DCT

1:20-cv-00104

Allergan USA Inc v. Prollenium US Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:20-cv-00104, D. Del., 01/23/2020
  • Venue Allegations: Plaintiff alleges venue is proper in the District of Delaware because Defendant Prollenium US Inc. is a Delaware corporation and because Defendants place the accused products into the stream of commerce for sale within the district.
  • Core Dispute: Plaintiff alleges that Defendant’s Revanesse® Versa+TM dermal filler infringes two patents related to stable formulations of hyaluronic acid-based gels that include the anesthetic lidocaine.
  • Technical Context: The technology involves injectable dermal fillers used for cosmetic purposes, where hyaluronic acid provides volume and lidocaine is added to reduce pain during the injection procedure.
  • Key Procedural History: The complaint alleges that Defendant was aware of Plaintiff's related patented products since at least August 2016 and aware of related patents asserted in a prior lawsuit filed on January 22, 2019, which may be used to support allegations of willful infringement. The complaint also references a patent marking webpage as a form of public notice.

Case Timeline

Date Event
2008-08-04 Earliest Priority Date for '202 and '896 Patents
2018-12-17 Accused Product (Revanesse® Versa+TM) Launch Date
2019-01-22 Prior litigation filed by Allergan against Prollenium
2019-08-27 '202 Patent Issue Date
2019-11-26 '896 Patent Issue Date
2020-01-23 Complaint Filing Date

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 10,391,202 - "Hyaluronic Acid-Based Gels Including Lidocaine," Issued August 27, 2019

The Invention Explained

  • Problem Addressed: The patent describes that prior attempts to incorporate anesthetic agents like lidocaine into hyaluronic acid (HA) dermal fillers were unsuccessful because the anesthetic was prone to degradation, particularly during the high-temperature sterilization process required for medical products (Compl. ¶21; ’202 Patent, col. 2:27-39).
  • The Patented Solution: The invention provides a method to create a stable, injectable HA gel containing lidocaine. The described solution involves adjusting the pH of the HA component to be alkaline (above 7.2) before adding the lidocaine solution. This pre-adjustment of pH is described as enabling the final composition to withstand heat sterilization without significant degradation of the lidocaine (’202 Patent, col. 3:40-54, col. 10:24-34).
  • Technical Importance: This innovation allowed for the production of commercially viable dermal fillers that provide the desired cosmetic effect while significantly improving patient comfort by reducing pain upon injection (Compl. ¶21).

Key Claims at a Glance

  • The complaint asserts at least claim 9, which depends on independent claim 1 (Compl. ¶¶ 27-28).
  • The essential elements of independent claim 1 include:
    • A stable, sterile soft tissue filler comprising an HA component (crosslinked with BDDE and uncrosslinked HA with >10% uncrosslinked HA by volume) and lidocaine (at about 0.3% by weight).
    • The filler is made by a process that includes (1) providing the HA component, (2) adjusting its pH to above 7.2, (3) adding a lidocaine solution, and (4) heat sterilizing the final filler.
  • The complaint reserves the right to assert other claims (’202 Patent, Claim 1; Compl. ¶33).

U.S. Patent No. 10,485,896 - "Hyaluronic Acid-Based Gels Including Lidocaine," Issued November 26, 2019

The Invention Explained

  • Problem Addressed: As with the ’202 Patent, the ’896 Patent addresses the technical challenge of lidocaine degrading when combined with HA compositions during manufacturing, particularly during heat sterilization (’896 Patent, col. 2:33-41; Compl. ¶21).
  • The Patented Solution: The patent discloses cohesive HA/lidocaine compositions and methods of making them that result in a sterile, stable final product where the lidocaine is "freely released in vivo." The specification describes a process of preparing a cohesive HA gel, adjusting its pH to be alkaline, and then adding lidocaine, which preserves the anesthetic's integrity through autoclaving (’896 Patent, Abstract; col. 10:24-40).
  • Technical Importance: The technology enabled the creation of a new class of dermal fillers that combined the volumizing properties of HA with the pain-reducing benefits of an anesthetic, improving the overall patient experience in a widely used cosmetic treatment (Compl. ¶21).

