DCT

3:25-cv-02515

Amazentis SA v. Neurogan Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:25-cv-02515, S.D. Cal., 09/24/2025
  • Venue Allegations: Venue is alleged to be proper as Defendant is a California corporation with its principal place of business and a regular and established place of business within the Southern District of California.
  • Core Dispute: Plaintiff alleges that Defendant’s dietary supplements and skin care products containing the compound urolithin A infringe six patents related to the use of urolithins for improving muscle performance, mitochondrial function, cognitive function, and cellular autophagy.
  • Technical Context: The technology concerns the administration of urolithin A, a metabolite produced by gut microflora from dietary precursors like ellagitannins, to stimulate mitophagy—a cellular process for recycling damaged mitochondria—thereby promoting healthy aging.
  • Key Procedural History: The complaint alleges that Plaintiff sent Defendant notice letters on August 30, 2023, and June 6, 2025, identifying the patents-in-suit and the accused infringing products. It further alleges that Defendant has cited Plaintiff’s own published clinical studies in its advertising materials for the accused products.

Case Timeline

Date Event
2010-12-23 Priority Date for ’850, ’782, ’126, and ’943 Patents
2012-06-27 Priority Date for ’373 Patent
2015-08-28 Priority Date for ’784 Patent
2018-01-23 U.S. Patent 9,872,850 Issues
2019-10-15 U.S. Patent 10,442,784 Issues
2019-11-26 U.S. Patent 10,485,782 Issues
2020-12-08 U.S. Patent 10,857,126 Issues
2021-06-01 U.S. Patent 11,020,373 Issues
2023-08-30 Plaintiff sends first notice letter to Defendant regarding ’850, ’782, and ’373 Patents
2025-05-27 U.S. Patent 12,310,943 Issues
2025-06-06 Plaintiff sends second notice letter to Defendant regarding all Patents-in-Suit
2025-09-24 Complaint Filed

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

U.S. Patent 9,872,850 - "Compositions and Methods for Improving Mitochondrial Function and Treating Neurodegenerative Diseases and Cognitive Disorders," Issued January 23, 2018

The Invention Explained

  • Problem Addressed: The patent describes the problem of declining mitochondrial energy production, increased oxidative stress, and apoptosis, which play significant roles in degenerative diseases and the aging process (Compl. ¶22; ’782 Patent, col. 1:11-19). This decline can impair cognitive function, metabolic health, and muscle performance (Compl. ¶14; ’782 Patent, col. 51:50-56).
  • The Patented Solution: The invention provides methods of using urolithins, which are metabolites of compounds found in fruits like pomegranates, to improve or maintain mitochondrial function ('782 Patent, col. 3:28-44). By administering an effective amount of a urolithin, the patented methods claim to increase or maintain muscle performance, improve cognitive function, and treat diseases associated with reduced mitochondrial activity ('782 Patent, Abstract).
  • Technical Importance: The invention provides a nutritional or therapeutic approach to counteract age-related declines in cellular and muscular function by targeting the fundamental mechanism of mitochondrial health (Compl. ¶¶14, 16).

Key Claims at a Glance

  • The complaint asserts independent claims 1 and 20 (’850 Patent, col. 84:45-56).
  • Independent Claim 1 elements:
    • A method of enhancing muscle performance
    • comprising: administering to a mammal in need thereof
    • an effective amount of a urolithin
    • to increase muscle performance
  • Independent Claim 20 elements:
    • A method of maintaining muscle performance
    • comprising: administering to a mammal in need thereof
    • an effective amount of a urolithin
    • to maintain muscle performance
  • The complaint reserves the right to assert numerous dependent claims (Compl. ¶¶59, 61).

