DCT

1:13-cv-00851

Eli Lilly Co v. Perrigo Co

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:13-cv-0851, S.D. Ind., 05/24/2013
  • Venue Allegations: Plaintiffs allege venue is proper in the Southern District of Indiana, the location of Plaintiff Eli Lilly and Company's principal place of business, and based on Defendants' alleged business activities within the state.
  • Core Dispute: Plaintiffs allege that Defendants’ filing of an Abbreviated New Drug Application (ANDA) for a generic version of the testosterone drug Axiron® constitutes an act of infringement of three patents related to transdermal drug delivery compositions and applicator devices.
  • Technical Context: The dispute concerns transdermal drug delivery systems for testosterone, a key product in the hormone replacement therapy market, and specifically involves application to the axilla (underarm).
  • Key Procedural History: The lawsuit was initiated under the Hatch-Waxman Act following Defendants' Paragraph IV certifications asserting that the patents-in-suit are invalid, unenforceable, and/or not infringed by their proposed generic product. The complaint states it was filed within 45 days of receiving Defendants' notice letters, which triggers a 30-month statutory stay of FDA approval for the generic drug.

Case Timeline

Date Event
2005-12-23 ’944 Patent Priority Date
2007-01-11 ’449 and ’307 Patents Priority Date
2010-11-23 FDA Approval of Axiron®
2012-05-15 '449 Patent Issue Date
2012-09-07 Defendants' Notice Letter Regarding '449 Patent
2013-04-16 '307 Patent Issue Date
2013-04-16 Defendants' Notice Letter Regarding '307 Patent
2013-05-07 '944 Patent Issue Date
2013-05-09 Defendants' Notice Letter Regarding '944 Patent
2013-05-24 Complaint Filing Date

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

U.S. Patent No. 8,435,944 - Method and Composition for Transdermal Drug Delivery, issued May 7, 2013

The Invention Explained

  • Problem Addressed: The patent describes challenges with existing transdermal testosterone therapies, including the need to apply medication over a large skin area, which creates a risk of accidental transfer to others, and the development of undesirable side effects when applied to certain areas like the scrotum (e.g., abnormally high DHT levels) (Compl. ¶24; ’944 Patent, col. 1:36-61). Application to areas prone to perspiration, such as the axilla, was also considered problematic and generally avoided (Compl. ¶24; ’944 Patent, col. 2:20-30).
  • The Patented Solution: The invention is a method and composition for delivering testosterone through the skin, specifically designed for application to the axilla. The composition consists of testosterone, a volatile solvent (like alcohol), a penetration enhancer, and a viscosity modulator, which provides a rapid-drying, non-occlusive formulation with inherent antiperspirant and deodorant properties, making underarm application practical and effective (Compl. ¶24; ’944 Patent, Abstract, col. 2:40-54).
  • Technical Importance: This technology established the axilla as a viable and advantageous application site for transdermal hormones, aiming to improve patient compliance and safety by minimizing the application area and reducing the risk of drug transference (Compl. ¶24; ’944 Patent, col. 2:31-36).

Key Claims at a Glance

  • The complaint asserts infringement of at least one claim without specification (Compl. ¶40). Independent claim 1 is a method claim directed to:
    • A method of increasing a subject's testosterone blood level by applying a specific non-occlusive composition to at least one axilla.
    • The composition is defined using the transitional phrase "consisting of" a list of components: testosterone, lower alkyl alcohols (>60% v/v), one or more penetration enhancers from a specified group, and one or more viscosity modulating agents, with optional inclusion of an activator, antiperspirant/deodorant, and water.
    • The method must achieve a testosterone blood level of at least 200 ng/dL.

U.S. Patent No. 8,419,307 - Spreading Implement, issued April 16, 2013

The Invention Explained

  • Problem Addressed: The patent identifies drawbacks with conventional methods of applying liquid pharmaceuticals. Spreading a liquid by hand is imprecise and contaminates the hand, while applicators like brushes or sponges can retain significant, variable amounts of the product, leading to inaccurate dosing and waste (Compl. ¶25; ’307 Patent, col. 1:21-49).
  • The Patented Solution: The invention is a method of application using a specialized implement. The implement features a cup-like receptacle to hold the liquid and a flexible, resilient wall that functions as a spreading member. This design allows the user to apply the liquid to a contoured surface like the axilla with consistent contact, minimizing residual liquid left in the applicator and improving dose accuracy (Compl. ¶25; ’307 Patent, Abstract, col. 6:4-13). The claims specifically recite an implement with a "double-wall structure" formed by an inner portion and an outer skirt (Compl. ¶25; ’307 Patent, col. 15:7-10).
  • Technical Importance: The invention provides a means for hygienic, dose-controlled, and efficient application of topical medications, directly addressing the waste, contamination, and imprecision of prior art methods (Compl. ¶25; ’307 Patent, col. 1:50-54).

