DCT

1:19-cv-00221

Leo Pharma As v. Taro Pharmaceuticals

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:19-cv-00221, D. Del., 07/31/2019
  • Venue Allegations: Venue is alleged to be proper based on Defendant Taro's business of developing, manufacturing, and selling generic pharmaceutical products throughout the United States, including in Delaware, and its regular engagement in patent litigation within the district.
  • Core Dispute: Plaintiffs allege that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of FINACEA® Foam constitutes an act of infringement of eight U.S. patents related to pharmaceutical foam compositions and their use.
  • Technical Context: The technology concerns foamable pharmaceutical compositions for topical administration, specifically for treating dermatological conditions like rosacea.
  • Key Procedural History: This action arises under the Hatch-Waxman Act following Defendant Taro's submission of ANDA No. 212581 and its Paragraph IV Certifications asserting that the patents-in-suit are invalid, unenforceable, or will not be infringed by Taro's generic product. The complaint notes three separate notice letters from Taro corresponding to different groups of asserted patents.

Case Timeline

Date Event
2002-11-29 Earliest Priority Date ('021, '554, '259, '725, '812, '085 Patents)
2003-08-25 Earliest Priority Date ('076, '498 Patents)
2006-12-08 Intendis GmbH takes an exclusive license to the FINACEA® Foam Product
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
2018-09-18 LEO Pharma A/S grants sublicense to LEO Pharma Inc.
2018-11-06 U.S. Patent No. 10,117,812 Issued
2018-12-20 Date of Taro's First Notice Letter regarding '076, '498, '021, '554, '259, '725 patents
2019-01-18 Date of Taro's Second Notice Letter regarding '812 patent
2019-02-01 Plaintiffs commence original action
2019-06-18 U.S. Patent No. 10,322,085 Issued
2019-07-18 Date of Taro's Third Notice Letter regarding '085 patent
2019-07-31 First Amended Complaint Filed

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

U.S. Patent No. 7,700,076 - "Penetrating Pharmaceutical Foam"

  • Issued: April 20, 2010

The Invention Explained

  • Problem Addressed: The patent background describes the problem of topical drug formulations, particularly those containing alcohol, which can impair the skin barrier, cause dryness, and lead to skin irritation ('076 Patent, col. 2:3-11).
  • The Patented Solution: The invention provides an alcohol-free foamable composition that is thermally stable but breaks easily under shear force, allowing for effective topical application without the irritation associated with alcohol-based carriers ('076 Patent, col. 2:40-47). The foam is an oil-in-water emulsion containing a hydrophobic solvent, a surface-active agent, a gelling agent, and a therapeutic enhancer to improve drug delivery ('076 Patent, col. 1:12-25).
  • Technical Importance: This approach aimed to improve patient compliance and therapeutic outcomes by providing a non-irritating, aesthetically pleasing vehicle for delivering active pharmaceutical ingredients to the skin (Compl. ¶15).

Key Claims at a Glance

  • The complaint asserts independent claim 11 (Compl. ¶40).
  • Claim 11 of the '076 Patent recites an oil-in-water foamable composition with the following essential elements:
    • 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 from a specified Markush group;
    • about 0.1 to 5% by weight of a gelling agent;
    • a therapeutic enhancer from a specified Markush group;
    • a liquefied or compressed gas propellant at about 3% to about 18% by weight;
    • wherein the composition contains no more than 7.5% of certain short-chain alcohols; and
    • wherein the composition is a stable emulsion that forms a breakable foam upon dispensing.
  • The complaint alleges infringement of "one or more claims" either literally or under the doctrine of equivalents (Compl. ¶39).

U.S. Patent No. 8,435,498 - "Penetrating Pharmaceutical Foam"

  • Issued: May 7, 2013

The Invention Explained

  • Problem Addressed: As with the '076 Patent, this patent addresses the skin irritation and drying caused by alcohol in conventional topical foam formulations ('498 Patent, col. 2:4-11).
  • The Patented Solution: The patent describes a method of applying a breakable, thermally stable foam to the skin. The foam is generated from a foamable emulsion composition that is substantially free of short-chain alcohols and contains specific ranges of a surface-active agent, a non-volatile hydrophobic solvent, a gelling agent, and a therapeutic enhancer ('498 Patent, col. 1:16-29, col. 2:48-55).
  • Technical Importance: This patented method provides a way to use a non-irritating foam vehicle to deliver therapeutic agents, improving the user experience compared to alcohol-based alternatives (Compl. ¶15).

