use specify intravaginal administration on a dosing schedule of one insert daily for two weeks, followed by one insert twice weekly (Compl. ¶36). The complaint alleges the ANDA Product will be available in 4 mcg and 10 mcg dosage strengths (Compl. ¶46).

IV. Analysis of Infringement Allegations

U.S. Patent No. 10,888,516 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of treating a symptom of vulvovaginal atrophy in a female human patient in need thereof... Defendants' proposed product label indicates the product for the treatment of dyspareunia, a symptom of vulvar and vaginal atrophy due to menopause. ¶35 col. 18:30-32
...the method comprising administering to the female human an estradiol-containing soft gelatin capsule intravaginally once daily for 14 days and one capsule twice weekly thereafter... Defendants' proposed product label allegedly instructs users to administer the product intravaginally on a schedule of one insert daily for two weeks, followed by one insert twice weekly. ¶36 col. 18:32-36
...the estradiol-containing liquid fill material comprising one or more C6 to C14 fatty acid mono-, di-, or triesters of glycerol... The complaint does not provide sufficient detail for analysis of this element. col. 18:39-41
...and 1 to 10 mcg of estradiol... Defendants' ANDA Product is an "Estradiol Vaginal Insert, 4 mcg and 10 mcg," which falls within the claimed dosage range. ¶46 col. 18:41-42
...wherein the estradiol-containing liquid fill material has a viscosity of between 50 to 1000 cP as measured at 25° C. The complaint does not provide sufficient detail for analysis of this element. col. 18:42-44
...wherein: administering the estradiol-containing soft gelatin capsule... provides an estradiol AUC and estradiol Cmax that are each 80% to 125% of the estradiol AUC and estradiol Cmax obtained upon... administration of a reference soft gelatin capsule... As a generic drug submitted under an ANDA, Defendants' product must be bioequivalent to the reference listed drug, Imvexxy®. The complaint alleges the ANDA is based on Imvexxy®. ¶45 col. 18:45-50

Identified Points of Contention

  • Technical Questions: The complaint does not contain specific allegations about the formulation of Defendants' ANDA product. A central factual dispute will likely concern whether the accused product's liquid fill material meets the claim limitations requiring "one or more C6 to C14 fatty acid mono-, di-, or triesters of glycerol" and a viscosity "between 50 to 1000 cP." This information is contained within the confidential ANDA and will be a key subject of discovery.
  • Scope Questions: Claim 1 includes a bioequivalence limitation that defines infringement relative to a "reference soft gelatin capsule," which is described with a highly specific formulation. A potential issue for the court could be whether Plaintiff's own commercial product, Imvexxy®, which serves as the basis for Defendants' ANDA, meets all the limitations of this "reference" as defined in the claim. If it does not, it may raise the question of whether a product designed to be bioequivalent to Imvexxy® can infringe.

No probative visual evidence provided in complaint.

V. Key Claim Terms for Construction

  • The Term: "liquid fill material"
  • Context and Importance: The composition of the "liquid fill material" is the technical core of the invention. The patentability and infringement analyses will depend heavily on the scope of this term, particularly the specific classes of glycerides and the required viscosity recited in Claim 1. Practitioners may focus on this term because Defendants could argue their formulation uses different excipients that fall outside a properly construed definition of the claimed material.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification discloses a wide range of suitable solubilizing agents, including various mono-, di-, and triglycerides, as well as glycols and their derivatives, suggesting the invention is not limited to a single embodiment (’516 Patent, col. 6:15-65).
    • Evidence for a Narrower Interpretation: Claim 1 specifically recites "one or more C6 to C14 fatty acid mono-, di-, or triesters of glycerol" and a specific viscosity range (’516 Patent, col. 18:39-44). The patent also distinguishes its "solubilized" formulation from prior art that required different components, such as a "hydrophilic gel-forming bioadhesive agent," which the patent explicitly excludes (’516 Patent, col. 3:56-4:4).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Defendants will induce infringement by third parties (Compl. ¶54). The alleged basis for inducement is the proposed prescribing information for the ANDA Product, which will allegedly instruct physicians to prescribe and patients to use the product in a manner that directly practices the patented method of treatment (Compl. ¶35-36).
  • Willful Infringement: The prayer for relief seeks a judgment that infringement is willful (Prayer for Relief ¶G). The complaint alleges that Defendants' submission of the ANDA was made with knowledge of the ’516 Patent, as evidenced by their Paragraph IV certification sent to the Plaintiff (Compl. ¶33, ¶47).

VII. Analyst’s Conclusion: Key Questions for the Case

  1. A central evidentiary question will be one of compositional identity: does the formulation detailed in Defendants' confidential ANDA meet the specific compositional and physical property limitations of the asserted claims, particularly the requirements for C6-C14 fatty acid esters of glycerol and the specified viscosity range?
  2. A key legal and factual question will be one of claim scope and commercial embodiment: does the asserted claim language, which defines infringement by reference to a bioequivalent "reference" product with a specific formulation, accurately describe Plaintiff's own commercial Imvexxy® product? The answer will determine the standard against which Defendants' bioequivalent generic will be judged.