Key Claims at a Glance

  • The complaint asserts independent claims 1, 16, and 25, as well as dependent claim 24 (Compl. ¶¶ 27, 29-32).
  • The essential elements of independent claim 1 include:
    • A dermal filler comprising HA crosslinked with BDDE and lidocaine.
    • The lidocaine is "freely released in vivo."
    • The filler is sterile.
    • The filler is made by a process of crosslinking the HA, adding lidocaine, and heat sterilizing the mixture.
  • The essential elements of independent claim 16 include:
    • A dermal filler composition with HA crosslinked with BDDE (but not to a non-HA biopolymer) and lidocaine.
    • The filler is made by a process of crosslinking the HA, adding lidocaine, and heat sterilizing.
  • The essential elements of independent claim 25 include:
    • A dermal filler product comprising a sterile dermal filler composition (with HA crosslinked with BDDE and 0.1-5.0% lidocaine) contained within a syringe.
    • The product is made by a process of crosslinking HA, adding lidocaine, packaging the mixture in a syringe, and autoclaving the syringe.
  • The complaint reserves the right to assert other claims (’896 Patent, Claims 1, 16, 25; Compl. ¶33).

III. The Accused Instrumentality

Product Identification

  • Revanesse® Versa+TM dermal filler (Compl. ¶25).

Functionality and Market Context

  • The accused product is an injectable hyaluronic acid gel that contains lidocaine and is used for the correction of moderate to severe facial wrinkles and folds (Compl. ¶25).
  • No probative visual evidence provided in complaint.
  • The complaint does not provide specific details on the market position of the accused product, but it establishes Plaintiff's competing JUVÉDERM® products as a line with over $500 million in annual U.S. sales, framing the dispute as one between direct competitors in a significant market (Compl. ¶23).

IV. Analysis of Infringement Allegations

’202 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A stable, sterile soft tissue filler comprising: a hyaluronic acid (HA) component comprising HA cross-linked with 1,4-butanediol diglycidyl ether (BDDE), and uncrosslinked HA... The Accused Products are alleged to be a stable, sterile soft tissue filler containing an HA component crosslinked with BDDE and uncrosslinked HA. ¶28 col. 17:1-6
lidocaine at a concentration of about 0.3% by weight of the soft tissue filler... The Accused Products are alleged to contain lidocaine at a concentration of about 0.3% by weight. ¶28 col. 17:7-10
wherein the soft tissue filler is stable after heat sterilization at between about 120 degrees C. and about 130 degrees C.; and wherein the soft tissue filler has a pH of about 7... The Accused Products are alleged to be stable after heat sterilization within the claimed temperature range and to have a pH of about 7. ¶28 col. 18:47-50
wherein the stable, sterile soft tissue filler is made by a process comprising: providing the HA component... adding a solution containing lidocaine... and heat sterilizing the soft tissue filler... The Accused Products are alleged to be made by a process that includes providing the HA component, adding lidocaine, and heat sterilizing the final product. ¶28 col. 17:10-19

’896 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A dermal filler comprising: hyaluronic acid (HA) crosslinked with 1,4 butanediol diglycidyl ether (BDDE), and lidocaine; The Accused Products are alleged to be a dermal filler composition containing HA crosslinked with BDDE and lidocaine. ¶29 col. 19:40-43
wherein the lidocaine is freely released in vivo; The Accused Products are alleged to have lidocaine that is freely released in vivo. ¶29 col. 19:44
wherein the dermal filler is sterile; and The Accused Products are alleged to be sterile. ¶29 col. 19:45
wherein the dermal filler is made by a process comprising: crosslinking HA with BDDE... adding lidocaine to the crosslinked HA composition, and heat sterilizing the crosslinked HA composition with the added lidocaine... The Accused Products are alleged to be made by a process that includes crosslinking HA with BDDE, adding lidocaine, and heat sterilizing the composition. ¶29 col. 19:46-51

