DCT
1:18-cv-00460
Delcor Asset Corp v. Glenmark Pharma Ltd
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Delcor Asset Corporation (Delaware) and Mylan Pharmaceuticals Inc. (West Virginia)
- Defendant: Glenmark Pharmaceuticals Limited (India) and Glenmark Pharmaceuticals Inc., USA (Delaware)
- Plaintiff’s Counsel: Potter Anderson & Corroon LLP
- Case Identification: 1:18-cv-00460, D. Del., 03/26/2018
- Venue Allegations: Venue is alleged to be proper in the District of Delaware, where Defendant Glenmark USA is incorporated and where Involuntary Party Stiefel is registered to do business.
- Core Dispute: Plaintiffs allege that Defendants' filing of an Abbreviated New Drug Application (ANDA) to market a generic version of the topical foam Olux-E® constitutes an act of infringement of a patent related to pharmaceutical mousse compositions.
- Technical Context: The technology concerns pharmaceutical foam formulations designed to enhance the topical delivery of active ingredients, such as corticosteroids, through the skin.
- Key Procedural History: This is a Hatch-Waxman action initiated in response to a notice letter dated February 8, 2018, in which Glenmark informed Plaintiffs of its ANDA filing. The notice included a Paragraph IV certification, asserting that U.S. Patent No. 6,730,288 is invalid, unenforceable, or will not be infringed by Glenmark’s proposed generic product. The patent is listed in the FDA's "Orange Book" as covering Plaintiffs' Olux-E® product. The patent’s assignee, Stiefel West Coast, LLC, has been joined as an involuntary party.
Case Timeline
| Date | Event |
|---|---|
| 1998-09-11 | ’288 Patent Priority Date |
| 2004-05-04 | ’288 Patent Issue Date |
| 2018-02-08 | Glenmark sends Paragraph IV Notice Letter |
| 2018-03-26 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 6,730,288 - Mousse Composition, Issued May 4, 2004
The Invention Explained
- Problem Addressed: The patent describes a challenge in formulating topical drugs: while occlusive agents like petrolatum enhance drug penetration by trapping moisture, they are often used in large amounts that leave a greasy, sticky residue, making them unsuitable for consumer-friendly "mousse" or foam products (’288 Patent, col. 1:15-32).
- The Patented Solution: The invention is a pharmaceutical foam composition that purports to solve this problem through the "surprising discovery" that a "relatively low amount of an occlusive agent" can still effectively reduce trans-epidermal water loss, thereby enhancing skin permeability and drug delivery while remaining cosmetically "elegant" (’288 Patent, col. 1:59-65). The formulation requires a specific combination of an active ingredient, an occlusive agent, an aqueous solvent, and an organic cosolvent, where the active ingredient is insoluble in both the water and the occlusive agent (’288 Patent, col. 1:47-58).
- Technical Importance: The technology aimed to provide a vehicle for topical drug delivery that combined the therapeutic benefit of an occlusive formulation with the superior cosmetic feel and consumer acceptance of a quick-breaking foam (’288 Patent, col. 1:33-46).
Key Claims at a Glance
- The complaint asserts infringement of "one or more claims" without specifying them (Compl. ¶39). Independent Claim 1 is representative of the core invention.
- Independent Claim 1 requires:
- A pharmaceutical aerosol foam composition comprising:
- an effective amount of a pharmaceutically active ingredient;
- an occlusive agent;
- an aqueous solvent;
- an organic cosolvent;
- an emulsifier component in a specific ratio to the other ingredients ("about 1:5 to about 1:8");
- the active ingredient being "insoluble in both water and the occlusive agent"; and
- the occlusive agent being present in an "amount sufficient to form an occlusive layer on the skin, in use."
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is Glenmark's proposed clobetasol propionate aerosol, foam 0.05% (the "ANDA Product") (Compl. ¶21).
Functionality and Market Context
- The complaint alleges the ANDA Product is a generic version of the commercial drug Olux-E® (Compl. ¶21). The active ingredient is clobetasol propionate, the same as in Olux-E® and in the compositions described in the patent (’288 Patent, col. 2:13; Compl. ¶23). Glenmark's ANDA allegedly asserts that its product is bioequivalent to Olux-E® and seeks approval for the same medical indication: the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses (Compl. ¶¶ 24-26). The act of infringement alleged is the submission of the ANDA itself to the FDA (Compl. ¶39).
IV. Analysis of Infringement Allegations
No probative visual evidence provided in complaint.
