DCT

1:18-cv-00703

Sun Pharmaceutical Industries Inc v. Perrigo Co

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:18-cv-00703, D. Del., 05/09/2018
  • Venue Allegations: Plaintiff alleges venue is proper in the District of Delaware because Defendant Perrigo New York, Inc. is a Delaware corporation, and the Perrigo corporate family has systematic and continuous contacts with the state, including a pattern of litigation behavior and distribution of products within the district.
  • Core Dispute: Plaintiffs allege that Defendants' filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiffs' Ultravate® (halobetasol propionate) Lotion, 0.05% constitutes an act of infringement of a patent covering the brand-name drug's formulation.
  • Technical Context: The technology relates to pharmaceutical formulations for topical corticosteroids, which are widely used to treat skin conditions like plaque psoriasis.
  • Key Procedural History: This is a Hatch-Waxman action triggered by Defendants' filing of ANDA No. 211464 with the U.S. Food and Drug Administration (FDA). The complaint alleges Defendants became aware of the patent-in-suit no later than its listing in the FDA's "Orange Book," which lists patents deemed to cover approved drug products.

Case Timeline

Date Event
2012-10-18 Priority Date for U.S. Patent No. 8,962,028
2015-02-24 U.S. Patent No. 8,962,028 Issued
2015-11-06 FDA approved Plaintiff's NDA for Ultravate® Lotion
2018-05-09 Complaint Filed

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

U.S. Patent No. 8,962,028 - "Topical Steroid Composition And Method"

  • Patent Identification: U.S. Patent No. 8,962,028, "Topical Steroid Composition And Method", issued February 24, 2015.

The Invention Explained

  • Problem Addressed: The patent's background section notes a general belief in the pharmaceutical field that lotion-based preparations of corticosteroids are "inferior in their therapeutic performance as compared to corresponding cream-based preparations" (’028 Patent, col. 1:28-31).
  • The Patented Solution: The invention is a "storage stable, topical lotion" formulation for halobetasol that claims to solve this problem by using a specific combination of ingredients that "interact synergistically" ('028 Patent, col. 2:52-54). The core of the invention is a pharmaceutically acceptable carrier containing a specific trio of components: one or more fatty alcohols, one or more polyol humectants, and diisopropyl adipate, combined in particular ratios to achieve high stability and efficacy ('028 Patent, Abstract; col. 2:56-65).
  • Technical Importance: The claimed formulation provides a topical lotion with high patient acceptability that allegedly demonstrates a clinical efficacy "equal to, and in many instances superior to, that of cream-based halobetasol propionate 0.05% preparations" ('028 Patent, col. 1:41-43).

Key Claims at a Glance

  • The complaint asserts infringement of at least independent claim 1 (Compl. ¶44).
  • The essential elements of independent claim 1 are:
    • A storage stable, topical lotion composition for treating a skin disorder or condition,
    • comprising: a halobetasol material comprising halobetasol or its pharmaceutically acceptable salts, esters, and solvates; and a pharmaceutically acceptable carrier which includes: (a) one or more fatty alcohols and/or one or more alkoxylated fatty alcohols, (b) one or more polyol humectants, and (c) diisopropyl adipate,
    • wherein the amount of said halobetasol material after storage for six months at 40° C. is >98.5% of the total amount of halobetasol material present at the time of manufacture of the topical lotion,
    • wherein the amount of degradation of said halobetasol material after storage for 26 months at 30° C. is <1% of the total amount of halobetasol material present at the time of manufacture of the topical lotion and wherein the amount of degradation of said halobetasol material after storage at 25° C. for 30 months is <3% of the total amount of halobetasol material present at the time of manufacture of the topical lotion, and
    • wherein the ratio of said fatty alcohols and alkoxylated fatty alcohols to said humectants, to said diisopropyl adipate is, on a weight basis, in the range of 30-60:30-60:5-15.
  • The complaint does not explicitly reserve the right to assert dependent claims but makes a general prayer for relief covering the patent.

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is Defendants' "proposed generic halobetasol propionate lotion, 0.05%," for which Defendants submitted ANDA No. 211464 to the FDA (Compl. ¶10, ¶34).

Functionality and Market Context

  • The complaint alleges that Defendants' product is a generic version of Plaintiffs' commercially successful Ultravate® Lotion, a corticosteroid indicated for the treatment of plaque psoriasis (Compl. ¶1, ¶31). The act of infringement alleged under 35 U.S.C. § 271(e)(2) is the submission of the ANDA itself, which seeks approval to market this generic drug prior to the expiration of the ’028 Patent (Compl. ¶1, ¶34).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not contain a detailed claim chart. The infringement theory is that by filing an ANDA for a generic version of Plaintiffs' patented Ultravate® Lotion, Defendants' proposed product will necessarily meet the limitations of the asserted claims.

