DCT
3:19-cv-14502
Bausch Health Ireland Ltd v. Glenmark Pharma Ltd
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Bausch Health Ireland Limited (Ireland) and Bausch Health Americas Inc. (Delaware)
- Defendant: Glenmark Pharmaceuticals Limited (India)
- Plaintiff’s Counsel: GIBBONS P.C.
- Case Identification: 3:19-cv-14502, D.N.J., 06/28/2019
- Venue Allegations: Venue is asserted on the basis that the defendant is a foreign corporation and may be sued in any judicial district. The complaint also alleges that Defendant, through its U.S. subsidiaries, has substantial and continuous contacts with New Jersey.
- Core Dispute: Plaintiffs allege that Defendant’s filing of an Abbreviated New Drug Application (ANDA) for a generic version of Plaintiffs’ Bryhali™ topical lotion constitutes an act of patent infringement under the Hatch-Waxman Act.
- Technical Context: The technology concerns pharmaceutical formulations for topical corticosteroids, designed to treat inflammatory skin conditions while potentially reducing systemic side effects.
- Key Procedural History: This action was initiated in response to Defendant's submission of ANDA No. 213323 and its accompanying Paragraph IV certification, which challenges the validity and/or infringement of the patent-in-suit. The patent is listed in the FDA’s Orange Book for the Bryhali™ product. The complaint was filed within the 45-day statutory window following receipt of Defendant's notice letter, which triggers a 30-month stay of FDA approval for the generic product.
Case Timeline
| Date | Event |
|---|---|
| 2010-11-22 | '307 Patent Priority Date |
| 2014-08-19 | '307 Patent Issue Date |
| 2019-05-15 | Date of Glenmark's Paragraph IV Notice Letter |
| 2019-06-28 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,809,307 - "Pharmaceutical Formulations Containing Corticosteroids for Topical Administration," issued August 19, 2014
The Invention Explained
- Problem Addressed: The patent’s background section describes a dilemma with high-potency topical corticosteroids: they are highly effective for skin conditions like psoriasis but carry a significant risk of systemic side effects, such as hypothalamic-pituitary-adrenal (HPA) axis suppression. This risk generally limits their use to short durations (e.g., two weeks), which is often insufficient for managing chronic skin diseases. ('307 Patent, col. 2:33-51).
- The Patented Solution: The invention claims to solve this problem with a formulation that maintains the therapeutic potency of a corticosteroid even when its concentration is substantially reduced. This is accomplished by dissolving the corticosteroid in a specific "liquid oil component" containing a dicarboxylic acid ester (e.g., diethyl sebacate). This formulation is hypothesized to provide preferential delivery of the corticosteroid into the skin for local effect, rather than through the skin and into the systemic circulation. ('307 Patent, col. 3:50-67; col. 4:35-46).
- Technical Importance: The described technology suggests a pathway to create safer formulations of potent corticosteroids, potentially allowing for longer treatment periods for chronic conditions with a reduced risk of systemic absorption and associated side effects. ('307 Patent, col. 4:60-67).
Key Claims at a Glance
- The complaint asserts infringement of "at least one claim" of the '307 Patent (Compl. ¶27). Independent claim 1 is representative of the core invention.
- Independent Claim 1:
- A pharmaceutical composition for topical application to the skin of an individual
- comprising halobetasol propionate at a concentration of 0.04% or less
- and a liquid oil component comprising one or more dicarboxylic acid esters, wherein the dicarboxylic acid esters are selected from diethyl sebacate, diisopropyl adipate, and dibutyl sebacate
- and wherein at least 25% of the halobetasol propionate is solubilized in the liquid oil component at 22° C.
- The complaint reserves the right to assert infringement of other claims, including under the doctrine of equivalents (Compl. ¶28).
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is the act of filing ANDA No. 213323, which seeks FDA approval to market the "Glenmark ANDA Product" (Compl. ¶22).
Functionality and Market Context
- The Glenmark ANDA Product is identified as a halobetasol propionate 0.01% topical lotion, intended as a generic version of Plaintiffs' Bryhali™ product (Compl. ¶¶1, 22). The complaint alleges that Glenmark's ANDA refers to and relies upon the Bryhali™ New Drug Application and contains data to demonstrate bioequivalence between the two products (Compl. ¶24). The complaint does not specify the excipients or other formulation details of the accused product, as that information is contained within the confidential ANDA filing. No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint alleges infringement under 35 U.S.C. § 271(e)(2)(A), where the filing of the ANDA is the statutory act of infringement. The infringement theory rests on the allegation that the product described in the ANDA, if commercially manufactured, would infringe the '307 Patent.
