DCT

1:18-cv-01892

Galderma Laboratories LP v. Medinter US LLC

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:18-cv-01892, D. Del., 11/29/2018
  • Venue Allegations: Venue is asserted under 28 U.S.C. §§ 1391(b)-(c) and 1400(b), based on allegations that Defendants are incorporated in Delaware or have sufficient contacts with the United States, and that upon FDA approval the accused product will be sold nationwide, including within the district.
  • Core Dispute: Plaintiff alleges that Defendants' DERMA VEIL injectable dermal filler infringes two patents related to bioresorbable implant compositions and formulations.
  • Technical Context: The technology lies in the field of aesthetic dermatology, specifically concerning injectable, polymer-based dermal fillers used to correct wrinkles and skin depressions.
  • Key Procedural History: The complaint asserts two related patents: U.S. Patent No. 7,731,758 is a divisional of U.S. Patent No. 6,716,251. The ’251 patent expired prior to the filing of the complaint, with infringement alleged during its term. The ’758 patent received a Patent Term Adjustment of 1,784 days. The complaint alleges that the CEO of Defendant DermAvance was previously an executive at Sanofi-Aventis involved in the development and launch of Plaintiff's competing product, SCULPTRA®.

Case Timeline

Date Event
1997-06-13 Priority Date for '251 and '758 Patents
2004-04-06 '251 Patent Issue Date
2010-06-08 '758 Patent Issue Date
2014-10-09 Accused Product (DERMA VEIL) first use in commerce alleged
2014-12-08 Accused Product clinical trial initiated
2018-06-12 '251 Patent Expiration Date
2018-11-29 Complaint Filing Date

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

U.S. Patent No. 6,716,251 - Implant for Subcutaneous or Intradermal Injection (Issued: Apr. 6, 2004)

The Invention Explained

  • Problem Addressed: The patent's background describes the shortcomings of prior art dermal fillers, including the migration and inflammation associated with silicone, allergic reactions and short duration of animal-based collagens, and the non-biodegradable nature of polymers like PMMA (’251 Patent, col. 1:15-61).
  • The Patented Solution: The invention is a bioresorbable injectable implant composed of polymer microspheres (such as polylactic acid) suspended in a carrier gel, where both the microspheres and the gel are made from materials of non-animal origin to eliminate allergenicity tests (’251 Patent, Abstract; col. 2:1-5). The formulation is designed for controlled bioresorbability, providing aesthetic correction for a period of one to three years, a significant improvement over temporary fillers (’251 Patent, col. 2:6-13).
  • Technical Importance: This technology provided a biocompatible, non-allergenic filler with a predictable and extended, yet not permanent, duration of effect, addressing a key gap between short-term collagen and permanent synthetic implants (’251 Patent, col. 2:58-65).

Key Claims at a Glance

  • The complaint asserts infringement of independent claims 1 and 16, as well as several dependent claims (Compl. ¶50).
  • Independent Claim 1 recites a bioresorbable injectable implant "consisting essentially of" bioresorbable microspheres (e.g., polylactic acid polymers) of non-animal origin suspended in a gel that also consists essentially of materials of non-animal origin (’251 Patent, col. 5:10-19).
  • Independent Claim 16 recites a bioresorbable injectable implant "free of materials of animal origin" comprising microparticles and a gel, where the gel is specified to contain water, a gelling agent, and a surfactant, and is resorbable within about two months (’251 Patent, col. 6:16-33).

U.S. Patent No. 7,731,758 - Implant for Subcutaneous or Intradermal Injection (Issued: Jun. 8, 2010)

The Invention Explained

  • Problem Addressed: As a divisional of the '251 patent, this patent addresses the same fundamental need for a better dermal filler. Its specific focus is on product stability and ease of preparation for clinical use. Pre-mixed gel suspensions can have limited shelf life.
  • The Patented Solution: The invention is a reconstitutable product provided in a freeze-dried (lyophilized) form (’758 Patent, col. 3:52-57). This composition includes the polymer microparticles and a "hydrogel precursor." Upon the addition of water by a clinician, it transforms into the bioresorbable, injectable implant, ready for administration (’758 Patent, col. 5:11-24).
  • Technical Importance: The freeze-dried format provides superior long-term stability and shelf life compared to a liquid suspension, while allowing for on-demand preparation of the implant immediately prior to use (’758 Patent, col. 3:23-33).

