PTAB

IPR2019-00981

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 ’486 patent relates to a clutch for use within a pen-type drug delivery device. The clutch is designed to releasably couple a dose-dial sleeve to a drive sleeve, enabling a user to set and subsequently administer variable doses of medicine from a cartridge.

3. Grounds for Unpatentability

Ground 1: Anticipation of Claims 51-55 and 57 by Burroughs

  • Prior Art Relied Upon: Burroughs (6,221,046).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Burroughs discloses a multi-use medication dispensing pen that anticipates every limitation of the challenged claims. The "button 32" in Burroughs was identified as the claimed clutch, which has a "hollow cylindrical portion 48" (the tubular body). Petitioner asserted this button's distal end is positioned within the proximal end of "dial mechanism 34" (the dial member), thus meeting independent claim 51. For dependent claims, Petitioner mapped "proximal portion 78" of the dial mechanism as the dose knob, within which the button's proximal end resides (claim 52). Activating the dose knob by pressing the button moves the clutch distally to dispense medication (claim 53). Petitioner further argued Burroughs discloses a standard multi-dose cartridge 40 with a glass tube reservoir, piston stopper, and a cap with a rubber disc serving as the septum and ferrule, anticipating claims 54-55. The spatial arrangement of the button, dial mechanism, and dose knob in Burroughs was also alleged to satisfy claim 57.

Ground 2: Anticipation of Claims 51-53 and 56-57 by Steenfeldt-Jensen

  • Prior Art Relied Upon: Steenfeldt-Jensen (6,235,004).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner contended that Steenfeldt-Jensen's injection syringe discloses a "bushing 82" that functions as the claimed clutch. This bushing is a tubular body that fits into the "scale drum 80" (the dial member), satisfying claim 51. The "dose setting button 81" was identified as the dose knob, and the bushing's proximal end is configured to reside within this button's inner space, meeting claim 52. When a user presses injection button 88, the bushing moves distally to dispense a dose, anticipating claim 53. Petitioner also argued that the bushing includes a flange with a "rosette 93 of teeth" that extend axially from its interior, which releasably engages a corresponding rosette in the dose setting button. This structure was asserted to meet the limitations of claim 56. The overall arrangement of the bushing within the scale drum and adjacent to the dose setting button was argued to anticipate claim 57.

Ground 3: Obviousness of Claims 54-55 over Steenfeldt-Jensen in view of Burroughs

  • Prior Art Relied Upon: Steenfeldt-Jensen (Patent 6,235,004), Burroughs (Patent 6,221,046).

  • Core Argument for this Ground:

    • Prior Art Mapping: Petitioner argued that while Steenfeldt-Jensen taught a pen-type injector meeting the limitations of claims 51-52, it did not explicitly describe the detailed structure of its medicine cartridge. Burroughs, addressing the same problem of multi-dose injection, was presented as teaching the specific cartridge limitations of claims 54-55: a multi-dose cartridge comprising a reservoir, stopper, septum, and ferrule.
    • Motivation to Combine: A Person of Ordinary Skill in the Art (POSA) would combine Steenfeldt-Jensen’s injector mechanism with Burroughs’ well-disclosed cartridge because both references are analogous art from the same field. Implementing a standard, known cartridge structure as detailed in Burroughs would be an obvious, simple, and predictable solution for completing the multi-dose injector taught by Steenfeldt-Jensen. The ’486 patent’s own lack of detail regarding its cartridge components was cited as evidence that such features were well-known and conventional.
    • Expectation of Success: A POSA would have a high expectation of success in making this combination. The interface between a drive mechanism and a standard medicine cartridge was well-understood, and integrating the Burroughs cartridge into the Steenfeldt-Jensen device would involve nothing more than applying known design principles with predictable results.

  • Additional Grounds: Petitioner asserted additional challenges, including that Burroughs renders claims 54-55 obvious (Ground 2), that claim 56 is obvious over Steenfeldt-Jensen alone (Ground 4), and that Møller (2002/0052578) anticipates claims 51-53 and 56-57 (Ground 6). An additional obviousness combination of Møller and Burroughs was also presented for claims 54-55 (Ground 7).

4. Key Claim Construction Positions

  • Petitioner argued that claim terms should be given their ordinary and customary meaning but highlighted constructions for "clutch" and "tubular clutch" proffered by the Patent Owner itself in related district court litigation. These constructions were presented as admissions that cannot be argued as unreasonable:
    • "clutch": "A structure that couples and decouples a moveable component from another component."
    • "tubular clutch": "A tubular structure that couples and decouples a moveable component from another component."

5. Arguments Regarding Discretionary Denial

  • Petitioner noted that the Board had already instituted review of the same claims (51-57) of the ’486 patent in a related case, IPR2018-01679, filed by another party. Petitioner stated that it had moved for joinder with that proceeding, implicitly arguing that institution and joinder would serve judicial efficiency and avoid inconsistent outcomes, weighing against a discretionary denial of the petition.

6. Relief Requested

  • Petitioner requested the institution of an inter partes review and cancellation of claims 51-57 of the ’486 patent as unpatentable.