DCT
1:19-cv-00126
Allergan USA Inc v. Prollenium US Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Allergan Inc USA, Inc. (Delaware) and Allergan Industrie SAS (France)
- Defendant: Prollenium US Inc. (Delaware) and Prollenium Medical Technologies Inc. (Canada)
- Plaintiff’s Counsel: Morris Nichols Arsht & Tunnell LLP
- Case Identification: 1:19-cv-00126, D. Del., 02/26/2019
- Venue Allegations: Venue is alleged based on Defendant Prollenium US Inc. being a Delaware corporation and on Defendants’ commercial activities, including manufacturing, importing, offering for sale, and selling the accused products within the judicial district.
- Core Dispute: Plaintiff alleges that Defendant’s Revanesse® Versa+TM dermal filler infringes six patents related to stable formulations of hyaluronic acid-based gels that include the anesthetic lidocaine.
- Technical Context: The technology concerns injectable dermal fillers used in cosmetic procedures to smooth wrinkles, where hyaluronic acid provides volume and lidocaine is added to reduce patient discomfort during injection.
- Key Procedural History: The complaint notes that after U.S. Patent Nos. 8,450,475 and 8,357,795 issued, a third party filed petitions for inter partes review, which the Patent Trial and Appeal Board (PTAB) denied after finding the petitioner failed to show a reasonable likelihood of prevailing on its invalidity challenges. This procedural history may inform the parties' strategies regarding patent validity.
Case Timeline
| Date | Event |
|---|---|
| 2008-08-04 | Earliest Priority Date for all Patents-in-Suit |
| 2013-01-22 | U.S. Patent No. 8,357,795 Issues |
| 2013-05-28 | U.S. Patent No. 8,450,475 Issues |
| 2014-09-02 | U.S. Patent No. 8,822,676 Issues |
| 2015-07-28 | U.S. Patent No. 9,089,519 Issues |
| 2016-01-19 | U.S. Patent No. 9,238,013 Issues |
| 2016-06-07 | U.S. Patent No. 9,358,322 Issues |
| 2016-08 | Alleged date of Defendant's awareness of Allergan's patented products |
| 2018-12-17 | Launch date of Accused Products |
| 2019-02-26 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,450,475 - "Hyaluronic Acid-Based Gels Including Lidocaine"
The Invention Explained
- Problem Addressed: The patent addresses the technical challenge that prior attempts to incorporate the anesthetic lidocaine into hyaluronic acid (HA) dermal fillers resulted in compositions that were "prone to partial or almost complete degradation prior to injection, particularly during high temperature sterilization steps" (Compl. ¶37; ’475 Patent, col. 2:22-29).
- The Patented Solution: The invention is a stable, HA-based soft tissue filler that successfully incorporates lidocaine. The solution is based on formulating a "cohesive" HA gel composition, which is described as better able to "retain its shape and resist deformation" and thereby "prevent or impede any breakdown or degradation of the crosslinked HA" when lidocaine is added and the mixture is sterilized (’475 Patent, col. 7:18-30). This allows the final product to withstand sterilization and storage without degrading.
- Technical Importance: The invention provides a dermal filler that combines the therapeutic effects of HA with an anesthetic to improve patient comfort, a desirable feature that was previously difficult to achieve due to chemical instability (Compl. ¶37).
Key Claims at a Glance
- The complaint asserts independent claim 1 and dependent claim 34 (Compl. ¶44-46).
- Independent Claim 1 requires:
- A stable, sterile soft tissue filler comprising:
- A hyaluronic acid (HA) component comprising HA crosslinked with 1,4-butanediol diglycidyl ether (BDDE), and uncrosslinked HA;
- Wherein the HA component comprises greater than about 10% uncrosslinked HA by volume; and
- Lidocaine combined with said crosslinked HA component.
- The complaint reserves the right to assert other claims (Compl. ¶56).
