PTAB

IPR2018-01678

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 ’486 patent discloses a drive mechanism for a pen-type medication injector. The technology centers on a six-component assembly comprising a main housing, a dose dial sleeve, a dose knob, a piston rod, a driver, and a tubular clutch, which work together to allow a user to set and dispense a precise dose of medicine.

3. Grounds for Unpatentability

Ground 1: Obviousness over Steenfeldt-Jensen - All challenged claims are obvious over Steenfeldt-Jensen.

  • Prior Art Relied Upon: Steenfeldt-Jensen (Patent 6,235,004).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Steenfeldt-Jensen, which discloses a syringe for dispensing medicine, teaches a nearly identical six-component structure meeting almost every limitation of independent claim 1. The primary difference identified was that the ’486 patent’s driver uses an "internal threading" to engage and drive the piston rod, whereas Steenfeldt-Jensen’s driver (driver tube 85) uses a non-circular bore to rotationally engage its piston rod.
    • Motivation to Combine (Modify): Petitioner contended that the motivation to make this modification was explicitly suggested within Steenfeldt-Jensen itself. The reference contemplates an alternative embodiment where a "nut element" (implying internal threads) is rotated by the driver tube to drive the piston rod. This effectively swaps the engagement mechanisms between the components, a simple design choice for a person of ordinary skill in the art (POSA).
    • Expectation of Success: A POSA would have had a reasonable expectation of success in implementing this modification. It involved the predictable substitution of one well-known mechanical engagement method (a non-circular bore) for another equally well-known method (a threaded nut) to accomplish the same function of converting rotational motion into axial displacement.

Ground 2: Obviousness over Møller in view of Steenfeldt-Jensen - All challenged claims are obvious over Møller in view of Steenfeldt-Jensen.

  • Prior Art Relied Upon: Møller (Application # 2002/0052578) and Steenfeldt-Jensen (Patent 6,235,004).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner asserted that Møller discloses an injection device having all six core components recited in claim 1, including a non-rotatable piston rod and a driver (connection bars 12 with nut 13) that features the claimed internal threading. However, Petitioner noted that Møller’s dose-setting drum (the claimed dose dial sleeve) engages the housing via an internal thread on the drum, whereas the ’486 patent claims a helical groove on the outer surface of the sleeve that engages a helical rib on the inner surface of the housing.
    • Motivation to Combine: A POSA would have been motivated to modify Møller’s device by incorporating the dose dial sleeve engagement mechanism taught by Steenfeldt-Jensen. Møller itself discusses the high-pitch thread design of Steenfeldt-Jensen and its advantages in reducing friction. Therefore, a POSA would have looked to Steenfeldt-Jensen to improve Møller's design by implementing its more efficient external groove/internal rib configuration, which was known to be functionally equivalent and largely interchangeable with Møller's design.
    • Expectation of Success: The combination represented a routine design task. A POSA would have reasonably expected that substituting one type of threaded engagement for another to achieve a known benefit (reduced friction) would result in a predictable and successful operation of the device.

4. Key Claim Construction Positions

  • Petitioner argued that while the claim terms should be given their plain and ordinary meaning, it also addressed potential means-plus-function constructions for three key terms that were at issue in related district court litigation.
  • "clutch": Petitioner asserted the function is coupling and decoupling a movable component during dose setting. The corresponding structure in the ’486 patent was identified as component 60, a generally cylindrical element with teeth for engagement.
  • "clicker": Petitioner asserted the function is providing at least audible feedback to a user when the dose dial grip is rotated. The corresponding structure was identified as component 50, which includes a flexible arm and toothed member.
  • "insert": Petitioner asserted the function is preventing the piston rod from rotating during dose setting while permitting axial traversal during dose dispensing. The corresponding structure was identified as component 16.

5. Relief Requested

  • Petitioner requested institution of an inter partes review (IPR) and cancellation of claims 1-6, 12-18, 20, 23, 26-30, 32, 33, 36, and 38-40 of Patent 8,992,486 as unpatentable under 35 U.S.C. §103.