DCT

2:25-cv-01664

Biodermis LLC v. Alliance Pharma PLC

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:25-cv-01664, D. Nev., 09/05/2025
  • Venue Allegations: Venue is alleged to be proper in the District of Nevada because a substantial part of the events giving rise to the claim occurred in the district, specifically the creation and development of the accused products by Plaintiff Biodermis in Henderson, Nevada.
  • Core Dispute: Plaintiffs seek a declaratory judgment that their reformulated BIOCORNEUM® scar treatment products do not infringe six patents owned by Defendants related to silicone-based topical formulations.
  • Technical Context: The technology involves silicone-based gels for topical application, primarily for managing and improving the appearance of scars after injury or surgery.
  • Key Procedural History: The complaint outlines a complex business history wherein a previous owner and sublicensee of the patents-in-suit, Sientra, Inc., allegedly reformulated the BIOCORNEUM® product line around 2019. Plaintiffs acquired the assets, including the reformulated products, from Sientra's bankruptcy in 2024. Following communications between the parties regarding potential infringement, Plaintiffs filed this action seeking a declaration of non-infringement to resolve the controversy.

Case Timeline

Date Event
1996-08-26 U.S. Patent No. 5,741,509 Priority Date
1998-04-21 U.S. Patent No. 5,741,509 Issued
2002-07-16 U.S. Patent No. 8,021,683 Priority Date
2002-07-23 U.S. Patent No. 8,263,114 Priority Date
2009-06-18 U.S. Patent Nos. 8,802,133, 9,339,546, and 9,795,706 Priority Date
2011-09-20 U.S. Patent No. 8,021,683 Issued
2012-09-11 U.S. Patent No. 8,263,114 Issued
2014-08-12 U.S. Patent No. 8,802,133 Issued
2016-05-17 U.S. Patent No. 9,339,546 Issued
2016-08-26 U.S. Patent No. 5,741,509 Expired
2017-10-24 U.S. Patent No. 9,795,706 Issued
~2019 Original BIOCORNEUM® products reformulated by Sientra, Inc.
2024-05 Nuance acquired assets of Reformulated BIOCORNEUM® products
2024-08-01 Alliance Defendants communicated belief of infringement by '683 patent
2024-12-02 Sublicense Agreement terminated
2025-09-05 Complaint for Declaratory Judgment Filed

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

U.S. Patent No. 8,021,683 - "Wound Dressing"

The Invention Explained

  • Problem Addressed: The patent describes a problem with prior art silicone wound dressings, which incorporate a volatile diluent to make a stiff grease spreadable. These formulations can take a long time (e.g., 15 minutes or more) to dry, requiring immobilization of the target tissue site to prevent the dressing from being dislodged before it adheres properly ('683 Patent, col. 2:1-29).
  • The Patented Solution: The invention adds a "silicone elastomer" to the conventional three-part mixture of a non-volatile silicone fluid, fumed silica, and a volatile diluent. The patent asserts the unexpected finding that the inclusion of this silicone elastomer promotes the evaporation of the volatile diluent, thereby significantly reducing the time required for the dressing to dry and achieve its desired adhesive and smear-proofing properties ('683 Patent, col. 2:40-54, Abstract).
  • Technical Importance: By accelerating the drying time, the invention sought to improve patient compliance and the overall effectiveness and ease of use of self-drying silicone gel dressings ('683 Patent, col. 3:1-4).

Key Claims at a Glance

  • The complaint broadly seeks a declaration of non-infringement of "any claim" of the '683 patent (Compl. ¶33). Independent claim 1 is representative of the core composition.
  • Independent Claim 1 requires:
    • A wound dressing including a composition consisting of a non-volatile silicone fluid in admixture with fumed silica, a volatile diluent and a silicone elastomer.
  • The complaint does not explicitly reserve the right to assert dependent claims, though this is common practice.

U.S. Patent No. 9,339,546 - "Silicone Scar Treatment Preparation"

The Invention Explained

  • Problem Addressed: The patent addresses the difficulty of incorporating certain desirable active ingredients, such as sunscreens or anti-inflammatory compounds, into silicone-based wound dressings because these additives are often not soluble in the siloxane matrix precursors ('546 Patent, col. 3:1-12).
  • The Patented Solution: The invention introduces the use of a "volatile coagent" in addition to the standard volatile component. This coagent is selected to solvate the otherwise insoluble active ingredient, allowing it to be incorporated into the precursor mixture. The coagent is volatile and evaporates away along with the primary volatile component, leaving the active ingredient dispersed within the final formed silicone matrix on the skin ('546 Patent, col. 3:19-34, Abstract).
  • Technical Importance: This technology allows for the creation of multi-functional silicone scar treatments that can provide benefits beyond simple occlusion, such as UV protection or pain relief, which were previously difficult to formulate ('546 Patent, col. 3:46-51).