U.S. Patent No. 8,357,795 - "Hyaluronic Acid-Based Gels Including Lidocaine"
The Invention Explained
- Problem Addressed: The patent addresses the same technical problem as the ’475 Patent: the degradation of HA-based compositions when lidocaine is incorporated during the manufacturing process, especially during high-temperature sterilization (’795 Patent, col. 2:22-29).
- The Patented Solution: This patent also discloses stable, lidocaine-containing HA compositions, focusing on specific formulations and properties. The solution involves creating a cohesive HA gel and carefully controlling the manufacturing process, such as adjusting the gel's pH to be slightly alkaline (above 7.2) before adding the lidocaine solution, which enhances the stability of the final product through sterilization and storage (’795 Patent, col. 7:31-42). The patent also claims compositions where the lidocaine is "freely released in vivo," a desirable functional property for an anesthetic (’795 Patent, col. 19:29-30).
- Technical Importance: The invention enables the production of a commercially viable dermal filler that reduces injection pain without compromising the stability and shelf-life of the HA gel (Compl. ¶37).
Key Claims at a Glance
- The complaint asserts independent claims 1 and 29 (Compl. ¶44, 47-48).
- Independent Claim 1 requires:
- A soft tissue filler composition comprising:
- A hyaluronic acid (HA) component crosslinked with a specified crosslinking agent (e.g., BDDE);
- Wherein the HA is not crosslinked to a non-HA biopolymer;
- Lidocaine combined with said crosslinked HA component;
- Wherein the lidocaine is freely released in vivo; and
- Wherein the composition is sterile.
- The complaint reserves the right to assert other claims (Compl. ¶56).
U.S. Patent No. 8,822,676 - "Hyaluronic Acid-Based Gels Including Lidocaine"
- Technology Synopsis: This patent, from the same family as the ’475 and ’795 patents, is also directed at solving the problem of HA degradation when combined with lidocaine. It claims specific dermal filler compositions comprising HA crosslinked with BDDE, a specified amount of lidocaine, and free HA, where the lidocaine is "freely released in vivo" (Compl. ¶49-50).
- Asserted Claims: Independent claims 1 and 2 (Compl. ¶44, 49-50).
- Accused Features: The complaint alleges the Accused Products are dermal filler compositions containing HA crosslinked with BDDE, about 0.3% lidocaine, and free HA, meeting the limitations of the asserted claims (Compl. ¶49-50).
U.S. Patent No. 9,089,519 - "Hyaluronic Acid-Based Gels Including Lidocaine"
- Technology Synopsis: This patent claims a first sterile dermal filler containing crosslinked HA and lidocaine, defining its efficacy by the functional requirement that it "fills in facial lines and depressions substantially the same as a second sterile dermal filler" that is identical but lacks lidocaine. This claim structure focuses on ensuring the addition of lidocaine does not negatively impact the filler's performance.
- Asserted Claims: Independent claims 1 and 2 (Compl. ¶44, 51-52).
- Accused Features: The Accused Products are alleged to be a first dermal filler composition with HA and lidocaine that performs substantially the same as a second composition without lidocaine (Compl. ¶51-52).
U.S. Patent No. 9,238,013 - "Hyaluronic Acid-Based Gels Including Lidocaine"
- Technology Synopsis: This patent claims a dermal filler comprising a mixture of crosslinked HA particles and free HA, combined with about 0.3% lidocaine. It specifies that the filler must be heat sterile and have a pH of about 7.
- Asserted Claims: Independent claim 1 (Compl. ¶44, 53).
- Accused Features: The Accused Products are alleged to be a dermal filler containing a mixture of crosslinked HA particles, free HA, and about 0.3% lidocaine, and to be heat sterile with a pH of about 7 (Compl. ¶53).