'028 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A storage stable, topical lotion composition for treating a skin disorder or condition... Defendants' product is alleged to be a generic topical lotion for treating dermatological conditions (Compl. ¶10). ¶10, ¶34 col. 3:32-49
comprising: a halobetasol material... and a pharmaceutically acceptable carrier which includes: (a) one or more fatty alcohols and/or one or more alkoxylated fatty alcohols, (b) one or more polyol humectants, and (c) diisopropyl adipate... As a proposed generic equivalent to Plaintiffs' product, Defendants' product is alleged to contain halobetasol propionate and the same or equivalent carrier components required by the claim (Compl. ¶1, ¶10). ¶1, ¶10, ¶44 col. 2:60-65
wherein the amount of said halobetasol material after storage for six months at 40° C. is >98.5% of the total amount... [and other stability requirements] The complaint alleges that the commercial manufacture and sale of Defendants' product will constitute infringement, which implies that the product will meet the claim's stability requirements (Compl. ¶35, ¶44). ¶35, ¶44 col. 4:38-49
and wherein the ratio of said fatty alcohols and alkoxylated fatty alcohols to said humectants, to said diisopropyl adipate is, on a weight basis, in the range of 30-60:30-60:5-15. The complaint alleges that Defendants' proposed generic lotion will infringe the claim, which implies that its formulation will contain the claimed ingredients within the specified ratios (Compl. ¶44). ¶44 col. 4:1-10
  • Identified Points of Contention:
    • Scope Questions: A central question will be whether Defendants' proposed formulation falls within the specific three-part component ratio of "30-60:30-60:5-15" required by claim 1. The complaint does not provide the specific formulation from Defendants' ANDA.
    • Technical Questions: What evidence will be presented to show that Defendants' product meets the specific, quantitative "storage stable" limitations of claim 1, which define maximum degradation amounts over set time periods and temperatures? The court will need to assess whether the ANDA data demonstrates compliance with these claimed stability profiles.

V. Key Claim Terms for Construction

  • The Term: "lotion"

  • Context and Importance: The patent explicitly distinguishes a "lotion" from a "cream," stating that lotions are "pourable at room temperature" while creams are not ('028 Patent, col. 8:6-14). The physical characteristics of Defendants' product will be critical. Practitioners may focus on this term because if Defendants' product is determined to have the viscosity and flow properties of a "cream" as defined in the patent, it may avoid infringement of claims directed specifically to a "lotion."

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The complaint does not offer evidence for a broad interpretation. Parties seeking one might argue the term should be given its plain and ordinary meaning in the pharmaceutical arts without being strictly limited by the specification's examples.
    • Evidence for a Narrower Interpretation: The specification provides a detailed, functional definition: "A lotion formulation is an emulsion, pourable at room temperature. A lotion flows at room temperature and conforms to a container when the lotion is inserted into the container at room temperature" ('028 Patent, col. 8:6-9). This provides strong evidence for a narrow construction tied to pourability.

  • The Term: "storage stable"

  • Context and Importance: This term is not merely descriptive but is defined in claim 1 by specific, quantitative stability metrics (e.g., ">98.5%" of material remaining after six months at 40° C.). The infringement analysis will depend on whether Defendants' ANDA data proves their product meets these precise numerical thresholds.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: A party might argue that minor deviations from the numerical limits are acceptable under the doctrine of equivalents, or that "storage stable" encompasses products that are commercially viable, even if they do not meet the precise claim limitations under all testing conditions.
    • Evidence for a Narrower Interpretation: The claim language itself provides the narrow definition by explicitly reciting the percentages and conditions: "wherein the amount of said halobetasol material after storage for six months at 40° C. is >98.5%..." ('028 Patent, col. 24:46-49). This explicit recitation suggests the patentee intended to be their own lexicographer, binding the term to these specific values.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges active inducement on the grounds that Defendants' commercial activities will induce infringement of the patent (Compl. ¶37, ¶53-57). Contributory infringement is alleged on the basis that Defendants' product is "especially made for or especially adapted for use in infringement" and is "not a staple article or commodity of commerce suitable for substantial non-infringing use" (Compl. ¶38, ¶58).
  • Willful Infringement: The complaint alleges willfulness based on Defendants' alleged actual knowledge of the ’028 Patent, purportedly obtained "no later than the date on which that patent was listed in the Orange Book" (Compl. ¶36, ¶50). It further alleges Defendants "willfully, wantonly, and deliberately prepare to infringe" despite this knowledge (Compl. ¶46, ¶65).

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

  1. A Factual Question of Composition: The central issue will be a factual one resolved through discovery: Does the specific formulation detailed in Perrigo’s ANDA No. 211464 contain the claimed combination of a halobetasol material, fatty alcohols, polyol humectants, and diisopropyl adipate, and, most critically, are these components present in the specific weight ratios ("30-60:30-60:5-15") required by claim 1?
  2. A Question of Functional Performance: A key evidentiary battle will focus on whether Perrigo’s proposed product meets the quantitative performance limitations of the claims. Can Plaintiffs prove that Perrigo's product fails to satisfy the patent's explicit "storage stable" criteria, or conversely, can Perrigo demonstrate from its ANDA data that its product meets those precise stability and degradation thresholds?
  3. A Definitional Question of Physical Form: The dispute may also turn on claim construction. Will the court adopt the patent's narrow, functional definition of a "lotion" (i.e., pourable at room temperature), and if so, do the physical properties of Perrigo's product meet that definition, or does it behave more like a "cream" as distinguished by the patent's own text?