U.S. Patent 10,442,784 - "Compositions Comprising an Urolithin Compound," Issued October 15, 2019

The Invention Explained

  • Problem Addressed: The patent identifies the technical challenge of improving muscle mass and performance, particularly in the context of age-related decline or pathological conditions ('784 Patent, col. 1:10-18). While protein supplementation is a known strategy, the invention seeks to enhance its efficacy ('784 Patent, col. 1:41-47).
  • The Patented Solution: The invention is a composition that combines a source of protein with a urolithin, specifically urolithin A ('784 Patent, claim 1). This combination is asserted to produce a "surprisingly beneficial and enhanced effect" on muscle endurance and performance compared to the administration of protein alone ('784 Patent, col. 2:10-15). Figure 1 of the patent illustrates this synergistic effect in mice, showing improved running distance and time with the combination diet ('784 Patent, Fig. 1).
  • Technical Importance: This technology offers a synergistic formulation that could increase the effectiveness of nutritional products aimed at muscle health, a significant consumer market (Compl. ¶¶12, 17).

Key Claims at a Glance

  • The complaint asserts independent claim 1 (’784 Patent, col. 20:64-66).
  • Independent Claim 1 elements:
    • A composition comprising:
    • a) a source of protein; and
    • b) urolithin A.
  • The complaint also asserts dependent claim 10 (Compl. ¶67).

U.S. Patent 10,485,782 ("the '782 Patent") - "Compositions and Methods for Improving Mitochondrial Function and Treating Neurodegenerative Diseases and Cognitive Disorders," Issued November 26, 2019

  • Technology Synopsis: The '782 Patent, which is a divisional of the '850 Patent, is directed to methods of increasing or maintaining mitochondrial function by administering an effective amount of a urolithin to a subject in need thereof (Compl. ¶¶28, 30, 72). The invention also covers methods of treating or preventing mitochondria-related diseases or conditions (Compl. ¶75).
  • Asserted Claims: Independent claims 1 and 2 (Compl. ¶¶72, 75).
  • Accused Features: The complaint alleges that Defendant’s marketing of its urolithin A supplements and skin care products for benefits like promoting "mitochondrial function" instructs users to perform the patented methods (Compl. ¶¶48, 73, 76).

U.S. Patent 10,857,126 ("the '126 Patent") - "Compositions and Methods for Improving Mitochondrial Function and Treating Neurodegenerative Diseases and Cognitive Disorders," Issued December 8, 2020

  • Technology Synopsis: The '126 Patent, also in the '850 patent family, is directed to a method of improving a cognitive function by administering an effective amount of a urolithin to a subject in need thereof (Compl. ¶¶31, 33, 81).
  • Asserted Claims: Independent claim 1 (Compl. ¶81).
  • Accused Features: The complaint alleges that Defendant’s marketing of its urolithin A supplements with suggested benefits including "Cognitive support" induces customers to perform the claimed method (Compl. ¶¶46, 82).

U.S. Patent 11,020,373 ("the '373 Patent") - "Enhancing Autophagy Or Increasing Longevity By Administration Of Urolithins Or Precursors Thereof," Issued June 1, 2021

  • Technology Synopsis: The '373 Patent is directed to a method of increasing autophagy in a healthy human by orally administering an effective amount of urolithin A, specified as being between about 70 mg and 1050 mg (Compl. ¶¶34, 36, 87).
  • Asserted Claims: Independent claim 1 (Compl. ¶87).
  • Accused Features: The complaint alleges that Defendant’s urolithin A supplement products, offered in dosages such as 700 mg, 800 mg, and 1000 mg per serving, fall within the claimed effective amount and that their sale induces infringement (Compl. ¶¶42, 88).

U.S. Patent 12,310,943 ("the '943 Patent") - "Compositions and Methods for Improving Mitochondrial Function and Treating Neurodegenerative Diseases and Cognitive Disorders," Issued May 27, 2025

  • Technology Synopsis: The '943 Patent, also in the '850 patent family, claims methods for enhancing muscle performance and increasing or maintaining mitochondrial function by administering specific daily dosages of a urolithin, including ranges of 300-500 mg/day, 450-750 mg/day, or 600-1000 mg/day (Compl. ¶¶37, 39, 93, 96).
  • Asserted Claims: Independent claims 1 and 2 (Compl. ¶¶93, 96).
  • Accused Features: The complaint alleges that Defendant’s urolithin A supplements providing 700 mg, 800 mg, and 1000 mg per serving directly meet the claimed dosage limitations, and that their sale induces infringement by customers (Compl. ¶¶42, 94, 97).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are Neurogan's urolithin A dietary supplements, including encapsulated, powder, and "gummy" products, and Neurogan's urolithin A skin care product (Compl. ¶¶42-43).

