DCT
1:22-cv-01264
GlycoBioSciences Inc v. Vichy Laboratories SA
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: GlycoBioSciences, Inc. (a Canadian Company)
- Defendant: Vichy Laboratories, SA (France) and L'Oreal S.A. (France)
- Plaintiff’s Counsel: DNL Zito Castellano
- Case Identification: 1:22-cv-01264, D.D.C., 05/09/2022
- Venue Allegations: The complaint alleges that venue is proper in the Eastern District of Virginia because the defendants are foreign corporations that have committed acts of infringement and caused injury to the plaintiff in that judicial district.
- Core Dispute: Plaintiff alleges that Defendants’ hyaluronic acid-based cosmetic serums and creams infringe patents related to stable, high-concentration polymer matrix formulations for topical delivery.
- Technical Context: The technology concerns cosmetic and pharmaceutical compositions designed to overcome the inherent instability and manufacturing challenges of formulating products with high concentrations of hyaluronic acid.
- Key Procedural History: The complaint states that the asserted U.S. Patent No. 10,322,142 is a continuation of the application that led to the asserted U.S. Patent No. 9,821,005. Plaintiff alleges it contacted Defendants prior to filing suit, citing the patents and offering a license, which Defendants allegedly refused.
Case Timeline
| Date | Event |
|---|---|
| 2015-07-23 | Priority Date for ’005 & ’142 Patents |
| 2017-11-21 | U.S. Patent No. 9,821,005 Issued |
| 2019-06-18 | U.S. Patent No. 10,322,142 Issued |
| 2022-05-09 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 9,821,005 - "Polymer Matrix Compositions Comprising a High Concentration of Bio-fermented Sodium Hyaluronate and Uses Thereof," issued November 21, 2017
The Invention Explained
- Problem Addressed: The patent describes the difficulty of creating stable cosmetic formulations with high concentrations (above 1.5% w/w) of sodium hyaluronate (HA), a popular moisturizing agent (ʼ005 Patent, col. 2:10-18). Such high-concentration formulas are prone to instability, quickly breaking down and losing efficacy, and formulations using animal-sourced HA (from rooster combs) carry risks of allergic reactions (ʼ005 Patent, col. 2:1-9, 2:19-28).
- The Patented Solution: The invention is a stable gel composition that combines a high concentration of bio-fermented sodium hyaluronate (derived from bacteria, not animals) with a specific non-ionic polymer (hydroxyethylcellulose), polyethylene glycol (PEG), and a preservative (methylparaben) in water (ʼ005 Patent, Abstract; col. 3:55-65). This specific combination is described as creating a stable, commercially viable polymer matrix for topical delivery (ʼ005 Patent, col. 2:51-58).
- Technical Importance: The claimed formulation enables the production of stable, high-concentration HA products that avoid the allergenic potential of animal-sourced ingredients, thereby improving shelf-life and therapeutic or cosmetic performance (ʼ005 Patent, col. 4:41-54).
Key Claims at a Glance
- The complaint asserts independent claim 1 and dependent claim 5 (Compl. ¶22, ¶34).
- The essential elements of independent claim 1 are:
- A stable topical polymer matrix gel composition comprising:
- 1.5% w/w to 3.5% w/w bio-fermented sodium hyaluronate;
- 0.1% w/w to 2.0% w/w hydroxyethylcellulose;
- 2% w/w to 4% w/w polyethylene glycol;
- 0.1% w/w to 0.3% w/w methylparaben; and
- water.
U.S. Patent No. 10,322,142 - "Polymer Matrix Compositions Comprising a High Concentration of Bio-fermented Sodium Hyaluronate and Uses Thereof," issued June 18, 2019
The Invention Explained
- Problem Addressed: The '142 Patent addresses the same technical problems as its parent '005 Patent: the instability of high-concentration HA formulations and the impurity and allergy risks associated with animal-derived HA (ʼ142 Patent, col. 2:1-9, 2:10-28).
- The Patented Solution: The invention is a polymer matrix composition that, like the '005 Patent, uses bio-fermented sodium hyaluronate. However, its claims add specific purity and stability requirements. The solution is described as a composition using ingredients of compendial or pharmaceutical grade to achieve improved stability and reduced cytotoxicity compared to prior formulations (ʼ142 Patent, col. 4:41-54). The claims explicitly define "stable" based on the HA concentration remaining within +/-10% of its original amount over specified time periods and conditions (ʼ142 Patent, col. 3:1-9).
- Technical Importance: This invention provides a method for creating high-purity, verifiably stable HA formulations, which is critical for ensuring consistent performance and quality in cosmetic and pharmaceutical products (ʼ142 Patent, col. 4:30-40).
