DCT

2:23-cv-08772

Epitracker Inc v. AGOURA Health Products LLC

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:23-cv-08772, C.D. Cal., 10/18/2023
  • Venue Allegations: Venue is alleged to be proper as Defendant Gundry MD is a California company with its principal place of business in the district, and Defendant Dr. Gundry is an individual domiciled in the district.
  • Core Dispute: Plaintiffs allege that Defendants’ “C15 Advantage” dietary supplement infringes a patent directed to methods of using pentadecanoic acid to treat symptoms of metabolic syndrome.
  • Technical Context: The lawsuit concerns the use of pentadecanoic acid (C15:0), an odd-chain saturated fatty acid, in dietary supplements marketed for improving metabolic health and cellular function.
  • Key Procedural History: The patent-in-suit is subject to a terminal disclaimer over prior patents in the same family. Plaintiffs allege they sent cease-and-desist letters to Defendants beginning on November 11, 2022, placing Defendants on notice of the patent prior to a period of continued alleged infringement.

Case Timeline

Date Event
2015-01-07 ’740 Patent Priority Date
2020-10-01 Plaintiff's product (Fatty15®) launched
2021-04-01 Dr. Gundry allegedly became a customer of Plaintiff's product
2021-09-14 ’740 Patent Issue Date
2022-11-09 Accused Product (C15 Advantage) launched
2022-11-11 Defendants allegedly had actual knowledge of the ’740 Patent
2023-10-18 Complaint Filing Date

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

U.S. Patent No. 11,116,740 - "Methods for Use in Support of Planned Supplement and Food Ingredient Products for Diagnosis and Treatment of Metabolic Syndrome"

  • Patent Identification: U.S. Patent No. 11,116,740, "Methods for Use in Support of Planned Supplement and Food Ingredient Products for Diagnosis and Treatment of Metabolic Syndrome," issued September 14, 2021.

The Invention Explained

  • Problem Addressed: The patent’s background section describes metabolic syndrome as a widespread disorder of energy use and storage that increases the risk of cardiovascular disease and type 2 diabetes (’740 Patent, col. 1:47-53). It also notes a correlation between metabolic syndrome and high serum ferritin (hyperferritinemia), and that conventional early-stage treatments are often limited to diet and exercise recommendations that some subjects are unable to follow (’740 Patent, col. 2:1-7, 2:25-30).
  • The Patented Solution: The invention provides methods for treating or preventing metabolic syndrome by administering compositions containing one or more odd-chain fatty acids, with a particular focus on pentadecanoic acid (referred to as C17:0 in the patent and C15:0 in the complaint) (’740 Patent, Abstract; col. 2:31-42). The administration of this fatty acid is claimed to modulate various markers associated with metabolic syndrome, such as elevated insulin, glucose, and ferritin (’740 Patent, col. 2:38-42).
  • Technical Importance: The invention proposes a specific nutritional intervention using odd-chain fatty acids as a targeted method to address the underlying factors of metabolic syndrome, moving beyond general dietary advice (’740 Patent, col. 2:16-30).

Key Claims at a Glance

  • The complaint asserts independent claim 3 of the ’740 Patent (Compl. ¶36, 102).
  • The essential elements of independent claim 3 are:
    • A method comprising: administering, to a patient, pentadecanoic acid
    • at a daily dose comprising an approximate minimum of 0.3 mg per kg of the patient's body weight
    • wherein the pentadecanoic acid is administered in a form selected from the group consisting of a supplement, a food, a food additive, a food fortifier, a beverage additive, a beverage fortifier, and a pharmaceutical.
  • The complaint does not explicitly reserve the right to assert other claims but infringement allegations are directed at "one or more claims..., including claim 3" (Compl. ¶52).

III. The Accused Instrumentality

Product Identification

  • The accused product is the "C15 Advantage" daily dietary supplement (Compl. ¶23).

Functionality and Market Context

  • The C15 Advantage product is a softgel capsule marketed as a "revolutionary mitochondrial health formula" (Compl. p. 18). According to its "Supplement Facts" label, each serving contains 50 mg of pentadecanoic acid, referred to as “NutraAssure™ Pentadecanoic Acid[C15]” (Compl. ¶45, p. 11). The complaint alleges the product is sold as a daily supplement intended for oral administration by consumers to achieve various health benefits (Compl. ¶45, 56). A photograph provided in the complaint shows the accused C15 Advantage product bottle alongside the Plaintiffs' Fatty15® product bottle, underscoring the direct competition between them (Compl. p. 20).
  • The complaint alleges the accused product directly competes with Plaintiffs' own Fatty15® product and that Defendants have engaged in a marketing campaign that leverages Plaintiffs' research to promote C15 Advantage (Compl. ¶50, 62-64).

