DCT
8:23-cv-01062
GlycoBioSciences Inc v. Johnson & Johnson
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: GlycoBioSciences, Inc. (Canada)
- Defendant: Johnson & Johnson (New Jersey)
- Plaintiff’s Counsel: DNL Zito Castellano
- Case Identification: 8:23-cv-01062, D. Md., 04/19/2023
- Venue Allegations: Venue is alleged to be proper in the District of Maryland because Defendant Johnson & Johnson maintains regular and established places of business in the state, including subsidiaries and research facilities.
- Core Dispute: Plaintiff alleges that Defendant’s Neutrogena® Hydro Boost line of cosmetic products infringes two patents related to stable, high-concentration formulations of bio-fermented sodium hyaluronate.
- Technical Context: The technology addresses the challenge of creating stable and effective topical skincare products using high concentrations of hyaluronic acid, a popular humectant in the cosmetics industry.
- Key Procedural History: The complaint alleges that the '142 Patent is a continuation of the '005 Patent. Plaintiff also states it contacted Defendant pre-suit, cited the patents-in-suit, and made offers of a license, which were allegedly refused. This history is asserted as a basis for willful infringement.
Case Timeline
| Date | Event |
|---|---|
| 2015-07-23 | Priority Date for '005 and '142 Patents |
| 2017-11-21 | U.S. Patent No. 9,821,005 Issued |
| 2019-06-18 | U.S. Patent No. 10,322,142 Issued |
| 2023-04-19 | 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"
- Patent Identification: U.S. Patent No. 9,821,005, titled "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's background section describes the difficulty in creating stable cosmetic or pharmaceutical formulations with high concentrations (above 1.5% w/w) of sodium hyaluronate (HA), noting that such compositions tend to be unstable, break down quickly, and are often too viscous for practical use in packaging like tubes ('005 Patent, col. 2:11-25). It also identifies a risk of allergic reactions and disease transmission from HA derived from animal sources, such as rooster combs ('005 Patent, col. 2:1-8).
- The Patented Solution: The invention claims to solve these problems by creating a stable polymer matrix composition using a specific combination of ingredients. The core of the solution is the use of a high concentration of bio-fermented sodium hyaluronate, which avoids animal-source issues, combined with hydroxyethylcellulose (a non-ionic polymer), polyethylene glycol, and methylparaben in water to form a stable gel ('005 Patent, Abstract; col. 3:56-65).
- Technical Importance: This approach provided a method to formulate HA at high concentrations that were previously difficult to achieve, while ensuring product stability and avoiding the safety concerns associated with animal-derived ingredients ('005 Patent, col. 3:35-54).
Key Claims at a Glance
- The complaint asserts independent claim 1 and dependent claim 5 (Compl. ¶21).
- The essential elements of independent claim 1 are:
- A stable topical polymer matrix gel composition comprising:
- 1.5% to 3.5% w/w bio-fermented sodium hyaluronate;
- 0.1% 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"
- Patent Identification: U.S. Patent No. 10,322,142, titled "Polymer Matrix Compositions Comprising a High Concentration of Bio-fermented Sodium Hyaluronate and Uses Thereof," issued June 18, 2019.
The Invention Explained
- Problem Addressed: As a continuation of the '005 Patent, the '142 Patent addresses the same technical problems: the instability and high viscosity of high-concentration HA formulations and the allergenic risks of animal-sourced HA ('142 Patent, col. 2:11-25).
- The Patented Solution: The patented solution is a stable polymer matrix composition. The claims of the '142 patent are broader in some respects, for example, reciting a generic "non-ionic polymer" rather than being limited to hydroxyethylcellulose. Claim 1 also introduces specific purity and molecular weight limitations for the polyethylene glycol (PEG) component, which are not present in the '005 patent's independent claim ('142 Patent, col. 31:12-26).
- Technical Importance: The invention provides a stable and commercially viable platform for delivering high concentrations of non-animal-sourced HA for various topical applications, including cosmetic and dermatological treatments ('142 Patent, col. 3:51-54).