Key Claims at a Glance
- The complaint asserts independent claim 1 and multiple dependent claims (Compl. ¶28, ¶40).
- The essential elements of independent claim 1 are:
- A polymer matrix composition comprising:
- about 1.5% w/w to about 3.5% w/w bio-fermented sodium hyaluronate,
- about 0.1% w/w to about 2.0% w/w hydroxyethylcellulose non-ionic polymer,
- about 2% w/w to about 4% w/w of polyethylene glycol (PEG), and
- water, and
- wherein the PEG has a combined ethylene glycol and diethylene glycol content of less than or equal to 0.25% w/w;
- and the amount of PEG having a molecular weight of at least 400 is less than 5 weight % by total weight of the PEG, and
- the sodium hyaluronate in the gel is stable upon storage for at least 6 months at 40° C. and 75% relative humidity and/or for at least 18 months at 25° C. and 60% relative humidity.
III. The Accused Instrumentality
Product Identification
- The L'Oreal products identified are: Revitalift 1.5% Pure Hyaluronic Acid; 1.5% HA Revitalift; and Revitalift Filler 1.5% Hyaluronic Acid Serum (Compl. ¶14).
- The Vichy products identified are: Liftactiv Supreme H.A. Wrinkle Filler 1.5% Hyaluronic Acid Serum + Vitamin C; Liftactiv HA Wrinkle Filler 1ml; and Liftactiv Supreme Night 1.5ML Firming Anti-Aging Cream (Compl. ¶15).
Functionality and Market Context
- The complaint alleges that the accused products are cosmetic formulations containing high concentrations of hyaluronic acid within a polymer matrix that includes a non-ionic polymer (Compl. ¶14, ¶15).
- These products are alleged to be manufactured, sold, and distributed by Defendants throughout the United States (Compl. ¶3, ¶4). The complaint asserts, based on "investigation, testing, information and belief," that these products contain all the elements of one or more asserted patent claims (Compl. ¶14, ¶15).
- No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint pleads infringement in a conclusory manner, asserting that the accused products meet the limitations of the claims without providing a detailed, element-by-element mapping based on specific evidence.
’005 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A stable topical polymer matrix gel composition comprising: 1.5% w/w to 3.5% w/w bio-fermented sodium hyaluronate; | The complaint alleges the Accused Products are formulations containing "high concentrations of Hyaluronic Acid in a Polymer matrix" and include each of the recited elements of the asserted claims (Compl. ¶14, ¶17, ¶19). | ¶14, ¶17, ¶19 | col. 8:52-56 |
| 0.1% w/w to 2.0% w/w hydroxyethylcellulose; | The complaint alleges the Accused Products contain a non-ionic polymer and have all the elements of the claimed formulas (Compl. ¶14, ¶17, ¶19). | ¶14, ¶17, ¶19 | col. 8:61-65 |
| 2% w/w to 4% w/w polyethylene glycol; | The complaint alleges the Accused Products contain the claimed elements (Compl. ¶17, ¶19). | ¶17, ¶19 | col. 8:63-65 |
| 0.1% w/w to 0.3% w/w methylparaben; | The complaint alleges the Accused Products contain the claimed elements (Compl. ¶17, ¶19). | ¶17, ¶19 | col. 8:35-36 |
| and water. | The complaint alleges the Accused Products contain the claimed elements (Compl. ¶17, ¶19). | ¶17, ¶19 | col. 6:53 |
’142 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A polymer matrix composition comprising: about 1.5% w/w to about 3.5% w/w bio-fermented sodium hyaluronate, | The complaint alleges the Accused Products contain "high concentrations of Hyaluronic Acid" and that the formulations have all the elements of the claims asserted (Compl. ¶15, ¶18, ¶19). | ¶15, ¶18, ¶19 | col. 8:52-56 |
| about 0.1% w/w to about 2.0% w/w hydroxyethylcellulose non-ionic polymer, | The complaint alleges the Accused Products include a "non-ionic polymer" and have all the elements of the claims asserted (Compl. ¶15, ¶18, ¶19). | ¶15, ¶18, ¶19 | col. 8:61-65 |
| about 2% w/w to about 4% w/w of the polyethylene glycol (PEG), | The complaint alleges the Accused Products contain the claimed elements (Compl. ¶18, ¶19). | ¶18, ¶19 | col. 8:63-65 |
| wherein the PEG has a combined ethylene glycol and diethylene glycol content of less than or equal to 0.25% w/w; | The complaint makes a general allegation that the Accused Products "have all of the elements of one or more of the claims" without providing specific facts regarding this purity limitation (Compl. ¶14, ¶15, ¶19). | ¶14, ¶15, ¶19 | col. 8:50-52 |
| and the amount of PEG having a molecular weight of at least 400 is less than 5 weight % by total weight of the PEG, | The complaint does not provide specific facts to support this limitation, relying on its general allegation of infringement (Compl. ¶14, ¶15, ¶19). | ¶14, ¶15, ¶19 | col. 8:57-60 |
| and the sodium hyaluronate in the gel is stable upon storage for at least 6 months at 40° C. and 75% relative humidity and/or for at least 18 months at 25° C. and 60% relative humidity. | The complaint does not provide specific facts to support this stability limitation, relying on its general allegation of infringement (Compl. ¶14, ¶15, ¶19). | ¶14, ¶15, ¶19 | col. 3:1-9 |
Identified Points of Contention
- Evidentiary Questions: The primary point of contention will be factual and evidentiary. The complaint's allegations regarding the specific chemical compositions of the accused products will require proof through discovery and expert testing to determine if the products actually contain each ingredient within the precise weight-percentage ranges recited in the claims.