'288 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A pharmaceutical aerosol foam composition comprising: an effective amount of a pharmaceutically active ingredient... | The ANDA Product is a foam composition containing clobetasol propionate as the active ingredient. | ¶21, ¶23 | col. 2:10-13 |
| an occlusive agent... | The complaint alleges infringement of claims requiring an occlusive agent, and the patent identifies petrolatum as a preferred example. | ¶15, ¶39 | col. 2:36-46 |
| an aqueous solvent; an organic cosolvent; and an emulsifier component in an amount wherein the ratio of emulsifier component to a combination of the occlusive agent, pharmaceutically active ingredient, and organic cosolvent is about 1:5 to about 1:8 | The complaint alleges that the ANDA Product infringes the claim, which requires these components in this specific ratio, by being a generic version of a product covered by the patent. | ¶24, ¶39 | col. 8:35-39 |
| the pharmaceutically active ingredient being insoluble in both water and the occlusive agent | The complaint alleges infringement of claims that require this property for the active ingredient. | ¶15, ¶39 | col. 8:40-41 |
| the occlusive agent being present in an amount sufficient to form an occlusive layer on the skin, in use. | The ANDA Product is alleged to be a generic version of Olux-E®, which is listed in the Orange Book as being covered by the patent and is intended to provide this therapeutic effect. | ¶20, ¶24, ¶26 | col. 8:42-44 |
- Identified Points of Contention:
- Technical Questions: A primary factual dispute will concern the precise formulation of Glenmark’s ANDA Product, which is not public. The case will require evidence establishing whether that formulation contains an "occlusive agent", "organic cosolvent", and "emulsifier" that meet the claim limitations. A further technical question is whether the components are present in the specific ratio of "about 1:5 to about 1:8" required by Claim 1.
- Scope Questions: The infringement analysis raises the question of what constitutes an "amount sufficient to form an occlusive layer." The patent suggests that a "relatively low amount" is sufficient, but the proper construction of this functional language, and whether the amount of occlusive agent in Glenmark’s product meets that standard, will be a central issue.
V. Key Claim Terms for Construction
The Term: "amount sufficient to form an occlusive layer on the skin"
- Context and Importance: This functional limitation is at the heart of the patent's purported advance over the prior art. Its construction will likely determine whether the "relatively low amount" of occlusive agent in a formulation like the accused product falls within the scope of the claims.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent specification states the invention is predicated on the "surprising discovery that a mousse formulation with a relatively low amount of an occlusive agent is still able to reduce trans epidermal water loss" (’288 Patent, col. 1:59-63). This could support an interpretation where any statistically significant reduction in water loss is "sufficient."
- Evidence for a Narrower Interpretation: The patent provides experimental data showing the quantitative effects of formulations with 30% and 50% petrolatum on trans-epidermal water loss (TEWL) (’288 Patent, Fig. 2). A party could argue that "sufficient" requires achieving a degree of occlusion comparable to that demonstrated in these specific examples.
The Term: "occlusive agent"
- Context and Importance: The identity and properties of the "occlusive agent" are fundamental to the invention. Practitioners may focus on this term because its definition, combined with the "amount sufficient" limitation, defines the boundary of the claim.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent defines the term broadly and functionally as "any excipient or combination thereof that provides an occlusive layer or hydration barrier to the skin" that is "sufficient to result in reduction in trans epidermal water loss" (’288 Patent, col. 2:36-42).
- Evidence for a Narrower Interpretation: A party might argue the term should be understood in light of the preferred embodiment, which is petrolatum, and the other listed examples, such as mineral oils, greases, and long chain acids (’288 Patent, col. 2:42-46).
VI. Other Allegations
- Indirect Infringement: The complaint alleges induced infringement, stating that Glenmark knows its product will be used to infringe and that its prescribing information will "instruct users to administer the ANDA Product" for the patented use (Compl. ¶¶ 29, 32, 34). It also alleges contributory infringement, asserting the ANDA product is "especially made or adapted for use in a way that would infringe" and is "not suitable for substantial non-infringing use" (Compl. ¶35).
- Willful Infringement: Willfulness is alleged based on Glenmark having "knowledge of the '288 patent when it submitted and filed ANDA No. 211450" and that its infringement "has been, and continues to be, deliberate" (Compl. ¶¶ 27, 40).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of functional scope: how should the phrase "an amount sufficient to form an occlusive layer on the skin" be construed? The court's interpretation of this limitation—whether it requires a specific quantitative reduction in water loss as shown in the patent's examples or merely any measurable occlusive effect—will be critical to the infringement analysis.
- A key evidentiary question will be one of compositional identity: does the confidential formulation detailed in Glenmark's ANDA contain all the elements of the asserted claims, particularly an "emulsifier", "occlusive agent", "active ingredient", and "cosolvent" in the specific ratio of "about 1:5 to about 1:8" recited in Claim 1? The case will likely turn on a comparison of the ANDA's chemistry with the patent's claim language.