DCT

1:18-cv-01037

Eli Lilly Co v. Apotex Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:18-cv-1037, S.D. Ind., 04/04/2018
  • Venue Allegations: Plaintiff alleges venue is proper in the Southern District of Indiana because Defendants conduct substantial business in the state, including operating a distribution facility, maintaining a registered agent, and deriving revenue from drug sales. The complaint also notes that Defendants have previously litigated patent cases in the district and sent the required statutory notice letter for this case to Plaintiff's headquarters in Indiana.
  • Core Dispute: Plaintiff alleges that Defendants’ submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of Plaintiff's Forteo® osteoporosis treatment constitutes an act of infringement of a patent directed to a medication dispensing apparatus.
  • Technical Context: The technology at issue is a mechanical, multi-dose injector pen designed to be disposed of after a final dose is administered, featuring a safety lock-out mechanism.
  • Key Procedural History: This is a Hatch-Waxman action initiated under 35 U.S.C. § 271(e)(2) following Defendants' submission of ANDA No. 211097 with a Paragraph IV certification. The certification alleges that Plaintiff’s patent is invalid, unenforceable, or will not be infringed by the proposed generic product. The complaint was filed within the 45-day statutory window after Plaintiff received Defendants' notice letter, triggering an automatic 30-month stay of FDA approval for the generic product.

Case Timeline

Date Event
2002-11-26 FDA approves Lilly's Forteo® New Drug Application (NDA)
2004-03-30 Earliest Priority Date for U.S. Patent No. 7,517,334
2009-04-14 U.S. Patent No. 7,517,334 issues
2018-02-22 Apotex sends Paragraph IV Notice Letter to Lilly regarding its ANDA
2018-04-04 Complaint filed

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

U.S. Patent No. 7,517,334 - “Medication Dispensing Apparatus with Spring-Driven Locking Feature Enabled by Administration of Final Dose”

  • Patent Identification: U.S. Patent No. 7,517,334, titled “Medication Dispensing Apparatus with Spring-Driven Locking Feature Enabled by Administration of Final Dose,” issued April 14, 2009 (’334 Patent).

The Invention Explained

  • Problem Addressed: The patent’s background section identifies shortcomings in prior art injector pens, including the potential for users to set a dose larger than the remaining medicine and the lack of a simple design platform allowing manufacturers to easily adapt the device for different mechanical advantages (e.g., for delivering large vs. small volume doses) (’334 Patent, col. 1:41-54).
  • The Patented Solution: The patent describes a medication dispensing apparatus with a final-dose lockout mechanism to prevent reuse (’334 Patent, Abstract). The core of the invention is a "latching element" that includes a "skid" designed to slide along a specific surface of the internal drive member during each dose administration. Upon administration of the final dose, the drive member travels to a point where the skid slides off the end of this surface. This allows the spring-loaded latching element to move into a second position, where a "latching lip" physically engages a hook on the plunger, permanently locking the device and preventing further use (’334 Patent, col. 2:1-14; col. 7:60-col. 8:14).
  • Technical Importance: The invention claims to provide an uncomplicated and robust mechanism that automatically and permanently disables a disposable injector pen after its intended course of treatment is complete, which may enhance patient safety by preventing under-dosing or attempts at reuse (’334 Patent, col. 2:15-18).

Key Claims at a Glance

  • The complaint asserts infringement of at least independent Claim 1 (’334 Patent, col. 9:56-col. 10:23; Compl. ¶38).
  • The essential elements of independent Claim 1 include:
    • A housing, a drive member movable distally, and a fluid container.
    • A plunger element.
    • A gear set with first and second pinions, pivotal on the plunger element.
    • A first rack, stationary in the housing, engaged with the first pinion.
    • A second rack, engaged with the second pinion, movable on a piece "clutchably connected" to the drive member.
    • A "latching element including a latching lip and a skid."
    • A "skid-engaging surface" on the drive member, where the skid slides until it passes a proximal end upon final dose administration, causing the latching lip to engage a "latchable element" on the plunger to "physically lock" it.
  • The complaint states that the accused product is covered by "one or more claims," reserving the right to assert additional claims (Compl. ¶32).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is "Apotex's ANDA Product," identified as a generic version of Lilly's Forteo® product, specifically "Teriparatide Injection USP, 600 mcg / 2.4 mL (250 mcg/mL)" (Compl. ¶17, 28). The infringement action is based on Apotex's submission of Abbreviated New Drug Application (ANDA) No. 211097 to the FDA (Compl. ¶28).

