PTAB

IPR2018-01670

Mylan Pharmaceuticals Inc v. Sanofi Aventis DeutshLand GmbH

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Pen-Type Injector
  • Brief Description: The ’069 patent relates to a pen-type injector for the self-administration of medicine, such as insulin. The technology specifically concerns a housing part containing a drive mechanism with six primary components designed for setting and dispensing a dose.

3. Grounds for Unpatentability

Ground 1: Claim 1 is obvious over Burroughs

  • Prior Art Relied Upon: Burroughs (Patent 6,221,046).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Burroughs, a prior art medication dispensing pen, disclosed a device with the same six-component structure recited in claim 1. Specifically, Burroughs taught a main housing, dose dial sleeve (dial mechanism 34), dose dial grip (proximal portion 78), a non-rotatable piston rod (leadscrew 38), a drive sleeve (nut 36), and a tubular clutch (button 32). The only material difference alleged was that the claimed "dose dial sleeve" requires a helical groove on its outer surface to engage threading on the housing, whereas Burroughs disclosed the inverse: a helical rib (threads 110, 112) on its dial mechanism that engages a helical groove in the housing.
    • Motivation to Combine: Petitioner contended that modifying Burroughs to reverse the placement of the rib and groove was merely an obvious design choice. The use of a rib-to-groove threaded connection to provide relative rotational movement between components was a common and well-known mechanism. A person of ordinary skill in the art (POSA) would have recognized that the placement of the rib on one component and the groove on the other was largely interchangeable.
    • Expectation of Success: A POSA would have reasonably expected that reversing the rib and groove would not change the fundamental rotational operability between the dial mechanism and the housing. The modified components would perform their same, predictable functions, and the releasable connection would remain substantially the same.

Ground 2: Claim 1 is obvious over Steenfeldt-Jensen

  • Prior Art Relied Upon: Steenfeldt-Jensen (Patent 6,235,004).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner asserted that Steenfeldt-Jensen disclosed a single injection syringe comprising all components and structural limitations of claim 1, with one potential exception. Steenfeldt-Jensen’s drive sleeve (driver tube 85) rotationally engaged its piston rod (piston rod 6) via a non-circular bore, rather than through the claimed "internal threading near a distal portion" that engages an external thread on the piston rod.
    • Motivation to Combine: Petitioner argued that Steenfeldt-Jensen itself expressly contemplated the necessary modification. The reference suggested that alternative embodiments could provide a "nut element" (a component with internal threading) on the driver tube and a corresponding "piston rod guide" (a non-circular cross-section) on the housing member. A POSA would have understood this to be a direct suggestion to swap the functions of the existing components, leading to a driver tube with internal threading as claimed.
    • Expectation of Success: Because Steenfeldt-Jensen explicitly suggested the modification, a POSA would have had a high expectation of success. It was argued that the modified device would operate in the same predictable manner, where rotation of the driver tube would cause axial displacement of the piston rod via the new threaded engagement.

Ground 3: Claim 1 is obvious over the combination of Møller and 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 Møller disclosed an injection device with the same six components of claim 1, but its "dose dial sleeve" (dose setting drum 17) used an internal thread to engage the housing. The claim required a helical groove on the outer surface of the dose dial sleeve. Petitioner asserted that Steenfeldt-Jensen remedied this deficiency by teaching the use of a dose dial sleeve (scale drum 80) with a helical groove on its outer surface for engagement with a housing.
    • Motivation to Combine: A POSA would combine these references to solve a known problem. Møller, in its background, explicitly discussed Steenfeldt-Jensen's design and noted the disadvantage of force being lost to friction between the sliding surfaces of the drum and housing. Steenfeldt-Jensen taught that its high-pitch helical groove configuration reduced friction. Therefore, a POSA would have been motivated to incorporate the beneficial high-pitch, external groove from Steenfeldt-Jensen onto the dose setting drum of Møller’s device to reduce the force required to rotate the drum during injection.
    • Expectation of Success: A POSA would have reasonably expected that substituting Møller’s internal thread with Steenfeldt-Jensen’s external groove would successfully reduce friction while retaining the necessary rotational movement between the drum and housing. The combination involved applying a known technique (Steenfeldt-Jensen's groove) to a similar device (Møller's injector) to obtain a predictable result (reduced friction).

4. Key Claim Construction Positions

  • tubular clutch: Petitioner noted that in related litigation, it proffered a preliminary means-plus-function construction for this term. The asserted function was "coupling and decoupling a movable component from another component" or "reversibly lock[ing] two components in rotation" during dose setting. The corresponding structure identified in the ’069 patent was component 60 and its associated features as shown in Figures 1 and 5-11.
  • Other Terms: Petitioner acknowledged several constructions proffered by the Patent Owner in related litigation for terms including "drive sleeve," "main housing," "piston rod," and "thread/threaded/threading," stating that they should be given their ordinary and customary meaning consistent with those proffered constructions.

5. Relief Requested

  • Petitioner requested institution of an inter partes review and cancellation of claim 1 of Patent 8,679,069 as unpatentable under 35 U.S.C. §103.