'307 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A pharmaceutical composition for topical application to the skin of an individual comprising halobetasol propionate at a concentration of 0.04% or less | The Glenmark ANDA Product is described as a "halobetasol propionate 0.01% topical lotion," a concentration that is less than the claimed 0.04%. | ¶22 | col. 11:53-54 |
| and a liquid oil component comprising one or more dicarboxylic acid esters, wherein the dicarboxylic acid esters are selected from diethyl sebacate, diisopropyl adipate, and dibutyl sebacate | The complaint does not explicitly identify the excipients in the Glenmark ANDA product. The infringement allegation implies Plaintiffs' belief that the accused product contains a claimed ester to achieve its alleged bioequivalence with the patented Bryhali™ formulation. | ¶27 | col. 11:55-58 |
| and wherein at least 25% of the halobetasol propionate is solubilized in the liquid oil component at 22° C. | The complaint does not provide data on drug solubilization in the accused product. The infringement allegation suggests a theory that the formulation described in the ANDA necessarily meets this functional requirement. | ¶27 | col. 11:58-60 |
- Identified Points of Contention:
- Technical Question: The primary factual dispute will be whether the formulation detailed in Glenmark's confidential ANDA contains a dicarboxylic acid ester that falls within the literal scope of claim 1 (i.e., diethyl sebacate, diisopropyl adipate, or dibutyl sebacate).
- Functional Question: A central evidentiary question will be whether the formulation described in the ANDA meets the functional limitation that "at least 25% of the halobetasol propionate is solubilized in the liquid oil component." This will likely require laboratory testing of the proposed generic product.
V. Key Claim Terms for Construction
The Term: "liquid oil component"
- Context and Importance: The identity and properties of this "component" are central to the patent's claimed invention and the infringement analysis. The infringement case hinges on the accused product containing a "liquid oil component" that includes a claimed dicarboxylic acid ester.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification defines the term to include "all ingredients of the formulation that are practically insoluble or insoluble in water and which are liquid at room temperature," and notes it may contain other substances like mineral oil or triglycerides ('307 Patent, col. 4:17-27).
- Evidence for a Narrower Interpretation: The patent states that the liquid oil component and the corticosteroid "may interact in the formulation in order to dissolve or substantially dissolve the corticosteroid" ('307 Patent, col. 4:37-40). A party could argue this functional interaction is a required characteristic of the "component," potentially narrowing its scope.
The Term: "solubilized"
- Context and Importance: This term sets a specific, measurable threshold for infringement. How "solubilized" is defined and measured will be critical. Practitioners may focus on this term because its verification requires a specific testing methodology.
- Intrinsic Evidence for Interpretation:
- Evidence for Interpretation: Example 2 of the patent provides a detailed methodology for determining "Saturation Solubility," involving shaking samples for 72 hours, centrifugation, filtration, and HPLC analysis ('307 Patent, col. 9:57 - col. 10:5). A court may look to this example as defining the proper method for assessing whether the "at least 25%... solubilized" limitation is met.
VI. Other Allegations
- Indirect Infringement: The complaint includes allegations of induced and contributory infringement (Compl. ¶28). This is likely premised on the future marketing of the Glenmark ANDA product with a label instructing use for patented methods of treating skin conditions, thereby inducing infringement by physicians and patients.
- Willful Infringement: The complaint does not explicitly allege willfulness but does plead that the case is "exceptional" and seeks attorneys' fees under 35 U.S.C. § 285 (Compl. ¶32). The basis for this appears to be Glenmark's knowledge of the '307 Patent, as evidenced by its filing of a Paragraph IV certification against an Orange Book-listed patent (Compl. ¶23).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of compositional fact: Does the generic formulation detailed in Glenmark’s confidential ANDA contain a dicarboxylic acid ester recited in claim 1, such as diethyl sebacate? The case's trajectory will heavily depend on the contents of the ANDA, which will be revealed during discovery.
- A key evidentiary question will be one of functional proof: Can Plaintiffs demonstrate, likely through expert testing and analysis, that the Glenmark ANDA product meets the quantitative limitation that "at least 25%" of the active ingredient is "solubilized" in the liquid oil component as required by the claims?
- Finally, the case will involve a significant question of validity: Glenmark has certified that the '307 Patent is invalid (Compl. ¶6). The nature of its invalidity arguments, presumably focused on obviousness over prior art corticosteroid formulations, will form a central pillar of its defense.