Key Claims at a Glance

  • The complaint asserts independent claim 1 (Compl. ¶51).
  • Claim 1 of the '498 Patent recites a method of skin application comprising the steps of:
    • spreading or collapsing a breakable thermally stable foam by mechanical force at a target site;
    • the foam being obtained by dispensing a foamable emulsion composition comprising: about 0.1 to 5% surface-active agent; about 5 to 50% liquid, non-volatile hydrophobic solvent; about 0.1 to 5% gelling agent; a component selected from urea, a hydroxy acid, a therapeutic enhancer, or mixtures; water; and a propellant;
    • wherein the foamable emulsion composition contains no more than 7.5% by weight of certain short-chain alcohols.
  • The complaint alleges infringement of "one or more claims" either literally or under the doctrine of equivalents (Compl. ¶50).

U.S. Patent No. 8,722,021 - "Foamable Carriers"

  • Patent Identification: '021 Patent, Issued May 13, 2014 (Compl. ¶18).
  • Technology Synopsis: This patent describes a foamable composition comprising a carrier and a propellant. The carrier is specifically defined by weight percentages of a surface-active agent, an organic solvent, a polymeric agent, and water, and is designed to produce a foam that remains stable for at least 60 seconds at 37° C ('021 Patent, Abstract).
  • Asserted Claims: Claim 1 (independent) is asserted as an example (Compl. ¶63).
  • Accused Features: Taro's ANDA Product is alleged to be a foamable composition that contains the claimed carrier and propellant and produces a stable foam as recited in the claims (Compl. ¶61, ¶64).

U.S. Patent No. 8,900,554 - "Foamable Composition and Uses Thereof"

  • Patent Identification: '554 Patent, Issued December 2, 2014 (Compl. ¶19).
  • Technology Synopsis: This patent relates to a foamable composition containing an active agent, an organic carrier, a surface active agent, and water. The composition is stored in a container with a propellant and forms a breakable foam that collapses upon application of shear force, and which contains less than 5% of lower alcohols ('554 Patent, Abstract).
  • Asserted Claims: Claim 1 (independent) is asserted as an example (Compl. ¶75).
  • Accused Features: Taro's ANDA Product is alleged to be a composition that contains the claimed active agent and carrier system and forms a breakable foam as recited in the claims (Compl. ¶73, ¶76).

U.S. Patent No. 9,211,259 - "Antibiotic Kit and Composition and Uses Thereof"

  • Patent Identification: '259 Patent, Issued December 15, 2015 (Compl. ¶20).
  • Technology Synopsis: This patent describes a method for treating inflammatory skin disorders by releasing a thermally stable foam from an aerosol container. The foam comprises an antibiotic agent, a specific therapeutically active oil (capric/caprylic triglyceride), a surface-active agent, a polymeric additive, and water, and is low in short-chain alcohols ('259 Patent, Abstract).
  • Asserted Claims: Claim 1 (independent) is asserted as an example (Compl. ¶86).
  • Accused Features: The proposed labeling for Taro's ANDA Product is alleged to direct a method of use that practices the claimed steps of releasing, administering, and collapsing the foam composition (Compl. ¶85, ¶87).

U.S. Patent No. 9,265,725 - "Dicarboxylic Acid Foamable Vehicle and Pharmaceutical Compositions Thereof"

  • Patent Identification: '725 Patent, Issued February 23, 2016 (Compl. ¶21).
  • Technology Synopsis: This patent describes a foamable composition comprising a carrier with specific weight percentages of azelaic acid, medium-chain triglycerides, propylene glycol, and other excipients. The composition has a defined pH range and is combined with a propellant ('725 Patent, Abstract).
  • Asserted Claims: Claim 1 (independent) is asserted as an example (Compl. ¶97).
  • Accused Features: Taro's ANDA Product is alleged to be a foamable composition containing the specific ingredients at the claimed weight percentages and pH (Compl. ¶96, ¶98).

U.S. Patent No. 10,117,812 - "Foamable Composition Combining a Polar Solvent and a Hydrophobic Carrier"

  • Patent Identification: '812 Patent, Issued November 6, 2018 (Compl. ¶22).
  • Technology Synopsis: This patent describes a foamable composition comprising a liquid organic carrier that concurrently includes a hydrophobic carrier (triglyceride) and a polar solvent (dimethyl isosorbide). The composition also specifies a surface-active agent with a non-ionic to ionic ratio greater than 14:1, and upon release forms a breakable foam ('812 Patent, Abstract).
  • Asserted Claims: Claim 1 (independent) is asserted as an example (Compl. ¶109).
  • Accused Features: Taro's ANDA Product and its proposed labeling are alleged to embody the claimed composition with its specific carrier and surfactant system (Compl. ¶107, ¶110).

