DCT
2:17-cv-00544
Dow Pharmaceutical Sciences Inc v. Taro Pharma USA Inc
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Dow Pharmaceutical Sciences, Inc. (California) and Valeant Pharmaceuticals North America LLC (Delaware)
- Defendant: Taro Pharmaceuticals U.S.A., Inc. (New York) and Taro Pharmaceutical Industries Ltd. (Israel)
- Plaintiff’s Counsel: GIBBONS P.C.
- Case Identification: 2:17-cv-00544, D.N.J., 01/26/2017
- Venue Allegations: Venue is based on Defendant Taro USA having a drug distribution facility and places of business in New Jersey, being a registered business in the state, and having previously filed lawsuits and counterclaims in the district.
- Core Dispute: Plaintiffs allege that Defendant’s filing of an Abbreviated New Drug Application (ANDA) for a generic version of Plaintiffs' Onexton® topical gel constitutes an act of infringement of a patent covering the drug's formulation.
- Technical Context: The technology relates to aqueous gel formulations for treating acne that combine an antibiotic (clindamycin) with a low concentration of benzoyl peroxide to improve efficacy while reducing skin irritation.
- Key Procedural History: The patent-in-suit is listed in the FDA's "Orange Book" in connection with the branded drug Onexton®. The lawsuit was triggered by Defendants' submission of an ANDA with a Paragraph IV certification, and the complaint notes that the certification letter did not allege non-infringement of claims 9-18 of the patent.
Case Timeline
| Date | Event |
|---|---|
| 2008-06-05 | '704 Patent Priority Date |
| 2014-11-24 | FDA approves Onexton® New Drug Application |
| 2016-11-29 | '704 Patent Issues |
| 2016-12-12 | Plaintiffs receive Defendant's notice letter |
| 2017-01-26 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 9,504,704 - "Topical Pharmaceutical Formulations Containing a Low Concentration of Benzoyl Peroxide in Suspension in Water and a Water-Miscible Organic Solvent," issued November 29, 2016
The Invention Explained
- Problem Addressed: The patent addresses the skin irritation caused by topical benzoyl peroxide (BPO) acne treatments. The background section states that this irritation is concentration-dependent and is primarily caused by the portion of BPO that is in a solid, suspended state, rather than the portion that is dissolved in the formulation’s vehicle. ('704 Patent, col. 3:1-15). Prior art attempts to fully dissolve BPO required high concentrations of organic solvents, which themselves can be irritating to the skin. ('704 Patent, col. 3:23-28).
- The Patented Solution: The invention is an aqueous gel formulation that uses a low concentration of BPO (<5.0%) suspended in a saturated solution of water and a water-miscible organic solvent (e.g., propylene glycol). ('704 Patent, Abstract; col. 3:56-62). The formulation is designed with a high water-to-organic-solvent ratio, which maintains the BPO at or near saturated solubility on the skin even as the water evaporates, thereby maximizing the drug's "thermodynamic activity" without requiring high, irritating concentrations. ('704 Patent, col. 4:21-29). The formulation is also preferably free of surfactants. ('704 Patent, col. 4:10-11).
- Technical Importance: This approach provided a method to achieve clinical efficacy comparable to higher-concentration BPO products while reducing the associated skin irritation, a significant factor in patient compliance for acne therapies. ('704 Patent, col. 3:61-65).
Key Claims at a Glance
- The complaint states that Defendant's notice letter did not allege non-infringement of claims 9-18. (Compl. ¶25). Claim 9 is the broadest independent claim in this group.
- Independent Claim 9:
- An aqueous formulation for topical application to the skin comprising water, propylene glycol, benzoyl peroxide, and clindamycin phosphate,
- wherein the concentration of propylene glycol is sufficient to provide a stable suspension of benzoyl peroxide in the aqueous formulation without the inclusion of a surfactant in the formulation,
- wherein the combined concentration of water and propylene glycol is sufficient to provide a suspension of a benzoyl peroxide in a saturated solution of benzoyl peroxide,
- wherein the concentration of benzoyl peroxide in the formulation is 3.75% w/w,
- and wherein the concentration of clindamycin phosphate in the formulation is 1.2% w/w.
- The complaint alleges infringement of "at least one claim" of the patent. (Compl. ¶29).
III. The Accused Instrumentality
- Product Identification: The accused instrumentality is Defendant Taro’s Abbreviated New Drug Application (ANDA) No. 208683, which seeks FDA approval to market a "generic benzoyl peroxide and clindamycin phosphate topical gel (3.75%; Eq. 1.2% Base)." (Compl. ¶¶ 6, 21-22).
- Functionality and Market Context: The filing of the ANDA is the statutory act of infringement under 35 U.S.C. § 271(e)(2). (Compl. ¶29). The complaint alleges that Taro’s proposed generic product is intended to be a generic version of Plaintiffs' Onexton® and is "the same, or substantially the same, as Onexton®." (Compl. ¶¶ 22, 26). Onexton® is an FDA-approved prescription drug for the treatment of acne. (Compl. ¶¶ 19-20).
