DCT
1:17-cv-01653
Delcor Asset Corp v. Glenmark Pharma Ltd
Key Events
Complaint
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: 1:17-cv-01653, D. Del., 11/15/2017
- Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant Glenmark USA and Involuntary Party Stiefel West Coast, LLC are incorporated in Delaware.
- Core Dispute: Plaintiffs allege that Defendants’ filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Evoclin® foam infringes patents covering the pharmaceutical foam composition and its method of use for treating bacteria-mediated diseases.
- Technical Context: The technology concerns quick-breaking, temperature-sensitive pharmaceutical foams for the topical delivery of antibiotics, primarily for the treatment of acne vulgaris.
- Key Procedural History: This action was initiated under the Hatch-Waxman Act following a notice letter from Glenmark, dated September 29, 2017, which included a Paragraph IV certification against the patents-in-suit. The patents are listed in the U.S. Food and Drug Administration's "Orange Book" as covering the branded drug Evoclin®.
Case Timeline
| Date | Event |
|---|---|
| 2003-01-24 | Priority Date for '237 and '747 Patents |
| 2006-11-28 | U.S. Patent No. 7,141,237 Issued |
| 2008-05-20 | U.S. Patent No. 7,374,747 Issued |
| 2017-09-29 | Glenmark sends Paragraph IV Notice Letter to Plaintiffs |
| 2017-11-15 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 7,141,237, “Pharmaceutical Foam” (issued Nov. 28, 2006)
The Invention Explained
- Problem Addressed: The patent describes challenges with conventional topical drug formulations. It notes that lotions and gels can require extended rub-in time or leave undesirable oily residues, while liquid solutions are often runny and difficult to apply in controlled amounts (ʼ237 Patent, Background of the Invention, col. 1:33-46).
- The Patented Solution: The invention is a topical delivery composition stored in a pressurized container that dispenses as a "quick-breaking temperature sensitive foam" (ʼ237 Patent, Abstract). This foam is designed to be non-runny for easy application, but to break down upon contact with skin (i.e., from body heat), depositing the active ingredient in a solution-like vehicle ('237 Patent, col. 1:47-58). The formulation's stability and thermal sensitivity are achieved through a specific combination of components, including a short-chain alcohol, a fatty alcohol, water, a surfactant, and a propellant ('237 Patent, col. 2:7-17).
- Technical Importance: This foam vehicle technology was designed to provide enhanced skin delivery of an active pharmaceutical ingredient compared to gels, while offering superior cosmetic and application characteristics compared to traditional solutions ('237 Patent, col. 1:63-65).
Key Claims at a Glance
- The complaint asserts infringement of one or more claims, including independent claim 1 (Compl. ¶41).
- Independent Claim 1 requires:
- A topical delivery composition in a pressurized container
- Comprising up to 15% w/w of clindamycin phosphate
- Comprising from about 83% to about 97.9% w/w of a quick-breaking foaming agent, which in turn comprises a C1-C6 alcohol, a C14-C22 alcohol, water, and a surfactant
- Comprising from about 2% to about 7% w/w of an aerosol propellant
- Comprising a base
- Wherein the composition is a quick-breaking temperature sensitive foam after release from the container
U.S. Patent No. 7,374,747, “Pharmaceutical Foam” (issued May 20, 2008)
The Invention Explained
- Problem Addressed: As a divisional of the '237 patent, the '747 patent addresses the same technical problem: the need for a more effective and cosmetically acceptable vehicle for topical drug delivery, particularly for antibiotics like clindamycin used to treat skin conditions ('747 Patent, col. 1:20-46).
- The Patented Solution: Rather than claiming the composition itself, this patent claims a method of using the foam formulation to treat disease. Specifically, it claims a method for the percutaneous treatment of a bacteria-mediated disease, such as acne, which involves applying the quick-breaking foam composition containing clindamycin phosphate to a patient's skin ('747 Patent, Abstract; col. 3:21-34).
- Technical Importance: The patent extends protection from the novel foam formulation to its specific therapeutic application, linking the delivery system to a claimed medical benefit.
