DCT

2:25-cv-02000

Bausch Health Ireland Ltd v. Taro Pharma Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:25-cv-02000, D.N.J., 03/20/2025
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey based on Defendant Taro USA maintaining a regular and established place of business in the district, and on all three foreign-domiciled defendants having previously consented to venue in the jurisdiction in prior litigation and engaging in business contacts with New Jersey.
  • Core Dispute: Plaintiffs allege that Defendants' submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of Plaintiffs' acne treatment product, Cabtreo®, constitutes an act of infringement of eight U.S. patents.
  • Technical Context: The patents relate to topical pharmaceutical gel formulations for the treatment of acne, a large and competitive segment of the dermatology market.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Plaintiffs' receipt of a Notice of Paragraph IV Certification from Defendants, which stated that the patents-in-suit are invalid, unenforceable, or will not be infringed by the proposed generic product.

Case Timeline

Date Event
2008-06-05 Earliest Priority Date ('434, '208, '049, '918 Patents)
2012-10-16 U.S. Patent No. 8,288,434 Issues
2017-02-07 U.S. Patent No. 9,561,208 Issues
2019-03-05 U.S. Patent No. 10,220,049 Issues
2019-08-01 Earliest Priority Date ('467, '059, '859, '278 Patents)
2020-04-21 U.S. Patent No. 10,624,918 Issues
2022-07-19 U.S. Patent No. 11,389,467 Issues
2023-10-20 FDA Approves NDA for Cabtreo®
2024-10-29 U.S. Patent No. 12,128,059 Issues
2024-11-05 U.S. Patent No. 12,133,859 Issues
2024-11-12 U.S. Patent No. 12,138,278 Issues
2025-02-05 Plaintiffs Receive Defendants' Paragraph IV Notice Letter
2025-03-20 Complaint Filed

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

U.S. Patent No. 8,288,434 - "Topical Pharmaceutical Formulations Containing A Low Concentration Of Benzoyl Peroxide In Suspension In Water And A Water-Miscible Organic Solvent"

  • Patent Identification: U.S. Patent No. 8,288,434 ("the “’434 Patent”"), issued October 16, 2012.
  • The Invention Explained:
    • Problem Addressed: The patent background describes a known trade-off in topical acne treatments containing benzoyl peroxide (BPO): higher concentrations are more effective but also cause significant skin irritation ('049 Patent, col. 1:59-66). This irritation is attributed to the portion of BPO that is in a solid, suspended state, rather than dissolved ('049 Patent, col. 2:1-6). Prior attempts to dissolve all the BPO required high concentrations of organic solvents, which are themselves irritating to the skin ('049 Patent, col. 2:14-18).
    • The Patented Solution: The invention is an aqueous topical formulation that uses a low concentration of BPO (less than 5.0% w/w) in a suspension containing both water and a water-miscible organic solvent ('049 Patent, Abstract). The formulation is designed with a high ratio of water to organic solvent, which maintains the BPO at or near a state of "saturated solubility" in the residual formulation that remains on the skin after the water evaporates ('049 Patent, col. 4:15-22). This approach seeks to maximize the thermodynamic activity and efficacy of the BPO while minimizing the concentration of both the BPO and the organic solvent to reduce irritation ('049 Patent, col. 4:48-59).
    • Technical Importance: This formulation strategy provided a pathway to reduce the adverse side effects associated with BPO treatments, potentially improving patient adherence and outcomes without compromising clinical efficacy ('049 Patent, col. 4:55-59).
  • Key Claims at a Glance:
    The complaint alleges infringement of "at least one claim" of the ’434 Patent (Compl. ¶57). U.S. Patent No. 10,220,049, which is in the same patent family, contains representative independent claim 1, a composition claim with the following essential elements:
    • An aqueous suspension formulation for topical application to the skin comprising 2.5% w/w to 4.5% w/w benzoyl peroxide, about 1.2% w/w clindamycin phosphate, propylene glycol, a gelling agent, and water;
    • Wherein the combined concentration of water and propylene glycol is sufficient to provide a suspension of benzoyl peroxide in a saturated solution of benzoyl peroxide;
    • Wherein the ratio of water to propylene glycol in the formulation ranges from 12:1 to 20:1; and
    • Wherein the concentration of the propylene glycol is one to four times the concentration of the benzoyl peroxide.
      The complaint does not specify any dependent claims but makes a general allegation of infringement.

