DCT

1:15-cv-06990

Horizon Pharma Ireland Ltd v. Amneal Pharma LLC

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:15-cv-06896, D.N.J., 09/17/2015
  • Venue Allegations: Venue is based on Defendant having its principal place of business in Bridgewater, New Jersey, and maintaining manufacturing and R&D facilities within the district.
  • Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) for a generic version of Plaintiff's PENNSAID® 2% topical solution for knee osteoarthritis pain constitutes an act of infringement of a patent covering methods of using the drug.
  • Technical Context: The technology involves topical non-steroidal anti-inflammatory drug (NSAID) formulations using a penetration enhancer to provide localized pain relief, offered as a safer alternative to the systemic risks of oral NSAIDs.
  • Key Procedural History: This is a Hatch-Waxman action under 35 U.S.C. § 271(e)(2) triggered by Defendant’s submission of ANDA No. 208198. The complaint notes that Defendant previously sent a Paragraph IV certification letter concerning a related patent, signaling its intent to challenge the patent portfolio for PENNSAID® 2%.

Case Timeline

Date Event
2009-03-31 U.S. Patent No. 9,132,110 Priority Date
2015-04-02 Defendant sends Paragraph IV Certification letter regarding related '613 patent
2015-09-15 U.S. Patent No. 9,132,110 Issues
2015-09-17 Complaint Filed

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

U.S. Patent No. 9,132,110 - "Treatment of Pain with Topical Diclofenac"

  • Patent Identification: U.S. Patent No. 9,132,110, "Treatment of Pain with Topical Diclofenac", issued September 15, 2015.

The Invention Explained

  • Problem Addressed: The patent’s background section describes the significant gastrointestinal and cardiovascular risks associated with systemically delivered oral non-steroidal anti-inflammatory drugs (NSAIDs) used to treat chronic pain from conditions like osteoarthritis ('110 Patent, col. 2:5-33). It notes that topical delivery is a safer alternative, but its effectiveness is limited by the skin's stratum corneum, which acts as a barrier to drug penetration ('110 Patent, col. 2:47-65).
  • The Patented Solution: The invention is a method of using a topical formulation of the NSAID diclofenac combined with a high concentration of dimethyl sulfoxide (DMSO), a chemical that enhances skin penetration ('110 Patent, col. 3:10-12). The claims are not directed to the formulation itself, but rather to methods of treatment that involve providing specific information to patients on how to use the product safely and effectively, including instructions on application technique and concomitant use with other topical products like sunscreen ('110 Patent, col. 4:22-65). The patent includes instructional diagrams, such as Figure 10, showing the user how to dispense and spread the product on the knee ('110 Patent, Fig. 10A-10C).
  • Technical Importance: This approach sought to provide effective, localized pain relief comparable to an oral NSAID, but with significantly lower systemic drug exposure, thereby reducing the risk of associated side effects ('110 Patent, col. 2:66-col. 3:2).

Key Claims at a Glance

  • The complaint alleges infringement of "one or more claims" of the '110 Patent without specification (Compl. Prayer ¶A). Independent claim 1 is representative of the asserted technology.
  • Essential elements of Independent Claim 1 include:
    • A method for applying topical agents to a knee of a patient with pain, comprising:
    • a patient obtaining a topical diclofenac preparation;
    • the patient being informed to:
      • apply a first medication consisting of the topical diclofenac preparation to treat osteoarthritis of the knee, where the preparation contains a therapeutically effective amount of diclofenac and 40-50% w/w dimethyl sulfoxide;
      • wait for the treated area to dry;
      • subsequently apply a sunscreen, insect repellant, or other topical medication to the area after it is dry; and
    • the patient carrying out the informed steps.

III. The Accused Instrumentality

Product Identification

The accused instrumentality is Defendant’s proposed generic "diclofenac sodium topical solution 2% w/w," which is the subject of Abbreviated New Drug Application (ANDA) No. 208198 ("the Amneal Product") (Compl. ¶10).

Functionality and Market Context

The complaint alleges that the Amneal Product is a generic version of Plaintiff's branded drug, PENNSAID® 2%, and that the ANDA relies on data demonstrating its bioequivalence to the branded product (Compl. ¶24). The Amneal Product is intended for the same therapeutic use: "the relief of pain of osteoarthritis of the knees" (Compl. ¶23). As a generic, it is positioned to be a lower-cost market competitor to the branded drug upon receiving FDA approval (Compl. ¶¶1, 6).