Key Claims at a Glance
- The complaint asserts infringement of one or more claims, including independent claim 1 (Compl. ¶59).
- Independent Claim 1 requires:
- A method for treating a bacteria-mediated disease
- Comprising the step of applying a quick-breaking temperature sensitive foam composition to the skin of a subject in need thereof
- Wherein the composition comprises clindamycin phosphate, a quick-breaking foaming agent (containing a C1-C6 alcohol, a C14-C22 alcohol, water, and a surfactant), an aerosol propellant, and a base
III. The Accused Instrumentality
Product Identification
The accused instrumentality is Defendant Glenmark's proposed generic clindamycin phosphate aerosol, foam 1%, for which it filed ANDA No. 210778 with the FDA (Compl. ¶23).
Functionality and Market Context
The complaint alleges that Glenmark's ANDA Product is a generic version of the branded drug Evoclin® and is intended for the same approved use: the treatment of acne vulgaris (Compl. ¶¶1, 27-28). The complaint further alleges that the ANDA Product contains clindamycin phosphate as its active ingredient and is asserted by Glenmark to be bioequivalent to Evoclin® (Compl. ¶¶25-26). The infringement action was triggered by Glenmark’s filing of the ANDA seeking approval to market this product prior to the expiration of the patents-in-suit (Compl. ¶23).
No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
'237 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A topical delivery composition in a pressurized container | The ANDA Product is an aerosol foam, which is dispensed from a pressurized container (Compl. ¶23). | ¶23 | col. 2:5-6 |
| comprising up to 15% w/w of clindamycin phosphate; | The ANDA Product is a 1% clindamycin phosphate foam, which contains the same active ingredient as the patented composition (Compl. ¶23, ¶25). | ¶23, ¶25 | col. 2:7-9 |
| comprising...a quick-breaking foaming agent, wherein said...agent comprises a C1-C6 alcohol, a C14-C22 alcohol, water, and a surfactant; | As a proposed generic version of Evoclin®, the ANDA Product is alleged to contain the same or equivalent excipients that constitute the claimed quick-breaking foaming agent (Compl. ¶26). | ¶26 | col. 2:10-13 |
| comprising...an aerosol propellant...; | The ANDA Product is an aerosol foam that requires a propellant for dispensing (Compl. ¶23). | ¶23 | col. 2:14-17 |
| a base; and | The ANDA Product is alleged to contain the claimed components, including a base, by virtue of being a generic equivalent of the product covered by the patent (Compl. ¶26). | ¶26 | col. 31:27 |
| wherein said composition is a quick-breaking temperature sensitive foam after release from said container. | The ANDA Product is alleged to be a generic version of Evoclin® foam, which is described and claimed as a quick-breaking temperature sensitive foam (Compl. ¶26). | ¶26 | col. 2:18-20 |
'747 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method for treating a bacteria-mediated disease, | Glenmark is seeking approval to market the ANDA Product for the treatment of acne vulgaris, which is a bacteria-mediated disease (Compl. ¶28). | ¶28 | col. 3:21-22 |
| said method comprising: applying a quick-breaking temperature sensitive foam composition to the skin of a subject in need thereof, | Glenmark's prescribing information for the ANDA Product will instruct users to apply the foam product to the skin to treat acne (Compl. ¶¶33-34). | ¶33, ¶34 | col. 3:23-25 |
| said composition comprising: up to 15% w/w of clindamycin phosphate; | The ANDA Product is a 1% clindamycin phosphate foam (Compl. ¶23, ¶25). | ¶23, ¶25 | col. 3:27-28 |
| ...a quick-breaking foaming agent, wherein said...agent comprises a C1-C6 alcohol, a C14-C22 alcohol, water, and a surfactant; | As a proposed generic version of Evoclin®, the ANDA Product is alleged to contain the same or equivalent excipients that constitute the claimed quick-breaking foaming agent (Compl. ¶26). | ¶26 | col. 3:29-32 |
| ...an aerosol propellant...; | The ANDA Product is an aerosol foam that requires a propellant for dispensing (Compl. ¶23). | ¶23 | col. 3:33 |
| a base... | The ANDA Product is alleged to contain a base by virtue of being a generic equivalent of the product covered by the patent (Compl. ¶26). | ¶26 | col. 32:2 |
- Identified Points of Contention:
- Scope Questions: The core dispute in this ANDA litigation will be whether the specific formulation disclosed in Glenmark's confidential ANDA falls within the scope of the asserted claims. Glenmark’s Paragraph IV letter asserts non-infringement, which suggests it may argue its formulation omits at least one required element of the claims (Compl. ¶24).
