DCT

1:18-cv-00013

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: 1:18-cv-00013, D. Del., 01/03/2018
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware on the basis that Defendant is a Delaware corporation.
  • Core Dispute: Plaintiffs allege that Defendant’s filing of an Abbreviated New Drug Application (ANDA) to market a generic version of FINACEA® (azelaic acid) Foam constitutes an act of infringement of six patents related to pharmaceutical foam compositions and methods of use.
  • Technical Context: The technology concerns alcohol-free, foam-based vehicles for topical delivery of pharmaceutical agents used to treat skin conditions such as rosacea.
  • Key Procedural History: The litigation was initiated under the Hatch-Waxman Act following Plaintiffs’ receipt of a notice letter from Teva dated November 20, 2017. This letter informed Plaintiffs of Teva’s ANDA No. 210928 submission, which seeks FDA approval to market a generic version of Plaintiffs’ FINACEA® Foam product. The notice included Paragraph IV Certifications asserting that the six patents-in-suit, which are listed in the FDA’s “Orange Book” in connection with FINACEA® Foam, are invalid or will not be infringed by Teva’s proposed generic product.

Case Timeline

Date Event
2002-10-25 Priority Date for U.S. Patent Nos. 7,700,076 and 8,435,498
2004-04-28 Priority Date for U.S. Patent No. 8,900,554
2004-08-20 Priority Date for U.S. Patent No. 8,722,021
2005-03-11 Priority Date for U.S. Patent No. 9,211,259
2007-07-05 Priority Date for U.S. Patent No. 9,265,725
2010-04-20 U.S. Patent No. 7,700,076 Issued
2013-05-07 U.S. Patent No. 8,435,498 Issued
2014-05-13 U.S. Patent No. 8,722,021 Issued
2014-12-02 U.S. Patent No. 8,900,554 Issued
2015-12-15 U.S. Patent No. 9,211,259 Issued
2016-02-23 U.S. Patent No. 9,265,725 Issued
2017-11-20 Teva sends ANDA Notice Letter to Plaintiffs
2018-01-03 Complaint Filed

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

U.S. Patent No. 7,700,076

  • Patent Identification: U.S. Patent No. 7,700,076, entitled “Penetrating Pharmaceutical Foam,” issued April 20, 2010 (Compl. ¶11).

The Invention Explained

  • Problem Addressed: The patent’s background section notes that creating stable pharmaceutical foams is technically challenging, as minor compositional changes can cause the foam structure to collapse (ʼ076 Patent, col. 1:30-36). It further distinguishes the invention from prior art, such as shaving foams, which are described as not "breakable" and therefore unsuitable for effective topical drug delivery (ʼ076 Patent, col. 1:49-55).
  • The Patented Solution: The invention is an alcohol-free foamable composition comprising a specific combination of water, a hydrophobic solvent, a surface-active agent, a gelling agent, and a propellant (ʼ076 Patent, Abstract). This formulation creates an oil-in-water emulsion that, when dispensed from an aerosol container, forms a "breakable foam" that is stable enough for application but can be broken down by shear force (e.g., rubbing) to release the active drug (ʼ076 Patent, col. 2:10-16).
  • Technical Importance: This approach provides a non-irritating and non-drying foam vehicle capable of delivering both water-soluble and oil-soluble active pharmaceutical ingredients for topical treatment (ʼ076 Patent, col. 2:32-34, 63-65).

Key Claims at a Glance

  • The complaint identifies independent claim 11 as an example of an asserted claim (Compl. ¶27).
  • The essential elements of independent claim 11 are:
    • An oil in water foamable composition comprising:
    • about 5% to about 50% by weight of a liquid, non-volatile hydrophobic solvent;
    • about 0.1% to 5% by weight of a surface-active agent selected from a specified list of compounds;
    • about 0.1% to 5% by weight of a gelling agent;
    • a therapeutic enhancer selected from a specified list of compounds;
    • a liquefied or compressed gas propellant at a concentration of about 3% to about 18% by weight;
    • wherein the composition contains no more than 7.5% of specified short-chain alcohols; and
    • wherein the composition is a stable emulsion that forms a breakable foam upon dispensing.
  • The complaint alleges infringement of additional claims, including dependent claims 13–16, 19, 21–22, 24–25, 27–28, and 46–51 (Compl. ¶26).

U.S. Patent No. 8,435,498

  • Patent Identification: U.S. Patent No. 8,435,498, entitled “Penetrating Pharmaceutical Foam,” issued May 7, 2013 (Compl. ¶12).

