DCT

2:20-cv-11087

TherapeuticsMD Inc v. Teva Pharma USA Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:20-cv-11087, D.N.J., 08/21/2020
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey based on Defendant Teva USA maintaining a principal place of business in the district, conducting continuous business there, and having previously consented to jurisdiction in related matters.
  • Core Dispute: Plaintiff alleges that Defendants' filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff's Imvexxy® product constitutes an act of infringement of a patent covering low-dose estradiol pharmaceutical compositions and methods.
  • Technical Context: The technology concerns formulations for hormone replacement therapy, specifically low-dose, vaginally-administered estradiol to treat symptoms of menopause, a field focused on balancing therapeutic efficacy with minimal systemic side effects.
  • Key Procedural History: This action arises under the Hatch-Waxman Act, triggered by Defendants' ANDA filing containing a Paragraph IV certification against the patent-in-suit. The complaint notes that this is the third lawsuit filed by TherapeuticsMD against Teva concerning its ANDA for a generic version of Imvexxy®, with prior suits targeting different patents listed in the FDA's Orange Book for the same drug.

Case Timeline

Date Event
2014-10-22 Earliest Priority Date for ’082 Patent
2018-05-29 FDA approves Plaintiff's New Drug Application for Imvexxy®
2020-06-02 U.S. Patent No. 10,668,082 Issues
2020-08-05 Teva sends Paragraph IV Notice Letter regarding the ’082 Patent
2020-08-21 Complaint Filed

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

U.S. Patent No. 10,668,082 - "Vaginal Inserted Estradiol Pharmaceutical Compositions and Methods"

  • Patent Identification: U.S. Patent No. 10,668,082, "Vaginal Inserted Estradiol Pharmaceutical Compositions and Methods," issued June 2, 2020 (the "’082 Patent").

The Invention Explained

  • Problem Addressed: The patent describes the challenge of treating postmenopausal conditions like vulvovaginal atrophy (VVA) and associated dyspareunia (painful intercourse). It notes that while estrogen treatments are effective, there is a need for formulations that provide local relief without significant systemic absorption of the hormone, thereby improving the safety profile and patient compliance (’082 Patent, col. 1:25-41, 1:52-61).
  • The Patented Solution: The invention is a soft gelatin capsule containing a liquid pharmaceutical composition for vaginal administration. This composition includes a low dose of solubilized estradiol (e.g., 4 or 10 mcg) in a medium-chain oil carrier. The formulation is designed to dissolve after insertion, delivering the active ingredient directly to the vaginal tissue to treat VVA symptoms locally, with the goal of limiting systemic exposure (’082 Patent, Abstract; col. 2:1-5, 2:30-33). The process of creating the suppository is illustrated in a flowchart in the patent's Figure 1 (’082 Patent, Fig. 1).
  • Technical Importance: The technology aims to provide the therapeutic benefits of estrogen for a common menopausal condition while addressing long-standing safety concerns associated with systemic hormone replacement therapy (’082 Patent, col. 1:52-61).

Key Claims at a Glance

  • The complaint alleges infringement of "one or more" of the patent's claims without specifying them (Compl. ¶53). The asserted independent claims are method claims 1, 8, and 15.
  • Independent Claim 1 recites a method of treating VVA with the following essential elements:
    • Vaginally administering a liquid pharmaceutical composition to a subject in need.
    • The composition comprises estradiol in a dosage of 4 mcg.
    • The composition has a viscosity in the range of "about 50 cP to about 1000 cP at 25° C."
    • The method includes "increasing the dosage of estradiol if the subject does not exhibit an improvement in the clinical response."
  • Independent Claim 15 is directed to a method of treating moderate to severe dyspareunia with a similar composition.

III. The Accused Instrumentality

Product Identification

  • Defendants' "Estradiol Vaginal Insert 4 mcg and 10 mcg" product, for which Teva filed ANDA No. 214137 (the "ANDA Product") (Compl. ¶¶18, 46).

Functionality and Market Context

  • The ANDA Product is a proposed generic equivalent to Plaintiff's Imvexxy®, identified as the reference listed drug (Compl. ¶45).
  • The proposed prescribing information indicates the product is for treating "moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause" (Compl. ¶34). It is to be administered intravaginally, with a recommended starting dose of 4 mcg daily for two weeks, followed by twice-weekly maintenance dosing (Compl. ¶35). The label allegedly states that "Dosage adjustment should be guided by the clinical response" (Compl. ¶35).
  • The filing of the ANDA signifies Defendants' intent to market a generic version of Imvexxy® before the expiration of the ’082 Patent, positioning it as a direct competitor (Compl. ¶18). The complaint lists the inactive ingredients of the proposed product, which include medium chain triglycerides and polyethylene glycol stearates (Compl. ¶36).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

Claim Chart Summary

The complaint provides a basis for infringement of method claims, such as Claim 1, through induced infringement based on the proposed product label.

