PTAB

IPR2019-00982

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 discloses a drive mechanism for a pen-type injector used for self-administering drugs like insulin. The claimed mechanism comprises a six-component structure including a main housing, a dose dial sleeve, a dose knob, a non-rotatable piston rod, a driver, and a tubular clutch that interact to set and dispense a dose of medication.

3. Grounds for Unpatentability

Ground 1: Claims 1-6, 12-18, 20, 23, 26-30, 32, 33, 36, and 38-40 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 recyclable medication dispensing pen, teaches every limitation of the challenged claims. Independent claim 1 recites a six-component structure, which Petitioner mapped to analogous components in Burroughs: the claimed "main housing" corresponds to Burroughs' housing 22; the "dose dial sleeve" to dial mechanism 34; the "dose knob" to proximal portion 78 of the dial mechanism; the non-rotatable "piston rod" to leadscrew 38; the "driver" to nut 36; and the "tubular clutch" to button 32. The only significant alleged difference is that the ’486 patent claims a dose dial sleeve with a helical groove on its outer surface to engage threading on the main housing, whereas Burroughs discloses a dial mechanism with a helical rib (threads 110, 112) that engages a groove in the housing. Petitioner contended this distinction does not render the claims non-obvious. For the dependent claims, Petitioner provided element-by-element mapping, arguing that features like a dose window (claim 3), a clicker mechanism (claims 14-18, 20), and a radial stop (claims 30, 32) are all disclosed by corresponding structures in Burroughs.
    • Motivation to Combine (for §103 grounds): As this is a single-reference obviousness ground, the argument focused on the motivation to modify Burroughs. Petitioner asserted that a person of ordinary skill in the art (POSA) would have viewed implementing the threaded engagement between the dose dial sleeve and the housing with a groove on the sleeve and a rib on the housing as a simple and interchangeable alternative to Burroughs' rib-on-sleeve, groove-on-housing design. A POSA would have recognized that these are functionally equivalent and well-known options for achieving the same relative rotation and axial displacement.
    • Expectation of Success (for §103 grounds): Petitioner argued a POSA would have had a high expectation of success in making this modification. The use of grooved threading is a common, predictable mechanical principle, and swapping the placement of the rib and groove would not change the fundamental operation of the injector mechanism.

4. Key Claim Construction Positions

  • Petitioner argued that claim terms should be given their ordinary and customary meaning but also addressed constructions proposed by the Patent Owner in related litigation for key terms, which Petitioner asserted were reasonable.
  • "driver": "A component releasably connected to the dose dial sleeve that drives the piston during dose dispensing."
  • "tubular clutch": "A tubular structure that couples and decouples a moveable component from another component."
  • Means-Plus-Function: To the extent the Board might construe terms like "clutch," "clicker," and "insert" under means-plus-function, Petitioner provided proposed constructions. For "clutch," the asserted function is coupling and decoupling components during dose setting, with the corresponding structure being component 60 in the ’486 patent's figures. For "clicker," the function is providing audible clicks during dose setting, with the structure being component 50.

5. Relief Requested

  • Petitioner requests institution of an inter partes review and cancellation of claims 1-6, 12-18, 20, 23, 26-30, 32, 33, 36, and 38-40 of the ’486 patent as unpatentable.