Functionality and Market Context

  • The accused product is a proposed generic drug for treating osteoporosis, intended for administration via an injection device (Compl. ¶7, 26, 31). The complaint was filed before Plaintiff's counsel had received a sample of the injection device for evaluation (Compl. ¶31). Consequently, the complaint does not describe the specific technical features or operation of the accused device. The core of the legal action is the submission of the ANDA itself, which statutorily constitutes an act of infringement if the proposed product, once marketed, would infringe the patent (Compl. ¶33). No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not provide a claim chart or a detailed, element-by-element comparison of the accused product to the asserted patent claims. The infringement theory is articulated at a high level. The complaint alleges, on "information and belief," that Apotex's ANDA Product is covered by one or more claims of the ’334 patent (Compl. ¶32). The act of infringement is identified as the submission of ANDA No. 211097 to the FDA for a product that, if commercially manufactured or sold, would infringe at least Claim 1 of the ’334 patent (Compl. ¶33, 38-39). The complaint lacks specific factual allegations detailing how Apotex's proposed injection device meets the limitations of Claim 1.

  • Identified Points of Contention:
    • Technical Questions: A central issue will be establishing the actual design and mechanism of Apotex's proposed injection device. Since the complaint indicates a physical sample was not available pre-suit (Compl. ¶31), a key question is what evidence from the confidential ANDA filing and subsequent discovery will show that the accused device contains structures corresponding to the specific mechanical components of Claim 1, such as the "latching element including a latching lip and a skid" and the dual-pinion gear set with a "clutchably connected" rack.
    • Scope Questions: The dispute may focus on the scope of the claim language. For example, does the specific two-pinion, two-rack gear system described in the claim read on the drive mechanism used in the accused device? Further, does the accused device's end-of-life locking feature, if any, operate in a manner that falls within the scope of the claimed "latching element" and "skid" interaction?

V. Key Claim Terms for Construction

  • The Term: "latching element including a latching lip and a skid" (Claim 1)

    • Context and Importance: This term describes the core components of the patented final-dose locking mechanism. The definition of these interconnected parts and their required functionality will be critical to the infringement analysis, as any alleged infringement will depend on the accused device possessing a structurally and functionally similar feature.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: A party might argue that the terms should be construed functionally, focusing on the purpose described in the patent: a "skid" is any surface that slides along another to hold a "latching lip" disengaged until it passes an endpoint, triggering a lock. The claim language itself does not limit the element to a specific material or shape.
      • Evidence for a Narrower Interpretation: The specification discloses specific embodiments, including a "C-shaped latching element" made from a "metal stamping" and a "blade-shaped" skid (’334 Patent, col. 7:34-48, col. 9:40-41). A party could argue these disclosures limit the scope of the claim term to structures that are the same as or equivalent to these specific examples.

  • The Term: "a piece clutchably connected to said drive member" (Claim 1)

    • Context and Importance: This term defines the relationship between the second rack and the main drive member of the injector pen's gear system. Whether the accused device's mechanism has a "clutchably connected" piece will be a point of technical comparison.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: A party could argue that "clutchably connected" should be given its ordinary meaning, covering any mechanical arrangement that allows for intermittent engagement or one-way motion between two components.
      • Evidence for a Narrower Interpretation: The specification describes a specific implementation of this connection using a system of ratchet teeth on the drive member and resilient pawls on the pinion-engaging piece, which creates a one-way clutch (’334 Patent, col. 4:36-60). Practitioners may focus on whether this term should be limited to the disclosed ratchet-and-pawl embodiment or its structural equivalents.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges inducement to infringe under Count II. The factual basis is that Apotex has knowledge of the ’334 patent and, by seeking FDA approval, "intends that physicians will prescribe, and patients will take" the accused product, thereby intentionally encouraging direct infringement by end-users (Compl. ¶34, 43).
  • Willful Infringement: While the complaint does not contain a separate count for "willful infringement," it alleges that Apotex had knowledge of the ’334 patent and seeks an award of attorneys' fees for an "exceptional case" under 35 U.S.C. § 285 (Compl. ¶34, Prayer for Relief ¶F). The allegation of knowledge is predicated on Apotex’s Paragraph IV certification against the ’334 patent, which is listed in the FDA’s Orange Book for the Forteo® product (Compl. ¶27, 29).

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

  • A central issue will be one of evidentiary proof: As the complaint was filed on "information and belief" without a physical sample of the accused device, a threshold question is whether discovery will reveal that Apotex's proposed injector pen, as detailed in its confidential ANDA, contains the specific mechanical structures recited in Claim 1. The case will depend on Lilly's ability to map these undisclosed features to the claim limitations.
  • The litigation will likely hinge on claim construction: A core legal question will be whether the term "latching element including a latching lip and a skid" is interpreted narrowly, limited to the C-shaped metal stamping and blade-like structures shown in the patent's figures, or more broadly to encompass a wider range of last-dose lockout mechanisms. The outcome of this definitional dispute will likely be dispositive of infringement.