DCT

1:17-cv-03342

Horizon Pharma USA Inc v. Actavis Laboratories Ut Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:17-cv-03342, D.N.J., 05/11/2017
  • Venue Allegations: Plaintiff alleges venue is proper in the District of New Jersey because Defendant has conducted systematic and continuous business in the state, availed itself of New Jersey law, has previously submitted to jurisdiction in the district, and intends to market and sell the accused product in the district upon FDA approval.
  • Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff's PENNSAID® 2% topical solution constitutes an act of patent infringement.
  • Technical Context: The technology concerns a topical gel formulation of the non-steroidal anti-inflammatory drug (NSAID) diclofenac sodium, designed for treating pain associated with osteoarthritis of the knee.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendant’s submission of an ANDA with a Paragraph IV certification. This certification asserts that the patent-in-suit is invalid, unenforceable, or will not be infringed by the proposed generic product. The complaint notes that Defendant has been a party to at least 14 prior actions in the District of New Jersey.

Case Timeline

Date Event
2006-10-17 Earliest Priority Date for '335 Patent
2017-01-10 '335 Patent Issue Date
2017-05-03 Date of Defendant's Paragraph IV Notification Letter
2017-05-11 Complaint Filing Date

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

  • Patent Identification: U.S. Patent No. 9,539,335, "Diclofenac Topical Formulation," issued January 10, 2017.
  • The Invention Explained:
    • Problem Addressed: The patent describes the challenge of treating osteoarthritis (OA) effectively. Oral NSAIDs carry risks of serious systemic side effects, while prior topical NSAIDs were often commercially unsuccessful due to drawbacks such as being slow to dry, runny, and requiring frequent dosing (e.g., three to four times daily), which increases the potential for skin irritation (’335 Patent, col. 1:42-53; col. 2:11-28). The fundamental technical problem is delivering the drug through the skin barrier in sufficient therapeutic quantities without creating an inconvenient or irritating product for the patient (’335 Patent, col. 2:29-34).
    • The Patented Solution: The invention is a specific gel formulation of diclofenac sodium that claims superior properties for transdermal delivery (’335 Patent, Abstract). The formulation combines the active ingredient with a high concentration of dimethyl sulfoxide (DMSO) as a penetration enhancer, ethanol, propylene glycol, and a thickening agent (hydroxypropyl cellulose). This combination is designed to create a stable gel that dries quickly, adheres well to the skin, and delivers the active ingredient more effectively through the skin compared to prior art formulations (’335 Patent, col. 3:40-col. 4:2).
    • Technical Importance: This formulation aimed to provide a topical OA treatment with a more patient-friendly, twice-daily dosing schedule, potentially improving compliance while delivering therapeutic benefit and minimizing systemic exposure (’335 Patent, col. 28:13-20).
  • Key Claims at a Glance:
    • The complaint alleges infringement of "one or more claims" without specifying them (Prayer for Relief, A). The following analysis focuses on independent method-of-use claim 9, which incorporates the formulation of independent claim 1, as this is representative of an infringement theory in the ANDA context.
    • Independent Claim 9: "A method for treating pain due to osteoarthritis of a knee of a patient in need thereof, said method comprising: administering to the knee twice daily a topical formulation prepared by the process of claim 1."
    • The key elements of the formulation from Independent Claim 1 are:
      • diclofenac sodium present at 2% w/w
      • DMSO present at about 40 to about 50% w/w
      • ethanol present at 23-29% w/w
      • propylene glycol present at 10-12% w/w
      • hydroxypropyl cellulose
      • water to make 100% w/w
      • wherein the formulation has a viscosity of 500-5000 centipoise
    • It is standard practice for plaintiffs to reserve the right to assert additional claims, including dependent claims, as a case proceeds.

III. The Accused Instrumentality

  • Product Identification: The accused instrumentality is Defendant's proposed generic "diclofenac sodium topical solution 2% w/w," identified in ANDA No. 207238 ("the Actavis UT Product") (Compl. ¶1, 8, 19).
  • Functionality and Market Context: The Actavis UT Product is intended for the "relief of pain of osteoarthritis of the knees," the same indication as Plaintiff's PENNSAID® 2% product (Compl. ¶16, 19). The complaint alleges that Defendant's ANDA filing relies on data intended to demonstrate the bioequivalence of its proposed generic product to PENNSAID® 2% (Compl. ¶20). The infringement action under 35 U.S.C. § 271(e)(2) arises from the filing of this ANDA, which seeks FDA approval to market the product before the expiration of the ’335 patent (Compl. ¶1, 22). No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

