DCT
1:23-cv-04564
Microvascular Health Solutions LLC v. Ortho Molecular Products Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Microvascular Health Solutions, LLC (Delaware)
- Defendant: Ortho Molecular Products, Inc. (Wisconsin)
- Plaintiff’s Counsel: Akerman LLP / Workman Nydegger
- Case Identification: 1:23-cv-04564, N.D. Ill., 07/14/2023
- Venue Allegations: Plaintiff alleges venue is proper because Defendant transacts business in the district, maintains continuous contacts, and has corporate offices located within the Northern District of Illinois.
- Core Dispute: Plaintiff alleges that Defendant’s "Glycocalyx Pro" dietary supplement infringes a patent related to compositions and methods for treating the endothelial glycocalyx, a protective lining in blood vessels.
- Technical Context: The technology involves nutritional supplements formulated with a combination of precursors, antioxidants, and mimetics to restore, protect, and repair the endothelial glycocalyx, a structure increasingly recognized as critical for cardiovascular health.
- Key Procedural History: The complaint alleges that Plaintiff sent a cease-and-desist letter to Defendant on or about June 27, 2023, putting Defendant on notice of the asserted patent prior to the filing of the lawsuit.
Case Timeline
| Date | Event |
|---|---|
| 2015-04-08 | U.S. Patent No. 9,943,572 Priority Date |
| 2018-04-17 | U.S. Patent No. 9,943,572 Issue Date |
| 2023-06-27 | Cease-and-Desist Letter Sent to Defendant (alleged) |
| 2023-07-14 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 9,943,572 - Synergistic Glycocalyx Treatment Compositions and Methods, issued April 17, 2018
The Invention Explained
- Problem Addressed: The patent describes how a damaged or depleted endothelial glycocalyx—the delicate, gel-like layer lining all blood vessels—can lead to microvascular dysfunction, including "leaky" vessel walls and reduced blood flow, contributing to negative vascular health conditions (ʼ572 Patent, col. 1:56-65; col. 2:1-7).
- The Patented Solution: The invention claims a composition that provides a multi-pronged, synergistic approach to treating the glycocalyx. It combines: (1) molecular precursors like glucosamine to stimulate the synthesis of new glycocalyx; (2) antioxidants like superoxide dismutase to protect the existing glycocalyx from oxidative damage; and (3) "glycocalyx mimetics" like hyaluronan and fucoidan to directly repair or "patch" damaged areas ('572 Patent, Abstract; col. 2:16-28). The flowchart in Figure 4 of the patent illustrates these distinct but interrelated mechanisms of action ('572 Patent, Fig. 4).
- Technical Importance: The claimed invention provides a formulation that purports to have a synergistic effect—greater than the sum of its individual components—in maintaining and restoring the glycocalyx, a structure whose critical role in vascular health was an area of growing scientific and medical interest ('572 Patent, col. 5:15-26).
Key Claims at a Glance
- The complaint asserts independent claims 1 and 17.
- Independent Claim 1 is a method for treating endothelial glycocalyx by administering a composition with three key components:
- A molecular precursor comprising glucosamine to increase glycocalyx production.
- An antioxidant comprising superoxide dismutase to protect the existing glycocalyx.
- A glycocalyx mimetic selected from a group including hyaluronan and fucoidan to increase glycocalyx density at damaged sites.
- Independent Claim 17 is a similar method claim, also requiring a three-part composition comprising glucosamine, superoxide dismutase, and a mimetic group including hyaluronan and fucoidan.
III. The Accused Instrumentality
Product Identification
- Defendant's dietary supplement product named "Glycocalyx Pro" (Compl. ¶18).
Functionality and Market Context
- The complaint alleges that Glycocalyx Pro is marketed with claims that it helps to "preserve, protect and regenerate the endothelial glycocalyx" and "strengthen the endothelial glycocalyx by providing the foundational building blocks" (Compl. ¶18).
- The product's "Supplement Facts" label, included in the complaint, lists ingredients including "Glucosamine Sulfate Potassium Chloride USP," "Fucus Vesiculosis Seaweed Extract (Whole Plant) (Contains Fucoidan...)," and "Chicken Comb Extract (MOBILEE®) (Standardized to contain 40 mg Hyaluronic Acid)" (Compl. ¶21). This visual from the complaint shows the product's ingredients as listed on its packaging (Compl. ¶21, p. 5).
