DCT
1:17-cv-00970
Delcor Asset Corp v. Taro Pharmaceutical Industries Ltd
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Delcor Asset Corporation (Delaware) and Mylan Pharmaceuticals Inc. (West Virginia)
- Defendant: Taro Pharmaceutical Industries, Ltd. (Israel) and Taro Pharmaceuticals U.S.A., Inc. (New York)
- Plaintiff’s Counsel: Potter Anderson & Corroon LLP (lead counsel listed on complaint)
- Case Identification: 1:17-cv-00970, D. Del., 07/17/2017
- Venue Allegations: Venue is alleged to be proper as Defendants have substantial, systematic, and continuous contacts with Delaware and under the specific venue provisions for foreign defendants.
- Core Dispute: Plaintiffs allege that Defendants’ submission of an Abbreviated New Drug Application (ANDA) to market a generic version of Evoclin® foam constitutes infringement of two patents covering pharmaceutical foam compositions and their use.
- Technical Context: The technology relates to topical foam formulations for drug delivery, designed to provide better stability, cosmetic characteristics, and application control than traditional lotions, gels, or solutions for treating skin conditions like acne.
- Key Procedural History: This action was initiated under the Hatch-Waxman Act following a notice letter from Taro, which included a Paragraph IV certification stating that the patents-in-suit are invalid, unenforceable, or will not be infringed by its proposed generic product. The patents are listed in the FDA's "Orange Book" as covering the branded drug Evoclin®. The complaint notes that patent assignee Stiefel West Coast, LLC, has been joined as an involuntary party and will be realigned as a co-plaintiff.
Case Timeline
| Date | Event |
|---|---|
| 2003-01-24 | Earliest 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 |
| 2017-06-02 | Date of Defendant's ANDA Notice Letter |
| 2017-07-17 | 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 identifies drawbacks with conventional topical drug delivery systems. Lotions and gels can leave oily residues and require extended rub-in, while liquid solutions are "runny" and difficult to apply in a controlled manner, especially for dermatological treatments (Compl. ¶15; ’237 Patent, col. 1:39-47).
- The Patented Solution: The invention is a pharmaceutical composition stored in a pressurized container that, when dispensed, creates a "quick-breaking temperature sensitive foam." This foam is designed to be stable at ambient temperature but break down upon contact with warmer skin, depositing the active drug in a non-runny, low-residue vehicle. This is achieved through a specific combination of a foaming agent (including certain alcohols and a surfactant), water, and a propellant (’237 Patent, Abstract; col. 1:48-58).
- Technical Importance: This formulation aimed to improve the ease of use and cosmetic elegance of topical antibiotics, potentially enhancing patient adherence to treatment regimens for conditions like acne (’237 Patent, col. 1:28-34).
Key Claims at a Glance
- The complaint asserts infringement of "one or more claims" without specifying them (Compl. ¶44). Independent claim 1 is a representative composition claim.
- Independent Claim 1 requires:
- A topical delivery composition in a pressurized container
- comprising up to 15% w/w of clindamycin phosphate
- from about 83% to about 97.9% w/w of a quick-breaking foaming agent, which itself comprises a C1-C6 alcohol, a C14-C22 alcohol, water, and a surfactant
- a base
- from about 2% to about 7% w/w of an aerosol propellant
- The complaint reserves the right to assert other claims, including dependent claims.
U.S. Patent No. 7,374,747 - "Pharmaceutical Foam" (Issued May 20, 2008)
The Invention Explained
- Problem Addressed: The patent addresses the same challenges as its parent, the ’237 Patent: the runniness and undesirable residue of existing topical drug formulations (’747 Patent, col. 1:39-47).
- The Patented Solution: As a divisional of the ’237 Patent, the ’747 Patent claims methods of using the previously described foam. The invention is a method for treating a "bacteria-mediated disease," such as acne vulgaris, by topically applying the specific quick-breaking foam composition containing clindamycin phosphate to a subject in need of treatment (’747 Patent, Abstract; col. 2:22-34).
- Technical Importance: This patent extends protection from the foam composition itself to the act of using that composition for its intended therapeutic purpose, a common strategy in pharmaceutical patenting.
Key Claims at a Glance
- The complaint asserts infringement of "one or more claims" without specification (Compl. ¶62). Independent claim 1 is a representative method claim.
- Independent Claim 1 requires:
- A method for treating a bacteria-mediated disease
- comprising 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), a propellant, and a base
- The complaint reserves the right to assert other claims, including dependent claims.
III. The Accused Instrumentality
Product Identification
The accused instrumentality is Defendants' proposed generic clindamycin phosphate aerosol, foam 1% ("ANDA Product"), for which Taro filed ANDA No. 210004 with the FDA (Compl. ¶23).
Functionality and Market Context
The complaint alleges, on information and belief, that the ANDA Product is a generic version of the branded drug Evoclin® and that Taro asserts it is bioequivalent to Evoclin® (Compl. ¶¶ 23, 32). The active ingredient is clindamycin phosphate, and the product is intended for the topical treatment of acne vulgaris (Compl. ¶¶ 31, 34). Plaintiffs allege they have not been able to obtain a copy of the ANDA, and therefore the complaint's allegations regarding the product's specific formulation are based on the product being a generic equivalent (Compl. ¶29).
No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint does not provide detailed infringement contentions or an element-by-element analysis. The infringement allegations are based on the statutory act of filing an ANDA and on the belief that the ANDA Product, as a generic equivalent of Evoclin®, will meet the limitations of the asserted claims.
