DCT

1:19-cv-01282

Leo Pharma As v. Teva Pharma USA Inc

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:19-cv-01282, D. Del., 07/09/2019
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware pursuant to 28 U.S.C. § 1400(b).
  • Core Dispute: Plaintiffs allege that Defendant’s Abbreviated New Drug Application (ANDA) to market a generic version of FINACEA® Foam constitutes an act of infringement of a patent related to dicarboxylic acid foamable compositions.
  • Technical Context: The technology relates to foamable pharmaceutical compositions, specifically for delivering the active ingredient azelaic acid to treat skin conditions such as rosacea.
  • Key Procedural History: This is a Hatch-Waxman action triggered by Defendant Teva’s submission of ANDA No. 210928. The patent-in-suit, U.S. Patent No. 10,322,085, issued on June 18, 2019, and was subsequently listed in the FDA’s Orange Book for FINACEA® Foam. The complaint notes a related, prior litigation between the parties involving other patents in the same family, but not the patent-in-suit.

Case Timeline

Date Event
2002-10-25 '085 Patent Priority Date
2006-12-08 Intendis GmbH granted exclusive license to FINACEA® Foam product
2017-11-20 Teva sends Notice Letter regarding Related Patents
2018-01-03 Prior litigation ("Teva I Action") filed
2019-06-18 U.S. Patent No. 10,322,085 Issues
2019-07-09 Complaint Filed

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

U.S. Patent No. 10,322,085 - "Dicarboxylic Acid Foamable Vehicle and Pharmaceutical Compositions Thereof"

The Invention Explained

  • Problem Addressed: The patent’s background section identifies drawbacks with traditional topical drug delivery vehicles like ointments and creams, noting they can be greasy, form an impermeable barrier on the skin that hinders wound respiration, and may reduce drug efficacy (’085 Patent, col. 1:59-2:4). While foams are presented as a more convenient alternative, the patent implies a need for improved, stable oil-containing foam formulations (’085 Patent, col. 2:44-50).
  • The Patented Solution: The invention is a foamable pharmaceutical carrier that uses a dicarboxylic acid, such as azelaic acid, as a key "benefit agent." The carrier is a complex emulsion containing a hydrophobic solvent, a polar solvent, water, a polymeric agent, and a specific combination of surface-active agents, all stabilized to resist aging and phase separation. When packaged with a propellant, this composition creates a stable, breakable foam designed for effective topical drug delivery (’085 Patent, Abstract; col. 6:1-11).
  • Technical Importance: The invention provides a stable, non-greasy foam vehicle for delivering dicarboxylic acids, which are known to have therapeutic properties for treating skin conditions like rosacea, thereby overcoming the application and feel limitations of traditional ointments (’085 Patent, col. 2:11-20).

Key Claims at a Glance

  • The complaint asserts independent claim 1 as an example of infringement (Compl. ¶34).
  • The essential elements of independent claim 1 are:
    • A foamable composition comprising a carrier and a liquefied or compressed gas propellant.
    • The carrier comprises: (a) about 15% by weight of azelaic acid; (b) about 2% to about 50% by weight of a hydrophobic solvent; (c) a polar solvent; (d) a surface-active agent; (e) a polymeric agent; and (f) water.
    • A further limitation requires that the surface-active agent is a combination of at least two such agents having a difference of about 4 or more units between their respective hydrophile-lipophile balance (HLB) values.
    • The combined amount of the polymeric agent and the surface-active agent is required to be about 0.05% to about 10% by weight of the carrier.
    • The propellant must be present at about 3% to about 25% by weight of the total composition.
  • The complaint alleges infringement of "one or more claims," reserving the right to assert additional claims (Compl. ¶33).

III. The Accused Instrumentality

Product Identification

  • Defendant Teva’s proposed generic version of FINACEA® (azelaic acid) Foam, as described in Teva's ANDA No. 210928 (Compl. ¶1, ¶19).

Functionality and Market Context

  • The complaint alleges that Teva’s ANDA Product is an azelaic acid foam composition containing 15% azelaic acid and is a generic version of the branded product FINACEA® Foam (Compl. ¶19).
  • The branded product is a topical prescription medicine used to treat the inflammatory papules and pustules of mild to moderate rosacea (Compl. ¶14).
  • The lawsuit was triggered by Teva’s filing of the ANDA, which seeks FDA approval to market this generic product prior to the expiration of the ’085 Patent (Compl. ¶1, ¶36).
  • No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

