DCT

2:22-cv-04248

Bausch Health Ireland Ltd v. Padagis Israel Pharma Ltd

Log In
Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:22-cv-04248, D.N.J., 06/24/2022
  • Venue Allegations: Venue is alleged to be proper based on Defendants’ business activities in New Jersey, their intent to market the accused product in the district upon FDA approval, and a stipulation by the parties not to oppose venue in the District of New Jersey for this action.
  • Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff’s Arazlo® lotion constitutes an act of patent infringement under the Hatch-Waxman Act.
  • Technical Context: The dispute involves a topical pharmaceutical formulation, specifically an oil-in-water lotion, designed to treat skin conditions such as acne vulgaris while minimizing skin irritation.
  • Key Procedural History: The lawsuit was initiated in response to Defendant’s submission of ANDA No. 215393, which included a Paragraph IV certification asserting that Plaintiff’s patent is invalid, unenforceable, or will not be infringed. The complaint was filed within the 45-day statutory window following receipt of Defendant’s notice letter, which triggers an automatic 30-month stay on the FDA’s approval of the generic product.

Case Timeline

Date Event
2017-05-12 ’482 Patent Priority Date
2022-04-26 ’482 Patent Issue Date
2022-05-12 Plaintiff received Defendant's Paragraph IV Notice Letter
2022-06-24 Complaint Filing Date

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

U.S. Patent No. 11,311,482 - "Topical Compositions and Methods for Treating Skin Diseases"

The Invention Explained

  • Problem Addressed: The patent’s background section states that the retinoid tazarotene, while effective for treating acne and psoriasis, can cause "significant local skin irritation," leading many patients to discontinue therapy (’482 Patent, col. 1:21-25). The stated need is for a more effective and safer topical medication with reduced adverse effects (’482 Patent, col. 1:25-28).
  • The Patented Solution: The invention is a specific oil-in-water emulsion vehicle (a lotion) that delivers a low concentration of tazarotene (less than 0.050% by weight) (’482 Patent, col. 1:35-40). The solution lies in the particular combination of ingredients in the vehicle—including a dicarboxylic acid ester and mineral oil in the oil phase, and a specific "carbomer homopolymer" and "polymeric emulsifier" in the aqueous phase—which is designed to maintain efficacy while improving skin tolerability (’482 Patent, Abstract; col. 1:53-col. 2:7).
  • Technical Importance: This formulation approach attempts to improve patient compliance and therapeutic outcomes by mitigating the common side effects associated with a known active pharmaceutical ingredient (’482 Patent, col. 1:21-28).

Key Claims at a Glance

  • The complaint asserts infringement of "at least one claim" without specifying which ones (Compl. ¶34). The broadest asserted independent claim is likely Claim 1, a method of use claim.
  • The essential elements of Claim 1 are:
    • A method of treating acne vulgaris comprising topically applying a pharmaceutical composition once per day to an affected area of a body of a subject suffering from acne vulgaris.
    • The composition comprises tazarotene at a concentration of about 0.045 percent by weight of the composition as a sole active pharmaceutical ingredient.
    • The composition is an oil-in-water emulsion lotion comprising an oil phase and an aqueous phase.
    • The oil phase comprises a dicarboxylic acid ester and a mineral oil at a total concentration of 10-12 percent by weight of the composition.
    • The aqueous phase comprises water and a carbomer homopolymer, wherein the concentration of the carbomer homopolymer is 0.5-0.7 percent by weight of the composition.
    • The composition further comprises a polymeric emulsifier at a concentration of 0.3-0.5 percent by weight of the composition.
  • The complaint does not explicitly reserve the right to assert dependent claims.

III. The Accused Instrumentality

Product Identification

The accused instrumentality is the "Padagis ANDA Product," a generic tazarotene (0.045%) lotion for which Defendant Padagis seeks FDA approval via Abbreviated New Drug Application (ANDA) No. 215393 (Compl. ¶¶ 1, 29).

Functionality and Market Context

The Padagis ANDA Product is intended for the topical treatment of acne vulgaris in patients 9 years of age or older, the same indication as Plaintiffs' Arazlo® product (Compl. ¶¶ 27, 29). The complaint alleges that Padagis's ANDA filing relies on the FDA's prior approval of Arazlo® and contains data demonstrating the bioequivalence of its generic product to Arazlo® (Compl. ¶31). The relevant act of infringement alleged is the submission of the ANDA itself, which seeks approval for commercial manufacture, use, and sale of the generic lotion in the United States (Compl. ¶34).

IV. Analysis of Infringement Allegations

The complaint does not contain a detailed claim chart but alleges that the filing of the ANDA for the proposed generic product, which is purported to be a bioequivalent copy of Arazlo®, constitutes infringement. The core infringement allegations for the representative independent claim are summarized below.

