Prollenium US Inc v. Allergan Industrie SAS

1. Case Identification

• Case #: IPR2019-01509
• Patent #: 9,358,322
• Filed: September 3, 2019
• Petitioner(s): Prollenium US Inc.
• Patent Owner(s): Allergan Industrie, SAS
• Challenged Claims: 1-4

2. Patent Overview

• Title: Injectable Soft Tissue Filler Composition
• Brief Description: The ’322 patent relates to soft tissue filler compositions. Specifically, it discloses a sterile, stable injectable gel comprising a mixture of soluble hyaluronic acid (HA), particles of HA crosslinked with 1,4-butanediol diglycidyl ether (BDDE), and lidocaine to mitigate injection pain.

3. Grounds for Unpatentability

Ground 1: Obviousness over Lebreton/Sadozai/Monheit - Claims 1-4 are obvious over Lebreton in view of Sadozai and Monheit.

• Prior Art Relied Upon: Lebreton (Application # 2006/0194758), Sadozai (Application # 2005/0136122), and Monheit (a Feb. 2007 journal article).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Lebreton disclosed the base composition: a dermal filler of HA crosslinked with BDDE, which is sterilized in an autoclave. However, Lebreton's filler lacked an anesthetic. Sadozai taught incorporating 0.3% lidocaine into a different crosslinked HA (BDCI-crosslinked) filler to reduce injection pain and demonstrated that the resulting composition remained stable after autoclaving. Monheit taught that adding soluble HA was a well-known method to act as a "lubricant for flow characteristics," a routine optimization technique.
  • Motivation to Combine: Petitioner contended a POSITA would combine Lebreton's BDDE-crosslinked filler with lidocaine as taught by Sadozai to address the known problem of injection pain. By the patent's priority date, lidocaine had been successfully incorporated into stable, sterilized HA fillers using the three other conventional crosslinkers (DVS, BDCI, and DEO). Applying this known solution to the fourth conventional crosslinker, BDDE, was an obvious next step. A POSITA would also add soluble HA per Monheit to optimize the filler's injectability.
  • Expectation of Success: The repeated and documented success of incorporating lidocaine across a spectrum of crosslinked HA dermal fillers provided a POSITA with a reasonable expectation of success for combining it with Lebreton's BDDE-based filler.

Ground 2: Obviousness over Kinney/Zhao/Narins/Monheit - Claims 1-4 are obvious over Kinney, Zhao, and Narins in view of Monheit.

• Prior Art Relied Upon: Kinney (a Nov. 2006 journal article), Zhao (Application # 2005/0250939), Narins (an Apr. 2005 journal article), and Monheit (a Feb. 2007 journal article).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner asserted that Kinney and Narins described Restylane, a well-established BDDE-crosslinked HA filler, as effective but noted its injections were painful. Kinney also described Puragen Plus, a DEO-crosslinked HA filler containing lidocaine, as providing a less painful injection. Zhao taught that various crosslinking agents, including BDDE and DEO, were interchangeable for preparing crosslinked HA fillers. Narins provided details on the heat sterilization of Restylane. Monheit again taught the routine addition of soluble HA to improve flow.
  • Motivation to Combine: A POSITA would have been motivated to create a filler with the benefits of both products: the market-preferred BDDE crosslinker of Restylane and the pain-reducing lidocaine of Puragen Plus. Since Zhao taught that BDDE and DEO were interchangeable bis-epoxide crosslinkers, a POSITA would have found it obvious to substitute the DEO in Puragen Plus with BDDE to create the claimed composition.
  • Expectation of Success: Given the chemical similarity between the DEO and BDDE crosslinkers, a POSITA would have reasonably expected that lidocaine would function analogously in a BDDE-crosslinked gel and that the resulting product would be stable upon heat sterilization.

Ground 3: Obviousness over Reinmuller/Lebreton/Monheit - Claims 1-4 are obvious over Reinmuller and Lebreton in view of Monheit.

• Prior Art Relied Upon: Reinmuller (Patent 5,731,298), Lebreton (Application # 2006/0194758), and Monheit (a Feb. 2007 journal article).
• Core Argument for this Ground:
  • Prior Art Mapping: Reinmuller disclosed an injectable, heat-sterilized, and stable composition containing DVS-crosslinked HA and lidocaine (2% by weight) to prevent injection pain. Lebreton taught an improved HA filler using the BDDE crosslinker, which offered advantages over DVS, such as increased in vivo residence time. Monheit disclosed adding soluble HA to optimize filler properties.
  • Motivation to Combine: Petitioner argued a POSITA would have been motivated to improve upon Reinmuller's composition by substituting the older DVS crosslinker with the superior BDDE crosslinker taught by Lebreton. This was a simple substitution of one conventional, well-understood crosslinker for another to gain a known benefit.
  • Expectation of Success: Since all four conventional crosslinkers were viewed as functionally interchangeable for crosslinking HA, a POSITA would have had a reasonable expectation that replacing DVS with BDDE in a lidocaine-containing formulation would result in a stable and effective dermal filler.
• Additional Grounds: Petitioner asserted additional obviousness challenges (Grounds 2, 4, and 6) that relied on the same primary combinations but added Smith (a 2007 journal article) to explicitly teach the claimed range of about 10% to 20% soluble HA, which was present in the Juvéderm product.

4. Key Claim Construction Positions

• sterile: Petitioner proposed construing "sterile" as "substantially free of detectable, viable microorganisms," consistent with a district court construction for the parent patent.
• stable: Petitioner proposed "stable" means the composition maintains at least one of a list of specified characteristics (e.g., transparent appearance, pH, sterility, lidocaine concentration) after sterilization or storage. This construction was central to rebutting the Patent Owner's prosecution argument that adding lidocaine was expected to cause instability.
• soluble form HA: Petitioner proposed this term means "water soluble HA (i.e., uncrosslinked HA and/or lightly crosslinked HA)."

5. Key Technical Contentions (Beyond Claim Construction)

• Petitioner's central technical argument was that the patent was improvidently granted based on a false premise. During prosecution, the Patent Owner argued for patentability based on the "unexpected result" that its BDDE-crosslinked HA gel remained stable after adding lidocaine and undergoing heat sterilization. The Patent Owner claimed a POSITA would have expected degradation.
• Petitioner contended this premise was factually incorrect, as multiple prior art products and publications demonstrated that HA gels made with the three other conventional crosslinkers (DVS, BDCI, DEO) were successfully and stably combined with lidocaine and heat-sterilized well before the patent's priority date. This prior art, which contradicted the inventor's declaration, demonstrated there was no "unexpected result," removing the stated basis for allowance.

6. Arguments Regarding Discretionary Denial

• Petitioner argued against discretionary denial under 35 U.S.C. §325(d), asserting that the Examiner did not have a complete picture of the prior art. Key references demonstrating the stability of lidocaine-containing HA fillers (like Sadozai and Kinney) were not considered. The Examiner's allowance was based on an unsubstantiated inventor declaration about "unexpected results" that is directly refuted by the prior art presented in the petition. Petitioner argued that this Examiner error warrants reconsideration.

7. Relief Requested

• Petitioner requests institution of an inter partes review and cancellation of claims 1-4 of Patent 9,358,322 as unpatentable.