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of treating vulvovaginal atrophy (VVA) comprising vaginally administering to a subject in need thereof a liquid pharmaceutical composition... The proposed label for the ANDA Product instructs intravaginal administration for the treatment of dyspareunia, a symptom of VVA. ¶34, ¶35 col. 5:19-22
...comprising estradiol in a dosage of 4 mcg... The ANDA Product is identified as an "Estradiol Vaginal Insert, 4 mcg and 10 mcg," and the proposed label instructs starting at the 4 mcg dosage strength. ¶35, ¶46 col. 64:9-10
...wherein the composition has a viscosity in the range of about 50 cP to about 1000 cP at 25° C.... The complaint alleges the ANDA product is based on Plaintiff's Imvexxy® as the reference listed drug, implying it must have equivalent physical properties to be approved as a generic. ¶45 col. 19:1-3
...and increasing the dosage of estradiol if the subject does not exhibit an improvement in the clinical response. The proposed label for the ANDA Product allegedly states, "Dosage adjustment should be guided by the clinical response." ¶35 col. 122:38-40

Identified Points of Contention

  • Factual Question (Viscosity): The complaint does not provide direct evidence that Teva's ANDA Product has a viscosity within the claimed range. It relies on the assertion that the product is a generic version of Imvexxy® (Compl. ¶45). A central factual dispute may be whether the accused product's physical properties, specifically its viscosity, meet this claim limitation.
  • Legal Question (Inducement): The infringement allegation for this method claim rests on a theory of induced infringement. A key question for the court will be whether the language in the ANDA Product's proposed label—specifically "Dosage adjustment should be guided by the clinical response" (Compl. ¶35)—is sufficient to demonstrate that Teva intended to, and would, encourage or instruct medical professionals to perform every step of the claimed method.
  • Scope Question (Indefiniteness): Independent claim 15 of the patent contains the phrase "and the dosage does not exhibit an improvement in the moderate to severe dyspareunia" (’082 Patent, col. 122:52-54). This phrasing is unconventional and raises the question of whether the claim is indefinite under 35 U.S.C. § 112, as it appears to state a condition of non-efficacy as a claim limitation.

V. Key Claim Terms for Construction

  • The Term: "liquid pharmaceutical composition"

    • Context and Importance: The claims require a "liquid" composition, yet the product is delivered via a soft gelatin capsule, which is solid at room temperature. The definition of this term is critical because if the "composition" is deemed to be the entire solid capsule as administered, there would be no literal infringement.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation (favoring Plaintiff): The specification consistently distinguishes between the "delivery vehicle" (the capsule) and the "pharmaceutical composition" (the fill material) (’082 Patent, col. 69:46-53). It also describes the fill material itself as a "liquid composition" that is encapsulated, supporting the view that the term refers only to the fill. ('082 Patent, col. 21:15-19).
      • Evidence for a Narrower Interpretation (favoring Defendant): The patent discloses that some formulations are "Solid/Liquid" or "Semisolid" at room temperature (’082 Patent, Table 1, col. 53-54). A defendant could argue that the fill material is not "liquid" under a plain and ordinary meaning, or that the term should be limited to only those embodiments that are fully liquid at 25°C.

  • The Term: "about 50 cP to about 1000 cP"

    • Context and Importance: This viscosity range is a key technical limitation differentiating the invention. Whether the ANDA Product infringes will depend on where its viscosity falls and how much leeway the term "about" provides.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation (favoring Plaintiff): The use of "about" suggests the inventors did not intend the numerical endpoints to be rigid limits. The specification describes a wide array of potential excipients and formulations, which may support an argument that the numbers are exemplary of a functional range rather than an absolute requirement (’082 Patent, col. 15-16).
      • Evidence for a Narrower Interpretation (favoring Defendant): Table 1 in the specification provides specific viscosity measurements for different formulations (e.g., 50 cP, 140 cP, 240 cP), none of which approach the 1000 cP upper limit (’082 Patent, col. 53-54). A defendant might argue that these examples define the practical scope of the invention and that "about" should therefore be construed narrowly around the exemplified values.

VI. Other Allegations

  • Indirect Infringement: The complaint is premised on statutory infringement under 35 U.S.C. § 271(e)(2), which defines the submission of an ANDA seeking to market a patented drug as an act of infringement (Compl. ¶51). The complaint also alleges that commercialization of the ANDA Product would induce infringement by third parties (e.g., patients and doctors) who would follow the instructions on the proposed product label (Compl. ¶54).
  • Willful Infringement: Plaintiff alleges that infringement will be willful, asserting that Defendants knew of the ’082 Patent, as evidenced by its listing in the Orange Book and the Paragraph IV certification letter sent to the Plaintiff (Compl. ¶¶31-33, 39). The prayer for relief seeks a finding of willful infringement and enhanced damages should the ANDA product be commercially launched (Compl. p. 14, ¶G).

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

The resolution of this Hatch-Waxman dispute will likely depend on the court's findings on three central questions:

  • A key evidentiary question will be one of physical properties: Does the defendant's proposed generic product possess a viscosity that falls within the "about 50 cP to about 1000 cP" range required by the claims? Proving this fact will be essential to the plaintiff's infringement case.
  • A core issue will be one of claim construction: How should the term "liquid pharmaceutical composition" be defined in the context of a product delivered in a solid softgel capsule? The answer will determine whether the accused product's form falls within the literal scope of the claims.
  • A dispositive legal question will be one of induced infringement: Is the language on the defendant's proposed product label sufficient to prove the intent required to induce medical professionals and patients to perform all the steps of the patented method, including the dosage adjustment step?