Key Claims at a Glance

  • The complaint asserts infringement of independent claims 1 and 11, as well as several dependent claims (Compl. ¶58).
  • Independent Claim 1 recites a "reconstitutable product" that becomes an injectable implant upon adding water. The product comprises a "freeze-dried composition" of polymer microparticles and a "hydrogel precursor" that forms a hydrogel when hydrated (’758 Patent, col. 5:11-24).
  • Independent Claim 11 recites a "reconstitutable bioresorbable injectable implant product made by freeze-drying a composition consisting essentially of" bioresorbable microspheres suspended in a gel, with both components being of non-animal origin (’758 Patent, col. 6:11-22).

III. The Accused Instrumentality

Product Identification

DERMA VEIL CUTANEOUS BIO-STIMULANT ("DERMA VEIL") (Compl. ¶10).

Functionality and Market Context

  • DERMA VEIL is described as an injectable dermal filler designed to diminish skin depressions such as wrinkles and scars (Compl. ¶1, ¶36).
  • The product is supplied as a "lyophilized, crystalline white powder" in vials, containing microparticles of polylactic acid and glycolic acid, along with carboxy methyl cellulose sodium, mannitol, and polysorbate 80 (Compl. ¶34).
  • It is prepared for use when a clinician "activates" the powder by injecting sterile water or saline into the vial, creating a "suspension of relative viscosity" for subdermal injection (Compl. ¶35, ¶36).
  • The complaint alleges DERMA VEIL is manufactured in the U.S. for export and directly competes with Plaintiff's SCULPTRA® product. Defendants are alleged to be seeking FDA approval for sales within the U.S. (Compl. ¶1, ¶33, ¶38, ¶44).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

’251 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A bioresorbable injectable implant for human administration DERMA VEIL is described in its Instructions for Use as a "bioabsorbable and biodegradable material" for injection to diminish wrinkles and scars. ¶36, ¶52 col. 1:7-13
consisting essentially of: bioresorbable microspheres or microparticles suspended in a gel DERMA VEIL is a powder of microparticles that, once activated with water, becomes a "suspension of relative viscosity" for injection. The complaint alleges this suspension constitutes the claimed "gel." ¶34, ¶35 col. 3:3-6
consisting essentially of materials of non-animal origin, said microspheres or microparticles consisting of at least one polymer of non-animal origin... The complaint's general infringement allegations imply this limitation is met. The patent identifies the claimed polymers as a solution to the problem of animal-origin materials. ¶50 col. 2:1-5
...selected from the group consisting of lactic acid polymers, glycolic acid polymers, and lactic acid-glycolic acid co-polymers. The vial of DERMA VEIL is alleged to comprise microparticles made of "polylactic acid, [and] glycolic acid." ¶34 col. 2:21-27

’758 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A reconstitutable product, which upon the addition of water becomes a bioresorbable, injectable implant product... DERMA VEIL is a lyophilized powder that is "activated by injecting into the vial...Physiological Saline Solution or Sterile Water for Injection," at which point it "becomes a suspension" for injection. ¶35 col. 3:25-33
wherein said reconstitutable product comprises a freeze-dried composition of: microparticles of at least one polymer of non-animal origin... DERMA VEIL is supplied as a "lyophilized, crystalline white powder of microparticles" made of "polylactic acid" and "glycolic acid." ¶34 col. 3:55-58
...and a hydrogel precursor consisting essentially of materials of non-animal origin, wherein said precursor forms a hydrogel upon the addition of water. The lyophilized DERMA VEIL powder includes "carboxy methyl cellulose sodium" (a gelling agent), and "mannitol" (a cryoprotecting agent), which allegedly form a hydrogel (the "suspension of relative viscosity") upon addition of water. ¶34, ¶35 col. 5:19-24

Identified Points of Contention

  • Scope Questions: A central dispute for both patents may involve the claim phrase "consisting essentially of." The accused product contains polysorbate 80, a surfactant (’251 Patent, col. 6:30-31), which is not recited in '251 Claim 1 or '758 Claim 1. The court will have to determine if this unrecited ingredient materially affects the basic and novel properties of the claimed invention. The fact that other independent claims in the family (e.g., '251 Claim 16) explicitly require a surfactant raises the question of whether its inclusion is a material alteration.
  • Technical Questions: For the '251 patent, a question is whether the reconstituted "suspension" of DERMA VEIL meets the "gel" limitation of Claim 1, which appears to describe a ready-to-use product. For the ’758 patent, a question is whether the simple mixture of dry ingredients in the DERMA VEIL vial constitutes a "hydrogel precursor" as the term is used in the patent.