U.S. Patent No. 9,561,208 - "Topical Pharmaceutical Formulations Containing A Low Concentration Of Benzoyl Peroxide In Suspension In Water And A Water-Miscible Organic Solvent"

  • Patent Identification: U.S. Patent No. 9,561,208 ("the “’208 Patent”"), issued February 7, 2017.
  • The Invention Explained:
    • Problem Addressed: The ’208 Patent addresses the same technical problem as the ’434 Patent: the skin irritation caused by topical BPO formulations, which is linked to the concentration of suspended BPO particles ('208 Patent, col. 2:1-6).
    • The Patented Solution: The technology disclosed is substantially the same as in the ’434 Patent, focusing on a low-concentration BPO suspension in a water and water-miscible organic solvent system ('208 Patent, Abstract). The claims of the ’208 Patent are directed to methods of using such a formulation to treat acne.
    • Technical Importance: As with the ’434 Patent, this invention provided a method for treating acne that could offer comparable efficacy to existing higher-strength products but with a more favorable tolerability profile ('208 Patent, col. 4:48-59).
  • Key Claims at a Glance:
    The complaint alleges infringement of "at least one claim" of the ’208 Patent (Compl. ¶69). Independent claim 1 is a method claim with the following essential steps and conditions:
    • A method for treating acne comprising applying once a day for up to 12 weeks an aqueous gel formulation to the skin of a patient;
    • The formulation comprises: water, a water-miscible organic solvent, 2%-3.5% w/w benzoyl peroxide, 1.2% w/w clindamycin phosphate, and a gelling agent;
    • The formulation comprises a stable suspension of benzoyl peroxide in a saturated solution;
    • The clindamycin phosphate is dissolved in the formulation;
    • The water-miscible organic solvent comprises propylene glycol;
    • The concentration of propylene glycol is between one and four times the BPO concentration;
    • The ratio of water to propylene glycol is at least 12:1; and
    • The benzoyl peroxide has a mean particle size of less than 100 microns.
      The complaint does not specify any dependent claims but makes a general allegation of infringement.

U.S. Patent No. 10,220,049 - "Topical Pharmaceutical Formulations..."

  • Patent Identification: U.S. Patent No. 10,220,049, issued March 5, 2019.
  • Technology Synopsis: This patent is part of the same family as the ’434 and ’208 patents. It claims topical aqueous formulations containing a low concentration of BPO and an antibiotic (clindamycin) suspended in a specific ratio of water and a water-miscible organic solvent to reduce skin irritation while maintaining efficacy.
  • Asserted Claims: At least one claim (Compl. ¶80).
  • Accused Features: The entirety of Taro's Proposed Generic Product formulation is accused of infringement (Compl. ¶80).

U.S. Patent No. 10,624,918 - "Topical Pharmaceutical Formulations..."

  • Patent Identification: U.S. Patent No. 10,624,918, issued April 21, 2020.
  • Technology Synopsis: This patent is part of the same family as the ’434 and ’208 patents. It claims methods of treating acne using topical aqueous formulations containing a low concentration of BPO and an antibiotic (clindamycin) in a specific water/organic solvent system.
  • Asserted Claims: At least one claim (Compl. ¶91).
  • Accused Features: The intended use and formulation of Taro's Proposed Generic Product are accused of infringement (Compl. ¶91).

U.S. Patent No. 11,389,467 - "Topical Compositions"

  • Patent Identification: U.S. Patent No. 11,389,467, issued July 19, 2022.
  • Technology Synopsis: This patent family relates to a triple-combination therapy. The technology is a topical gel formulation combining three active ingredients—an antibiotic (clindamycin phosphate), an antimicrobial and keratolytic agent (BPO), and a retinoid (adapalene)—for the treatment of acne, seeking to provide enhanced efficacy over dual-combination products.
  • Asserted Claims: Claims 1-2, 4-8, 10, 12, 14-19, and 21 (Compl. ¶102).
  • Accused Features: The entirety of Taro's Proposed Generic Product, alleged to be a triple-combination gel, is accused of infringement (Compl. ¶103).

U.S. Patent No. 12,128,059 - "Topical Compositions"

  • Patent Identification: U.S. Patent No. 12,128,059, issued October 29, 2024.
  • Technology Synopsis: This patent is part of the same family as the ’467 Patent, covering triple-combination topical gel formulations containing clindamycin phosphate, BPO, and adapalene for treating acne.
  • Asserted Claims: Claims 1-2, 4-8, 11, 13-17, and 19 (Compl. ¶114).
  • Accused Features: The entirety of Taro's Proposed Generic Product is accused of infringement (Compl. ¶115).