IV. Analysis of Infringement Allegations

The complaint does not contain a claim chart. The infringement theory is based on inducement, alleging that the act of filing the ANDA for a generic copy constitutes infringement under 35 U.S.C. § 271(e)(2)(A) (Compl. ¶30). The core of the case will be whether Amneal’s proposed product label instructs users to perform the patented method. The patent itself, attached as Exhibit A to the complaint, provides an example of patient instructions in Figure 10C, which depicts spreading the medication on the back of the knee (Compl. Ex. A, '110 Patent, Fig. 10C).

'110 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
a patient being informed to: i) apply a first medication... to treat osteoarthritis of the knee... wherein the... preparation comprises... 40-50% w/w dimethyl sulfoxide The Amneal Product is intended for the treatment of osteoarthritis of the knee. It is alleged to be a bioequivalent copy of PENNSAID® 2%, which the patent describes as containing 45.5% DMSO. The proposed product label is expected to instruct this use. ¶¶23, 24 col. 132:50-59
ii) wait for the treated area to dry; The proposed label for the Amneal Product will allegedly instruct users to wait for the application area to dry, consistent with the instructions for the branded product it copies. ¶24 col. 132:60-60
iii) subsequently apply a sunscreen, an insect repellant or a second medication... to said treated area after said treated area is dry The proposed label for the Amneal Product will allegedly contain instructions or warnings regarding the subsequent application of other topical products, thereby informing the user to perform this step. ¶24 col. 132:61-64
(c) the patient carrying-out steps i-iii as informed. Patients who purchase the Amneal Product will allegedly directly infringe the claim by following the instructions on the product's label, an act Amneal is alleged to induce. ¶¶30, 32 col. 132:65-67

Identified Points of Contention

  • Scope Questions: A central question will be whether the language on Amneal's proposed product label, once produced in discovery, meets the "informed to" limitation of the claim. The dispute may focus on whether mere warnings or precautions are sufficient to "inform" a user to perform the claimed sequence of steps, or if more direct instructions are required.
  • Technical Questions: The infringement analysis will depend on the precise formulation of the Amneal Product as detailed in its ANDA. A key question for the court will be whether that formulation contains between 40-50% w/w dimethyl sulfoxide as required by the claim.

V. Key Claim Terms for Construction

The Term: "informed to"

Context and Importance

This term is the lynchpin of the inducement infringement theory. The outcome of the case may depend on whether the instructions and warnings on Amneal’s proposed label are found to "inform" the user to perform the claimed method steps. Practitioners may focus on this term because it directly links the accused infringer's actions (creating a label) to the direct infringement by the end-user (following the label).

Intrinsic Evidence for Interpretation

  • Evidence for a Broader Interpretation: The patent specification repeatedly discusses providing a wide range of "information" to the user, including clinical data, adverse event profiles, and pharmacokinetic results, suggesting "informed" could encompass the totality of information provided with the product ('110 Patent, col. 17:29-col. 18:62).
  • Evidence for a Narrower Interpretation: The claim recites that the patient is informed "to" perform specific actions (apply, wait, subsequently apply). This may support a narrower construction requiring explicit, affirmative instructions, rather than just background information or warnings against certain actions ('110 Patent, col. 132:52-64).

VI. Other Allegations

Indirect Infringement

The complaint's primary theory is inducement of infringement under 35 U.S.C. § 271(b). It alleges that by filing an ANDA to market a generic version of PENNSAID® 2% with a label instructing its use for osteoarthritis of the knee, Amneal intends for end-users to infringe the '110 patent's method claims (Compl. ¶¶30, 32).

Willful Infringement

The complaint alleges that Amneal had actual and constructive notice of the '110 patent from its date of issuance and that its infringement is therefore willful (Compl. ¶33).

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

  • A central evidentiary question will be one of inducement: does the specific language in Amneal's proposed generic drug label—which is not yet public—actively instruct or encourage patients to perform every step of the patented method, particularly the sequence of applying the drug, waiting for it to dry, and then applying a second topical product like sunscreen?
  • The case will also turn on a key question of claim construction: what is the scope of being "informed to" perform an action? The court will have to determine whether this requires explicit, step-by-step commands on the product label, or if it can be satisfied by a combination of use instructions, warnings, and precautions that would collectively lead a patient to follow the patented method.