- Plaintiff alleges that Defendant based its Glycocalyx Pro supplement on Plaintiff's own commercial product, Endocalyx Pro (Compl. ¶19).
IV. Analysis of Infringement Allegations
'572 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| one or more molecular precursor of endothelial glycocalyx, comprising glucosamine, in an amount effective to increase production of endothelial glycocalyx; | The accused product's "Supplement Facts" label identifies "Glucosamine Sulfate Potassium Chloride USP" as an ingredient. | ¶21 | col. 9:56-65 |
| one or more antioxidant that associates with endothelial glycocalyx, comprising superoxide dismutase, in an amount effective to at least partially protect existing endothelial glycocalyx...; | The product contains "Fucus Vesiculosis Seaweed Extract." The complaint alleges, citing an external scientific article, that this seaweed has high activities of superoxide dismutase. | ¶21 | col. 10:35-38 |
| and one or more glycocalyx mimetic selected from the group consisting of a nonsulfated glycosaminoglycan, hyaluronan, a sulfated polysaccharide, and fucoidan, in an amount effective to increase the density of endothelial glycocalyx... | The product's label identifies "Fucus Vesiculosis Seaweed Extract... (Contains Fucoidan...)" and "Chicken Comb Extract (MOBILEE®) (Standardized to contain 40 mg Hyaluronic Acid)," which the complaint maps to the claimed mimetics fucoidan and hyaluronan. | ¶21 | col. 8:1-4 |
Identified Points of Contention
- Technical Question: The complaint's theory for the "superoxide dismutase" element relies on an assertion that the accused product's seaweed extract "has high activities of superoxide dismutase," supported by an external scientific paper (Compl. ¶21). A central technical question will be what evidence demonstrates that this ingredient either is or contains the specific enzyme superoxide dismutase, as required by the claim.
- Scope Questions: The primary dispute over claim scope may focus on whether an ingredient that exhibits the activity of a claimed substance (superoxide dismutase) is sufficient to meet a limitation that requires comprising that substance. The patent's own disclosure of sourcing SOD from a plant extract may support the Plaintiff's position that providing an extract containing the enzyme meets the limitation ('572 Patent, col. 10:39-44).
V. Key Claim Terms for Construction
The Term: "comprising superoxide dismutase"
- Context and Importance: This term is central to the infringement analysis for a key element of the asserted claims. The defendant’s product does not appear to list "superoxide dismutase" as a standalone ingredient. Infringement will depend on whether the seaweed extract ingredient, alleged to have SOD activity, falls within the scope of this term.
- Intrinsic Evidence for a Broader Interpretation: The specification discloses that the claimed SOD can be "extracted and/or purified from...a (non-GMO) plant (part), preferably...Momordica charantia (a.k.a. bitter melon) (fruit)" ('572 Patent, col. 10:39-44). This may support an interpretation that providing a natural plant extract known to contain the active enzyme satisfies the "comprising" requirement.
- Intrinsic Evidence for a Narrower Interpretation: The claim language recites specific chemical and biological entities (glucosamine, hyaluronan, fucoidan). A party could argue that to "comprise superoxide dismutase," the composition must include the enzyme as a constituent, not merely an ingredient that exhibits the enzyme's function.
VI. Other Allegations
- Indirect Infringement: The complaint alleges both induced and contributory infringement. The inducement claim is based on allegations that Defendant instructs its customers, via marketing and product information, to use Glycocalyx Pro in an infringing manner, and did so with knowledge of the '572 patent (Compl. ¶21-24, 29). The contributory infringement claim is based on the allegation that Glycocalyx Pro has no substantial non-infringing use (Compl. ¶40).
- Willful Infringement: Willfulness is alleged based on both pre-suit and post-filing conduct. The complaint alleges on information and belief that Defendant was aware of the '572 patent even before receiving a cease-and-desist letter on June 27, 2023, and that it "launched" the accused product despite this knowledge (Compl. ¶22, 24).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central evidentiary question will be one of component identity: does the accused product's Fucus vesiculosus extract, which the complaint alleges possesses "high activities of superoxide dismutase," satisfy the claim requirement of a composition "comprising superoxide dismutase," or will the court require proof of the enzyme as a distinct, identifiable ingredient?
- The case may also present a question of functional proof: what level of evidence will be required to demonstrate that the accused ingredients perform the functions recited in the claims, such as being "in an amount effective to increase production of endothelial glycocalyx" in consumers of the product?