'237 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A topical delivery composition... comprising up to 15% w/w of clindamycin phosphate | The ANDA Product is alleged to be a clindamycin phosphate aerosol foam, 1%. | ¶23, ¶31 | col. 8:25-50 |
| a quick-breaking foaming agent, wherein said quick-breaking foaming agent comprises a C1-C6 alcohol, a C14-C22 alcohol, water, and a surfactant | As a generic equivalent to Evoclin®, the ANDA Product is alleged to be a foam composition that necessarily contains a foaming agent with these components to achieve bioequivalence. | ¶32 | col. 5:37-41 |
| a base | The complaint does not provide sufficient detail for analysis of this element. | col. 6:55-65 | |
| from about 2% to about 7% w/w of an aerosol propellant | The ANDA Product is an aerosol foam, which by definition requires a propellant. | ¶23 | col. 5:14-19 |
'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 | The ANDA Product is indicated for the treatment of acne vulgaris, a bacteria-mediated disease. | ¶34, ¶37 | col. 17:39-42 |
| applying a quick-breaking temperature sensitive foam composition... to the skin of a subject in need thereof | Taro’s prescribing information will allegedly instruct users to apply the ANDA Product to the skin of patients with acne. | ¶36, ¶37 | col. 2:22-34 |
| wherein the composition comprises clindamycin phosphate; a quick-breaking foaming agent...; a propellant; and a base | The ANDA Product is alleged to be a clindamycin phosphate foam with the same composition as described for the '237 Patent. | ¶31, ¶32 | col. 8:25-50 |
- Identified Points of Contention:
- Scope Questions: The primary question is one of formulation identity: does Taro's confidential ANDA formulation contain every recited component of the asserted claims, including a "C1-C6 alcohol," a "C14-C22 alcohol," a "surfactant," and a "base"? The case will depend on discovery of Taro's exact formulation.
- Technical Questions: A key technical question is whether Taro's product generates a "quick-breaking temperature sensitive foam" as that term is defined in the patents. The specifications provide detailed performance metrics (e.g., foam collapse temperature, foam quality scales) that may be used to argue that Taro's product does not meet this limitation, even if its chemical components are similar ('237 Patent, FIG. 1-2; col. 12:8-14).
V. Key Claim Terms for Construction
The Term: "quick-breaking temperature sensitive foam"
Context and Importance: This term appears in the independent claims of both patents and defines the central inventive concept. Its construction will be critical for infringement. Practitioners may focus on this term because if Taro's foam does not meet the definition, there is no infringement, and if the definition is construed narrowly based on the specification, it may be easier for Taro to design around or argue non-infringement.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claim language itself does not recite a specific temperature. A party could argue the plain meaning is a foam that simply breaks down upon application to the skin due to body heat, without being tied to a specific numeric range.
- Evidence for a Narrower Interpretation: The specification provides a detailed description of this property, including a graph showing a foam breaking temperature of approximately 35°C ('237 Patent, FIG. 1; col. 12:8-14). The patent also provides a "Foam Quality Scale" to characterize the foam ('237 Patent, FIG. 2). A party could argue these specific embodiments define and limit the scope of the term.
The Term: "a base"
Context and Importance: This is a required component of the claimed composition. Infringement will require the presence of a "base" in Taro's product. Practitioners may focus on this term because its interpretation could be outcome-determinative if Taro's formulation uses a pH-adjusting agent that falls outside the construed definition.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The term "base" is a standard chemical term without special definition in the patent. A party could argue it should be given its plain and ordinary meaning, encompassing any substance that can accept a proton or has a pH greater than 7.
- Evidence for a Narrower Interpretation: The patent describes the function of the pH adjusting agent as achieving a final pH of about 4.0 to 6.5 ('237 Patent, col. 7:1-4). The specification provides examples such as potassium hydroxide, a strong base ('237 Patent, col. 10:65). A party could argue the term should be limited to agents used for the specific purpose of adjusting pH within this range, or to the types of bases disclosed.
VI. Other Allegations
- Indirect Infringement: The complaint alleges induced infringement of the ’747 patent, asserting that Taro's product labeling and prescribing information will actively instruct and encourage medical professionals and patients to administer the ANDA Product for the treatment of acne vulgaris, thereby causing direct infringement of the method claims (Compl. ¶¶ 26, 36-39, 71-73). The complaint also pleads contributory infringement, alleging the ANDA Product is especially made for an infringing use and is not a staple article of commerce (Compl. ¶¶ 57, 75).
- Willful Infringement: Willfulness is alleged based on Taro's knowledge of the patents-in-suit at the time it filed its ANDA, as evidenced by its Paragraph IV certification notice (Compl. ¶¶ 24, 45, 58). Plaintiffs seek a finding of an exceptional case warranting treble damages and attorney fees (Compl. ¶¶ 47, 78).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of formulation equivalence: As the details of the accused product are contained within a confidential ANDA, the litigation will turn on discovery into whether Taro’s formulation contains every element of the asserted composition claims, particularly the specific classes of alcohols (C1-C6 and C14-C22), the surfactant, and the base.
- A dispositive legal question will be the scope of "quick-breaking temperature sensitive foam." The case may hinge on whether this term is construed broadly to mean any foam that collapses with body heat, or narrowly to require the specific thermal performance characteristics (e.g., collapse at ~35°C) and quality metrics detailed in the patent specification.
- A key evidentiary question will concern the basis for Taro's Paragraph IV certification. While the complaint focuses on infringement, the underlying dispute arises from Taro’s assertion of invalidity or non-infringement. The unstated validity challenges, likely based on prior art foam formulations or patent-specific issues like written description, will form a critical part of the defense and the overall case.