’335 Patent Infringement Allegations

Claim Element (from Independent Claim 9, incorporating Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
a topical formulation ... comprising ... diclofenac sodium present at 2% w/w The Actavis UT Product is identified as a "diclofenac sodium topical solution 2% w/w." ¶19 col. 28:51-52
DMSO present at about 40 to about 50% w/w The complaint alleges the Actavis product is bioequivalent to PENNSAID® 2%, which is allegedly covered by the patent. ¶18, 20 col. 28:53
ethanol present at 23-29% w/w The complaint alleges the Actavis product is bioequivalent to PENNSAID® 2%, which is allegedly covered by the patent. ¶18, 20 col. 28:54-55
propylene glycol present at 10-12% w/w The complaint alleges the Actavis product is bioequivalent to PENNSAID® 2%, which is allegedly covered by the patent. ¶18, 20 col. 28:56
hydroxypropyl cellulose The complaint alleges the Actavis product is bioequivalent to PENNSAID® 2%, which is allegedly covered by the patent. ¶18, 20 col. 28:57
wherein the formulation has a viscosity of 500-5000 centipoise The complaint alleges the Actavis product is bioequivalent to PENNSAID® 2%, which is allegedly covered by the patent. ¶18, 20 col. 28:59-60
administering to the knee twice daily Defendant seeks approval to market its product for the same indication as PENNSAID® 2%, and its label will allegedly instruct for this use. ¶19, 27 col. 29:16-17
  • Identified Points of Contention:
    • Technical Questions: A primary point of contention will be factual: does the precise formulation disclosed in Defendant's confidential ANDA meet the specific concentration ranges for excipients (DMSO, ethanol, propylene glycol) and the viscosity range required by claim 1? The complaint does not contain these details, relying instead on the allegation of bioequivalence.
    • Scope Questions: The dispute may center on whether Defendant's formulation constitutes a "design around" that achieves bioequivalence while using excipient concentrations or a viscosity that falls outside the literal scope of the claims. The interpretation of claim terms, such as "about," could become critical in this analysis.

V. Key Claim Terms for Construction

  • The Term: "about" (e.g., "about 40 to about 50% w/w")
  • Context and Importance: The construction of "about" is central to the literal infringement analysis. If Defendant’s formulation uses an excipient concentration just outside the specified numerical range (e.g., 39.5% DMSO), the case could turn on whether "about 40%" is broad enough to cover it. Practitioners may focus on this term because it directly addresses the permissible boundary of the claimed concentration ranges.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification uses the term "about" and "approximately" in relation to other formulations and ranges, which may suggest the patentee did not intend for the recited ranges to be rigidly absolute and was contemplating some degree of variability (’335 Patent, col. 7:52, col. 8:31-32).
    • Evidence for a Narrower Interpretation: The claims recite several specific and relatively narrow ranges (e.g., "10-12% w/w" for propylene glycol). A party could argue that such precision implies that "about" should be construed narrowly to mean little more than standard measurement error. The patent's examples also provide formulations with exact percentages, which could be used to argue against a broad reading of "about" that would encompass significantly different compositions (’335 Patent, Table 5).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that upon approval and commercialization, Defendant will actively induce infringement of the ’335 patent (Compl. ¶27). This allegation is based on the premise that Defendant's product label and marketing materials will instruct medical professionals and patients to use the generic product in a manner that directly practices the patented method—specifically, by applying it twice daily to the knee to treat OA pain (Compl. ¶19, 27).
  • Willful Infringement: Willfulness is alleged based on Defendant having "actual and constructive notice of the '335 patent as of its issue date" (Compl. ¶28). The key factual support for this is Defendant’s Paragraph IV Notification letter, dated May 3, 2017, which explicitly acknowledges the patent and constitutes pre-suit knowledge (Compl. ¶21).

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

  • A primary issue will be one of evidentiary proof: does the specific formulation disclosed in Defendant’s confidential ANDA fall within the literal scope of the patent's claims, particularly the concentration and viscosity limitations? The dispute will largely depend on facts that emerge during discovery.
  • A central legal and factual question will concern the implication of bioequivalence: To what extent can Plaintiff use Defendant’s regulatory assertion of bioequivalence to PENNSAID® 2%—a product Plaintiff contends embodies the invention—as a proxy for proving that the accused generic formulation necessarily meets every limitation of the asserted claims?