Key Claims at a Glance

  • The complaint asserts infringement of at least one claim without specification (Compl. ¶51). Independent claim 1 is a method claim directed to:
    • A method of increasing a person's testosterone blood level by applying a liquid testosterone composition to the axilla using a specific implement.
    • The implement comprises a support and a receptacle.
    • The receptacle is defined by specific structural and functional features, including a flexible membrane, a continuous base through which liquid cannot pass, a "double-wall structure," and a "resiliently deformable" wall.

Multi-Patent Capsule

  • Patent Identification: U.S. Patent No. 8,177,449, Spreading Implement, issued May 15, 2012 (Compl. ¶26).
  • Technology Synopsis: As the parent of the '307 patent, this patent discloses the apparatus for applying a liquid to a treatment surface. It addresses the problems of inaccurate dosing and contamination by providing an applicator with a reservoir and a resiliently deformable wall that spreads liquid effectively while minimizing waste (Compl. ¶26; ’449 Patent, Abstract).
  • Asserted Claims: The complaint does not specify claims but alleges infringement of one or more claims (Compl. ¶62).
  • Accused Features: The filing of ANDA No. 204255 for a generic version of Axiron® is alleged to be an act of infringement, as the product's intended use requires an applicator with the claimed features (Compl. ¶¶ 27, 61-62).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is "Perrigo's Generic Product," identified as "Testosterone Metered Transdermal Solution, 30mg/1.5mL," for which Defendants submitted Abbreviated New Drug Application (ANDA) No. 204255 to the FDA (Compl. ¶¶ 7, 27).

Functionality and Market Context

  • The complaint alleges that Perrigo's Generic Product is a generic version of Plaintiffs' Axiron® drug, a testosterone solution used to treat conditions associated with testosterone deficiency (Compl. ¶¶ 7, 23). As a generic, it is intended to be used in the same manner as the branded product, including application to the axilla, and to serve as a lower-cost market alternative upon FDA approval (Compl. ¶¶ 33-34).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

'944 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of increasing the testosterone blood level of an adult male subject in need thereof comprising applying to at least one axilla... a non-occlusive transdermal drug delivery composition... The proposed labeling for Perrigo's Generic Product will instruct physicians and patients to apply the testosterone solution to the axilla to treat testosterone deficiency. ¶¶ 33, 34 col. 23:18-22
...consisting of: (a) a pharmaceutically effective amount of testosterone; Perrigo's Generic Product is a "Testosterone Metered Transdermal Solution" intended to be bioequivalent to Axiron®. ¶¶ 7, 27 col. 23:23-24
(b) one or more lower alkyl alcohols, wherein the combined volume... is more than 60% (v/v) of the composition; Perrigo's ANDA specifies a formulation that, to be equivalent to Axiron®, includes a high concentration of volatile alcohols as the carrier. ¶¶ 27, 33 col. 23:25-28
(c) one or more penetration enhancers selected from the group consisting of glycols, oleic acid, isopropyl myristate... The formulation in Perrigo's ANDA contains penetration enhancers required to achieve bioequivalence with Axiron®. ¶¶ 27, 33 col. 23:29-34
(d) one or more viscosity modulating agents; The formulation in Perrigo's ANDA contains viscosity modulating agents required to achieve the physical properties of Axiron®. ¶¶ 27, 33 col. 23:35
...wherein the composition is applied in an amount effective to achieve a testosterone blood level in the subject of at least 200 ng/dL. Perrigo's Generic Product is intended to produce a therapeutic blood level of testosterone equivalent to that of Axiron®. ¶¶ 7, 34 col. 24:1-4
  • Identified Points of Contention:
    • Scope Questions: A central issue may be the claim's use of the transitional phrase "consisting of." The infringement analysis will question whether Perrigo's ANDA formulation contains any unlisted excipients that materially alter the composition's properties, which could be a basis to argue non-infringement.
    • Technical Questions: A key evidentiary question will be whether the product as defined in the ANDA is capable of achieving the claimed pharmacokinetic outcome (a blood level of at least 200 ng/dL) when used as instructed.

