DCT

2:16-cv-00217

Dow Pharmaceutical Sciences Inc v. Taro Pharma USA Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:16-cv-00217, D.N.J., 01/12/2016
  • Venue Allegations: Venue in the District of New Jersey is based on Defendant Taro USA maintaining places of business, including a drug distribution facility, within the district, and both defendants having previously consented to jurisdiction or availed themselves of the court by filing prior lawsuits in the district.
  • Core Dispute: Plaintiffs allege that Defendants' submission of an Abbreviated New Drug Application (ANDA) seeking FDA approval to market a generic version of the acne treatment Onexton® constitutes an act of infringement of a patent covering the drug's formulation.
  • Technical Context: The technology relates to topical pharmaceutical formulations for treating acne, specifically concerning stable, low-irritation suspensions of benzoyl peroxide, an active ingredient that can be chemically unstable and irritating to the skin.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Plaintiffs' receipt of a notice letter from Defendants regarding their ANDA filing. The patent-in-suit is listed in the FDA's "Orange Book" for Plaintiffs' branded drug, Onexton®, which signifies that the patent claims the approved drug product or a method of using it. The complaint notes that Defendants' notice letter allegedly did not include a detailed explanation for non-infringement of numerous asserted claims.

Case Timeline

Date Event
2008-06-05 U.S. Patent No. 8,288,434 Priority Date
2012-10-16 U.S. Patent No. 8,288,434 Issued
2014-11-24 FDA Approves Onexton® New Drug Application (NDA No. 050819)
2015-12-01 Defendants Send Notice of Certification for ANDA No. 208683
2016-01-12 Complaint Filed

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 8,288,434 - “Topical Pharmaceutical Formulations Containing a Low Concentration of Benzoyl Peroxide in Suspension in Water and a Water-Miscible Organic Solvent”

Issued October 16, 2012 (’434 Patent)

The Invention Explained

  • Problem Addressed: The patent's background describes a dilemma in formulating topical acne treatments with benzoyl peroxide (BPO). While effective, BPO is known to cause skin irritation, particularly at the common 5% concentration. The irritation is attributed to the portion of BPO that is in suspension, rather than dissolved. Prior attempts to dissolve all the BPO required high concentrations of organic solvents, which themselves can be irritating to the skin (’434 Patent, col. 1:46-65; col. 2:1-10).
  • The Patented Solution: The invention is an aqueous gel formulation that uses a lower, less irritating concentration of BPO (less than 5.0%) maintained in a stable suspension. It achieves this using a water-miscible organic solvent but, in certain embodiments, without a surfactant. A key aspect is a high ratio of water to the organic solvent, which is designed to maintain the BPO in a saturated solution on the skin as the water evaporates, thereby maximizing its therapeutic activity while minimizing irritation (’434 Patent, Abstract; col. 2:31-44; col. 3:57-65).
  • Technical Importance: This approach claims to provide clinical efficacy comparable to higher-dose BPO products but with a significant reduction in skin irritation, which is a critical factor for patient adherence in acne therapy (’434 Patent, col. 4:56-64).

Key Claims at a Glance

  • The complaint asserts infringement of claims 1, 4-9, 12-19, 22-27, 30-36, 41, 44-49, and 52-58 (Compl. ¶25). The lead independent composition claim appears to be Claim 1.
  • Independent Claim 1:
    • An aqueous formulation for topical application to the skin comprising water, a water-miscible organic solvent, and benzoyl peroxide,
    • wherein the concentration of the organic solvent 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 the organic solvent is sufficient to provide a suspension of a benzoyl peroxide in a saturated solution of benzoyl peroxide, and
    • wherein the concentration of benzoyl peroxide in the formulation is less than 5.0% and at least 1.0% w/w.
  • The complaint also asserts independent method claim 19 and independent composition claim 41, along with numerous dependent claims.

III. The Accused Instrumentality

Product Identification

  • Defendants' generic benzoyl peroxide and clindamycin phosphate topical gel (3.75%; Eq. 1.2% Base), as described in ANDA No. 208683 (Compl. ¶6, ¶21).

Functionality and Market Context

  • The accused product is a topical gel intended for the treatment of acne and is designed to be a generic version of Plaintiffs' Onexton® product (Compl. ¶22).
  • The complaint alleges that Defendants' ANDA product is "the same, or substantially the same, as Onexton®" (Compl. ¶26). This allegation is central to the infringement theory, as it implies that the generic product has the same formulation characteristics, including the active ingredient concentrations (3.75% BPO) and excipients, that allow it to be bioequivalent to the branded drug which Plaintiffs assert is covered by the '434 Patent (Compl. ¶19, ¶22).

IV. Analysis of Infringement Allegations

The complaint alleges that the very act of filing the ANDA constitutes infringement under 35 U.S.C. § 271(e)(2) (Compl. ¶29). The substantive infringement theory rests on the allegation that the product described in the ANDA, if commercially manufactured, would meet the limitations of the asserted claims.

No probative visual evidence provided in complaint.