U.S. Patent No. 10,322,085 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A foamable composition comprising a carrier and a liquefied or compressed gas propellant, The complaint alleges on information and belief that Teva's ANDA Product is a foamable composition containing a carrier and a propellant. ¶35 col. 6:7-11
wherein the carrier comprising: (a) about 15% by weight of the carrier of azelaic acid; The complaint alleges on information and belief that the carrier in Teva’s ANDA product contains about 15% azelaic acid. ¶34-35 col. 49:15-16
(b) about 2% to about 50% by weight of the carrier of a hydrophobic solvent; The complaint alleges on information and belief that the carrier in Teva’s ANDA product contains about 2% to 50% of a hydrophobic solvent. ¶34-35 col. 9:21-23
(c) a polar solvent; The complaint alleges on information and belief that the carrier in Teva’s ANDA product contains a polar solvent. ¶34-35 col. 9:44-45
(d) a surface-active agent; The complaint alleges on information and belief that the carrier in Teva’s ANDA product contains a surface-active agent. ¶34-35 col. 19:48-49
(e) a polymeric agent; and The complaint alleges on information and belief that the carrier in Teva’s ANDA product contains a polymeric agent. ¶34-35 col. 17:60-65
(f) water; The complaint alleges on information and belief that the carrier in Teva’s ANDA product contains water. ¶34-35 col. 6:3-4
wherein the surface-active agent comprises a combination of at least two surface-active agents and wherein there is a difference of about 4 or more units between the HLB values... The complaint alleges on information and belief that the surface-active agent in Teva’s ANDA product meets this limitation. ¶34-35 col. 23:25-29
wherein combined amount of the polymeric agent and the surface-active agent is about 0.05% to about 10% by weight of the carrier; and The complaint alleges on information and belief that the combined amount of these agents in Teva’s ANDA product falls within this range. ¶34-35 col. 25:46-49
wherein the liquefied or compressed gas propellant is present at about 3% to about 25% by weight of the composition. The complaint alleges on information and belief that the propellant in Teva’s ANDA product is present in this concentration range. ¶34-35 col. 32:50-52
  • Identified Points of Contention:
    • Factual Questions: As the complaint is based on "information and belief," the central dispute will be factual: does Teva's confidential ANDA formulation actually contain every component required by Claim 1, within the specified concentration ranges? Discovery into the precise composition of Teva’s product will be necessary to substantiate the infringement allegations.
    • Scope Questions: The claim uses the term "about" for several numerical limitations (e.g., "about 15%," "about 4 or more units"). A primary point of contention may be the proper scope of "about." If Teva’s formulation values are near but not identical to the claimed numbers, the interpretation of this term could be dispositive for literal infringement.

V. Key Claim Terms for Construction

  • The Term: "about"

    • Context and Importance: This term qualifies nearly every quantitative limitation in Claim 1, including the concentration of azelaic acid, the hydrophobic solvent, the combined surfactants/polymers, the propellant, and the HLB value difference. Its construction is critical because it defines the permissible range of deviation from the recited numbers. Practitioners may focus on this term because in a pharmaceutical context, even small variations in formulation can be significant, and Teva's generic formulation may be engineered to fall just outside a strict reading of the numerical ranges.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification consistently uses "about" when introducing ranges, such as "a concentration of about 2% to about 50% by weight" (’085 Patent, col. 9:21-23), which may suggest the patentee did not intend for the claim to be limited to the exact numerical values recited.
      • Evidence for a Narrower Interpretation: The patent provides numerous examples with highly specific weight percentages carried out to two decimal places (e.g., Azelaic Acid 15.00%, Water purified 32.74%) (’085 Patent, col. 42, Table for GOG 15). A party could argue that this specificity implies "about" should be narrowly construed to cover only minor rounding or measurement variability, not significant deviations.

  • The Term: "hydrophobic solvent"

    • Context and Importance: The claim requires "about 2% to about 50%" of a "hydrophobic solvent." The classification of ingredients in Teva's formulation will be key. A dispute could arise if an ingredient in Teva’s product has multiple functions (e.g., is both an emollient and a solvent), raising the question of whether it qualifies as a "hydrophobic solvent" for the purpose of meeting this limitation.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification provides a long, non-limiting list of potential "hydrophobic organic carrier[s]," including mineral oil, triglycerides, and various alkyl esters of fatty acids (’085 Patent, col. 17:59-18:31). This broad list could support an expansive definition.
      • Evidence for a Narrower Interpretation: A party might argue that in the context of the entire carrier system—which separately lists a "polar solvent" and "water"—the term "hydrophobic solvent" should be construed to mean a traditional oil-phase component whose primary function is as a solvent, as distinct from other components that may be hydrophobic but serve other primary purposes like emolliency.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement. Inducement is based on the allegation that Teva "plans and intends to" actively induce infringement, particularly through its proposed product labeling, which will instruct physicians and patients on the infringing use (Compl. ¶38-39). Contributory infringement is based on the allegation that Teva's product is "especially made or adapted for use in infringing the '085 patent, and is not suitable for substantial noninfringing use" (Compl. ¶40).
  • Willful Infringement: The complaint alleges that Teva has knowledge of the ’085 Patent and has proceeded with its infringing activities despite this knowledge and with "no reasonable basis to believe that it has not infringed" (Compl. ¶38, ¶47). This forms the basis for a willfulness claim and a request for a declaration that the case is "exceptional" and thus eligible for an award of attorneys' fees (Compl. ¶(e), p. 10).

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

  • A central evidentiary question will be one of compositional identity: will discovery reveal that Teva’s confidential generic formulation contains every element recited in the asserted claims, including the specific concentration ranges, the combination of two surfactants with the requisite HLB difference, and the specified polymeric and solvent agents?
  • A dispositive legal issue will be one of quantitative scope: how will the court construe the term "about" as it applies to the claimed weight percentages and HLB value differences? The resolution of this term will define the precise boundary for literal infringement and could determine the outcome if Teva's formulation is close to, but not exactly matching, the recited numerical values.