IV. Analysis of Infringement Allegations
The complaint does not contain a detailed claim chart. The infringement theory is predicated on the legal requirement that an ANDA generic product be the "same as" the reference listed drug (Onexton®), which Plaintiffs allege is covered by the '704 patent. No probative visual evidence provided in complaint.
'704 Patent Infringement Allegations
| Claim Element (from Independent Claim 9) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| An aqueous formulation for topical application to the skin comprising water, propylene glycol, benzoyl peroxide, and clindamycin phosphate | Taro's ANDA product is described as a "topical gel" containing benzoyl peroxide and clindamycin phosphate. (Compl. ¶6). The complaint alleges the product is the same as Onexton®, which embodies the claimed formulation. (Compl. ¶26). | ¶6, ¶26 | col. 5:31-35 |
| wherein the concentration of propylene glycol is sufficient to provide a stable suspension of benzoyl peroxide...without...a surfactant | The complaint does not provide specific facts on this element, but infringement is premised on the ANDA product being the same as Onexton®, which the patent describes as a surfactant-free, stable suspension. ('704 Patent, col. 5:53-54). | ¶26 | col. 4:8-11 |
| wherein the combined concentration of water and propylene glycol is sufficient to provide a suspension...in a saturated solution... | The complaint does not provide specific facts on this element. Infringement is premised on the ANDA product being the same as Onexton®, which the patent teaches is formulated to achieve this state. ('704 Patent, col. 4:18-22). | ¶26 | col. 4:18-22 |
| wherein the concentration of benzoyl peroxide in the formulation is 3.75% w/w | The complaint alleges Taro's ANDA product contains benzoyl peroxide at a concentration of 3.75%. | ¶6 | col. 5:32 |
| and wherein the concentration of clindamycin phosphate in the formulation is 1.2% w/w | The complaint alleges Taro's ANDA product contains clindamycin phosphate equivalent to 1.2% base. | ¶6 | col. 5:33 |
- Identified Points of Contention:
- Factual Questions: The complaint's infringement theory relies heavily on the ANDA "sameness" requirement. A primary point of contention, to be resolved through discovery, will be whether Taro's proposed generic formulation in fact contains the exact components and achieves the functional characteristics required by the claims, such as being "surfactant-free" and forming a "saturated solution" of BPO.
- Scope Questions: The complaint’s allegation that Taro's notice letter did not contest infringement of claims 9-18 suggests that the central dispute may not be over infringement, but rather over the patent's validity (e.g., obviousness). (Compl. ¶25). The complaint's lack of detailed infringement allegations may reflect a belief by Plaintiffs that infringement of these claims is conceded.
V. Key Claim Terms for Construction
The Term: "stable suspension ... without the inclusion of a surfactant"
Context and Importance: This combined functional and negative limitation is central to distinguishing the invention from prior art. The definition of "surfactant" will be critical, as Taro's formulation could be deemed non-infringing if it contains an excipient that falls within the construed definition of the term.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent does not provide an explicit definition for "surfactant." A party could argue for its plain and ordinary meaning, which might encompass any compound with surface-active properties, even if that is not its primary function in the formulation.
- Evidence for a Narrower Interpretation: The specification distinguishes the invention from a prior art commercial product, BenzaClin®, which contained "dioctyl sodium sulfosuccinate (surfactant)." ('704 Patent, col. 5:50-53). A party could argue this example implicitly limits the term "surfactant" to conventional emulsifying agents of that class, rather than any excipient that might exhibit minor surface-active properties.
The Term: "saturated solution of benzoyl peroxide"
Context and Importance: This term defines the specific physicochemical state of the active ingredient in the formulation's vehicle, which is core to the patent's theory of reduced irritation and high efficacy. Infringement requires that Taro's product achieve this specific state.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The term could be construed broadly to mean any solution that can dissolve no more solute at a given temperature.
- Evidence for a Narrower Interpretation: The specification provides specific context, describing the formulation as a "saturated solution of benzoyl peroxide with a dissolved concentration of benzoyl peroxide that is higher than when dissolved in water without the organic solvent." ('704 Patent, col. 4:18-22). This language suggests the term is not merely "saturated" in an absolute sense, but saturated in the specific water/organic solvent system created by the invention.
VI. Other Allegations
- Indirect Infringement: The complaint includes allegations of future contributory and induced infringement that would occur if the FDA approves Taro's ANDA and the generic product is commercially manufactured and sold. (Compl. ¶¶ 31, 36).
- Willful Infringement: The complaint does not contain an explicit allegation of willful infringement. However, it requests that the court declare the case "exceptional" under 35 U.S.C. § 285, which would allow for an award of attorney's fees. (Prayer for Relief ¶ 5). This request is based on the act of filing the ANDA with knowledge of the '704 patent.
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of compositional identity: Will discovery confirm that the formulation detailed in Taro's ANDA is identical to the claimed formulation, especially concerning the functional limitations of being "surfactant-free" and achieving a "saturated solution" of benzoyl peroxide in the specific vehicle claimed by the patent?
- Given the complaint’s assertion that infringement of key claims was not disputed in Defendant's pre-suit notice letter, a primary legal battle may be over patent validity. The case will likely focus on whether the specific combination of well-known ingredients at the claimed concentrations was obvious to a person of ordinary skill in the art, rather than on whether the accused product infringes.