Key Claims at a Glance
- The complaint asserts independent claims 1 and 13, as well as several dependent claims (Compl. ¶27).
- The essential elements of independent claim 1 (a composition claim) are:
- A polymer matrix composition comprising: about 1.5% to 3.5% w/w bio-fermented sodium hyaluronate;
- about 0.1% to 2.0% w/w hydroxyethylcellulose non-ionic polymer;
- about 2% to 4% w/w of polyethylene glycol (PEG);
- water;
- 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 a specified duration and condition.
- The essential elements of independent claim 13 (a method claim) are:
- A method of treatment comprising topically applying the polymer matrix composition of claim 3, thereby treating a condition selected from a specified group (including dermatological conditions, damaged skin, and musculoskeletal pain).
III. The Accused Instrumentality
Product Identification
- The accused instrumentalities are a line of cosmetic products sold under the brand name Neutrogena® Hydro Boost. The complaint lists numerous specific products, including various "Hydro Boost" Body Gels, Creams, Serums, and Cleansers (Compl. ¶14).
Functionality and Market Context
- The complaint alleges that the accused products are cosmetics containing hyaluronic acid that "utilize the patented formulations" (Compl. ¶1, ¶14). The core accused functionality is the formulation itself, which allegedly comprises "high concentrations of Hyaluronic Acid in a Polymer matrix which includes a non-ionic polymer" and other claimed components (Compl. ¶14, ¶21, ¶27). The products are alleged to be sold and distributed throughout the United States (Compl. ¶3).
Visual Evidence
- No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
'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: | The complaint alleges the accused products are formulations with the recited elements or their equivalents (Compl. ¶18). | ¶21 | col. 2:31-34 |
| 1.5% to 3.5% w/w bio-fermented sodium hyaluronate; | The accused products allegedly contain "Sodium Hyaluronate" (Compl. ¶21). The complaint alleges "high concentrations" (Compl. ¶14). | ¶21 | col. 2:58-62 |
| 0.1% to 2.0% w/w hydroxyethylcellulose; | The accused products allegedly contain "Hydroxyethylcellulose" (Compl. ¶21). | ¶21 | col. 4:41-42 |
| 2% w/w to 4% w/w polyethylene glycol; | The patent protects formulations with polyethylene glycol (Compl. ¶10), and the accused products are alleged to be infringing formulations (Compl. ¶1). | ¶21 | col. 5:50-53 |
| 0.1% w/w to 0.3% w/w methylparaben; and | The patent protects formulations with methylparaben ('005 Patent, claim 1), and the accused products are alleged to be infringing formulations (Compl. ¶1). | ¶21 | col. 5:50-53 |
| water. | The accused products allegedly contain "Water" (Compl. ¶21). | ¶21 | col. 5:53 |
'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 accused products allegedly contain "Sodium Hyaluronate" (Compl. ¶27). The complaint alleges "high concentrations" (Compl. ¶14). | ¶27 | col. 3:59-62 |
| about 0.1% w/w to about 2.0% w/w hydroxyethylcellulose non-ionic polymer, | The accused products allegedly contain "Hydroxyethylcellulose" and "cellulose," which are non-ionic polymers (Compl. ¶27). | ¶27 | col. 5:13-14 |
| about 2% w/w to about 4% w/w of the polyethylene glycol (PEG), and water | The accused products allegedly contain "Water" and other components including "Butylene Glycol" which can be a PEG (Compl. ¶27). | ¶27 | col. 8:47-49 |
| wherein the PEG has a combined ethylene glycol and diethylene glycol content of less than or equal to 0.25% w/w; | The complaint alleges the accused products have all elements of the claims (Compl. ¶14), but provides no specific data on this limitation. | ¶27 | col. 8:47-52 |
| and the sodium hyaluronate in the gel is stable upon storage... | The complaint does not provide specific evidence of stability, but alleges infringement of all claim elements (Compl. ¶14). | ¶27 | col. 3:1-9 |
- Identified Points of Contention:
- Evidentiary Questions: The complaint makes conclusory allegations that the accused products meet the claimed limitations. A primary point of contention will be factual: do the accused Neutrogena products contain the claimed ingredients within the specific weight-percentage ranges required by the claims? The complaint provides a list of ingredients but no quantitative analysis (Compl. ¶21, ¶27).