U.S. Patent No. 12,133,859 - "Topical Compositions"

  • Patent Identification: U.S. Patent No. 12,133,859, issued November 5, 2024.
  • Technology Synopsis: This patent is part of the same family as the ’467 Patent, covering triple-combination topical gel formulations containing clindamycin phosphate, BPO, and adapalene for treating acne.
  • Asserted Claims: Claims 1-2, 4-8, 10, 12-17, and 19-20 (Compl. ¶126).
  • Accused Features: The entirety of Taro's Proposed Generic Product is accused of infringement (Compl. ¶127).

U.S. Patent No. 12,138,278 - "Topical Compositions"

  • Patent Identification: U.S. Patent No. 12,138,278, issued November 12, 2024.
  • Technology Synopsis: This patent is part of the same family as the ’467 Patent, covering triple-combination topical gel formulations containing clindamycin phosphate, BPO, and adapalene for treating acne.
  • Asserted Claims: Claims 1-3, 5-8, 10, 12-16, and 18-20 (Compl. ¶138).
  • Accused Features: The entirety of Taro's Proposed Generic Product is accused of infringement (Compl. ¶139).

III. The Accused Instrumentality

Product Identification

The accused instrumentality is "Taro's Proposed Generic Product," a generic version of Cabtreo® topical gel for which Defendants have submitted Abbreviated New Drug Application (ANDA) No. 220097 to the FDA (Compl. ¶2).

Functionality and Market Context

The proposed product is a topical gel formulation containing clindamycin phosphate (1.2%), adapalene (0.15%), and benzoyl peroxide (3.1%) for the treatment of acne (Compl. ¶2). The complaint alleges that the proposed generic product is "the same, or substantially the same, as Cabtreo®" and contains "the same active ingredients in the same dosages" (Compl. ¶52, ¶54). The submission of the ANDA is alleged to be a statutory act of infringement under 35 U.S.C. § 271(e)(2), aimed at launching a generic competitor to Plaintiffs' branded drug prior to the expiration of the Asserted Patents (Compl. ¶2, ¶57).

IV. Analysis of Infringement Allegations

The complaint does not provide a detailed, element-by-element infringement analysis or include claim charts as exhibits. The infringement allegations are premised on the statutory framework of the Hatch-Waxman Act, where the act of submitting an ANDA for a product claimed in a patent is itself an act of infringement (Compl. ¶57). The core allegation is that because Taro's Proposed Generic Product is intended to be a generic version of Cabtreo®, it will necessarily embody the claimed inventions upon its manufacture and sale (Compl. ¶47, ¶52).

’434 Patent Infringement Allegations

(Based on representative claim 1 of U.S. Patent No. 10,220,049)

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
An aqueous suspension formulation for topical application to the skin comprising 2.5% w/w to 4.5% w/w benzoyl peroxide, about 1.2% w/w clindamycin phosphate... Taro's Proposed Generic Product is alleged to be a topical gel containing the same active ingredients as Cabtreo®, including benzoyl peroxide and clindamycin phosphate, at specific concentrations. ¶2, ¶52, ¶54 col. 7:50-53
wherein the combined concentration of water and propylene glycol is sufficient to provide a suspension of benzoyl peroxide in a saturated solution... The product is alleged to be a generic equivalent of Cabtreo®, which Plaintiffs assert embodies the patented formulation creating a saturated solution. ¶47, ¶52, ¶54 col. 7:54-57
wherein the ratio of water to propylene glycol in the formulation ranges from 12:1 to 20:1... The specific excipients and their ratios in Taro's product are alleged to meet the claimed limitations to achieve bioequivalence with Cabtreo®. ¶47, ¶52, ¶54 col. 7:58-60

’208 Patent Infringement Allegations

(Based on representative claim 1 of U.S. Patent No. 9,561,208)

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for treating acne, the method comprising applying once a day for up to 12 weeks to the skin of a patient in need thereof an aqueous gel formulation... Defendants' ANDA submission seeks approval to market the product for treating acne, and the proposed product label will allegedly instruct physicians and patients to apply it as claimed. ¶2, ¶47, ¶59 col. 8:20-24
...the formulation comprises: water, a water-miscible organic solvent, 2%-3.5% w/w benzoyl peroxide, 1.2% w/w clindamycin phosphate, and a gelling agent... The composition of Taro's Proposed Generic Product is alleged to contain the claimed ingredients within the specified concentration ranges. ¶2, ¶52, ¶54 col. 8:21-26
wherein the formulation comprises a stable suspension of benzoyl peroxide in a saturated solution... The physical and chemical properties of Taro's proposed formulation are alleged to meet the claim limitations regarding the state of the active ingredients. ¶47, ¶52 col. 8:27-28

No probative visual evidence provided in complaint.

