DCT

2:18-cv-12569

Taro Pharma USA Inc v. Glenmark Pharma Ltd

Log In

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:18-cv-12569, D.N.J., 08/08/2018
  • Venue Allegations: Plaintiff alleges venue is proper in the District of New Jersey because Defendant Glenmark committed a statutory act of infringement in the district by submitting its Abbreviated New Drug Application (ANDA) and maintains a "regular and established place of business" in the state, including its U.S. Headquarters.
  • Core Dispute: Plaintiff alleges that Defendant’s filing of an ANDA to market a generic version of Plaintiff’s Topicort® (desoximetasone) Topical Spray, 0.25% constitutes an act of infringement of two patents covering stable pharmaceutical formulations.
  • Technical Context: The technology relates to formulations for topical corticosteroids used to treat skin conditions like plaque psoriasis, which affects an estimated 2-3% of the U.S. population.
  • Key Procedural History: This lawsuit was triggered by Defendant’s submission of ANDA No. 211760 with a Paragraph IV certification, which asserts that the patents-in-suit are invalid, unenforceable, and/or will not be infringed by the proposed generic product. Plaintiff received notice of this certification on or about June 26, 2018. The complaint also certifies that this case is related to another pending action in the district, Taro Pharmaceuticals v. Lupin Limited, which involves infringement allegations concerning the same two patents.

Case Timeline

Date Event
2005-05-27 Priority Date for ’780 and ’624 Patents
2012-10-02 Issue Date for U.S. Patent No. 8,277,780
2013-04-11 FDA Approval for Taro’s Topicort® NDA No. 204141
2014-05-06 Issue Date for U.S. Patent No. 8,715,624
2018-06-26 Taro receives Glenmark's Paragraph IV Notice
2018-08-08 Complaint Filing Date

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

U.S. Patent No. 8,277,780 - "Stable Liquid Desoximetasone Compositions with Reduced Oxidized Impurity," issued October 2, 2012

The Invention Explained

  • Problem Addressed: The patent addresses the problem of chemical instability in liquid formulations containing the corticosteroid desoximetasone and the penetration enhancer isopropyl myristate. Specifically, these formulations were found to suffer from oxidation that creates an undesirable "oxidized impurity," rendering the product unsuitable for long-term storage and commercial use ('780 Patent, col. 1:12-24, col. 5:11-22). The patent notes that prior art attempts to solve similar degradation problems with other steroids using antioxidants were not effective for this specific impurity ('780 Patent, col. 6:5-16).
  • The Patented Solution: The invention provides a stable liquid formulation by incorporating a specific "stabilizing agent." This agent is described as being capable of inhibiting the formation of the oxidized impurity, particularly under accelerated storage conditions that simulate a long shelf life ('780 Patent, Abstract). The specification describes the stabilizing agent as either an oleaginous vehicle (e.g., mineral oil), a propellant, or a mixture of an oleaginous vehicle and a skin conditioning agent ('780 Patent, col. 2:42-47, 56-65).
  • Technical Importance: This technology enabled the development of a commercially stable, spray-based desoximetasone product, providing a convenient dosage form for a potent corticosteroid used in treating inflammatory skin diseases (Compl. ¶¶ 26-27).

Key Claims at a Glance

  • The complaint asserts the claims of the patent generally, without specifying individual claims (Compl. ¶33). Independent claim 1 is representative of the core invention.
  • The essential elements of independent claim 1 include:
    • A liquid formulation comprising:
    • about 0.01 wt % to about 2.5 wt % desoximetasone;
    • about 10 wt % to about 70 wt % isopropyl myristate;
    • about 20 wt % to about 70 wt % C2-C4 alcohol; and
    • a stabilizing agent comprising a mixture of (a) an oleaginous vehicle selected from mineral oil and light mineral oil and (b) a skin conditioning agent selected from a C15-C25 fatty alcohol or an ester of glycerin and a C15-C25 fatty acid.
  • The complaint does not explicitly reserve the right to assert dependent claims, but this is standard practice.