'307 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of increasing the testosterone blood level of a person... comprising applying to at least one axilla... a liquid pharmaceutical composition comprising testosterone... The intended use of Perrigo's Generic Product involves applying a testosterone solution to the axilla. ¶¶ 33, 34 col. 14:57-60
...wherein said composition is applied with an implement comprising: a support; and a receptacle mounted on the support... Perrigo's Generic Product is intended to be applied with an applicator that holds and dispenses the solution. ¶¶ 27, 34 col. 14:62-64
...wherein the receptacle includes a flexible membrane integrally forming a base and a wall... the wall includes an inner portion... and an outer skirt portion... form a double-wall structure... The applicator for Perrigo's Generic Product is alleged to have the specific structural features recited in the claim, including the double-wall design necessary for proper function. ¶¶ 33, 62 col. 15:1-10
...and wherein at least the wall is resiliently deformable so in use the working surface maintains contact with the treatment surface... The applicator for Perrigo's Generic Product is alleged to have a flexible wall that allows for effective spreading of the solution on the contoured surface of the axilla. ¶¶ 33, 62 col. 15:10-14
  • Identified Points of Contention:
    • Scope Questions: The infringement analysis will likely focus on whether the term "double-wall structure," as defined in the patent, reads on the specific design of the applicator Perrigo intends to provide or recommend for use with its generic product.
    • Technical Questions: An issue for the court may be the degree to which Perrigo's proposed applicator is "resiliently deformable." The parties may dispute whether its material properties and design allow it to function in the specific manner required by the claim.

V. Key Claim Terms for Construction

For the '944 Patent

  • The Term: "consisting of"
  • Context and Importance: This transitional phrase appears in independent claim 1 and is presumptively "closed," meaning it excludes any elements not specified in the claim. Its construction is critical because if Perrigo's formulation includes additional, unlisted excipients, it may fall outside the literal scope of the claim.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: A party might argue that the term does not exclude impurities or other components that do not materially alter the "basic and novel properties" of the claimed composition. The inclusion of several "optional" components (e.g., water, deodorant) within the "consisting of" list itself suggests some intended flexibility ('944 Patent, col. 23:35-40).
    • Evidence for a Narrower Interpretation: A party could argue for a strict interpretation where any unrecited substance, regardless of its effect, removes the accused product from the claim's scope. The patent's abstract and summary repeatedly emphasize a specific combination of components to solve the stated problems, which may support a narrow reading.

For the '307 Patent

  • The Term: "double-wall structure"
  • Context and Importance: This is a key structural limitation in independent claim 1 of the '307 patent and its parent '449 patent. A finding of infringement will likely depend on whether the applicator associated with Perrigo's generic product embodies this specific feature.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The claim language describes the structure as being formed by "an inner portion which extends from the base to an upper end and an outer skirt portion" ('307 Patent, col. 15:7-9). This could be argued to cover any applicator head with two generally concentric walls.
    • Evidence for a Narrower Interpretation: The specification's detailed description and figures (e.g., '307 Patent, Fig. 2) depict a specific geometry where the inner portion (7) and outer skirt (9) form a continuous, inverted U-shaped profile. A party could argue the term is limited to this disclosed embodiment, which creates a "blade-like member" ('307 Patent, col. 7:55-58).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement for all three patents-in-suit. The inducement allegations are based on the assertion that Defendants' product labeling, instructions, and marketing activities will actively encourage physicians to prescribe and patients to use the generic product in an infringing manner (Compl. ¶¶ 34, 35, 44, 55, 66). The contributory infringement allegations are based on the assertion that Perrigo's Generic Product is a material part of the infringement, is especially adapted for the infringing use, and has no substantial non-infringing use (Compl. ¶¶ 36, 47, 58, 69).
  • Willful Infringement: The complaint does not use the term "willful," but it alleges that Defendants had pre-suit knowledge of all three patents-in-suit via formal notice letters sent pursuant to the Hatch-Waxman Act (Compl. ¶¶ 30-32, 43, 54, 65). These allegations of knowing infringement after receiving notice could form the basis for a later claim for enhanced damages.

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

  • A core issue will be one of compositional scope: For the '944 patent, does Perrigo's ANDA formulation fall within the presumptively closed "consisting of" language of the asserted claims, or will differences in excipients or other components place it outside the literal scope of the invention?
  • A second key issue will be one of structural correspondence: For the '307 and '449 patents, does the applicator described in Perrigo's ANDA contain the specific "double-wall structure" taught in the patents, or have Defendants designed a non-infringing applicator, creating a mismatch between the accused product's use and the patented method?
  • Finally, as an ANDA case, a central evidentiary question will be whether the product for which Perrigo seeks FDA approval—as defined by the chemistry, manufacturing, and controls sections of its ANDA—would, if marketed, meet every limitation of the asserted claims, including the pharmacokinetic outcomes.