- Technical Questions: For the '142 Patent, a key question is whether the accused products meet the highly specific claim limitations related to PEG purity and long-term stability. Plaintiff will bear the burden of producing technical evidence, such as from chemical analysis and stability studies, to demonstrate that Defendants' products satisfy these quantitative requirements.
V. Key Claim Terms for Construction
The Term: "bio-fermented sodium hyaluronate"
- Context and Importance: This term defines the source and type of the main active ingredient. The patents distinguish this ingredient from "natural sodium hyaluronate" derived from animal sources, which is described as having disadvantages (ʼ142 Patent, col. 2:1-9, 4:41-45). Infringement will depend on whether the sodium hyaluronate used in the accused products falls within the scope of this term.
- Evidence for a Broader Interpretation: The specification states that "Sodium hyaluronate obtained from a bacterial source is referred to hereinafter as 'bio-fermented' sodium hyaluronate" and gives Streptococcus zooepidemicus or Bacillus subtilis as examples, which may support an interpretation covering HA derived from any bacterial fermentation process (ʼ142 Patent, col. 3:55-59).
- Evidence for a Narrower Interpretation: The abstract and detailed description repeatedly emphasize Streptococcus zooepidemicus as the source, which a defendant may argue narrows the term to HA derived from that specific bacterial family or a closely related one (ʼ142 Patent, Abstract; col. 3:28-30).
The Term: "stable"
- Context and Importance: This term is a critical limitation in claim 1 of the '142 Patent, which explicitly defines it with quantitative parameters. The dispute is less likely to be over the term's meaning and more over whether the accused products can be factually proven to meet this definition.
- Intrinsic Evidence for Interpretation: The patent provides its own definition for the term, both in the claim itself and in the specification. It is defined to mean that "the amount of sodium hyaluronate in the formulation does not vary by more than +/−10% (w/w) relative to the original amount" when stored under specified conditions (e.g., for at least 6 months at 40° C. and 75% relative humidity) (ʼ142 Patent, col. 3:1-9; cl. 1). This explicit definition will likely control any interpretation, shifting the focus to evidentiary proof of the accused products' performance.
VI. Other Allegations
Willful Infringement
- The complaint alleges that Defendants' infringement has been willful (Compl. ¶24, ¶30). The basis for this allegation is purported pre-suit knowledge of the patents. The complaint states that "Glyco contacted Defendants, citing the Glyco Patents," and that "Defendants have so far refused to respect the patent rights of Glyco, despite offers of license" (Compl. ¶16). This alleged refusal to cease infringement or take a license after being notified of the patents forms the basis for the willfulness claim.
VII. Analyst’s Conclusion: Key Questions for the Case
- A key evidentiary question will be one of compositional proof: what evidence, likely from laboratory testing, will Plaintiff produce to demonstrate that Defendants' products contain each of the claimed chemical components within the specific weight-percentage ranges required by the asserted claims, particularly given the "about" language in the '142 Patent?
- A central technical issue for the '142 patent will be one of performance metrics: can Plaintiff prove through chemical analysis and stability studies that the accused products meet the specific, quantified limitations for PEG purity and long-term stability as explicitly defined in claim 1?
- A foundational question will be one of definitional scope: can Plaintiff establish that the term "bio-fermented sodium hyaluronate," which the patent contrasts with animal-sourced HA, reads on the specific type and source of hyaluronic acid used in the L'Oreal and Vichy products?