U.S. Patent No. 8,715,624 - "Stable Liquid Desoximetasone Compositions with Reduced Oxidized Impurity," issued May 6, 2014

The Invention Explained

  • Problem Addressed: The ’624 Patent, a continuation of the application that led to the ’780 Patent, addresses the same technical problem of oxidative degradation in liquid desoximetasone formulations ('624 Patent, col. 2:17-24).
  • The Patented Solution: The patent claims similar solutions to the '780 Patent, focusing on the use of a stabilizing agent—selected from an oleaginous vehicle or a propellant—to reduce the formation of the specific oxidized impurity and ensure long-term stability of the formulation ('624 Patent, Abstract; col. 2:40-45).
  • Technical Importance: This patent expands the scope of protection for Plaintiff's commercially successful Topicort® spray, creating additional obstacles for generic competitors (Compl. ¶¶ 28-29).

Key Claims at a Glance

  • The complaint asserts the claims of the patent generally (Compl. ¶33). Independent claim 1 is identical to claim 1 of the '780 Patent.
  • The essential elements of independent claim 1 include:
    • A liquid formulation comprising:
    • about 0.01 wt % to about 2.5 wt % desoximetasone;
    • about 10 wt % to about 70 wt % isopropyl myristate;
    • about 20 wt % to about 70 wt % C2-C4 alcohol; and
    • a stabilizing agent comprising a mixture of (1) an oleaginous vehicle selected from mineral oil and light mineral oil and (2) a skin conditioning agent selected from a C15-C25 fatty alcohol or an ester of glycerin and a C15-C25 fatty acid.
  • The '624 Patent was filed with a terminal disclaimer over the '780 Patent, ensuring it expires on the same date.

III. The Accused Instrumentality

Product Identification

  • Defendant's proposed generic Desoximetasone Topical Spray, 0.25%, which is the subject of ANDA No. 211760 (Compl. ¶¶ 8, 30).

Functionality and Market Context

  • The accused product is a generic drug intended to be a substitute for Plaintiff's Topicort® spray (Compl. ¶30). As a generic, it is required by the FDA to have the same active ingredient (desoximetasone), dosage form (topical spray), and strength (0.25%) as Topicort®, and to be bioequivalent. The complaint alleges the product is indicated for treating plaque psoriasis in patients 18 years or older and will be sold in 30 ml, 50 ml, and 100 ml volumes upon approval (Compl. ¶¶ 8, 26).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

The complaint does not contain a claim chart or detailed technical allegations regarding the composition of the accused product. The infringement theory is based on the statutory framework of the Hatch-Waxman Act, wherein the submission of an ANDA for a drug claimed in a patent is a defined act of infringement under 35 U.S.C. § 271(e)(2). The core allegation is that because the accused product seeks to be a generic copy of Topicort®, its formulation will necessarily fall within the scope of the asserted patent claims covering that product (Compl. ¶¶ 37-38, 45-46).

'780 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A liquid formulation comprising: a) about 0.01 wt % to about 2.5 wt % desoximetasone; The complaint alleges that the proposed generic product, as a copy of Topicort® 0.25% spray, will contain desoximetasone within the claimed concentration range. ¶¶ 30, 37 col. 5:52-59
b) about 10 wt % to about 70 wt % isopropyl myristate; The generic product is alleged to contain isopropyl myristate, a known penetration enhancer, within the claimed range. ¶¶ 30, 37 col. 5:60-65
c) about 20 wt % to about 70 wt % C2-C4 alcohol; The generic product is alleged to utilize a C2-C4 alcohol (e.g., ethyl alcohol or isopropanol) as a solvent within the claimed range. ¶¶ 30, 37 col. 5:66-67
d) a stabilizing agent comprising a mixture of (a) an oleaginous vehicle...and (b) a skin conditioning agent... The generic product is alleged to contain a stabilizing system that meets the claim's two-part structural definition to achieve the required stability for FDA approval. ¶¶ 30, 37 col. 2:42-54
  • Identified Points of Contention:
    • Scope Questions: The primary dispute will likely concern the "stabilizing agent" limitation. A central question is whether Glenmark's formulation, as described in its confidential ANDA, contains a combination of ingredients that constitutes "a mixture of an oleaginous vehicle and a skin conditioning agent" as those terms are defined in the patent.
    • Technical Questions: Glenmark's Paragraph IV notice asserts non-infringement, suggesting it may have designed its formulation to avoid literal infringement of one or more claim elements (Compl. ¶31). The key technical question is what specific excipients Glenmark uses to ensure stability and whether they differ chemically or functionally from the claimed "stabilizing agent."