The Invention Explained

  • Problem Addressed: The technical problem is consistent with that of the parent ʼ076 Patent, focusing on the need for a stable yet administrable topical foam vehicle (ʼ498 Patent, col. 1:35-41).
  • The Patented Solution: This patent claims a method of applying a pharmaceutical foam. The core of the patented method is the step of "spreading or collapsing a breakable thermally stable foam by mechanical force" at a target site (ʼ498 Patent, Abstract). The foam itself is generated from a foamable emulsion composition with specified categories and concentrations of ingredients (ʼ498 Patent, col. 2:14-20).
  • Technical Importance: The invention claims a specific method of use that leverages the foam’s "breakable" property, distinguishing it from foams that collapse prematurely due to body heat or those that are not easily broken down for application (ʼ498 Patent, col. 19:1-5).

Key Claims at a Glance

  • The complaint identifies independent claim 1 as an example of an asserted claim (Compl. ¶39).
  • The essential elements of independent claim 1 are:
    • A method of skin or mucosal surface application comprising spreading or collapsing a breakable thermally stable foam by mechanical force at a target site;
    • The foam is obtained by dispensing a foamable emulsion composition comprising:
    • about 0.1% to about 5% by weight of a surface-active agent;
    • about 5% to about 50% by weight of a liquid, non-volatile hydrophobic solvent;
    • about 0.1% to about 5% by weight of a gelling agent;
    • a component selected from the group of urea, a hydroxy acid, a therapeutic enhancer, or mixtures thereof;
    • water; and
    • a liquefied or compressed gas propellant.
    • wherein the emulsion composition contains no more than 7.5% by weight of specified short-chain alcohols.
  • The complaint alleges infringement of additional claims, including dependent claims 2, 4, 12, 14–17, and 19–24 (Compl. ¶38).

U.S. Patent No. 8,722,021

  • Patent Identification: U.S. Patent No. 8,722,021, entitled “Foamable Carriers,” issued May 13, 2014 (Compl. ¶13).
  • Technology Synopsis: This patent claims a foamable composition defined by its carrier components and functional properties. The invention addresses the need for a stable foam by claiming a specific formulation of a surface-active agent, an organic solvent, a polymeric agent, and water that, upon release from a dispenser, produces a foam that remains stable for at least 60 seconds at 37° C (Compl. ¶51).
  • Asserted Claims: The complaint provides claim 1 as an example (Compl. ¶51).
  • Accused Features: The complaint alleges that Teva’s ANDA Product infringes one or more claims of the ʼ021 patent (Compl. ¶49).

U.S. Patent No. 8,900,554

  • Patent Identification: U.S. Patent No. 8,900,554, entitled “Foamable Composition and Uses Thereof,” issued December 2, 2014 (Compl. ¶14).
  • Technology Synopsis: This patent is directed to a composition comprising a foamable composition and a propellant. The claimed invention addresses the need for an effective topical delivery vehicle by specifying a formulation containing an active agent, organic carrier, surface-active agent, and water, which is stored in a container and forms a "breakable foam that collapses upon application of shear force" (Compl. ¶63).
  • Asserted Claims: The complaint provides claim 1 as an example (Compl. ¶63).
  • Accused Features: The complaint alleges that Teva’s ANDA Product infringes one or more claims of the ʼ554 patent (Compl. ¶61).

U.S. Patent No. 9,211,259

  • Patent Identification: U.S. Patent No. 9,211,259, entitled “Antibiotic Kit and Composition and Uses Thereof,” issued December 15, 2015 (Compl. ¶15).
  • Technology Synopsis: This patent claims a method for treating inflammatory disorders of the skin or mucosal surfaces. The method comprises releasing a foamable composition from an aerosol container to form a thermally stable foam that collapses upon mechanical force. The composition itself is defined by specific ingredients including an antibiotic agent and a therapeutically active oil (Compl. ¶75).
  • Asserted Claims: The complaint provides claim 1 as an example (Compl. ¶75).
  • Accused Features: The complaint alleges that Teva's ANDA Product and its proposed labeling, which directs its use, will infringe one or more claims of the ʼ259 patent (Compl. ¶73).

U.S. Patent No. 9,265,725

  • Patent Identification: U.S. Patent No. 9,265,725, entitled “Dicarboxylic Acid Foamable Vehicle and Pharmaceutical Compositions Thereof,” issued February 23, 2016 (Compl. ¶16).
  • Technology Synopsis: This patent claims a foamable composition comprising a specific foamable carrier and a propellant. The invention is defined by a carrier containing highly specific weight percentages of fifteen different components, including about 15% azelaic acid, and requires the carrier to have a pH of about 4.5–5.3 (Compl. ¶86).
  • Asserted Claims: The complaint provides claim 1 as an example (Compl. ¶86).
  • Accused Features: The complaint alleges that Teva’s ANDA Product infringes one or more claims of the ʼ725 patent (Compl. ¶85).

