DCT

2:18-cv-04225

Taro Pharma USA Inc v. Lupin Ltd

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:18-cv-04225, D.N.J., 03/23/2018
  • Venue Allegations: Plaintiff alleges venue is proper in the District of New Jersey because Defendant committed an act of infringement in the district via its ANDA submission and maintains a "regular and established place of business" at a manufacturing facility in Somerset, New Jersey.
  • Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff's Topicort® Topical Spray constitutes infringement of two patents related to stable topical corticosteroid formulations.
  • Technical Context: The technology concerns pharmaceutical formulations for the topical corticosteroid desoximetasone, specifically addressing the problem of chemical degradation and the formation of an oxidized impurity during storage.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendant's submission of ANDA No. 208124 and its public announcement of receiving final FDA approval to market its generic product. The patents-in-suit are listed in the FDA's "Orange Book" for Plaintiff's branded product, Topicort®, which serves as the basis for Plaintiff's allegation of Defendant's pre-suit knowledge of the patents.

Case Timeline

Date Event
2005-05-27 Priority Date for ’780 and ’624 Patents
2012-10-02 U.S. Patent No. 8,277,780 Issued
2013-04-11 FDA Approves Taro's NDA for Topicort® Topical Spray
2014-05-06 U.S. Patent No. 8,715,624 Issued
2018-03-19 Lupin Announces Final FDA Approval for Generic Product
2018-03-23 Complaint Filed

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

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

The Invention Explained

  • Problem Addressed: The patent's specification, incorporated from its parent applications, describes that liquid formulations containing the corticosteroid desoximetasone and the penetration enhancer isopropyl myristate are unstable and suffer from oxidation, leading to the formation of an undesirable "oxidized impurity" ('780 Patent, col. 1:12-24). This degradation occurs even when stored in inert glass containers and can exceed regulatory limits for impurities ('780 Patent, col. 1:15-24).
  • The Patented Solution: The invention claims to solve this stability problem by adding a specific "stabilizing agent" to the formulation, which reduces the formation of the oxidized impurity during storage ('624 Patent, Abstract). The '624 Patent claims a stabilizing agent that is a mixture of an oleaginous vehicle (like mineral oil) and a skin conditioning agent (like oleyl alcohol or glyceryl oleate) ('624 Patent, col. 22:11-20). The patent provides data in chromatogram figures suggesting that formulations with these stabilizing agents exhibit significantly less degradation compared to control formulations ('780 Patent, Figs. 1-10; col. 18:12-23).
  • Technical Importance: Maintaining the chemical stability of a topical drug formulation is critical to ensure its safety, efficacy, and shelf-life, as degradation products can be inactive, less potent, or potentially harmful ('780 Patent, col. 2:17-24).

Key Claims at a Glance

  • The complaint asserts infringement of at least independent claim 1 (Compl. ¶52).
  • The essential elements of Claim 1 of the '624 Patent are 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 complaint does not explicitly reserve the right to assert dependent claims.

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

The Invention Explained

  • Problem Addressed: As the parent of the application that led to the '624 patent, the '780 Patent addresses the same technical problem of oxidative degradation in desoximetasone and isopropyl myristate formulations ('780 Patent, col. 1:12-24).
  • The Patented Solution: The patented solution is also the addition of a "stabilizing agent" to inhibit the formation of the oxidized impurity ('780 Patent, Abstract). The '780 patent claims are broader in one respect, defining the stabilizing agent as being selected from the group consisting of an oleaginous vehicle and a propellant, without the requirement that it be a mixture ('780 Patent, col. 2:48-50).
  • Technical Importance: As with the '624 patent, this technology provides a method to create a commercially viable and safe topical steroid product with a stable shelf-life.

Key Claims at a Glance

  • The complaint asserts infringement of at least independent claim 1 (Compl. ¶79).
  • The essential elements of Claim 1 of the '780 Patent are 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 selected from the group consisting of an oleaginous vehicle and a propellant.
  • The complaint does not explicitly reserve the right to assert dependent claims.

III. The Accused Instrumentality

Product Identification

  • Lupin's generic Desoximetasone Topical Spray, 0.25%, to be sold in 30 ml, 50 ml, and 100 ml volumes (Compl. ¶10).

