PTAB

IPR2018-01682

Mylan Pharmaceuticals Inc v. Sanofi Aventis Deutschland GmbH

Log In
Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Pen-Type Injector
  • Brief Description: The ’844 patent relates to a pen-type injector for the self-administration of medicine, such as insulin and insulin analogs. The device comprises multiple interacting threaded components, including a housing, a dose indicator, a driving member, and a piston rod, to allow a user to set and dispense a precise dose.

3. Grounds for Unpatentability

Ground 1: Obviousness over Steenfeldt-Jensen - 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 disclosed a syringe with all structural limitations of independent claim 21 except for one detail in its drive mechanism. Specifically, Steenfeldt-Jensen’s piston rod drive uses a fixed, threaded component ("member 40") to engage the piston rod, while a non-threaded component ("driver tube 85") rotates the piston rod to dispense a dose. The challenged claim requires the opposite configuration: a rotating, threaded "driving member" and a non-threaded, fixed "piston rod holder." Petitioner further mapped elements of Steenfeldt-Jensen to the dependent claims, arguing its "bushing 82" functions as the claimed "clutch" (claim 23) and that its radial protrusion interacting with recesses provides the "audible and tactile feedback" required for the "clicker" (claims 24-25 and 29).
    • Motivation to Combine (Modify): Petitioner contended that Steenfeldt-Jensen itself taught that its disclosed "fixed-nut" drive mechanism was interchangeable with a "rotating-nut" drive mechanism, which is the configuration recited in the ’844 patent claims. A person of ordinary skill in the art (POSITA) would have been motivated to implement this known, alternative design by swapping the functions of Steenfeldt-Jensen's "member 40" and "driver tube 85"—making the driver tube threaded and member 40 a non-threaded guide—to achieve the same result in a predictable way.
    • Expectation of Success: A POSITA would have had a reasonable expectation of success in making this modification. Petitioner asserted that rotating-nut drive mechanisms were well-known and that the reference’s own suggestion of interchangeability confirmed that this was a routine design choice involving familiar elements operating in a predictable manner.

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

  • Prior Art Relied Upon: Steenfeldt-Jensen (Patent 6,235,004) and Klitgaard (Patent 6,582,404).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that claim 30 adds the limitation of "a nut that tracks each set dose of medicament delivered" to the base device of claim 21. It was asserted that while Steenfeldt-Jensen (as modified in Ground 1) provided the underlying injector device, Klitgaard taught a dose-limiting mechanism for a similar injection device that used a "nut member 32" to track the total administered dose. This tracking function prevents a user from setting a dose larger than the supply of medication remaining in the cartridge.
    • Motivation to Combine: A POSITA would combine these references to incorporate the known safety and convenience feature from Klitgaard into the Steenfeldt-Jensen device. Klitgaard expressly stated the benefit of making it "impossible to set a dose that exceeds the amount of medicament which is left in the cartridge," a feature that would have been desirable in any pen-type injector to prevent incorrect dosing.
    • Expectation of Success: A POSITA would have had a reasonable expectation of success in incorporating the Klitgaard tracking nut into the Steenfeldt-Jensen device. Petitioner argued this would be a straightforward addition of a known mechanical component to improve device functionality and safety, for instance by adapting and disposing the nut between the bushing and scale drum.

4. Key Claim Construction Positions

  • Petitioner argued for constructions based on the ordinary meaning of the terms and, where applicable, on positions the Patent Owner had taken in related district court litigation.
  • For several terms potentially subject to means-plus-function interpretation under 35 U.S.C. § 112, Petitioner proffered specific constructions:
    • "clutch": The function is "coupling and decoupling a movable component from another component" during dose setting. The corresponding structure in the ’844 patent is identified as component 60 and its associated features.
    • "holder": The function is "prevent[ing] the piston rod from rotating during dose setting and permit[ting] the piston rod to traverse axially...during dose dispensing." The corresponding structure is identified as component 16.
    • "driving member": Petitioner adopted the Patent Owner's proposed construction from related litigation: "A component releasably connected to the dose dial sleeve that drives the piston during dose dispensing."

5. Key Technical Contentions (Beyond Claim Construction)

  • Priority Date Entitlement: A central contention was that challenged claims 21-30 are not entitled to a priority date earlier than their filing date of May 17, 2016. Petitioner argued that the priority documents uniformly disclose and describe a piston rod with only external threads that engage internal threads of other components. The challenged claims, however, recite a piston rod comprising "either an internal or an external fourth thread," with the internally-threaded piston rod embodiment allegedly first appearing in the May 2016 application. This asserted lack of written description support in the priority documents was critical to Petitioner's argument that references like Steenfeldt-Jensen (2001) qualify as prior art under pre-AIA 35 U.S.C. §102.

6. Relief Requested

  • Petitioner requests institution of an inter partes review and cancellation of claims 21-30 of the ’844 patent as unpatentable under 35 U.S.C. §103.