PTAB

IPR2018-01675

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 ’044 patent discloses a drive mechanism for a pen-type medication injector, suitable for self-administration of drugs like insulin. The invention centers on a housing part comprising a specific six-component assembly that facilitates dose setting and injection.

3. Grounds for Unpatentability

Ground 1: Claims 11, 14, 15, 18, and 19 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 multi-use medication dispensing pen, teaches all six major components recited in independent claim 11. Specifically, Petitioner mapped Burroughs' components as follows: "housing 22" as the main housing; "dial mechanism 34" as the dose dial sleeve; "proximal portion 78" as the dose dial grip; "leadscrew 38" as the piston rod; "nut 36" as the drive sleeve; and "button 32" as the tubular clutch.

    • Petitioner contended that the only significant difference is the nature of the threaded engagement between the dose dial sleeve and the main housing. Claim 11 recites a dose dial sleeve with a "helical groove" on its outer surface that engages threading on the main housing. In contrast, Burroughs discloses the inverse arrangement: a "helical rib" (threads 110, 112) on its dose dial sleeve that engages a corresponding "helical groove" on the inner surface of its main housing.

    • For the dependent claims, Petitioner argued Burroughs teaches a clicker mechanism (claims 14-15) through its interacting splines and housing finger that provide audible feedback during dose dialing. Burroughs also allegedly discloses the relative positioning of the dose dial sleeve being outside the tubular clutch and radially inward of the main housing (claim 18). Finally, claim 19, which recites a rib on the housing and a groove on the sleeve, was argued to be obvious for the same reasons as claim 11, as it represents the exact design taught by Burroughs that Petitioner contends is an obvious alternative to the arrangement in claim 11.

    • Motivation to Modify: Petitioner asserted this was a single-reference obviousness challenge based on a motivation to modify Burroughs. The core motivation was design choice. Petitioner argued that a helical rib-and-groove connection is a common, well-known mechanism for achieving relative rotational movement between components. A person of ordinary skill in the art (POSITA) would have recognized that placing the rib on the housing and the groove on the sleeve, or vice versa, were simple, interchangeable design alternatives for achieving the same function. A POSITA would combine these familiar elements according to known methods to achieve a predictable result.

    • Expectation of Success: Petitioner argued a POSITA would have had a high expectation of success in reversing the rib and groove features. This modification was a simple mechanical swap that would predictably result in the same rotatable engagement between the dose dial sleeve and the housing, without altering the overall function or operability of the injection pen.

4. Key Claim Construction Positions

  • Petitioner stated that for the purpose of the petition, claim terms could be given their ordinary and accustomed meaning, but also highlighted several constructions proffered by the Patent Owner in related litigation, which Petitioner adopted as reasonable.
  • tubular clutch: "A tubular structure that couples and decouples a moveable component from another component."
  • 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."
  • Petitioner further argued that to the extent "tubular clutch" and "clicker" were construed as means-plus-function terms, Burroughs disclosed the corresponding structures for performing the claimed functions of coupling/decoupling components and providing audible feedback, respectively.

5. Relief Requested

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