PTAB

IPR2019-01023

Pfizer Inc v. Sanofi Aventis Deutschland

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Pen-Type Injector
  • Brief Description: The ’844 patent describes a drug delivery device, such as a pen-type injector for self-administration of medicine like insulin. The device comprises a housing, a piston rod, and a drive mechanism with several interacting components, including a dose indicator, a driving member, and a sleeve that operate via threaded engagements to allow a user to set a dose and then dispense the medication.

3. Grounds for Unpatentability

Ground 1: Claims 21-29 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 an injection syringe, taught every limitation of independent claim 21 except for the specific configuration of the drive mechanism. The primary difference identified was that in the ’844 patent, the "driving member" has internal threads engaging the piston rod, whereas in Steenfeldt-Jensen, a separate, rotatably fixed "piston rod holder" (member 40) contains the internal threads, and the driving member (driver tube 85) engages the piston rod via a non-circular cross-section to transmit rotation. Petitioner asserted that Steenfeldt-Jensen’s “bushing 82” meets the limitations of the claimed “sleeve” and “clutch,” and its “member 40” and associated pawl mechanism meet the limitations of the claimed “piston rod holder.”
    • Motivation to Combine (Modify): Petitioner contended that Steenfeldt-Jensen itself suggested the modification required to arrive at the claimed invention. Steenfeldt-Jensen described two interchangeable approaches for a piston rod drive: a "fixed-nut" design (as shown in its primary embodiment) and a "rotating-nut" design (as claimed in the ’844 patent). A POSITA would have recognized this express teaching of interchangeability and would have been motivated to implement the alternative rotating-nut configuration by swapping the functions of driver tube 85 and member 40.
    • Expectation of Success: A POSITA would have had a reasonable expectation of success in making this modification, as it involved implementing a well-known rotating-nut drive mechanism. This change was presented as a predictable design choice that would perform its known function without altering the device's overall principle of operation.

Ground 2: Claim 30 is obvious over Steenfeldt-Jensen in view of Klitgaard.

  • Prior Art Relied Upon: Steenfeldt-Jensen (Patent 6,235,004), Klitgaard (Patent 6,582,404).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground built upon the assertion that claims 21-29 were obvious over a modified Steenfeldt-Jensen. Claim 30 adds the limitation of "a nut that tracks each set dose of medicament delivered." Petitioner argued that Klitgaard taught this feature, disclosing a dose-setting limiter that uses a nut member to track the total amount of administered medication. This prevents a user from setting a dose that exceeds the supply remaining in the cartridge.
    • Motivation to Combine: A POSITA would combine Klitgaard's dose-tracking nut with the Steenfeldt-Jensen injector to improve safety and convenience. Klitgaard provided an explicit motivation by explaining that such a limiting device makes it "impossible to set a dose that exceeds the amount of medicament which is left in the cartridge." This known benefit would have prompted a POSITA to incorporate the feature into the injector of Steenfeldt-Jensen.
    • Expectation of Success: The proposed combination involved adding a known component (a dose-tracking nut) to an existing device (an injector pen) to achieve a predictable and desirable result (dose limitation). Therefore, a POSITA would have had a high expectation of success in implementing this combination.

4. Key Claim Construction Positions

  • Petitioner stated that for the purposes of the petition, it adopted several of the Patent Owner’s proposed claim constructions from related district court litigation. These included terms such as:
    • “driving member”: "A component releasably connected to the dose dial sleeve that drives the piston during dose dispensing."
    • “piston rod”: "A rod that engages with the drive sleeve/driver/driving member to advance the piston during dose dispensing."
  • As an alternative, Petitioner provided means-plus-function constructions for the terms “clutch,” “clicker,” and “holder.” For example, for "clutch," the asserted function was coupling and decoupling a movable component during dose setting, with the corresponding structure identified as component 60 and related elements in the ’844 patent figures.

5. Key Technical Contentions (Beyond Claim Construction)

  • Petitioner argued that the challenged claims were not entitled to a priority date earlier than May 17, 2016, the filing date of the application that issued as the ’844 patent.
  • The argument centered on the claim limitation "a piston rod comprising either an internal or an external fourth thread." Petitioner contended that the parent applications lacked written description support for a piston rod with internal threads, as those documents allegedly only described and depicted piston rods with external threads. This position, if accepted, would establish an effective filing date that makes references like Steenfeldt-Jensen (2001) and Klitgaard (2003) undisputedly prior art.

6. Relief Requested

  • Petitioner requested institution of an inter partes review and cancellation of claims 21-30 of Patent 9,526,844 as unpatentable under 35 U.S.C. §103.