III. The Accused Instrumentality

Product Identification

The accused instrumentality is Defendant Teva’s generic azelaic acid foam product, for which Teva seeks FDA approval under ANDA No. 210928 (“Teva’s ANDA Product”) (Compl. ¶19).

Functionality and Market Context

Teva’s ANDA Product is a generic version of Bayer’s FINACEA® Foam, a topical prescription medicine containing 15% azelaic acid used to treat inflammatory papules and pustules associated with mild to moderate rosacea (Compl. ¶¶10, 19). The complaint alleges that Teva’s submission of its ANDA was for the purpose of obtaining approval to manufacture, use, and sell its generic product in the United States prior to the expiration of the patents-in-suit (Compl. ¶20).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

7,700,076 Patent Infringement Allegations

Claim Element (from Independent Claim 11) Alleged Infringing Functionality Complaint Citation Patent Citation
An oil in water foamable composition comprising: about 5 to about 50% by weight of composition of a liquid, non-volatile hydrophobic solvent; The complaint alleges that Teva’s ANDA Product is an infringing composition. According to the complaint, Teva does not contest infringement of this claim in its Paragraph IV Notice Letter. ¶¶26, 28 col. 27:8-10
about 0.1 to 5% by weight of a surface-active agent selected from the group consisting of a polysorbate, a polyoxyethylene fatty acid ester, a polyoxyethylene alkyl ether, a sucrose ester, a partial ester of sorbitol, a partial ester of sorbitol anhydride, sodium methyl cocoyl taurate...and Myrj 52 (polyoxyethylene 40 stearate); The complaint alleges that Teva’s ANDA Product is an infringing composition. According to the complaint, Teva does not contest infringement of this claim in its Paragraph IV Notice Letter. ¶¶26, 28 col. 27:11-29
about 0.1 to 5% by weight of a gelling agent; The complaint alleges that Teva’s ANDA Product is an infringing composition. According to the complaint, Teva does not contest infringement of this claim in its Paragraph IV Notice Letter. ¶¶26, 28 col. 27:30-31
a therapeutic enhancer selected from the group consisting of propylene glycol, butylene glycols, glycerol...and cylcodextrins; The complaint alleges that Teva’s ANDA Product is an infringing composition. According to the complaint, Teva does not contest infringement of this claim in its Paragraph IV Notice Letter. ¶¶26, 28 col. 27:32-38
a liquefied or compressed gas propellant at a concentration of about 3% to about 18% by weight of the total composition; The complaint alleges that Teva’s ANDA Product is an infringing composition. According to the complaint, Teva does not contest infringement of this claim in its Paragraph IV Notice Letter. ¶¶26, 28 col. 27:39-42
wherein the composition contains no more than 7.5% of methyl alcohol, ethyl alcohol, isopropyl alcohol, butyl alcohol, or mixtures thereof; and The complaint alleges that Teva’s ANDA Product is an infringing composition. According to the complaint, Teva does not contest infringement of this claim in its Paragraph IV Notice Letter. ¶¶26, 28 col. 27:43-46
wherein said composition is a stable emulsion in its predispensed state and forms a breakable foam upon dispensing. The complaint alleges that Teva’s ANDA Product is an infringing composition. According to the complaint, Teva does not contest infringement of this claim in its Paragraph IV Notice Letter. ¶¶26, 28 col. 27:47-49

8,435,498 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of skin or mucosal surface application comprising spreading or collapsing a breakable thermally stable foam by mechanical force at or about a target site of a subject, The complaint alleges that Teva's ANDA Product and its proposed labeling directing use will infringe. According to the complaint, Teva does not contest infringement of this claim. ¶¶38, 40 col. 25:65-67
the breakable thermally stable foam obtained by dispensing a foamable emulsion composition comprising: about 0.1 to about 5% by weight of a surface-active agent; about 5 to about 50% by weight of a liquid, non-volatile hydrophobic solvent... The complaint alleges that Teva's ANDA Product is an infringing composition. According to the complaint, Teva does not contest infringement of this claim in its Paragraph IV Notice Letter. ¶¶38, 40 col. 26:1-11
a component selected from the group consisting of urea, a hydroxy acid, a therapeutic enhancer, and mixtures of two or more thereof; water; and a liquefied or a compressed gas propellant; The complaint alleges that Teva's ANDA Product is an infringing composition. According to the complaint, Teva does not contest infringement of this claim in its Paragraph IV Notice Letter. ¶¶38, 40 col. 26:12-16
wherein the foamable emulsion composition contains no more than 7.5% by weight methyl alcohol, ethyl alcohol, isopropyl alcohol, butyl alcohol, or mixtures thereof. The complaint alleges that Teva's ANDA Product is an infringing composition. According to the complaint, Teva does not contest infringement of this claim in its Paragraph IV Notice Letter. ¶¶38, 40 col. 26:17-20

