PTAB

IPR2019-00987

Pfizer Inc v. Sanofi Aventis Deutschland

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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 describes a drive mechanism for a pen-type injector used for self-administration of medicines such as insulin. The invention centers on a six-component mechanical assembly comprising a housing, a dose dial sleeve, an insert, a drive sleeve, a dual-threaded piston rod, and a clutch that couples the dose dial sleeve and the drive sleeve.

3. Grounds for Unpatentability

Ground 1: Claims 1, 3, 7-8, 11, and 17 are obvious over Møller in combination with Steenfeldt-Jensen.

  • Prior Art Relied Upon: Møller (Application # 2002/0052578) 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 disclosed all limitations of the challenged claims. The primary reference, Steenfeldt-Jensen, was asserted to teach the core dose-dispensing mechanism, including a housing, an insert (identified as "wall 4"), and a piston rod with two distinct threads—one engaging the insert and the other engaging a drive sleeve (identified as "injection button 23"). Petitioner highlighted that during the original prosecution of the ’008 patent, the Examiner found that Steenfeldt-Jensen taught nearly all limitations of independent claim 1. The claim was allowed only after being amended to add a specific clutch arrangement: a clutch located "(i) radially outward of the drive sleeve and (ii) radially inward of the dose dial sleeve." Petitioner contended that Møller supplied this missing element. Møller described a pen injector with a dose-setting mechanism that included a "cup shaped element" (the clutch) arranged concentrically between a drive sleeve and a dose dial sleeve, precisely matching the limitation added to secure allowance of the claims. The combination of Møller’s clutch and dose-setting interface with Steenfeldt-Jensen’s dual-threaded piston drive mechanism was argued to render the claims obvious.
    • Motivation to Combine: A Person of Ordinary Skill in the Art (POSA) would combine Møller's user-friendly dose-setting mechanism with Steenfeldt-Jensen's simpler, more robust, and mechanically advantageous dose-dispensing mechanism. Steenfeldt-Jensen’s design, which used a dual-threaded piston rod, provided a mechanical advantage with fewer and more stress-tolerant components than Møller's complex rack-and-pinion system. Petitioner argued that simplifying the internal mechanism was a well-known objective in the industry to reduce component count, increase durability, and ease assembly. The fundamental operational principles of the drive sleeves in both references were similar (rotating up a threaded piston rod during dose-setting and moving axially downward during injection), making their combination logical and predictable.
    • Expectation of Success: A POSA would have had a reasonable expectation of success in making this combination. Both references operate in the same technical field of pen-type injectors and share similar structural components and functional goals. The proposed modification involved combining Møller’s dose-setting front-end with Steenfeldt-Jensen’s dispensing back-end, which Petitioner characterized as a routine integration of familiar elements for their known, predictable functions.

4. Key Claim Construction Positions

  • Petitioner stated that for the purposes of the petition, claim terms should be given their ordinary and customary meaning but also addressed constructions from related litigation to ensure its invalidity arguments applied under any reasonable interpretation. Two terms were highlighted as potentially requiring more detailed construction.
  • clutch: Petitioner addressed the Patent Owner's construction from litigation ("A structure that couples and decouples a moveable component from another component") as well as a potential means-plus-function interpretation. Under a means-plus-function analysis, the function is coupling and decoupling components during dose setting, and the corresponding structure in the ’008 patent is identified as component 60 and its associated teeth and flanges.
  • insert: Similarly, Petitioner acknowledged the Patent Owner's simple construction ("a structure as defined in each of the claims") while also providing a means-plus-function analysis. Under this alternative, the function is to prevent the piston rod from rotating during dose setting while permitting its axial traversal during dose dispensing. The corresponding structure in the ’008 patent is component 16, a holder or flange with a threaded circular opening.

5. Relief Requested

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