Identified Points of Contention

  • Scope Questions: A primary question will be whether Allergan can prove that the process used to make the Accused Products falls within the scope of the asserted product-by-process claims. The complaint makes these allegations on "information and belief," and confirming the actual manufacturing steps, such as the specific sequence of pH adjustment and lidocaine addition, will be a central focus of discovery (Compl. ¶¶ 28-32).
  • Technical Questions: The infringement analysis for the ’896 patent will raise the technical question of what evidence demonstrates that lidocaine in the accused product is "freely released in vivo" as required by claim 1. The patent specification itself provides an in-vitro test and graph to illustrate this concept, suggesting that the parties may present competing expert analyses of release kinetics (’896 Patent, Fig. 9; col. 17:23-49).

V. Key Claim Terms for Construction

The Term: "adjusting the pH of the HA component to an adjusted pH above about 7.2" (’202 Patent, Claim 1)

  • Context and Importance: This process step is presented as the key to preventing lidocaine degradation. Proving that the accused process performs this specific step is crucial for infringement of the ’202 Patent. Practitioners may focus on this term because it appears to require a specific sequence of manufacturing operations that may be difficult to prove without direct evidence from the defendant.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: A party might argue that the term covers any process that results in an alkaline HA gel prior to lidocaine addition, regardless of how that pH level is achieved.
    • Evidence for a Narrower Interpretation: The specification describes a deliberate step: "The pH of the purified, substantially pH neutral, cross-linked HA gels are preferably adjusted to cause the gel to become slightly alkaline" (’202 Patent, col. 10:24-28). This language may support an interpretation that requires an affirmative, distinct step of adding an alkaline solution for the express purpose of raising the pH, not merely having a process that incidentally results in such a pH.

The Term: "freely released in vivo" (’896 Patent, Claim 1)

  • Context and Importance: This functional limitation is central to the claimed utility of providing effective, non-degraded anesthetic. Its definition will determine what type of evidence is needed to prove or disprove infringement.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: A party could argue the term simply means the lidocaine is not chemically bound in a way that prevents it from providing an anesthetic effect upon injection, without requiring a specific rate or profile of release.
    • Evidence for a Narrower Interpretation: The specification includes a detailed example (Example 5) and a corresponding graph (Fig. 9) illustrating the release kinetics of lidocaine from a gel in a dialysis test (’896 Patent, col. 17:23-49). A party may argue that "freely released" should be construed to mean a release profile that is consistent with or equivalent to the one shown in this exemplary embodiment.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Prollenium induces infringement by "actively encouraging customers or healthcare providers to use the Accused Products" with knowledge that such use is infringing (Compl. ¶¶ 40, 48).
  • Willful Infringement: The willfulness claim is based on alleged pre-suit knowledge of the patents and the infringing nature of the accused products. The complaint alleges this knowledge arises from Defendant’s awareness of Plaintiff’s JUVÉDERM® products, a prior lawsuit filed by Allergan against Prollenium on related patents, and Plaintiff's public patent marking webpage (Compl. ¶¶ 36, 37, 43, 51).

VII. Analyst’s Conclusion: Key Questions for the Case

  • A core issue will be one of evidentiary proof: Can Allergan, through discovery, produce evidence that Prollenium's confidential manufacturing process for its Revanesse® Versa+TM product includes the specific steps recited in the asserted product-by-process claims, most critically the step of adjusting the HA gel to an alkaline pH before adding lidocaine?
  • A second key issue will be one of claim construction: The litigation will likely focus on the proper legal meaning of terms such as "adjusting the pH" and the functional limitation "freely released in vivo." The court's interpretation of these terms will directly define the boundaries of the patent protection and may be dispositive of infringement.
  • A final question will relate to culpability: Given the allegation of a prior lawsuit on related patents, a central question for a willfulness finding will be whether Prollenium’s conduct following notice was objectively reckless, which could expose it to the risk of enhanced damages if found to infringe.