PTAB

IPR2018-01684

Mylan Pharmaceuticals Inc v. Sanofi Aventis Deutschland GmbH

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Drive Mechanisms Suitable for Use in Drug Delivery Devices
  • Brief Description: The ’008 patent discloses drive mechanisms for pen-type drug delivery injectors, such as those used for self-administration of insulin. The invention centers on a six-component assembly comprising a housing, a dose dial sleeve for setting a dose, a drive sleeve, a piston rod with two distinct threads, an insert, and a clutch to releasably connect the drive sleeve and the dose dial sleeve.

3. Grounds for Unpatentability

Ground 1: Obviousness over Møller and Steenfeldt-Jensen - Claims 1, 3, 7, 8, 11, and 17 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 the combination of Møller and Steenfeldt-Jensen taught every limitation of the challenged claims. During prosecution, the claims were allowed after an amendment specifying that the clutch is located "(i) radially outward of the drive sleeve and (ii) radially inward of the dose dial sleeve." Petitioner contended that Møller taught this exact concentric arrangement in its pen injector, which included a housing, a dose setting drum (the claimed dose dial sleeve), a drive mechanism (connection bars and nut), and a "cup shaped element" that functions as the claimed clutch. Steenfeldt-Jensen was asserted to teach a simpler and more robust piston-driving mechanism that uses a dual-threaded piston rod. One thread on the piston rod engages an insert fixed in the housing, while the second, oppositely-pitched thread engages the drive sleeve (an injection button). Petitioner argued this dual-threaded system disclosed the remaining limitations of independent claim 1 not fully met by Møller, particularly the specifics of the piston rod. The combination was also argued to teach the additional limitations of the challenged dependent claims, such as the insert being secured against rotation (claim 3) and the piston rod threads being oppositely disposed (claim 17), a feature essential to the function of Steenfeldt-Jensen’s differential-threading mechanism.
    • Motivation to Combine: A Person of Ordinary Skill in the Art (POSA) would combine Møller's user-friendly dose-setting interface (including its concentric clutch) with Steenfeldt-Jensen's mechanically simpler and more robust dual-threaded piston-driving mechanism. The petition argued that reducing the number of internal components and improving durability were known objectives in the drug-delivery pen industry. A POSA would recognize that Steenfeldt-Jensen's design achieved these goals and provided a desirable mechanical advantage, making it an attractive substitute for Møller's more complex rack-and-pinion system.
    • Expectation of Success: A POSA would have had a reasonable expectation of success because the references solve similar problems using components with analogous operational principles. Both Møller and Steenfeldt-Jensen disclose drive sleeves that rotate up a piston rod during dose-setting and then move axially to drive the piston rod for injection. Combining the well-understood dose-setting interface of Møller with the well-understood piston-driving mechanism of Steenfeldt-Jensen would have been a routine application of known design choices to achieve the predictable benefits of improved durability and simplified construction.

4. Key Claim Construction Positions

  • Petitioner argued that even if the terms "clutch" and "insert" were construed as means-plus-function terms, the invalidity ground would remain meritorious.
  • "Clutch": Petitioner proposed the function is to "reversibly lock two components in rotation" during dose setting. This construction was central to mapping Møller's "cup shaped element" to the claim, as Møller's element was argued to perform this precise function of rotationally coupling and decoupling the dose-setting and drive components.
  • "Insert": Petitioner proposed the function is "prevent[ing] the piston rod from rotating during dose setting and permit[ting] the piston rod to traverse axially" during dispensing. This was key to mapping Steenfeldt-Jensen’s "wall 4," which is fixed within the housing and has a threaded bore that guides the piston rod, thereby satisfying this functional requirement.

5. Relief Requested

  • Petitioner requested the institution of an inter partes review (IPR) and the cancellation of claims 1, 3, 7, 8, 11, and 17 of Patent 9,604,008 as unpatentable under 35 U.S.C. §103.