Key Claims at a Glance

  • The complaint seeks a declaration of non-infringement of "any claim" of the '546 patent (Compl. ¶53). Independent claim 7 is representative of the core composition.
  • Independent Claim 7 requires:
    • a) a volatile component having a cyclic siloxane
    • b) siloxane matrix precursors
    • c) an active component solubilized in the spreadable composition
    • d) a volatile coagent being present... and including at least one selected from the group consisting of dimethyl isosorbide, pentylene glycol, and isopropyl myristate
  • The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 5,741,509 - "Silicone Wound Dressing"

  • Patent Identification: U.S. Patent No. 5,741,509, "Silicone Wound Dressing," issued April 21, 1998.
  • Technology Synopsis: This patent describes a silicone wound dressing composed of a blend of silicone fluid and fumed silica, with a volatile diluent added to reduce the viscosity for application. The diluent evaporates, leaving a stiff, protective film.
  • Asserted Claims: All claims are at issue (Compl. ¶28).
  • Accused Features: Plaintiffs seek a declaratory judgment of non-infringement on the basis that the patent expired on August 26, 2016, and is therefore unenforceable (Compl. ¶¶29-30).

U.S. Patent No. 8,263,114 - "Topical Pharmaceutical Formulation"

  • Patent Identification: U.S. Patent No. 8,263,114, "Topical Pharmaceutical Formulation," issued September 11, 2012.
  • Technology Synopsis: The patent claims a topical formulation for a wound dressing. The core claims recite a composition "consisting of" specific ingredients, including a non-volatile silicone fluid, fumed silica, a volatile diluent, and an antibacterial active agent.
  • Asserted Claims: All claims are at issue (Compl. ¶39).
  • Accused Features: Plaintiffs allege their Reformulated BIOCORNEUM® products do not infringe because they do not contain any antibacterial active agents and because they contain additional ingredients (e.g., UV blockers) not recited in the claims, which use the restrictive "consisting of" transitional phrase (Compl. ¶¶40-43).

U.S. Patent No. 8,802,133 - "Silicone Scar Treatment preparation"

  • Patent Identification: U.S. Patent No. 8,802,133, "Silicone Scar Treatment preparation," issued August 12, 2014.
  • Technology Synopsis: This patent is from the same family as the '546 patent and describes a silicone preparation using a volatile coagent to incorporate an otherwise insoluble active. The claims require the active component to be a steroid compound and the volatile coagent to be selected from a specific list.
  • Asserted Claims: All claims are at issue (Compl. ¶47).
  • Accused Features: Plaintiffs allege non-infringement because their products do not contain a steroid compound or any of the specifically listed volatile coagents (e.g., isopropyl myristate) (Compl. ¶50).

U.S. Patent No. 9,795,706 - "Silicone Scar Treatment Preparation"

  • Patent Identification: U.S. Patent No. 9,795,706, "Silicone Scar Treatment Preparation," issued October 24, 2017.
  • Technology Synopsis: This patent is from the same family as the '546 patent and describes a silicone preparation using a volatile coagent. The claims require the active component to be a corticosteroid and the volatile coagent to be selected from a specific list.
  • Asserted Claims: All claims are at issue (Compl. ¶58).
  • Accused Features: Plaintiffs allege non-infringement because their products do not contain a corticosteroid compound or any of the specifically listed volatile coagents (Compl. ¶61).

III. The Accused Instrumentality

Product Identification

  • The "Reformulated BIOCORNEUM® advanced scar treatment products" (Compl. ¶1).

Functionality and Market Context

  • The products are topical scar treatments (Compl. ¶19). The complaint alleges that these products were reformulated from an "Original" version around 2019 to remove certain ingredients and add others (Compl. ¶14). Specifically, Plaintiffs allege the reformulated products now contain ingredients such as UV blockers but no longer contain ingredients such as isopropyl myristate, antibacterial agents, or steroid compounds (Compl. ¶¶18, 36, 41, 50). The product line was acquired by Plaintiffs from the bankruptcy of a prior owner, Sientra, Inc., in May 2024 (Compl. ¶15).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

U.S. Patent No. 8,021,683 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Non-Infringing Functionality Complaint Citation Patent Citation
A wound dressing including a composition consisting of The Reformulated BIOCORNEUM® products are alleged to include additional elements not specified in the claim, such as UV blockers. ¶36 col. 2:35-38
a non-volatile silicone fluid in admixture with fumed silica, The complaint argues that the transitional phrase "consisting of" excludes any element not specified, rendering the claim not met. ¶34 col. 7:6-18
a volatile diluent and The complaint's non-infringement theory rests on the composition as a whole, not the absence of this specific element. ¶34 col. 5:43-49
a silicone elastomer. The complaint's non-infringement theory rests on the composition as a whole, not the absence of this specific element. ¶34 col. 3:9-15
  • Identified Points of Contention:
    • Scope Questions: The primary dispute appears to be legal rather than technical. The case will question whether the transitional phrase "consisting of," as used in the '683 patent's claims, is to be interpreted strictly to exclude any unrecited ingredients. The complaint's position is that the presence of additional components like UV blockers places the accused products outside the literal scope of the claims (Compl. ¶¶34, 36).

