PTAB

IPR2018-01676

Mylan Pharmaceuticals Inc v. Sanofi Aventis Deutschland GmbH

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Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Pen-Type Injector
  • Brief Description: The ’044 patent discloses a drive mechanism for a pen-type injector used for self-administering medicine. The invention focuses on the housing part and the internal components that allow a user to set and inject a specific dose, including a dose dial sleeve, a drive sleeve, and a piston rod.

3. Grounds for Unpatentability

Ground 1: Obviousness over Steenfeldt-Jensen

Claims 11, 14, 15, 18, and 19 are obvious over Steenfeldt-Jensen.

  • Prior Art Relied Upon: Steenfeldt-Jensen (Patent 6,235,004).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner asserted that Steenfeldt-Jensen, which discloses a medicine-dispensing syringe, teaches every component of independent claim 11. Specifically, Petitioner mapped Steenfeldt-Jensen’s “tubular housing 1” to the claimed main housing; “scale drum 80” with an outer helical track to the dose dial sleeve; “dose setting button 81” to the dose dial grip; “piston rod 6” to the non-rotatable piston rod; and “bushing 82” to the tubular clutch. The central dispute focused on the “drive sleeve” limitation. Petitioner argued that Steenfeldt-Jensen’s piston rod drive, comprising driver tube 85 and member 40, collectively meets this limitation. Driver tube 85 extends along the piston rod and rotationally engages it, while member 40 provides the internal threading to drive it.
    • Reason to Modify: Petitioner argued that even if Steenfeldt-Jensen's two-part piston rod drive did not directly meet the "drive sleeve" limitation, it would have been obvious to modify it. The petition highlighted that Steenfeldt-Jensen itself expressly contemplates an alternative embodiment where the functions of its components are swapped: the "nut element" (with threading) is placed on the driver tube, and the "piston rod guide" (with a non-circular bore) is placed on the housing. This modification, suggested by the prior art itself, would result in a single-component driver tube with internal threading that engages the piston rod, directly corresponding to the claimed "drive sleeve."
    • Expectation of Success: A POSITA would have reasonably expected this modification to succeed because it involved a simple rearrangement of known components that would perform their same known functions in a predictable manner without altering the device's overall operation.

Ground 2: Obviousness over Møller and Steenfeldt-Jensen

Claims 11, 14, 15, 18, and 19 are obvious over Møller in view of Steenfeldt-Jensen.

  • Prior Art Relied Upon: Møller (Application # 2002/0053578) and Steenfeldt-Jensen (Patent 6,235,004).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Møller discloses an injection device with the same six-component structure as claim 11, mapping its housing, non-rotatable piston rod, drive sleeve (connection bars and nut), dose dial grip, and clutch (cup-shaped element). However, Møller’s "dose setting drum 17" (the dose dial sleeve) utilizes an internal thread to engage an inwardly-positioned tubular element of the housing. This contrasts with claim 11, which requires a "helical groove provided along an outer surface" of the sleeve. To supply this missing feature, Petitioner pointed to Steenfeldt-Jensen, which explicitly teaches a dose dial sleeve (scale drum 80) with an external helical groove for engaging a corresponding rib on the inner wall of its housing.
    • Motivation to Combine: The motivation was particularly strong, as Møller's own specification discusses the Steenfeldt-Jensen device. While Møller criticizes friction in Steenfeldt-Jensen's design, Petitioner argued a POSITA would recognize that Steenfeldt-Jensen's use of a high-pitch, non-self-locking external thread was intended to manage these forces. A POSITA would thus be motivated to incorporate this known, friction-reducing external thread design from Steenfeldt-Jensen onto the dose dial sleeve of Møller's device, representing a simple substitution of one known threaded engagement for another to improve ease of use.
    • Expectation of Success: A POSITA would expect success in this combination. Replacing Møller's internal threading with Steenfeldt-Jensen’s well-understood external threading was a simple substitution of one known engagement mechanism for another to achieve the predictable result of reduced friction while maintaining the required rotational movement for dose setting and injection.

4. Key Claim Construction Positions

  • Petitioner relied on several claim constructions proffered by the Patent Owner (Sanofi) in co-pending district court litigation, arguing Sanofi should be bound by them. Key constructions included:
    • drive sleeve: "An essentially tubular component of essentially circular cross-section releasably connected to the dose-dial sleeve that drives the piston during dose dispensing."
    • tubular clutch: "A tubular structure that couples and decouples a moveable component from another component."
  • Petitioner also contended that the terms "tubular clutch" and "clicker" (from dependent claim 14) lacked sufficient corresponding structure in the specification to perform their stated functions and should be construed as means-plus-function terms under 35 U.S.C. §112, ¶6. For the "tubular clutch," Petitioner identified component 60 in the patent's figures as the corresponding structure for performing the function of "coupling and decoupling a movable component."

5. Relief Requested

  • Petitioner requested the institution of an inter partes review and cancellation of claims 11, 14, 15, 18, and 19 of the ’044 patent as unpatentable under 35 U.S.C. §103.