Functionality and Market Context

  • The accused supplements are oral products purported to contain between 700 mg and 1000 mg of urolithin A per serving (Compl. ¶42). The accused skin care product is a topical cream purported to contain a 1% concentration of urolithin A and Copper peptide GHK-Cu (Compl. ¶43). The complaint alleges these products are advertised for benefits such as supporting "cellular health," "cellular function," "Energy boost," "Cognitive support," "Athletic performance," and "Longevity" (Compl. ¶¶45-46). The complaint provides an image of Neurogan’s 700 mg supplement bottle, which advertises benefits such as "Post-workout," "Energy," and "Healthy-Aging" (Compl. p. 10). The complaint also presents an image of the accused skin care product, described as "Diamond Blue GHK-Cu Peptide + Urolithin A Cream" (Compl. p. 12).

IV. Analysis of Infringement Allegations

'850 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of enhancing muscle performance, comprising: Defendant's customers allegedly perform this method by consuming the accused products as instructed by Defendant's marketing, which promotes benefits such as "Athletic performance" and "improved muscle strength and endurance." ¶46-47, 58 ’782 Patent, col. 52:1-4
administering to a mammal in need thereof Customers, who are mammals, purchase and consume the accused products for purported benefits like enhancing athletic performance and supporting muscle health, which allegedly establishes they are "in need thereof." ¶17, 46, 57 ’782 Patent, col. 51:4-6
an effective amount of a urolithin, The accused products contain and deliver urolithin A in amounts marketed as effective for the advertised purposes. ¶42, 57 ’782 Patent, col. 51:6-7
to increase muscle performance. Defendant’s marketing materials, including customer reviews and blog posts, allegedly state that taking the urolithin A products results in increased stamina, energy, and improved muscle strength and endurance. ¶47, 51, 58 ’782 Patent, col. 52:3-4
  • Identified Points of Contention:
    • Scope Questions: A central question may be whether marketing claims such as "Energy boost" or "supports active lifestyles" meet the claim limitation "enhancing muscle performance." A court may need to construe the scope of "enhancing muscle performance" and determine what level of scientific or functional evidence is required to satisfy it.
    • Technical Questions: The complaint's theory of infringement relies on inducement of customers. A key factual question will be what evidence demonstrates that customers actually use the products in a way that "enhances muscle performance" as required by the claim, beyond simply purchasing a product with certain marketing claims. The complaint references a promotional video showing individuals exercising, which may be presented as evidence of intent to induce this use (Compl. p. 15).

'784 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A composition comprising: Defendant makes, uses, offers for sale, and sells the accused urolithin A skin care product. ¶43, 66 ’784 Patent, col. 20:64
a) a source of protein; The accused skin care product includes Copper peptide GHK-Cu, which is a tripeptide and thus alleged to be "a source of protein." ¶66, p. 12 n.1 ’784 Patent, col. 4:20-22
and b) urolithin A. The accused skin care product is advertised as containing and is purported to contain a 1% concentration of urolithin A. ¶43, 66 ’784 Patent, col. 20:66
  • Identified Points of Contention:
    • Scope Questions: The primary point of contention will likely be the claim construction of "a source of protein." The infringement allegation hinges on whether a tripeptide (GHK-Cu) included in a topical skin cream falls within the scope of this term.
    • Technical Questions: The patent specification repeatedly discusses "a source of protein" in the context of nutritional supplements for muscle growth, citing examples like whey, casein, and pea protein. A question for the court will be whether the technical context of the patent limits the term's scope to proteins that provide a nutritional or muscle-building function, as opposed to a peptide that serves as an active ingredient for skin care.