U.S. Patent No. 9,358,322 - "Hyaluronic Acid-Based Gels Including Lidocaine"
- Technology Synopsis: This patent claims a soft tissue filler composition comprising a sterile, stable injectable gel. The gel is defined as a mixture of soluble (uncrosslinked) HA, particles of crosslinked HA, and lidocaine "in an amount effective to mitigate pain."
- Asserted Claims: Independent claims 1 and 4 (Compl. ¶44, 54-55).
- Accused Features: The Accused Products are alleged to be a sterile, stable injectable gel comprising a mixture of soluble HA, particles of crosslinked HA, and lidocaine in an amount effective to mitigate pain (Compl. ¶54-55).
III. The Accused Instrumentality
Product Identification
The accused instrumentality is Defendant's Revanesse® Versa+TM dermal filler product (Compl. ¶42-43).
Functionality and Market Context
The complaint describes the Accused Product as an "injectable hyaluronic acid gel that includes lidocaine" and is "indicated for the correction of moderate to severe facial wrinkles and folds" (Compl. ¶42). The product is alleged to compete with Plaintiff's JUVEDÉRM® line of products, which the complaint states account for over $500 million in annual U.S. sales (Compl. ¶40, 59). The complaint alleges the Accused Product was announced for release in the U.S. via a press release dated December 17, 2018 (Compl. ¶42).
IV. Analysis of Infringement Allegations
No probative visual evidence provided in complaint.
'475 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A stable, sterile soft tissue filler comprising: | The Accused Products are alleged to be a stable, sterile soft tissue filler. | ¶45 | col. 5:12-21 |
| a hyaluronic acid (HA) component comprising HA crosslinked with 1,4-butanediol diglycidyl ether (BDDE), and uncrosslinked HA, | The Accused Products are alleged to include an HA component comprising HA crosslinked with BDDE and uncrosslinked HA. | ¶45 | col. 2:50-54 |
| wherein the HA component comprises greater than about 10% uncrosslinked HA by volume; | The Accused Products are alleged to have an HA component with greater than about 10% uncrosslinked HA by volume. | ¶45 | col. 3:14-16 |
| and lidocaine combined with said crosslinked HA component. | The Accused Products are alleged to include lidocaine combined with the crosslinked HA component. | ¶45 | col. 2:60-65 |
'795 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A soft tissue filler composition comprising: | The Accused Products are alleged to be a soft tissue filler composition. | ¶47 | col. 2:36-37 |
| a hyaluronic acid (HA) component crosslinked with a crosslinking agent selected from the group consisting of 1,4-butanediol diglycidyl ether (BDDE)... | The Accused Products are alleged to include an HA component crosslinked with a member of the specified group of agents. | ¶47 | col. 2:50-54 |
| wherein the HA is not crosslinked to a non-HA biopolymer; | The Accused Products are alleged to have HA that is not crosslinked to a non-HA biopolymer. | ¶47 | col. 19:27-28 |
| and lidocaine combined with said crosslinked HA component; | The Accused Products are alleged to contain lidocaine combined with the crosslinked HA component. | ¶47 | col. 2:19-22 |
| wherein the lidocaine is freely released in vivo; | The Accused Products are alleged to have lidocaine that is freely released in vivo. | ¶47 | col. 17:11-13 |
| and wherein the composition is sterile. | The Accused Products are alleged to be sterile. | ¶47 | col. 12:4-20 |
Identified Points of Contention
- Factual Questions: The complaint’s infringement allegations are conclusory and lack specific factual support, such as test results or chemical analyses of the Accused Product. A primary point of contention will be establishing the actual composition of the Revanesse® Versa+TM filler. Key factual questions include:
- What evidence demonstrates that the Accused Product’s HA component comprises "greater than about 10% uncrosslinked HA by volume," as required by claim 1 of the ’475 Patent?
- What testing or data supports the allegation that the lidocaine in the Accused Product is "freely released in vivo" as required by claim 1 of the ’795 Patent?
