PTAB

IPR2017-02002

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 ’475 patent is directed to a soft tissue filler containing hyaluronic acid (HA) crosslinked with 1,4-butanediol diglycidyl ether (BDDE), uncrosslinked HA, and lidocaine. The patent asserts that this composition has enhanced stability when subjected to sterilization or long-term storage compared to conventional HA-based compositions containing lidocaine.

3. Grounds for Unpatentability

Ground 1: Anticipation over Hunter - Claims 1-7 and 9 are anticipated by Hunter under 35 U.S.C. §102(b).

  • Prior Art Relied Upon: Hunter (Application # 2006/0040894), evidenced by Beasley (a 2009 journal article).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Hunter discloses all limitations of claim 1. Hunter teaches a stable, sterile dermal filler (Restylane®) that can include an anesthetic such as lidocaine. Petitioner asserted that evidence from Beasley, a separate technical article, demonstrates that the Restylane® product disclosed in Hunter inherently contains the remaining claimed features: HA crosslinked with BDDE, approximately 25% uncrosslinked HA (meeting the ">10%" limitation), and a degree of crosslinking less than 2%. This single reference, as evidenced by Beasley, allegedly discloses every element of the challenged claims.

Ground 2: Obviousness over Lupo and Toth/Kinney - Claims 1-9 and 27-30 are obvious over Lupo in view of Toth or Kinney under 35 U.S.C. §103(a).

  • Prior Art Relied Upon: Lupo (a 2007 poster abstract), Toth (a 2007 poster abstract) or Kinney (a 2006 journal article), with supporting evidence from other references.
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner asserted that Lupo discloses commercially available Juvederm® products, which are stable, sterile dermal fillers containing BDDE-crosslinked HA and about 10% uncrosslinked HA. According to Petitioner, Lupo’s disclosure meets all limitations of independent claim 1 except for the inclusion of lidocaine.
    • Motivation to Combine: Petitioner argued that Toth and Kinney explicitly teach the desirability of adding lidocaine (e.g., 0.3%) to crosslinked HA fillers to reduce injection pain, a well-known problem. A POSITA would combine the well-known Juvederm® fillers described in Lupo with the well-known pain-reducing agent lidocaine as taught by Toth and Kinney to improve patient comfort and product acceptability.
    • Expectation of Success: A POSITA would have a reasonable expectation of success in creating a stable formulation. The stability of both HA fillers and lidocaine was well-established, and prior art showed that other HA fillers (using different crosslinkers) had already been successfully and stably combined with lidocaine. The combination was a simple application of known components to achieve predictable results.

Ground 3: Obviousness over Debacker and Sadozai - Claims 1-4, 8, 9, and 34-36 are obvious over Debacker in view of Sadozai under §103(a).

  • Prior Art Relied Upon: Debacker (WO 96/33751) and Sadozai (Application # 2005/0136122).

  • Core Argument for this Ground:

    • Prior Art Mapping: Debacker was argued to teach a two-phase, stable, sterile dermal filler containing BDDE-crosslinked HA and a high percentage (33%) of uncrosslinked HA, which can be sterilized in an autoclave. This composition meets the HA-related limitations of the claims but does not disclose lidocaine.
    • Motivation to Combine: Sadozai was cited for its teaching that adding lidocaine to a crosslinked HA composition can provide a synergistic stabilizing effect during and after autoclaving, in addition to reducing pain. Petitioner contended a POSITA would be motivated to modify Debacker’s autoclaved HA filler by adding lidocaine as taught by Sadozai to gain both the anesthetic and the potential stabilizing benefits.
    • Expectation of Success: A POSITA would reasonably expect success because Debacker already teaches a stable, autoclavable HA filler. Adding lidocaine, which Sadozai teaches improves stability upon autoclaving, would predictably result in a stable final product.

  • Additional Grounds: Petitioner asserted additional anticipation and obviousness challenges, including anticipation of claims 1, 4, 5, 8, 9, and 27-29 over Levy. Further obviousness grounds were asserted using Reinmuller I/II to teach heat sterilization and specific crosslinking degrees, and a combination including Expert Anti-Aging and Lebreton to challenge claims directed to mixtures of high and low molecular weight HA.

4. Key Claim Construction Positions

  • "Stable, sterile soft tissue filler": Petitioner proposed this term be construed to mean a filler that is free of viable microorganisms, can be sterilized, and is resistant to degradation such that it maintains key characteristics (e.g., appearance, pH, rheology, HA and lidocaine concentration) after autoclaving and subsequent storage at about 25° C for at least two months. This construction was central to Petitioner's argument that the prior art compositions met the stability requirements of the claims.

5. Key Technical Contentions (Beyond Claim Construction)

  • No Unexpected Superior Results: A central contention of the petition was that the patent was granted based on the patentee’s allegedly erroneous argument during prosecution that adding lidocaine was expected to destabilize the HA filler. Petitioner argued that the prior art, including references like Sadozai, taught the opposite: that lidocaine was known to be a stabilizing agent for HA, particularly during heat sterilization. Petitioner asserted that the premise for patentability was a fictitious problem and that the stability of the claimed composition was not unexpected but was instead a predictable outcome based on the state of the art.

6. Relief Requested

  • Petitioner requests institution of an inter partes review and cancellation of claims 1-9 and 18-37 of the ’475 patent as unpatentable.