IV. Analysis of Infringement Allegations

’740 Patent Infringement Allegations

Claim Element (from Independent Claim 3) Alleged Infringing Functionality Complaint Citation Patent Citation
A method comprising: administering, to a patient, pentadecanoic acid... Defendants sell and market the C15 Advantage product and instruct their customers to take it as a daily supplement. Defendant Dr. Gundry is also alleged to take the product. ¶45, 48, 56 col. 62:21-22
...at a daily dose comprising an approximate minimum of 0.3 mg per kg of the patient's body weight... Each serving of C15 Advantage contains 50 mg of pentadecanoic acid. This dose is alleged to meet the minimum threshold for any individual weighing less than approximately 367 lbs (166 kgs). ¶47 col. 62:22-24
...wherein the pentadecanoic acid is administered in a form selected from the group consisting of a supplement... The C15 Advantage product is sold and marketed as a daily dietary supplement. The product label is presented as a "Supplement Facts" label. The image of the product label is included in the complaint. ¶45, p. 11 col. 62:24-26
  • Identified Points of Contention:
    • Scope Questions: The central issue for infringement will likely be the dosage limitation. A key question is whether Defendants' sale of a fixed 50 mg dose supplement, which satisfies the "approximate minimum of 0.3 mg per kg" limitation only for consumers below a certain weight, is sufficient to support claims of indirect infringement. The analysis will depend on whether Plaintiffs can prove Defendants specifically intended for this weight-dependent method to be practiced by their customers.
    • Technical Questions: The complaint alleges the C15:0 in the accused product is in a "less bioavailable triacylglyceride form" compared to Plaintiffs' "pure, free fatty acid" (Compl. ¶20). While the claim recites "pentadecanoic acid" without specifying a chemical form, a potential dispute could arise over whether this term should be construed to cover various derivatives like triglycerides or be limited to the free acid form, which could be informed by the patent's specification.

V. Key Claim Terms for Construction

  • The Term: "approximate minimum of 0.3 mg per kg"
  • Context and Importance: This term is the lynchpin of the infringement allegation. The definition of "approximate minimum" will determine whether the accused product's 50 mg fixed dose falls within the scope of the claim for a substantial portion of the consumer base. Practitioners may focus on this term because its inherent imprecision ("approximate") creates a clear area for dispute over the boundary of the claimed invention.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The term "approximate" itself suggests the patentee did not intend a rigid, absolute numerical floor. A party could argue it is broad enough to cover doses that are reasonably close to, even if slightly below, the 0.3 mg/kg calculation for a given patient.
    • Evidence for a Narrower Interpretation: The patent specification also describes embodiments with significantly higher dosages, such as "from 2.5 mg to 11 mg, per 1 kg of body weight" (’740 Patent, col. 2:66-67). A party could argue that this disclosure of a higher range, combined with the specific recitation of "0.3 mg" in the claim, points to a more precise and less flexible "minimum."

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement, stating that Defendants encourage their customers to directly infringe by providing a product with instructions for use and marketing materials that promote its daily consumption in a manner taught by the patent (Compl. ¶56-58). It also alleges contributory infringement, stating the C15 Advantage product is not a staple article of commerce suitable for substantial noninfringing use (Compl. ¶59).
  • Willful Infringement: Willfulness is alleged based on Defendants' purported knowledge of the ’740 patent since at least November 11, 2022, following receipt of a cease-and-desist letter from Plaintiffs. The complaint alleges that Defendants continued to sell the accused product despite this knowledge (Compl. ¶49, 55, 80-83).

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

  • A core issue will be one of infringement scope and intent: Can Plaintiffs demonstrate that Defendants, by selling a fixed-dose supplement, possessed the specific intent to induce infringement of a method claim whose practice is dependent on the end-user's body weight? The resolution will likely depend on evidence of Defendants' marketing and knowledge regarding their customer base.
  • A second key issue will be one of claim construction: How will the court define the scope of "approximate minimum"? The interpretation of this term will directly impact whether the accused product's 50 mg dosage is capable of infringing for a legally significant portion of its users.
  • A final question will concern the interplay between the patent and non-patent claims: To what extent will the extensive allegations of false advertising—particularly those concerning product purity, bioavailability, and the misappropriation of Plaintiffs' research—influence the framing and perception of the more technical patent infringement dispute?