V. Key Claim Terms for Construction

  • The Term: "enhancing muscle performance" (from '850 Patent, claim 1)

  • Context and Importance: This term is the central functional limitation of the asserted method claim. The infringement case depends on whether the alleged induced activities of Neurogan’s customers meet this definition. Practitioners may focus on this term because the complaint relies on marketing language like "Energy boost" and "Athletic performance," which a defendant might characterize as subjective puffery rather than an objective technical function.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The '782 Patent (a divisional of the '850 Patent) specification states that "enhanced muscle performance may be one or more of improved muscle function, reduced decline in muscle function, improved muscle strength, improved muscle endurance and improved muscle recovery" (’782 Patent, col. 41:40-44).
    • Evidence for a Narrower Interpretation: The specification's examples demonstrating enhanced performance rely on objective, measurable endpoints in animal models, such as increased running time and distance on a treadmill (’784 Patent, Fig. 1, which is referenced in the '850 family prosecution history). A party could argue this context implies a requirement for a clinically measurable improvement, not just a user’s subjective feeling of increased energy.

  • The Term: "a source of protein" (from '784 Patent, claim 1)

  • Context and Importance: This term is critical to the infringement allegation against Neurogan's skin care product. The dispute may turn on whether a tripeptide in a topical cream qualifies as "a source of protein" within the meaning of a patent focused on nutritional compositions for muscle health.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification states that the "source of protein may be provided by individual amino acids or polypeptide made up of many amino acids, or mixtures of those" (’784 Patent, col. 4:20-22). This language could support a broad definition that includes a tripeptide.
    • Evidence for a Narrower Interpretation: The Background and Detailed Description sections of the '784 Patent consistently frame the invention in the context of "nutritional and medical formulations," "muscle-related pathological conditions," and improving muscle mass ('784 Patent, col. 1:5-18). The examples of protein sources provided are nutritional proteins like whey, casein, and pea protein, as well as specific amino acids known for muscle building, such as leucine ('784 Patent, col. 4:3-39). A party could argue that this consistent context limits the term to proteins with a nutritional purpose.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement for all asserted method claims. Inducement is based on Defendant’s labeling, marketing statements, blog posts, and promotional videos, which allegedly instruct and encourage customers to use the products for claimed purposes like enhancing muscle performance ('850 Patent), improving mitochondrial function ('782 Patent), and improving cognitive function ('126 Patent) (Compl. ¶¶62, 78, 84, 90, 99). Contributory infringement is based on allegations that the products are especially adapted for these infringing uses and are not staple articles of commerce (Compl. ¶¶64, 80, 86, 92, 101).
  • Willful Infringement: The complaint alleges willful infringement based on pre-suit knowledge. It specifically pleads that Defendant received notice letters identifying the patents and infringing products on August 30, 2023, and June 6, 2025 (Compl. ¶¶103-109). The complaint further supports willfulness by alleging that Defendant was aware of Plaintiff's clinical trials and MITOPURE® brand, and knowingly used Plaintiff’s own clinical study data in its advertising materials (Compl. ¶¶112-115). A screenshot from a prior Neurogan advertisement is provided as evidence, which explicitly cites a 2022 JAMA publication by Plaintiff's researchers (Compl. p. 30).

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

  • A core issue will be one of definitional scope: can terms like "enhancing muscle performance" ('850 Patent), rooted in measurable physiological outcomes, be proven by marketing claims for subjective benefits like "energy"? Similarly, can the term "a source of protein" ('784 Patent), described in the patent's context of nutritional science, be construed to cover a tripeptide used as an active ingredient in a topical skin cream?
  • A second central question will be one of intent and knowledge: the complaint provides specific evidence of pre-suit notice and alleges that Defendant used Plaintiff's own clinical trial data for marketing. This raises a key question for the willfulness inquiry: do these alleged facts demonstrate that Defendant acted with objective recklessness with respect to Plaintiff's patent rights?
  • A third key question will be evidentiary sufficiency for method claims: for the infringement theories based on inducement, what technical evidence, beyond marketing materials, will be presented to demonstrate that the accused supplements, when used as directed, actually perform the specific functions recited in the method claims, such as "increasing mitochondrial function" or "improving a cognitive function"?