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

  • Patent Identification: '085 Patent, Issued June 18, 2019 (Compl. ¶33).
  • Technology Synopsis: This patent covers a foamable composition with a carrier containing azelaic acid, a hydrophobic solvent, and a polar solvent. A key feature is the use of a combination of at least two surface-active agents having a difference of about 4 or more units between their HLB values ('085 Patent, Abstract).
  • Asserted Claims: Claim 1 (independent) is asserted as an example (Compl. ¶121).
  • Accused Features: Taro's ANDA Product is alleged to be a foamable composition containing the specific carrier and dual surface-active agent system recited in the claims (Compl. ¶119, ¶122).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is "Taro's ANDA Product," an azelaic acid foam composition for which Taro seeks FDA approval under ANDA No. 212581 (Compl. ¶26).

Functionality and Market Context

  • The complaint alleges that Taro's ANDA Product is a generic version of LEO's FINACEA® Foam, a topical prescription medicine containing 15% azelaic acid used to treat inflammatory papules and pustules of mild to moderate rosacea (Compl. ¶1, ¶15, ¶26).
  • The complaint alleges, upon information and belief, that the accused product has the same composition and is intended for the same method of use as the FINACEA® Foam product, which is covered by the patents-in-suit (Compl. ¶39, ¶50).
  • As a generic drug, it is intended to be a lower-cost, bioequivalent alternative to the branded product.
  • No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

'076 Patent Infringement Allegations

Claim Element (from Independent Claim 11) Alleged Infringing Functionality Complaint Citation Patent Citation
an oil in water foamable composition comprising: The complaint alleges Taro's ANDA Product is an oil-in-water foamable composition. ¶40, ¶41 col. 10:13-14
about 5 to about 50% by weight of composition of a liquid, non-volatile hydrophobic solvent; The complaint alleges the ANDA Product contains this component within the claimed weight range. ¶40a, ¶41 col. 5:11-14
about 0.1 to 5% by weight of a surface-active agent selected from the group consisting of... The complaint alleges the ANDA Product contains a surface-active agent from the specified group within the claimed weight range. ¶40b, ¶41 col. 11:1-20
about 0.1 to 5% by weight of a gelling agent; The complaint alleges the ANDA Product contains a gelling agent within the claimed weight range. ¶40c, ¶41 col. 11:59-60
a therapeutic enhancer selected from the group consisting of... The complaint alleges the ANDA Product contains a therapeutic enhancer from the specified group. ¶40d, ¶41 col. 12:47-49
a liquefied or compressed gas propellant at a concentration of about 3% to about 18% by weight of the total composition; The complaint alleges the ANDA Product contains a propellant within the claimed weight range. ¶40e, ¶41 col. 14:26-30
wherein the composition contains no more than 7.5% of methyl alcohol, ethyl alcohol, isopropyl alcohol, butyl alcohol, or mixtures thereof; The complaint alleges the ANDA Product's composition meets this negative limitation regarding alcohol content. ¶40, ¶41 col. 13:3-5
wherein said composition is a stable emulsion in its predispensed state and forms a breakable foam upon dispensing. The complaint alleges the ANDA Product is a stable emulsion that forms a breakable foam. ¶40, ¶41 col. 18:41-47
  • Identified Points of Contention:
    • Scope Questions: The dispute may center on the construction of the term "about" as it applies to the weight percentages of the various components. The scope of the Markush groups for the "surface-active agent" and "therapeutic enhancer" may also become points of contention.
    • Technical Questions: A central evidentiary question will be whether the specific formulation detailed in Taro's ANDA contains each of the recited ingredients within the claimed quantitative ranges. The complaint alleges this on "information and belief," which will need to be substantiated through discovery of the ANDA's contents.

'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... The complaint alleges that the proposed labeling for Taro's ANDA Product directs users to perform this method of application. ¶51, ¶52 col. 29:1-4
the breakable thermally stable foam obtained by dispensing a foamable emulsion composition comprising: The complaint alleges the ANDA Product is a foamable emulsion composition with the recited components. ¶51, ¶52 col. 1:16-17
about 0.1 to about 5% by weight of a surface-active agent; The complaint alleges the ANDA Product's composition contains this component within the claimed weight range. ¶51a, ¶52 col. 7:1-6
about 5 to about 50% by weight of a liquid, non-volatile hydrophobic solvent; The complaint alleges the ANDA Product's composition contains this component within the claimed weight range. ¶51b, ¶52 col. 4:9-13
about 0.1 to about 5% by weight of a gelling agent; The complaint alleges the ANDA Product's composition contains this component within the claimed weight range. ¶51c, ¶52 col. 7:7-10
a component selected from the group consisting of urea, a hydroxy acid, a therapeutic enhancer, and mixtures... The complaint alleges the ANDA Product's composition contains a component from this specified group. ¶51d, ¶52 col. 8:36-41
water; and a liquefied or a compressed gas propellant; The complaint alleges the ANDA Product's composition contains water and a propellant. ¶51e,f, ¶52 col. 7:51-54
wherein the foamable emulsion composition contains no more than 7.5% by weight methyl alcohol, ethyl alcohol... The complaint alleges the ANDA Product's composition meets this negative limitation regarding alcohol content. ¶51, ¶52 col. 13:4-7
  • Identified Points of Contention:
    • Scope Questions: The key questions will likely involve the construction of claim terms such as "breakable thermally stable foam" and "spreading or collapsing... by mechanical force." The definitions of these terms will determine whether the actions instructed by Taro's proposed labeling fall within the scope of the method claim.
    • Technical Questions: The primary technical question is whether Taro's proposed product labeling will, in fact, instruct users to perform the claimed steps. This analysis will require a review of the proposed package insert and any user instructions submitted with the ANDA.

