DCT
2:23-cv-02684
Bausch Health Ireland Ltd v. Taro Pharma Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Bausch Health Ireland Limited (Ireland); Bausch Health US, LLC (Delaware); Bausch Health Americas, Inc. (Delaware)
- Defendant: Taro Pharmaceuticals Inc. (Canada); Taro Pharmaceuticals U.S.A., Inc. (New York); Taro Pharmaceutical Industries Ltd. (Israel)
- Plaintiff’s Counsel: GIBBONS P.C.
- Case Identification: 2:23-cv-02684, D.N.J., 07/21/2023
- Venue Allegations: Venue is alleged to be proper for the foreign defendants (Taro Canada, Taro Ltd.) because the court has personal jurisdiction, and for the domestic defendant (Taro U.S.A.) because it allegedly maintains a regular and established place of business in the district. The complaint also asserts that the defendants have consented to venue by not challenging it in related, prior litigation.
- Core Dispute: Plaintiff alleges that Defendant's filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff's Duobrii® lotion constitutes an act of infringement of two patents covering topical compositions for treating psoriasis.
- Technical Context: The technology relates to topical pharmaceutical formulations for treating plaque psoriasis, a chronic autoimmune skin disease affecting millions of individuals and representing a significant pharmaceutical market.
- Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendant’s notification to Plaintiff of its ANDA filing (No. 217190). This notification included a "Paragraph IV certification," asserting that the patents listed in the FDA's Orange Book for Duobrii® are invalid, unenforceable, or will not be infringed by the proposed generic product. The complaint notes ongoing, related litigation between the parties (Civil Action No. 22-4670) concerning the same ANDA.
Case Timeline
| Date | Event |
|---|---|
| 2015-06-18 | Priority Date for ’256 and ’115 Patents |
| 2022-06-07 | Date of Taro's ANDA Notice Letter to Bausch |
| 2023-05-16 | U.S. Patent No. 11,648,256 ('256 Patent) Issues |
| 2023-06-20 | U.S. Patent No. 11,679,115 ('115 Patent) Issues |
| 2023-07-21 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 11,648,256 - "Topical Compositions and Methods for Treating Psoriasis," issued May 16, 2023
The Invention Explained
- Problem Addressed: The patent describes the limitations of existing psoriasis treatments. Super-potent corticosteroids like halobetasol propionate are effective but their chronic use is limited by adverse effects. Retinoids like tazarotene are also used but can cause significant local skin irritation. Combining these therapies sequentially (e.g., one in the morning, one in the evening) is effective but can be inconvenient for patients (’256 Patent, col. 1:49-col. 2:8).
- The Patented Solution: The invention is a single topical composition that combines a corticosteroid (halobetasol) and a retinoid (tazarotene). By combining the two active ingredients at specific low concentrations in a single formulation, the invention purports to achieve a synergistic therapeutic effect that is more efficacious than either drug used alone, while simultaneously managing the adverse effects associated with each (’256 Patent, Abstract; col. 3:28-38). The patent describes a preferred embodiment as an oil-in-water emulsion, or lotion (’256 Patent, col. 5:35-41).
- Technical Importance: This approach offers the potential for improved clinical outcomes and better patient compliance by providing the benefits of combination therapy in a single, convenient daily application with a favorable safety profile (’256 Patent, col. 15:5-16, Table 9).
Key Claims at a Glance
- The complaint asserts infringement of at least one claim of the '256 Patent (Compl. ¶39). Independent claim 1 is representative of the core composition invention.
- Essential elements of independent claim 1 include:
- A topical pharmaceutical composition for treating psoriasis, comprising:
- halobetasol propionate at a concentration of 0.01 percent by weight;
- tazarotene at a concentration of 0.045 percent by weight;
- a liquid oil component with one or more materials that are practically insoluble in water and liquid at 22° C.;
- an aqueous component; and
- wherein the composition is formulated as a lotion.
- The complaint does not identify specific dependent claims but reserves the right to assert them.
U.S. Patent No. 11,679,115 - "Topical Compositions and Methods for Treating Psoriasis," issued June 20, 2023
The Invention Explained
- Problem Addressed: As with the '256 Patent, this patent addresses the need for a more effective and safer topical treatment for psoriasis that overcomes the drawbacks of monotherapies with corticosteroids or retinoids, such as adverse effects and patient compliance issues with sequential therapy (’115 Patent, col. 1:49-col. 2:8).
