PTAB

IPR2019-00122

Mylan Pharmaceuticals Inc v. Sanofi Aventis Deutschland GmbH

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Key Events
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 injector used for self-administering drugs like insulin. The claimed apparatus comprises a housing with six core interacting components: a dose dial sleeve, a dose knob, a piston rod, a driver, and a tubular clutch that controls dose setting and injection functions.

3. Grounds for Unpatentability

Ground 1: Obviousness over Burroughs - Claims 1-6, 12-18, 20, 23, 26-30, 32, 33, 36, and 38-40 are obvious over 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 recyclable medication dispensing pen, teaches every limitation of the challenged claims. The core of the argument for independent claim 1 was a direct mapping of components: Burroughs' "housing 22" is the claimed "main housing"; "dial mechanism 34" is the "dose dial sleeve"; "proximal portion 78" is the "dose knob"; "leadscrew 38" is the "piston rod"; "nut 36" is the "driver"; and "button 32" is the "tubular clutch." The only alleged difference was that the Burroughs "dose dial sleeve" uses a discontinuous helical rib to engage a helical groove in the housing, whereas claim 1 recites a helical groove on the sleeve to engage threading on the housing. Petitioner contended this was an obvious design choice.
    • Prior Art Mapping (Dependent Claims): Petitioner asserted that Burroughs also disclosed the features of the dependent claims. For example, Burroughs taught a window (lens 25) for viewing the dose (claims 3-4), a cylindrical driver (nut 36) (claim 5), a clicker mechanism providing audible and tactile feedback (flexible leg 168 and splines 150) (claims 14-18, 20), a generally circular piston rod (leadscrew 38) (claim 23), and a radial stop to prevent overdosing (interference ledge at the end of helical groove 158) (claims 30, 32).
    • Motivation to Combine (for §103 grounds): This ground was based on modifying Burroughs rather than combining references. Petitioner argued a person of ordinary skill in the art (POSITA) would have found it obvious to modify the threaded engagement in Burroughs. A POSITA would have viewed the disclosed rib-on-sleeve/groove-on-housing configuration and the claimed groove-on-sleeve/rib-on-housing configuration as functionally equivalent and interchangeable design choices for achieving threaded movement. Swapping them would have been a predictable and routine task using known methods for their established functions.
    • Expectation of Success (for §103 grounds): A POSITA would have had a high expectation of success because grooved threading is a common, well-understood, and predictable mechanism. Implementing the claimed configuration would not change the fundamental principle of operation of the injector pen, as it would still facilitate rotation and corresponding axial displacement in the same manner as the structure disclosed in Burroughs.

4. Key Claim Construction Positions

  • Petitioner adopted Patent Owner's proposed constructions from related litigation for several key terms, including:
    • "driver": "A component 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."
  • As an alternative, Petitioner proposed means-plus-function constructions for three terms, arguing that if the Board found them to be means-plus-function terms, the corresponding structures were disclosed in the prior art:
    • "clutch": The asserted function was "coupling and decoupling a movable component from another component" during dose setting, with the corresponding structure being component 60 and its associated parts.
    • "clicker": The asserted function was "provid[ing] audible clicks during dose setting," with the corresponding structure being component 50 and its related features.
    • "insert": The asserted function was "prevent[ing] the piston rod from rotating during dose setting and permit[ting] the piston rod to traverse axially...during dose dispensing," with the corresponding structure being component 16.

5. Relief Requested

  • Petitioner requests 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 the ’486 patent as unpatentable.