Identified Points of Contention

  • Scope Questions: Since infringement of the lead asserted claims is allegedly not contested by Teva (Compl. ¶¶26, 38), the primary dispute may concern patent validity. However, from an infringement perspective, the repeated use of the term "about" in concentration ranges (e.g., "about 5 to about 50%") raises a potential question regarding the precise scope of these ranges. The doctrine of equivalents for numerical ranges, as well as arguments based on the patent's prosecution history, may become relevant for any claims where infringement is contested.
  • Technical Questions: For the method claim of the ʼ498 Patent, a central technical question is whether Teva's proposed labeling will direct or instruct end-users to perform the claimed step of "spreading or collapsing a breakable thermally stable foam by mechanical force" (Compl. ¶39). The analysis would require an examination of the specific instructions for use on Teva's proposed product label to determine if they meet the legal standard for inducing infringement.

V. Key Claim Terms for Construction

  • The Term: "breakable foam" (ʼ076 Patent, Claim 11)

  • Context and Importance: This term is critical for distinguishing the invention from prior art foams, such as shaving creams described as non-breakable, or thermally sensitive foams that collapse upon contact with skin without requiring mechanical force. Practitioners may focus on this term because its construction will define the line between infringement and non-infringement, as the foam's functional behavior upon dispensing is a core element of the claim.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification provides a functional description, stating the composition "forms a breakable foam product, which is suitable for topical or mucosal administration" (ʼ076 Patent, col. 2:14-16). This could support a construction based on the foam's suitability for its intended purpose rather than a specific mechanism of breaking.
    • Evidence for a Narrower Interpretation: The specification states that "The breakable foam is thermally stable, yet breaks under sheer force" (ʼ076 Patent, col. 18:66-67). This language could be used to argue for a narrower construction requiring both thermal stability (i.e., it does not collapse from skin heat alone) and a specific susceptibility to mechanical shear force.

  • The Term: "spreading or collapsing a breakable thermally stable foam by mechanical force" (ʼ498 Patent, Claim 1)

  • Context and Importance: This phrase defines the central action of the asserted method claim. The infringement analysis for this claim will depend on whether the actions instructed by the accused product's labeling constitute this specific type of "mechanical force."

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification notes the foam is "easily spreadable, allowing treatment of large areas" (ʼ498 Patent, col. 5:52-53). This may support an argument that the ordinary act of rubbing a topical product onto the skin constitutes the claimed "spreading...by mechanical force."
    • Evidence for a Narrower Interpretation: The patent contrasts the invention with foams that "immediately collapse upon exposure to skin temperature" (ʼ498 Patent, col. 19:1-2). A party could argue that "mechanical force" must mean something more than the incidental contact and force involved in a typical application, requiring a deliberate act of breaking down a foam structure that would otherwise remain stable on the skin.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges active inducement of infringement for all six patents-in-suit. It asserts that Teva "plans and intends to, and will, actively induce infringement" upon receiving ANDA approval (Compl. ¶¶32, 44, 56, 69, 80, 91). For method claims, the allegations are based on the defendant's "proposed labeling directing use" of the ANDA product (Compl. ¶¶37, 73).
  • Willful Infringement: The complaint alleges that "Teva has proceeded with knowledge of the patents-in-suit and with no reasonable basis to believe that it has not infringed" (Compl. ¶95). This allegation, which forms the basis for a request for a finding of an exceptional case, is predicated on Teva's knowledge of the patents from their listing in the FDA Orange Book and its subsequent filing of Paragraph IV certifications.

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

  • A primary issue will be one of patent validity, not infringement. The complaint repeatedly alleges that Teva’s notice letter does not contest infringement of the primary asserted claims of the patents-in-suit. Consequently, the case will likely center on Teva's affirmative defense that the patents are invalid (e.g., for obviousness or lack of enablement), a position inherent in its Paragraph IV certification but not detailed in the complaint.
  • A key question for the method patents will be one of inducement via labeling. The court will need to determine whether the instructions on Teva's proposed product label direct or encourage users to apply the foam in a manner that satisfies the claim limitation of "spreading or collapsing...by mechanical force," which is the central dispute point for induced infringement of a method of use.
  • A central question for claim construction will be the definitional scope of functional properties. The meaning of the term "breakable foam" will be critical. The court’s interpretation will determine whether this term requires a specific, measurable shear-force sensitivity that distinguishes it from prior art foams, or if it can be construed more broadly to cover any foam that is stable upon dispensing yet suitable for topical application.