Functionality and Market Context

  • The accused product is identified as the "generic equivalent" of Taro's Topicort® Topical Spray, 0.25% (Compl. ¶13).
  • It is a corticosteroid indicated for the treatment of plaque psoriasis in patients 18 years of age or older (Compl. ¶13). The complaint states that upon receiving final FDA approval for its ANDA, Lupin will manufacture, sell, and import the accused product in the United States (Compl. ¶10).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

The complaint, filed under the Hatch-Waxman Act, alleges infringement based on the submission of ANDA No. 208124 (Compl. ¶¶ 32, 40). It does not contain a claim chart or detailed factual allegations mapping the specific formulation of the accused product to the elements of the asserted claims. The infringement theory relies on the statutory act of filing an ANDA for a drug claimed in a patent, which itself constitutes an act of infringement for jurisdictional purposes. A central question for the court will be whether the formulation disclosed in Lupin's confidential ANDA contains all the elements of the asserted claims.

  • Identified Points of Contention:
    • Compositional Questions: The primary dispute will likely concern the precise composition of Lupin's generic product. The key factual question is whether Lupin's formulation contains desoximetasone, isopropyl myristate, and a C2-C4 alcohol within the claimed weight-percent ranges, and crucially, whether it contains a "stabilizing agent" that falls within the scope of the asserted claims of the '780 and '624 patents.
    • Scope Questions: A potential point of contention may arise over the interpretation of the weight-percent ranges. For example, does Lupin's 0.25% concentration of desoximetasone fall within the scope of "about 0.25 wt%" as claimed in dependent claims of the patents ('780 Patent, claim 3).

V. Key Claim Terms for Construction

  • The Term: "stabilizing agent"
  • Context and Importance: This term is the central point of novelty described in the patents, as it is the component alleged to solve the problem of oxidative degradation where prior art, such as traditional antioxidants, allegedly failed ('780 Patent, col. 6:25-32). The construction of this term will be dispositive for infringement, as Lupin's product must contain such an agent to infringe.
  • 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[s] the formation of oxidized impurity" ('780 Patent, col. 4:50-54). Plaintiff may argue for this broader, functional construction.
    • Evidence for a Narrower Interpretation: The independent claims explicitly limit the "stabilizing agent" to specific chemical classes. Claim 1 of the '780 Patent limits it to "an oleaginous vehicle and a propellant," while Claim 1 of the '624 Patent further limits it to a "mixture" of an oleaginous vehicle and a specific skin conditioning agent. Defendant may argue the term is exhausted by these express limitations. The specification's express finding that antioxidants were not effective could be used to argue that the scope of "stabilizing agent" excludes conventional antioxidants ('780 Patent, col. 13:17-21).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges active inducement, stating that Lupin's commercial activities will "encourage another's infringement" and will be done with knowledge of the patents and intent to encourage infringement (Compl. ¶¶ 63-64, 90-91). It also alleges contributory infringement, stating the product is "especially made or especially adapted for use in an infringement" and is not a staple article of commerce (Compl. ¶¶ 66, 93).
  • Willful Infringement: The complaint alleges that Lupin had "actual knowledge" or "actual notice" of the patents-in-suit no later than the date they were listed in the FDA's Orange Book (Compl. ¶¶ 59, 86). It alleges that despite this notice, Lupin is "willfully, wantonly, and deliberately" preparing to infringe, making the case exceptional (Compl. ¶¶ 54, 81).

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

  • A core issue will be one of compositional identity: Does the confidential formulation disclosed in Lupin's ANDA contain every component, within the specified weight-percent ranges, recited in at least one of the asserted independent claims of the '780 or '624 patents? Discovery into the ANDA's contents will be determinative.
  • A central legal question will be the definitional scope of "stabilizing agent": Will this term be construed functionally, as an agent that prevents a specific oxidized impurity, or will its meaning be confined to the specific structural classes (e.g., oleaginous vehicles, propellants, and particular mixtures thereof) explicitly recited in the claims and described as effective in the specification?
  • A third question will be one of claim scope differentiation: Given the different claim language for the "stabilizing agent" between the '780 patent (agent is A or B) and the '624 patent (agent is a mixture of C and D), the infringement analysis will require a separate inquiry for each patent, and it is possible for the accused product to infringe one patent but not the other.