- Technical Questions: A key factual question, to be resolved after claim construction, is whether Glenmark's formulation contains each of the four specified components of the "quick-breaking foaming agent" (a C1-C6 alcohol, a C14-C22 alcohol, water, and a surfactant). A further technical question may arise as to whether Glenmark's product, when released, forms a "quick-breaking temperature sensitive foam" with the functional characteristics described in the patents.
V. Key Claim Terms for Construction
The Term: "quick-breaking foaming agent"
- Context and Importance: This term defines the core vehicle of the invention. Its construction will determine which excipients are necessary for a formulation to infringe. Practitioners may focus on this term because Glenmark's non-infringement defense likely centers on an argument that its formulation's agent lacks a required component or is compositionally different.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification describes the agent functionally, and in some places uses permissive language, stating it comprises water, a surfactant, and "an optional component(s), such as a C1-C6 alcohol, a C14-C22 alcohol" ('237 Patent, col. 5:38-41).
- Evidence for a Narrower Interpretation: The asserted independent claim 1 itself explicitly lists the components: "a C1-C6 alcohol, a C14-C22 alcohol, water, and a surfactant" ('237 Patent, col. 2:12-13). This language suggests that all four components are required elements of the agent for literal infringement of this claim. The description of the preferred embodiment also recites these four components ('237 Patent, col. 5:50-53).
The Term: "quick-breaking temperature sensitive foam"
- Context and Importance: This functional limitation is critical, as it describes the novel behavior of the claimed product. A dispute may arise over how "quick" the break must be and at what temperature it must occur.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification broadly describes the foam as collapsing "at or near skin temperature" ('237 Patent, col. 7:62-63), which could support a range of temperatures.
- Evidence for a Narrower Interpretation: The specification provides a specific example where the foam breaking temperature is "about 35° C" ('237 Patent, col. 11:10). Figure 1 graphically depicts this sharp collapse around 35° C. A defendant could argue this exemplary embodiment limits the claim scope to foams that exhibit this specific thermal behavior.
VI. Other Allegations
- Indirect Infringement: The complaint alleges that Glenmark will induce infringement of the '747 patent's method claims. This allegation is based on the assertion that Glenmark's prescribing information will instruct medical professionals and patients to administer the ANDA Product to treat acne vulgaris, thereby directing them to perform the steps of the patented method (Compl. ¶¶33-34, ¶36, ¶68).
- Willful Infringement: The complaint alleges that Glenmark's infringement is and will be deliberate (Compl. ¶42, ¶60, ¶73). The basis for this allegation is Glenmark's pre-suit knowledge of the patents, evidenced by its filing of a Paragraph IV certification specifically challenging the patents-in-suit as listed in the FDA's Orange Book (Compl. ¶24, ¶29).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of compositional scope: following claim construction, does the specific formulation disclosed in Glenmark's ANDA contain every element of the claimed "quick-breaking foaming agent," including a C1-C6 alcohol, a C14-C22 alcohol, water, and a surfactant, or has Glenmark successfully designed around the claim?
- A key evidentiary question will be one of functional performance: does Glenmark’s foam product exhibit the behavior of a "quick-breaking temperature sensitive foam" as that term is construed in light of the patent's specification, particularly the thermal collapse profile detailed in Figure 1 of the patents?
- For the method patent ('747), a dispositive question will be whether Glenmark's proposed product label, by instructing the use of the foam for treating acne, induces infringement of the claimed "method for treating a bacteria-mediated disease."