’482 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of treating acne vulgaris... comprising topically applying a pharmaceutical composition once per day... The Padagis ANDA Product seeks approval for the topical treatment of acne vulgaris; its proposed labeling will allegedly instruct for once-daily use, thereby inducing infringement. ¶27, ¶29, ¶36 col. 14:36-41
the composition comprises tazarotene at a concentration of about 0.045 percent by weight... as a sole active pharmaceutical ingredient The Padagis ANDA Product is described as a generic tazarotene (0.045%) lotion. ¶29 col. 14:42-45
the composition is an oil-in-water emulsion lotion comprising an oil phase and an aqueous phase The Padagis ANDA Product is a lotion alleged to be bioequivalent to Arazlo®, which is an oil-in-water emulsion lotion. ¶29, ¶31 col. 14:46-48
the oil phase comprises a dicarboxylic acid ester and a mineral oil at a total concentration of 10-12 percent by weight of the composition As an alleged generic copy, the Padagis ANDA Product is asserted to contain an oil phase with these components within the claimed concentration range. ¶31, ¶34 col. 14:49-52
the aqueous phase comprises water and a carbomer homopolymer, wherein the concentration of the carbomer homopolymer is 0.5-0.7 percent by weight... As an alleged generic copy, the Padagis ANDA Product is asserted to contain an aqueous phase with this component within the claimed concentration range. ¶31, ¶34 col. 14:53-57
the composition further comprises a polymeric emulsifier at a concentration of 0.3-0.5 percent by weight of the composition As an alleged generic copy, the Padagis ANDA Product is asserted to contain this component within the claimed concentration range. ¶31, ¶34 col. 14:58-61
  • Identified Points of Contention:
    • No probative visual evidence provided in complaint.
    • Scope Questions: The primary question will be whether the specific formulation detailed in Padagis’s confidential ANDA filing meets every limitation of an asserted claim. Disputes may arise over the chemical identity and concentration of each excipient in the generic formulation compared to the claimed components and ranges.
    • Technical Questions: A key technical question will be whether the thickening and emulsifying agents used in the Padagis ANDA Product are properly classified as a "carbomer homopolymer" and a "polymeric emulsifier" as those terms are defined within the patent.

V. Key Claim Terms for Construction

The complaint does not provide sufficient detail for analysis of specific claim construction disputes. However, based on the patent's language, the following terms may be central to the case.

"carbomer homopolymer"

  • Context and Importance: This term defines a critical thickening agent in the aqueous phase. Practitioners may focus on this term because the defendant's non-infringement position could be that its formulation uses a different type of carbomer (e.g., a copolymer or interpolymer) that falls outside the scope of a "homopolymer."
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The complaint does not provide a basis for this analysis.
    • Evidence for a Narrower Interpretation: The specification explicitly distinguishes between types of carbomers, defining "Carbopol® homopolymers" as "polymers of acrylic acid crosslinked with allyl sucrose or allylpentaerythritol," while separately defining "Carbopol® copolymers" as polymers also containing a "C10-C30 alkyl acrylate" (’482 Patent, col. 3:33-38). This language may support a narrow construction that excludes polymers containing the alkyl acrylate component.

"about 0.045 percent by weight"

  • Context and Importance: This term defines the concentration of the sole active ingredient, tazarotene. In pharmaceutical cases, the word "about" can be critical. The dispute will center on how much deviation from "0.045 percent" is permissible while still falling within the claim scope.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification provides several ranges for the tazarotene concentration, such as "from about 0.01 to about 0.049 wt %," and "from about 0.03 to about 0.045 wt %," suggesting some flexibility was contemplated (’482 Patent, col. 1:53-54; col. 2:59-61).
    • Evidence for a Narrower Interpretation: The patent repeatedly highlights "about 0.045 wt %" as a specific concentration, including in the detailed example "Composition A," which has exactly 0.045% tazarotene (’482 Patent, col. 2:61; Table 2). This emphasis could be used to argue that "about" allows for only minor variations consistent with standard manufacturing tolerances.

VI. Other Allegations

Indirect Infringement

The complaint alleges that upon approval, Padagis will contributorily infringe and induce infringement of the asserted claims (Compl. ¶36, ¶42). This allegation is based on the premise that Padagis will sell its generic product with a label and instructions that direct medical professionals and patients to use it in a manner that directly infringes the patent's method claims (e.g., applying it once daily to treat acne).

Willful Infringement

The complaint does not include an explicit allegation of willful infringement. It does, however, request that the court declare the case "exceptional" under 35 U.S.C. § 285, which could entitle Plaintiffs to an award of attorney's fees (Prayer for Relief ¶5).

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

  • A core issue will be one of chemical identity and claim construction: can the term "carbomer homopolymer" be construed narrowly, based on the patent’s specific definitions, to exclude the polymer used in the Padagis ANDA Product? The patent’s clear distinction between homopolymers and copolymers suggests this will be a significant point of contention.
  • A second key question will be one of factual correspondence: does a direct comparison of the formulation disclosed in Padagis’s confidential ANDA filing show that every component and concentration falls within the precise ranges required by an asserted claim of the "'482'" Patent? The outcome will likely depend on expert analysis of the respective formulations.