PTAB

IPR2018-01679

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 drug delivery device, such as a pen-type injector for self-administering medicine. The invention focuses on a clutch mechanism that releasably couples a dose dial sleeve to a drive sleeve, enabling a user to set a dose and then inject it.

3. Grounds for Unpatentability

Ground 1: Anticipation over Burroughs - Claims 51-55 and 57 are anticipated by Burroughs

  • Prior Art Relied Upon: Burroughs (Patent 6,221,046).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Burroughs, which discloses a multi-use medication dispensing pen, teaches every limitation of the challenged claims. The "button 32" in Burroughs was identified as the claimed clutch. This button has a tubular body extending from a distal to a proximal end and is positioned within a "dial mechanism 34" (the claimed dial member). When the dose knob is activated (by depressing button 32), the clutch moves distally to dispense a dose. Burroughs also disclosed that the proximal portion of its dial mechanism serves as a dose knob, with the clutch residing within its inner space, thereby anticipating dependent claims.

Ground 2: Anticipation over Steenfeldt-Jensen - Claims 51-53, 56-57 are anticipated by 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 discloses an injection syringe with a clutch mechanism that meets all limitations of the claims. The "bushing 82" in Steenfeldt-Jensen was argued to be the claimed clutch, which has a tubular body and is positioned within a "scale drum 80" (the claimed dial member). The bushing releasably engages a dose-setting button via corresponding rosettes of teeth. When the injection button is pressed, the bushing moves distally, causing the rosettes to engage and dispense the dose. Petitioner contended that the flange on the bushing includes axially extending teeth formed on its interior, anticipating claim 56.

Ground 3: Obviousness over Steenfeldt-Jensen/Møller and Burroughs - Claims 54-55 are obvious over Steenfeldt-Jensen or Møller in view of Burroughs

  • Prior Art Relied Upon: Steenfeldt-Jensen (Patent 6,235,004) or Møller (Patent 6,663,602), combined with Burroughs (Patent 6,221,046).

  • Core Argument for this Ground:

    • Prior Art Mapping: Petitioner argued that while Steenfeldt-Jensen and Møller each teach the base pen injector with the clutch mechanism recited in claims 51-52, they do not explicitly detail the standard components of a multi-dose cartridge (reservoir, stopper, septum, ferrule) as recited in dependent claims 54-55. Burroughs was argued to explicitly teach a multi-dose cartridge containing all these standard components for use in a similar pen-type injector.
    • Motivation to Combine: A POSITA designing a multi-dose injector pen, like those in Steenfeldt-Jensen or Møller, would have been motivated to use a well-known, conventional multi-dose cartridge like the one disclosed in Burroughs. All references are in the same field of endeavor (pen-type injection devices) and address the same problem. Incorporating the standard cartridge from Burroughs into the devices of Steenfeldt-Jensen or Møller was presented as a predictable design choice to enhance cartridge use.
    • Expectation of Success: A POSITA would have had a high expectation of success in this combination due to the congruent features of the devices, such as the use of piston rods to dispense medicine, and the general predictability of cartridge and piston-rod operation in such devices.

  • Additional Grounds: Petitioner asserted additional anticipation and obviousness challenges, including anticipation of claims 51-53 and 56-57 by Møller, and obviousness of claims 54-55 over Burroughs alone. These arguments relied on similar mappings of clutch and dial components from the respective prior art.

4. Key Claim Construction Positions

  • Petitioner argued that the terms "clutch" and "tubular clutch" should be given their plain and ordinary meaning: "A structure that couples and decouples a moveable component from another component" and "A tubular structure that couples and decouples a moveable component from another component," respectively.
  • As an alternative, Petitioner contended that if the terms were construed under a means-plus-function framework, the function is coupling and decoupling components during dose setting. The corresponding structure in the ’486 patent was identified as clutch component 60 and its associated interacting elements as described in the specification.

5. Relief Requested

  • Petitioner requests institution of an inter partes review and cancellation of claims 51-57 of the ’486 patent as unpatentable under 35 U.S.C. §§102 and 103.