'434 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
An aqueous formulation for topical application to the skin comprising water, a water-miscible organic solvent, and benzoyl peroxide... Defendants' product is an aqueous topical gel containing benzoyl peroxide, intended to be a generic version of Onexton®. ¶6, ¶22 col. 7:22-25
wherein the concentration of the organic solvent is sufficient to provide a stable suspension of benzoyl peroxide in the aqueous formulation without the inclusion of a surfactant... The complaint alleges the accused product is the same or substantially the same as Onexton®, which Plaintiffs assert embodies the patent. Certain asserted claims require the absence of a surfactant. ¶25, ¶26 col. 7:25-29
wherein the combined concentration of water and the organic solvent is sufficient to provide a suspension of a benzoyl peroxide in a saturated solution of benzoyl peroxide... This functional limitation is allegedly met because the accused product is a bioequivalent generic of Onexton®, which is covered by the patent. ¶19, ¶26 col. 7:29-33
and wherein the concentration of benzoyl peroxide in the formulation is less than 5.0% and at least 1.0% w/w. Defendants' ANDA specifies a benzoyl peroxide concentration of 3.75%, which is between 1.0% and 5.0%. ¶6 col. 7:33-36
  • Identified Points of Contention:
    • Scope Questions: A primary dispute may arise over the negative limitation "without the inclusion of a surfactant" in claim 1 and other asserted claims (e.g., claim 11). The court will have to determine whether any excipients in Defendants' formulation, even if not primarily intended as such, function as a "surfactant" and thus allow the product to avoid infringement of these specific claims. The assertion of claims that do permit a surfactant (e.g., claim 12) suggests Plaintiffs anticipate this defense.
    • Technical Questions: The infringement analysis will depend entirely on the specific composition of Defendants' product as detailed in its confidential ANDA. A key question will be whether the specific type and concentration of the "water-miscible organic solvent" used by Defendants are sufficient to create the "stable suspension" and "saturated solution" as functionally required by the claims.

V. Key Claim Terms for Construction

  • The Term: "without the inclusion of a surfactant"

    • Context and Importance: This negative limitation is a potential bright-line distinction for non-infringement. Practitioners may focus on this term because Defendants could design their formulation to include a compound that meets the definition of a "surfactant," thereby avoiding claims containing this limitation. The outcome will depend on how broadly or narrowly the term is construed.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation (Plaintiff-favored): A broader view might limit "surfactant" to compounds added specifically for their surfactant properties. The patent contrasts its invention with the prior art BenzaClin® product, which it notes contains "dioctyl sodium sulfosuccinate (surfactant)" (’434 Patent, col. 6:12-14). This suggests the patentee viewed surfactants as a distinct class of ingredients, not compounds with incidental surface-active properties.
      • Evidence for a Narrower Interpretation (Defendant-favored): A narrower view (i.e., a broader definition of what constitutes a "surfactant") might encompass any excipient in the formulation that exhibits surface-active properties, regardless of its primary purpose. The patent does not provide an explicit definition of the term, leaving its scope open to construction based on its plain and ordinary meaning to a person of ordinary skill in the art.

  • The Term: "stable suspension"

    • Context and Importance: This term is a functional requirement at the core of the invention. Whether Defendants' product infringes will depend on whether its formulation achieves this specific state. A dispute could arise over the degree of stability required to meet this limitation.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation (Plaintiff-favored): The specification teaches that the concentration of the organic solvent should be "sufficiently high to provide a stable suspension of benzoyl peroxide in an aqueous fluid without the presence of a surfactant" (’434 Patent, col. 3:52-55). This ties the stability to the solvent's role, suggesting that any formulation achieving stability via this mechanism meets the claim.
      • Evidence for a Narrower Interpretation (Defendant-favored): The patent does not provide a quantitative metric for "stable" (e.g., no settling for X days). Defendants may argue for a specific, higher threshold of stability, potentially based on the examples in the patent, that their product does not meet.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that upon approval and marketing, Defendants will induce and contribute to infringement by medical professionals and patients (Compl. ¶¶31, 36). The factual basis for this is Defendants' act of filing the ANDA with a proposed product label that will instruct users on a method of use that allegedly infringes the patent's method claims (e.g., claim 19).
  • Willful Infringement: The complaint does not use the term "willful infringement" but requests that the court declare the case "exceptional" under 35 U.S.C. § 285 and award attorneys' fees (Compl., Prayer for Relief ¶5). The alleged basis for this is Defendants' knowledge of the '434 Patent from its Orange Book listing and the subsequent filing of the ANDA. The complaint further notes that Defendants' notice letter "does not allege non-infringement" of many asserted claims, which may be used to argue that Defendants lacked a good-faith basis for their certification (Compl. ¶25).

VII. Analyst’s Conclusion: Key Questions for the Case

  • A central issue will be one of formulation identity: does the specific composition disclosed in Defendants' confidential ANDA, including all excipients, contain a "surfactant"? The answer will be dispositive for a significant set of the asserted claims and will turn on the court's construction of that term.
  • A key evidentiary question will be one of functional performance: assuming the formulations are similar, does the accused product achieve a "stable suspension" and a "saturated solution" in the specific manner claimed by the patent? This will require a detailed technical comparison of the patented examples and the accused product's properties.
  • Finally, the case raises a question of good faith under the Hatch-Waxman Act: did Defendants have a sufficient basis for their Paragraph IV certification that the '434 Patent is not infringed, particularly in light of the allegation that their notice letter failed to provide a non-infringement rationale for numerous claims? The resolution of this issue will determine Plaintiffs' entitlement to enhanced damages or attorneys' fees.