U.S. Patent No. 9,339,546 Infringement Allegations

Claim Element (from Independent Claim 7) Alleged Non-Infringing Functionality Complaint Citation Patent Citation
a volatile component having a cyclic siloxane The complaint's non-infringement theory does not contest the presence of this element. ¶55 col. 4:40-44
siloxane matrix precursors The complaint's non-infringement theory does not contest the presence of this element. ¶55 col. 4:1-4
an active component solubilized in the spreadable composition The complaint does not specify whether an active component is present but focuses its non-infringement argument on other elements. ¶55 col. 5:35-36
a volatile coagent being present... and including at least one selected from the group consisting of dimethyl isosorbide, pentylene glycol, and isopropyl myristate Plaintiffs allege that the Reformulated BIOCORNEUM® products do not include any of the chemical compounds listed in this group. ¶55 col. 6:54-61
  • Identified Points of Contention:
    • Technical Questions: The dispute regarding the '546 patent appears to be factual. The central question is whether the chemical formulation of the accused products includes any of the specific compounds (dimethyl isosorbide, pentylene glycol, isopropyl myristate) required to meet the "volatile coagent" limitation of the claims (Compl. ¶55). The case will depend on evidence establishing the product's precise composition.

V. Key Claim Terms for Construction

  • The Term: "consisting of" (from '683 Patent, Claim 1)

    • Context and Importance: This transitional phrase is critical to the non-infringement arguments for the '683 and '114 patents. Its construction will determine whether the claims are "closed" to any additional, unrecited ingredients. If interpreted strictly, the alleged presence of UV blockers in the accused products could be dispositive of non-infringement.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: A defendant would argue for exceptions to the strict rule, though the intrinsic evidence rarely supports broadening a term of art like "consisting of." A party might point to the specification's focus on the combination of the four recited elements as the core of the invention, suggesting that other non-material additions should not defeat a finding of infringement.
      • Evidence for a Narrower Interpretation: The use of the phrase "consisting of" is itself strong evidence for a closed, narrow scope that excludes unrecited elements. The patent's abstract and detailed description consistently describe the invention in terms of these specific components, providing no suggestion that other ingredients are contemplated within the claimed composition ('683 Patent, Abstract; col. 2:35-38). This aligns with the default interpretation in patent law, as cited by the complaint (Compl. ¶34).

  • The Term: "volatile coagent" (from '546 Patent, Claim 7)

    • Context and Importance: This term is central to the non-infringement arguments for the entire 'coagent' patent family ('133, '546, '706). Plaintiffs allege their product does not contain the specific compounds that define this term in the claims.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: A party seeking a broader interpretation might focus on the functional language in the specification, which describes the coagent's purpose as aiding in "solvating the active in the matrix precursors" ('546 Patent, col. 5:37-41). They might argue that any compound performing this function should be considered a "volatile coagent."
      • Evidence for a Narrower Interpretation: The claim language provides a very strong basis for a narrow interpretation by explicitly defining the term with a Markush group: "the volatile coagent including at least one selected from the group consisting of dimethyl isosorbide, pentylene glycol, and isopropyl myristate." This structure is generally interpreted as limiting the claim scope to the specifically listed members of the group. The specification's examples reinforce this narrow scope by using the listed compounds ('546 Patent, col. 7-8, Examples 1-2).

VI. Other Allegations

  • Indirect Infringement: The complaint seeks a declaratory judgment that Plaintiffs' products do not infringe "either directly or indirectly, any claims of the Asserted Patents" (Compl. ¶¶ 28, 33, 39, 47, 53, 58). No specific facts related to indirect infringement are alleged; rather, the request is for a judicial declaration of its absence.

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

  • A core issue will be one of claim scope: can the transitional phrase "consisting of," as used in the '683 and '114 patents, be interpreted to permit the presence of unrecited ingredients, such as the UV blockers allegedly found in the accused products, or does its use strictly close the claim to only the recited elements?
  • A key evidentiary question will be one of chemical composition: does the Reformulated BIOCORNEUM® product, as a matter of scientific fact, contain any of the specific compounds required by the "volatile coagent" and "active component" limitations of the '133, '546, and '706 patents?