'624 Patent Infringement Allegations

The analysis for Claim 1 of the ’624 Patent is identical to that of the ’780 Patent, as the claim language is the same. The infringement allegations and likely points of contention are therefore mirrored.

V. Key Claim Terms for Construction

  • The Term: "stabilizing agent"

    • Context and Importance: This term is the central point of novelty claimed by the patents. Its construction will be dispositive for infringement, as Glenmark's non-infringement defense will almost certainly rely on a showing that its formulation's stabilizing components fall outside the scope of this term.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification provides a functional definition, stating a "‘stabilizing agent’ refers to an agent that improves stability of the liquid formulation and prevent the formation of oxidized impurity" (’780 Patent, col. 4:49-53). A plaintiff may argue this functional aspect should inform the term's scope.
      • Evidence for a Narrower Interpretation: Claim 1 itself provides a clear structural definition, requiring "a mixture of (a) an oleaginous vehicle... and (b) a skin conditioning agent..." (’780 Patent, col. 21:16-24). A defendant will argue that this explicit structural requirement in the claim body is limiting and that any agent that does not meet this two-part structure cannot be a "stabilizing agent" for infringement purposes, regardless of its function.

  • The Term: "oleaginous vehicle"

    • Context and Importance: As a required component of the "stabilizing agent," the scope of this term is critical. If Glenmark uses an oil-like substance not considered an "oleaginous vehicle," it could avoid infringement.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification states it "refers to a solvent that resembles or having the properties of oil such as vegetable oil... or mineral oil" (’780 Patent, col. 4:54-56). A plaintiff may argue this covers a wide class of oil-like solvents.
      • Evidence for a Narrower Interpretation: Claim 1 limits the "oleaginous vehicle" to being "selected from the group consisting of mineral oil and light mineral oil" (’780 Patent, col. 21:18-19). A defendant will argue this explicit selection in the claim itself strictly limits the term to those two specific substances, precluding other types of oils.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement. The inducement claim is based on the allegation that Glenmark, with knowledge of the patents, will encourage infringement through its product labeling and instructions to doctors and patients (Compl. ¶¶ 66-70). The contributory infringement claim alleges that Glenmark's product is especially made for an infringing use and is not a staple article of commerce suitable for substantial non-infringing use (Compl. ¶¶ 71-74).
  • Willful Infringement: Willfulness is alleged based on Glenmark’s purported actual knowledge of the patents, at least from the time they were listed in the FDA’s Orange Book (Compl. ¶¶ 63-64). The complaint alleges that despite this knowledge, Glenmark deliberately proceeded with conduct (filing the ANDA) that it knew or should have known would constitute infringement, making the case "exceptional" and justifying enhanced damages and attorneys' fees (Compl. ¶¶ 59, 79).

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

  1. A central issue will be one of claim construction: how will the court construe the term "stabilizing agent"? Will it be limited to the strict two-part structural definition recited in Claim 1, where the "oleaginous vehicle" is further limited to only mineral oil or light mineral oil, or could a broader functional definition apply? The outcome of this question will likely determine infringement.
  2. A key evidentiary question will be one of factual composition: what is the precise formulation of Glenmark’s proposed generic product as detailed in its confidential ANDA? Does that formulation contain excipients that fall within the court’s construction of the claimed "stabilizing agent", or has Glenmark successfully designed around the patent claims by using a chemically distinct stabilizing system?
  3. A third major question, raised by Glenmark's Paragraph IV certification, will be patent validity: are the asserted claims obvious in light of prior art? The dispute may focus on whether it would have been obvious to a skilled formulator to combine a known corticosteroid with the specific claimed stabilizing components to solve the known problem of oxidative degradation.