V. Key Claim Terms for Construction

  • The Term: "about [X] % by weight" (e.g., "about 5 to about 50%")

  • Context and Importance: This term appears in nearly every asserted patent's independent claims, defining the quantitative ranges of the composition's ingredients. The scope of "about" will be critical in determining literal infringement, as a slight deviation in the accused product's formulation from the recited number could avoid infringement under a narrow construction but still infringe under a broader one.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The patents' specifications do not appear to explicitly define "about." A party arguing for a broader scope may point to the general nature of chemical formulations and the inherent variability in manufacturing processes as context for interpreting "about" to encompass a reasonable range of equivalents around the stated values.
    • Evidence for a Narrower Interpretation: The patents provide numerous specific examples with precise weight percentages (e.g., '076 Patent, col. 24, Example 1). A party arguing for a narrower scope may contend that these specific examples demonstrate the importance of the recited ranges and that "about" should not be interpreted so broadly as to vitiate these specific teachings.

  • The Term: "breakable foam"

  • Context and Importance: This term is central to the functionality of the claimed invention in both composition ('076 Patent) and method ('498 Patent) claims. Infringement depends on whether the accused product produces a foam that has this specific "breakable" quality, as opposed to a "quick breaking" foam that collapses on its own from skin temperature.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification describes the foam as one that "freely spreads on the surface and is rapidly absorbed" upon application of mechanical force, contrasting it with thermally sensitive foams ('076 Patent, col. 22:42-49). This could support a functional definition based on the foam's behavior upon rubbing.
    • Evidence for a Narrower Interpretation: The patent defines "breakable foam" with some specificity, stating it is "thermally stable, yet breaks under sheer force" and distinguishes this from foams that "immediately collapse upon exposure to skin temperature" ('076 Patent, col. 22:30-36). The patent also provides a qualitative grading scale for foam quality (E, G, FG, etc.), which could be used to argue that only foams meeting a certain quality standard qualify as "breakable" ('076 Patent, col. 21-22).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges active inducement and contributory infringement for each asserted patent. The allegations for inducement are based on the contention that Taro's proposed labeling will instruct medical professionals and patients to use the generic product in a manner that directly infringes the asserted method claims (e.g., Compl. ¶56 for '498 Patent). Contributory infringement is alleged on the basis that Taro's product is especially made or adapted for an infringing use and is not suitable for a substantial non-infringing use (e.g., Compl. ¶57 for '498 Patent).
  • Willful Infringement: The complaint alleges that Taro proceeded with knowledge of the patents-in-suit after receiving notice and had "no reasonable basis to believe that it has not infringed and will not infringe those patents" (Compl. ¶130). This allegation forms the basis for a claim of willful infringement and a request for a declaration that the case is "exceptional," which could entitle Plaintiffs to enhanced damages and attorney's fees (Compl. ¶130, Prayer for Relief (e)).

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

  • A core issue will be one of claim construction: how will the court define the scope of quantitative terms like "about X%" and functional terms like "breakable foam"? The outcome of this construction will likely determine whether Taro's product, which is designed to be bioequivalent to FINACEA® Foam, falls within the literal scope of the claims.
  • A central evidentiary question will be the comparison of Taro's ANDA formulation against the asserted claims. While the complaint is based on "information and belief," discovery will focus on the precise composition and manufacturing details of Taro's proposed product to determine if it meets each limitation of the asserted composition claims.
  • A key legal and factual question for the method claims will be whether Taro's proposed product label instructs users to perform the patented methods. This will involve an analysis of the proposed label's language regarding application and use, and whether those instructions map onto the claimed steps of "spreading or collapsing" the foam by "mechanical force."