PTAB

IPR2019-01658

Mylan Pharmaceuticals Inc v. Sanofi Aventis Deutschland GmbH

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Drug-Delivery Device
  • Brief Description: The ’614 patent discloses a drug-delivery device, such as an injection pen, designed to securely hold a drug cartridge. The invention centers on using a spring washer, arranged within the device housing, that exerts an axial biasing force on the cartridge to press it against a cartridge-retaining member, thereby preventing unwanted movement. A key feature is that the spring washer includes at least two fixing elements configured to axially and rotationally fix the washer relative to the housing.

3. Grounds for Unpatentability

Ground 1: Claims 1-18 are obvious over Bitdinger, Schofield, and De Gennes.

  • Prior Art Relied Upon: Bitdinger (Patent 6,648,859), Schofield (GB Patent 743,839), and De Gennes (Patent 4,144,957).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that the prior art combination discloses all limitations of the challenged claims. Bitdinger was asserted to teach the foundational structure of a drug-delivery pen, including a housing, a drug cartridge, and a cartridge-retaining member (comprising an upper and lower vial retainer) that is releasably secured to the housing. However, Bitdinger uses a rigid, integrated annular stop to secure the cartridge, not a separate spring washer. Schofield was asserted to remedy this deficiency by teaching a medicinal injection device that incorporates a resilient cushion, explicitly disclosing that this cushion can be a "spring loaded metallic washer," to secure the cartridge and advantageously accommodate varying cartridge lengths. Finally, De Gennes was asserted to teach the specific "fixing elements" limitation by disclosing a spring washer for a clutch bearing that includes at least two axially-extending legs that snap-fit onto another component, thereby providing the claimed axial and rotational fixation of the washer.
    • Motivation to Combine (for 35 U.S.C. §103 grounds): Petitioner contended a person of ordinary skill in the art (POSA) would combine these references to arrive at the claimed invention. A POSA would modify Bitdinger’s device by replacing its rigid annular stop with the resilient spring washer taught by Schofield to gain the known benefit of accommodating manufacturing tolerances in cartridge length, a common problem in the field. To ensure this substituted spring washer could effectively exert its biasing force, the POSA would need to fix it relative to the housing. The POSA would then turn to a reference like De Gennes, which provides a well-understood, common, and effective method for axially and rotationally fixing a spring washer using snap-fit fixing elements. This combination was argued to be a predictable design choice, using known components for their intended and understood purposes.
    • Expectation of Success (for §103 grounds): Petitioner asserted that a POSA would have had a high expectation of success because the combination involved applying known solutions (a resilient washer for tolerance compensation, snap-fit legs for fixation) to solve predictable problems in a known device architecture. The function of each element was well-understood, and their integration into Bitdinger's pen would have been a routine task for one skilled in the art.

4. Key Claim Construction Positions

  • Petitioner argued that two terms may warrant means-plus-function construction.
    • "cartridge retaining member": For this term, Petitioner identified the corresponding structure in the ’614 patent’s specification as "cartridge-retaining member 45," which is shown with an inner cavity for receiving the cartridge and a proximal end for securing to the housing.
    • "fixing elements": For this term, Petitioner identified the corresponding structure as "fixing elements 52," which are described in the specification as "hook-shaped" axial extensions that snap-fit onto another component, or alternatively as protrusions from the washer's outer circumference.

5. Relief Requested

  • Petitioner requests the institution of an inter partes review and the cancellation of claims 1-18 of Patent RE47,614 as unpatentable.