Identified Points of Contention

  • Scope Questions: A central issue will be factual: does the precise formulation detailed in Taro's confidential ANDA fall within the specific weight percentages and component ratios required by the claims? A dispute may arise over the meaning of "about" as applied to the claimed concentrations.
  • Technical Questions: The complaint does not present technical data. A key question for discovery will be whether Taro's formulation technically achieves a "suspension of benzoyl peroxide in a saturated solution," as this is a core functional limitation of the first patent family. For the method claims, a question will be whether the proposed label for the generic product instructs users to perform all steps of the claimed method.

V. Key Claim Terms for Construction

"a saturated solution of benzoyl peroxide"

  • Context and Importance: This term is central to the asserted novelty of the first patent family (’434, ’208, ’049, ’918 patents), which purports to reduce irritation by maintaining BPO in this specific state on the skin. Infringement will depend on whether Taro's formulation creates this condition. Practitioners may focus on this term because its definition—whether based on specific compositional parameters or a functional outcome—will determine the scope of the claims.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification describes the concept functionally, stating the goal is to "maintain the benzoyl peroxide at or near saturated solubility... thereby maximizing the thermodynamic activity of the benzoyl peroxide" ('049 Patent, col. 4:15-22). This language may support a construction that covers any formulation achieving this functional result.
    • Evidence for a Narrower Interpretation: The specification discloses specific embodiments with precise ratios of water to propylene glycol that achieve the invention ('049 Patent, Tables 1-2). A defendant may argue the term should be limited to formulations with similar compositional properties, pointing to language tying the "saturated solution" to these specific parameters.

"stable suspension"

  • Context and Importance: The claims require BPO to be in a "stable suspension," a key feature allegedly achieved without surfactants. Whether Taro's product meets this limitation depends on the definition of "stable." Practitioners may focus on this term because its required degree and duration could be a point of contention.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent does not provide a quantitative measure for "stable." Plaintiffs may argue it means the formulation remains adequately suspended for its intended shelf life and clinical use, a common industry understanding.
    • Evidence for a Narrower Interpretation: A defendant could argue that "stable" implies a specific degree of physical stability defined by the patent's examples. The specification's description of forming an "aqueous gel of substantially uniform consistency" could be cited to argue for a high standard of stability ('049 Patent, col. 5:45-47).

VI. Other Allegations

Indirect Infringement

The complaint alleges that Defendants' future commercial activities would contribute to and induce infringement (Compl. ¶59, ¶70, ¶81). The basis for inducement is the allegation that the proposed product labeling will instruct physicians and patients to use the generic product in a manner that directly infringes the asserted method claims.

Willful Infringement

The complaint does not use the term "willful," but it requests a finding of an "exceptional case" under 35 U.S.C. § 285 and an award of attorneys' fees, which is the relief associated with such conduct (Compl., Prayer for Relief ¶vii). The basis for this allegation is Defendants' alleged knowledge of the Asserted Patents, which are listed in the FDA's Orange Book for Cabtreo®, prior to the submission of the ANDA (Compl. ¶36, ¶54).

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

  • A central issue will be one of factual correspondence: does the specific, confidential formulation in Taro’s ANDA meet every quantitative limitation of the asserted claims, including the precise weight-by-weight percentages and component ratios? The outcome will likely depend on expert analysis of the ANDA filing during discovery.
  • The case may also turn on a question of claim construction: how will the court define the phrase "saturated solution of benzoyl peroxide"? A narrow construction tied to the patent’s specific examples could provide a path for non-infringement, while a broader, more functional definition could favor the patentee.
  • For the patents covering the triple-combination therapy (’467 family), a key question will be non-obviousness. Given the existence of the active ingredients in other acne treatments, the dispute will likely involve whether it was obvious to a person of ordinary skill in the art to combine these three specific agents into a single, stable, and effective topical gel formulation with a predictable safety and efficacy profile.