- The Patented Solution: The invention is a topical composition combining halobetasol propionate and tazarotene, but the claims focus on a specific formulation for the carrier. The claims recite a "dermatologically acceptable carrier" comprising a precise combination of excipients, including diethyl sebacate, mineral oil, and specific types of carbomer polymers, within defined concentration ranges (’115 Patent, col. 21:58-67). This specific carrier is designed to stably and effectively deliver the two active ingredients in a single lotion formulation (’115 Patent, col. 10:41-43).
- Technical Importance: The invention provides a specific, stable, and clinically tested formulation that enables the synergistic combination of two active pharmaceutical ingredients, which can be chemically and physically challenging to co-formulate, into a single product.
Key Claims at a Glance
- The complaint asserts infringement of at least one claim of the ’115 Patent (Compl. ¶50). Independent claim 1 is representative of the more specific composition claimed.
- Essential elements of independent claim 1 include:
- A topical pharmaceutical composition for treating psoriasis, comprising:
- (a) halobetasol propionate at a concentration of about 0.01% by weight;
- (b) tazarotene at a concentration of about 0.045% by weight; and
- (c) a dermatologically acceptable carrier comprising diethyl sebacate (2.5% to 3.5%), a mineral oil (7.5% to 8.5%), carbomer copolymer type B (0.3% to 0.5%), carbomer homopolymer type A (0.5% to 0.7%), and purified water.
- The complaint does not identify specific dependent claims but reserves the right to assert them.
III. The Accused Instrumentality
- Product Identification: The accused product is the "Taro ANDA Product," a generic lotion of halobetasol propionate 0.01% and tazarotene 0.045% for which Defendant Taro seeks FDA approval via ANDA No. 217190 (Compl. ¶9).
- Functionality and Market Context: The complaint alleges the Taro ANDA Product is a generic version of and bioequivalent to Plaintiffs' approved Duobrii® lotion, which is indicated for the topical treatment of plaque psoriasis in adults (Compl. ¶¶9, 10, 32). The filing of the ANDA is a statutory act of infringement under 35 U.S.C. § 271(e)(2), signifying Taro's intent to market its generic product upon receiving FDA approval (Compl. ¶39). The commercial context is Taro's attempt to enter the market with a lower-cost generic alternative to Bausch's branded drug.
- Visual Evidence: No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
’256 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| halobetasol propionate at a concentration of 0.01 percent by weight of the composition | The complaint alleges the Taro ANDA Product is a "generic halobetasol propionate (0.01%) and tazarotene (0.045%) lotion." | ¶9 | col. 21:6-8 |
| tazarotene at a concentration of 0.045 percent by weight of the composition | The complaint alleges the Taro ANDA Product contains tazarotene at a concentration of 0.045%. | ¶9 | col. 21:9-10 |
| a liquid oil component, wherein the liquid oil component comprises one or more materials that are... liquid at 22° C. | As a lotion alleged to be bioequivalent to Duobrii®, which the patent describes as an oil-in-water emulsion, the Taro ANDA Product is alleged to contain a liquid oil component. The complaint does not specify the excipients. | ¶¶10, 37, 40 | col. 21:11-15 |
| an aqueous component | As a lotion formulation, the Taro ANDA Product is alleged to contain an aqueous component. | ¶¶9, 40 | col. 21:16-16 |
| wherein the pharmaceutical composition is formulated as a lotion | The complaint identifies the Taro ANDA Product as a "lotion." | ¶9 | col. 21:18-19 |
- Identified Points of Contention:
- Technical Questions: A key evidentiary question is whether the full, confidential formulation in Taro's ANDA meets every limitation of the claims. While the active ingredient concentrations appear to match, infringement will depend on whether the specific excipients used in the Taro ANDA Product meet the definitions of "liquid oil component" and "aqueous component" as construed in light of the patent's specification.
- Scope Questions: The primary dispute may center on the scope of the term "lotion." A defendant could argue that its product, despite being called a lotion, has physical or chemical properties that place it outside the scope of the term as it is used and implicitly defined by the examples in the patent.