V. Key Claim Terms for Construction

  • The Term: "consisting essentially of" (’251 Patent, Claim 1; ’758 Patent, Claim 11)

    • Context and Importance: This transitional phrase is critical because the accused product contains ingredients (e.g., polysorbate 80) not explicitly listed in the elements of these claims (Compl. ¶34). The infringement analysis will depend on whether these additional components materially alter the invention's fundamental character.
    • Evidence for a Broader Interpretation: Plaintiff may argue the specification teaches that a surfactant like polysorbate (Tween 80) can be used to ensure "good dispersion" and homogeneity, suggesting it aids the invention's function without altering its core properties (’251 Patent, col. 3:17-22).
    • Evidence for a Narrower Interpretation: Defendant may point to claim differentiation. Independent claim 16 of the ’251 patent explicitly adds a "surfactant" as a required element (’251 Patent, col. 6:30-31). This suggests that a formulation with a surfactant is a distinct, separately claimed invention, and its presence in the accused product prevents infringement of claims that do not recite it.

  • The Term: "gel" (’251 Patent, Claim 1)

    • Context and Importance: The '251 patent claims microspheres suspended in a "gel." The accused product is reconstituted from a powder into a "suspension of relative viscosity" (Compl. ¶35). Whether this suspension qualifies as a "gel" is a likely point of dispute.
    • Evidence for a Broader Interpretation: The specification describes the gel's purpose as a "vector to maintain the microspheres or microparticles in a homogeneous suspension" (’251 Patent, col. 3:4-6). Plaintiff may argue that any medium achieving this functional requirement, regardless of its specific rheological properties or method of creation, falls within the scope of "gel."
    • Evidence for a Narrower Interpretation: Defendant may argue that the term implies a pre-formed, stable hydrogel matrix as described in the specification's examples and that a suspension created ad-hoc from a powder does not meet the definition intended by the patent.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges inducement of infringement for both patents, based on Defendants actively encouraging the manufacture, use, and sale of DERMA VEIL (Compl. ¶53, ¶62). Evidence cited includes the product's "Instructions for Use," which allegedly direct clinicians to perform the infringing acts of reconstituting and injecting the product (Compl. ¶51, ¶59).
  • Willful Infringement: Willfulness is alleged for both patents. For the ’251 patent, the complaint alleges Defendants had knowledge through the patent marking of Plaintiff's competing product, SCULPTRA® (Compl. ¶25). For both patents, it alleges a key executive at Defendant DermAvance was "intimately aware" of the patents from his prior role developing SCULPTRA® (Compl. ¶24). The allegations state that the infringement was "deliberate, egregious, willful, and in reckless disregard" of Plaintiff's rights (Compl. ¶54, ¶63).

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

  • A core issue will be one of definitional scope: can the phrase "consisting essentially of" be interpreted to read on a formulation containing a surfactant (polysorbate 80), when other claims in the same patent family explicitly recite a surfactant as an element? The resolution of this question of claim scope may be dispositive for several asserted claims.
  • A second key issue will be one of physical state and timing: does the accused DERMA VEIL product, which is sold as a dry powder and reconstituted into a "suspension," infringe claims of the '251 patent that recite a pre-formed "gel"? This raises a fundamental question about whether a product must be in its final infringing configuration at the time of sale to directly infringe a product claim.
  • Finally, a central evidentiary question will be one of willfulness and intent. Given the specific allegation that a defendant's executive was previously involved with the patented technology, the case will likely feature a detailed inquiry into the extent of Defendants' pre-suit knowledge and whether their actions in developing and marketing a competing product constituted deliberate disregard for known patent rights, which would have significant implications for potential damages.