PTAB

IPR2017-01906

Teoxane SA v. Allergan PLC

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Hyaluronic Acid-Based Gels Including Lidocaine
  • Brief Description: The ’795 patent discloses soft tissue filler compositions containing lidocaine and hyaluronic acid (HA) crosslinked with an agent such as 1,4-butanediol diglycidyl ether (BDDE). The patent alleges these compositions have enhanced stability compared to conventional HA-based compositions when subjected to sterilization or long-term storage.

3. Grounds for Unpatentability

Ground 1: Anticipation of Claims 26-38 by Elevess Summary

  • Prior Art Relied Upon: Elevess Summary (a Summary of Safety and Effectiveness from the FDA, issued 12/20/2006).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that the Elevess Summary, which describes the FDA-approved dermal filler Elevess®, discloses every limitation of independent claim 26. Specifically, it teaches a composition with crosslinked HA at a concentration of 21-29 mg/mL, 0.3% lidocaine, and a pH of 6.2-7.6, which reads on the claimed ranges. Petitioner contended that the limitation "stable to autoclaving" in dependent claim 28 is an inherent property of the Elevess® composition, as a POSITA would understand that a sterile, stable commercial product would necessarily be stable to a common sterilization method like autoclaving.
    • Key Aspects: The argument relied on the premise that properties of an approved commercial product, as described in public FDA documents, anticipate claims that describe the same composition, even if certain properties like "stable to autoclaving" are not explicitly stated but are inherent.

Ground 2: Anticipation or Obviousness of Claims 1, 3-6, 8, and 40 over Wang

  • Prior Art Relied Upon: Wang (WO 2005/112888).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner asserted that Wang teaches processes for preparing injectable HA gels containing HA crosslinked with BDDE (HA-BDDE), which can be sterilized by autoclaving and can include an anesthetic like lidocaine. Wang’s disclosure of a sterile, HA-BDDE gel buffered at pH 7.4 that can include lidocaine was argued to anticipate every element of independent claim 1. Wang’s gels are washed to remove uncrosslinked HA, inherently meeting the limitations of claims 4 and 5.
    • Motivation to Combine (for §103 grounds): In the alternative, Petitioner argued that Wang explicitly suggests including anesthetics like lidocaine in its HA-BDDE gels for therapeutic delivery, providing a clear reason to modify its base composition to arrive at the claimed invention.
    • Expectation of Success (for §103 grounds): As Wang already taught stable, autoclavable HA-BDDE gels and separately suggested adding lidocaine, a POSITA would have a high expectation of success in creating a stable final product.

Ground 3: Obviousness of Claims 1-11, 22, 40, and 41 over Lupo in view of Toth or Kinney

  • Prior Art Relied Upon: Lupo (a 2007 abstract on Juvederm® fillers), Toth (a 2007 abstract on HA fillers), and Kinney (a 2006 journal article). Evidenced by Allemann (a 2008 clinical article), Gold (a journal article), and Monheit (a journal article).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner contended that Lupo describes the Juvederm® family of products (J30, J24HV, J30HV), which are sterile, cohesive, soft tissue fillers containing HA crosslinked with BDDE, suspended in a physiological buffer, and not crosslinked to a non-HA biopolymer. The only element missing from Lupo to meet the limitations of the challenged claims was the inclusion of lidocaine. Toth and Kinney both explicitly taught that a major drawback of HA fillers was injection pain and that adding lidocaine was a desirable and known solution to create a stable, more tolerable product.
    • Motivation to Combine (for §103 grounds): A POSITA would combine the Juvederm® fillers of Lupo with lidocaine as taught by Toth and Kinney for the well-understood purpose of reducing patient pain during injection, a known problem with a known solution. Patient preference for lidocaine-containing fillers, as noted in Kinney, provided a strong market-based motivation.
    • Expectation of Success (for §103 grounds): A POSITA would have a high expectation of success, as it was merely the combination of a known, stable HA filler (Juvederm®) with a known, stable anesthetic (lidocaine) using conventional methods to achieve the predictable result of a pain-reduced, stable filler.
  • Additional Grounds: Petitioner asserted additional challenges, including that claims 1-3, 6, 8, and 40-41 are anticipated by Hunter (Application # 2006/0040894); claims 29-31, 33, 37, and 38 are anticipated or obvious over Kinney; and claims 1-3, 6-8, 11, 22, and 40-41 are anticipated by Levy (a 2008 poster abstract).

4. Key Claim Construction Positions

  • "sterile": Petitioner proposed the construction "a composition that is free of viable microorganisms as determined by a sterility test recognized by a regulatory authority, the composition can be sterilized by any method known in the art." This broad construction supports the argument that prior art teaching a composition's components anticipates a claim requiring sterility, as sterilization is a known, required step for such products.
  • "stable to autoclaving" / "autoclave stable": Petitioner proposed this means the composition maintains "one or more" of its key aspects (e.g., appearance, pH, HA concentration, sterility, lidocaine concentration) after autoclaving. This construction is critical because it does not require all properties to be maintained, making it easier for a prior art reference to be considered anticipatory even if some degradation occurs, a known effect of autoclaving.

5. Key Technical Contentions (Beyond Claim Construction)

  • Refutation of Unexpected Results: A central contention was that the patent's allowance was based on overcoming a "fictitious problem." The Patent Owner argued during prosecution that a POSITA would have expected lidocaine to degrade HA compositions during sterilization. Petitioner countered that numerous prior art references (e.g., Sadozai, Wang) taught that lidocaine was stable with crosslinked HA, could be autoclaved, and in some cases even had a stabilizing effect by acting as a radical scavenger. Petitioner argued the patent offered no evidence for its claim of unexpected stability, and the discovery was merely predictable.

6. Relief Requested

  • Petitioner requested institution of an inter partes review and cancellation of claims 1-11, 22, 26-38, and 40-41 of the ’795 patent as unpatentable.