- Scope Questions: A core question will be whether the "Sodium Hyaluronate" used in the accused products qualifies as "bio-fermented sodium hyaluronate" as required by the claims. This term is defined in the patents as being obtained from a bacterial source ('142 Patent, col. 3:59-62). Discovery into Defendant’s sourcing and manufacturing will be necessary to resolve this.
- Technical Questions: The complaint does not provide any evidence to support the "stable" limitation, which is defined in the patents with specific, testable criteria ('142 Patent, col. 3:1-9). Proving that the accused products meet this technical requirement will be a key evidentiary burden for the Plaintiff. The complaint also lists "hydrolyzed hyaluronic acid" as an ingredient in the accused products (Compl. ¶21, ¶27), which is not a claimed element and may raise questions of technical and compositional differences.
V. Key Claim Terms for Construction
The Term: "bio-fermented sodium hyaluronate"
- Context and Importance: This term is central to the invention's novelty, distinguishing it from prior art that used animal-sourced HA. Infringement hinges on whether the HA in Defendant's products is sourced in a way that falls within the scope of this term.
- Evidence for a Broader Interpretation: The specification defines the term as "Sodium hyaluronate obtained from a bacterial source such as Streptococcus zooepidemicus or Bacillus subtilis source" ('142 Patent, col. 3:59-62). Plaintiff may argue this covers any HA produced via bacterial fermentation, regardless of the specific strain or process.
- Evidence for a Narrower Interpretation: Defendant may argue the term should be construed more narrowly, potentially limited by the specific purity standards discussed elsewhere in the specification, such as having low protein and nucleic acid content ('142 Patent, col. 8:7-9), or by the specific fermentation processes disclosed ('142 Patent, col. 5:48-58).
The Term: "stable"
- Context and Importance: Stability is a key feature and limitation of the claimed compositions. The patent provides an explicit definition, making this a likely focus for factual, rather than legal, dispute.
- Intrinsic Evidence for Interpretation: The patent defines "stable" 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 specific conditions (e.g., "at 40° C., 75% relative humidity... for a period of at least 6 months") ('142 Patent, col. 3:1-9). This provides a clear, technical benchmark. The question for the court will be whether the accused products factually meet this definition, an issue for which the complaint currently provides no evidence.
VI. Other Allegations
- Willful Infringement: The complaint alleges that Defendant's infringement has been willful for both patents (Compl. ¶23, ¶29). The basis for this allegation is claimed pre-suit knowledge. Plaintiff asserts that it "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. ¶15). The complaint further alleges that Defendant has "no good faith defense" and "intentionally continued its infringement" (Compl. ¶23, ¶29).
VII. Analyst’s Conclusion: Key Questions for the Case
- An Evidentiary Question of Composition: The case will likely turn on a critical evidentiary question: can the Plaintiff produce evidence, such as through chemical analysis, that the accused Neutrogena products contain the claimed ingredients within the specific weight-percentage ranges recited in the patent claims? The complaint's allegations are currently conclusory on this point.
- A Definitional Question of Sourcing: A central issue will be one of definitional scope and fact: is the "Sodium Hyaluronate" used in Defendant's products "bio-fermented" as the patents define the term? Resolution will depend on discovery into Defendant's supply chain and manufacturing processes to determine the origin of its ingredients.
- A Factual Question of Performance: A key factual dispute will be whether the accused formulations meet the patents' explicit definition of "stable." This requires specific, time-based testing under controlled conditions, presenting a significant evidentiary hurdle for the Plaintiff to overcome.