’115 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| (a) halobetasol propionate at a concentration of about 0.01% by weight of the composition | The Taro ANDA Product is alleged to contain 0.01% halobetasol propionate. | ¶9 | col. 21:52-54 |
| (b) tazarotene at a concentration of about 0.045% by weight of the composition | The Taro ANDA Product is alleged to contain 0.045% tazarotene. | ¶9 | col. 21:55-57 |
| (c) a dermatologically acceptable carrier comprising: diethyl sebacate at a concentration of about 2.5% to 3.5%... a mineral oil at a concentration of about 7.5% to 8.5%... carbomer copolymer type B... carbomer homopolymer type A... and purified water | The complaint alleges that the Taro ANDA product infringes but does not provide specific facts about its excipient composition. Infringement is implied from the allegation that it is a generic copy. | ¶¶37, 51 | col. 21:58-67 |
- Identified Points of Contention:
- Technical Questions: The infringement analysis for the ’115 Patent will be highly fact-dependent. The central question is whether the formulation specified in ANDA No. 217190 contains the exact excipients (diethyl sebacate, mineral oil, specific carbomers) in the specific concentration ranges required by claim 1. This information is not in the complaint and will be the focus of discovery.
- Scope Questions: Should Taro's formulation use concentrations near but not identical to the claimed ones, the interpretation of the term "about" will become critical. The court will need to determine the degree of variability permitted by "about" in the context of the patent's disclosure and the field of pharmaceutical formulation.
V. Key Claim Terms for Construction
- The Term: "about" (from '115 Patent, claim 1)
- Context and Importance: This term modifies all the concentration values in the asserted independent claim of the '115 Patent. Its construction is critical because infringement may turn on whether the precise concentrations of ingredients in Taro's ANDA product, if not identical to the patent's figures, fall within the range encompassed by "about." Practitioners may focus on this term as it is a frequent source of dispute in chemical and pharmaceutical patent cases.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification uses ranges throughout its description, suggesting that the inventors contemplated some variability around the stated values. Plaintiffs may argue "about" should be interpreted to include variations that result from normal manufacturing tolerances and do not alter the fundamental properties of the composition (’115 Patent, col. 4:46-54).
- Evidence for a Narrower Interpretation: The patent includes tables detailing a clinical study where the formulation ingredients are listed with precise concentrations (e.g., "0.01," "0.045") without the modifier "about" (’115 Patent, col. 12, Table 4). A defendant may argue this suggests the inventors could be precise when intended, and "about" should therefore be given a narrow scope, limited to the degree of precision disclosed in the examples.
VI. Other Allegations
- Indirect Infringement: The complaint alleges that Taro will induce and contribute to infringement (Compl. ¶¶41, 52). In an ANDA case, this allegation is based on the defendant's proposed product label. The complaint implies that by submitting an ANDA with a label that will instruct physicians and patients to use the generic product for the treatment of psoriasis, Taro is taking active steps to encourage direct infringement by end-users upon the product's launch (Compl. ¶¶39, 50).
- Willful Infringement: The complaint does not use the term "willful infringement." However, it requests a declaration that the case is "exceptional" under 35 U.S.C. § 285, which is the statutory basis for awarding attorney's fees and can be predicated on litigation misconduct or egregious infringement conduct (Compl., Prayer for Relief ¶8). The factual basis alleged is Taro's filing of the ANDA with knowledge of the patents, evidenced by its Paragraph IV certification (Compl. ¶35).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central factual question will be one of compositional identity: Does the specific formulation detailed in Taro’s confidential ANDA, particularly its full list of excipients and their concentrations, fall within the literal scope of the asserted claims of the ’115 Patent, which recite a very specific carrier composition?
- A key legal question for the court will be one of claim construction: How broadly should the term "about" be interpreted in the context of the specific concentration ranges recited in the ’115 Patent? The outcome of this construction could be dispositive if Taro’s formulation deviates, even slightly, from the claimed values.
- The ultimate issue, prompted by Taro’s Paragraph IV certification, will be patent validity: While not a focus of the complaint, a core part of the litigation will be Taro's expected defense and counterclaim that the patent claims are invalid, likely on the grounds of obviousness over prior art methods of treating psoriasis with corticosteroids, retinoids, or their combination.