- Scope Questions: The interpretation of quantitative terms may become a point of contention. For example, the meaning of "about" in claim limitations such as "greater than about 10%" ('475 Patent) or "pH of about 7" ('013 Patent) could be disputed. The parties may contest whether the Accused Product's measured properties fall within the scope of these terms.
V. Key Claim Terms for Construction
The Term: "uncrosslinked HA"
- Context and Importance: This term is central to claim 1 of the ’475 Patent, which requires "greater than about 10% uncrosslinked HA by volume." The definition of this term will be critical for determining whether the accused product, which is alleged to contain both crosslinked and uncrosslinked HA, meets this quantitative limitation. Practitioners may focus on this term because the specific ratio of uncrosslinked to crosslinked HA is a key point of novelty and a precise infringement question.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification provides an explicit definition for the related term "Free HA," stating it "includes truly uncrosslinked HA as well as lightly crosslinked HA chains and fragments, all in soluble form in water" ('475 Patent, col. 3:9-13). This language suggests "uncrosslinked HA" could be construed broadly to encompass not only monomeric HA but also lightly crosslinked and fragmented portions that remain soluble.
- Evidence for a Narrower Interpretation: A defendant might argue that the term should be limited to only truly un-crosslinked HA molecules, distinguishing it from the "lightly crosslinked" species also mentioned in the specification's definition of "Free HA." The distinction between "uncrosslinked" in the claim and "Free HA" in the specification could be a basis for argument.
The Term: "freely released in vivo"
- Context and Importance: This term from claim 1 of the ’795 Patent defines a functional characteristic of the lidocaine within the composition. Infringement depends on whether the lidocaine in the Accused Product exhibits this property. The dispute may center on how this functional behavior is demonstrated and measured, as it is less a structural feature and more an outcome of the formulation.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: This phrase could be interpreted to mean simply that the lidocaine is not covalently bonded to the HA matrix and is therefore capable of diffusing out of the gel to provide an anesthetic effect once injected.
- Evidence for a Narrower Interpretation: The specification includes a detailed example with a kinetic release study (Example 5 and FIG. 9 of the ’795 Patent), which shows data suggesting that the lidocaine concentration in the gel over time "reaches an equilibrium that corresponds to free release." A party could argue that this example defines the scope of "freely released," requiring a particular release profile or equilibrium characteristic, rather than just the absence of a chemical bond.
VI. Other Allegations
Indirect Infringement
The complaint alleges that Defendant induces infringement by "actively encouraging customers or healthcare providers to use the Accused Products in the United States with knowledge that such use would infringe" the patents-in-suit (Compl. ¶62, 70, 78, 86, 94, 102).
Willful Infringement
The complaint alleges willful infringement based on Defendant's alleged pre-suit knowledge. It asserts that Defendant was aware of Allergan's JUVEDÉRM® products, which practice the asserted patents, as early as August 2016, and was aware of the specific patents-in-suit since at least December 17, 2018, the date of the Accused Product's press release (Compl. ¶59, 64-65).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of evidentiary proof: what is the precise chemical composition and what are the physical properties of the accused Revanesse® Versa+TM filler? The case will likely depend on competing expert analyses to determine if the product meets the specific quantitative and qualitative limitations recited in the asserted claims, such as the percentage of uncrosslinked HA and the release profile of lidocaine.
- A key question will be one of functional performance: how is the "freely released in vivo" limitation of the ’795 Patent and its relatives to be construed and tested? The court will need to determine whether this requires only that the lidocaine is not chemically bound or if it requires a specific, measurable rate of diffusion from the gel matrix, as potentially defined by the patent's own examples.
- A further question will involve validity resilience: can the defendant present invalidity arguments for the ’475 and ’795 patents that are substantively different from, or more persuasive than, those previously considered and rejected by the PTAB at the institution stage? While the PTAB's non-institution decision is not binding, it provides an early data point on the perceived strength of certain invalidity theories.