DCT
1:24-cv-11983
Amazentis SA v. Axoa Co Ltd
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Amazentis SA (Switzerland) and Timeline Longevity, Inc. (Delaware)
- Defendant: The AXOA Company Ltd. d/b/a The Aeternum Company (England)
- Plaintiff’s Counsel: Foley Hoag LLP
- Case Identification: 1:24-cv-11983, D. Mass., 08/01/2024
- Venue Allegations: Venue is alleged to be proper because the Defendant is a foreign entity and has allegedly committed infringing acts within the District of Massachusetts.
- Core Dispute: Plaintiff alleges that Defendant’s Urolithin A dietary supplement products infringe three U.S. patents directed to methods of using urolithins to improve mitochondrial function, enhance muscle performance, and increase autophagy.
- Technical Context: The technology relates to nutritional supplements containing Urolithin A, a metabolite of compounds found in pomegranates and other foods, for promoting cellular health and mitigating effects of aging.
- Key Procedural History: The complaint alleges that Plaintiff sent a cease and desist letter to Defendant on April 21, 2023, identifying the patents-in-suit and the accused products. Defendant allegedly acknowledged receipt but continued its accused activities, including launching a new capsule product, which may form the basis for the willfulness allegations.
Case Timeline
| Date | Event |
|---|---|
| 2010-12-23 | Priority Date for ’850 and ’782 Patents |
| 2012-06-27 | Priority Date for ’373 Patent |
| 2018-01-23 | ’850 Patent Issued |
| 2019-11-26 | ’782 Patent Issued |
| 2021-06-01 | ’373 Patent Issued |
| 2023-04-21 | Plaintiff allegedly sent cease and desist letter to Defendant |
| 2023-05-02 | Defendant allegedly acknowledged receipt of letter |
| 2024-04-30 | Defendant allegedly released 500 mg Urolithin A capsule product |
| 2024-08-01 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 9,872,850 - "Compositions and Methods for Improving Mitochondrial Function and Treating Neurodegenerative Diseases and Cognitive Disorders"
The Invention Explained
- Problem Addressed: The patent's background describes how declining mitochondrial energy production and increased oxidative stress contribute to a variety of degenerative diseases, metabolic disorders, cognitive decline, and the general process of aging (’850 Patent, col. 1:12-2:65). It also notes that while dietary precursors like ellagitannins can be converted into beneficial urolithins by gut microflora, this process is highly variable and often insufficient among individuals (Compl. ¶13).
- The Patented Solution: The invention provides methods of administering urolithins, such as Urolithin A, directly to a subject to bypass the inconsistent natural conversion process (’850 Patent, col. 3:3-4:65). This direct administration is claimed to improve mitochondrial function, enhance muscle performance, and treat various related disorders by providing a reliable and effective dose of the active compound (’850 Patent, Abstract).
- Technical Importance: The technology provides a method for delivering the benefits of urolithins consistently to a broad population that may not be able to produce them effectively from diet alone (Compl. ¶¶13-14).
Key Claims at a Glance
- The complaint asserts independent claims 1 and 20 (Compl. ¶¶37, 40).
- Independent Claim 1:
- 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:
- 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 specifying, for example, oral administration, Urolithin A as the specific urolithin, and humans as the mammal (Compl. ¶¶39, 41).
U.S. Patent No. 10,485,782 - "Compositions and Methods for Improving Mitochondrial Function and Treating Neurodegenerative Diseases and Cognitive Disorders"
The Invention Explained
- Problem Addressed: As a divisional of the application leading to the ’850 Patent, the ’782 Patent addresses the same technical problem: the role of declining mitochondrial function in aging, metabolic diseases, and cognitive decline (’782 Patent, col. 1:12-2:65).
- The Patented Solution: The invention is a method of directly administering a urolithin to a subject to increase or maintain mitochondrial function (’782 Patent, Abstract). This method is intended to provide therapeutic and health benefits by improving cellular energy production and mitigating the effects of age-related mitochondrial decline (’782 Patent, col. 3:28-34).
- Technical Importance: The invention provides a direct therapeutic intervention to bolster mitochondrial health, which is implicated in a wide array of age-related conditions (Compl. ¶¶13-14).
Key Claims at a Glance
- The complaint asserts independent claim 1 (Compl. ¶45).
- Independent Claim 1:
- A method of increasing or maintaining mitochondrial function, comprising:
- administering to a subject in need thereof
- an effective amount of a urolithin,
- thereby increasing or maintaining mitochondrial function.
- The complaint reserves the right to assert dependent claims, including those specifying Urolithin A, oral administration, and use in humans (Compl. ¶47).
U.S. Patent No. 11,020,373 - "Enhancing Autophagy Or Increasing Longevity By Administration Of Urolithins Or Precursors Thereof"
Technology Synopsis
The patent describes that autophagy, the process by which cells eliminate and recycle damaged components, becomes less efficient with age (’373 Patent, Abstract). The invention is a method to counteract this decline by orally administering an effective amount of Urolithin A (between 70 mg and 1050 mg) to a healthy human, thereby increasing autophagy and promoting healthy aging (’373 Patent, Abstract; col. 2:1-9).
Asserted Claims
The complaint asserts independent claim 1 (Compl. ¶51).
Accused Features
The accused features are Defendant's Urolithin A supplements, particularly the 500 mg capsules and the suggested serving size of "1 to 2 capsules per day," which allegedly cause customers to perform the patented method by consuming an amount of Urolithin A within the claimed range (Compl. ¶¶30, 52-53).
III. The Accused Instrumentality
Product Identification
The accused instrumentalities are Defendant Aeternum's Urolithin A dietary supplements, sold online in both capsule and powder forms (Compl. ¶¶28, 30).
Functionality and Market Context
The products are marketed as dietary supplements containing Urolithin A and are promoted with claims of health benefits including "Increased Endurance," "Stronger Muscles," "Mitochondrial Support," and helping with "the removal of damaged cellular components" (Compl. ¶¶32, 34, 35). The complaint includes screenshots of product labels indicating that the capsules contain 500mg of Urolithin A and suggesting a serving of 1 to 2 capsules per day (Compl. p. 11, ¶30). The products are sold through Defendant's website and on e-commerce platforms like Amazon.com, and are promoted on social media (Compl. ¶¶28-29).
IV. Analysis of Infringement Allegations
'850 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| administering to a mammal in need thereof | Customers, who are human mammals, are allegedly instructed to take the supplement for benefits such as increased muscle strength and endurance. | ¶¶32, 34, 39 | col. 7:65-8:4 |
| an effective amount of a urolithin, | Defendant sells supplements containing Urolithin A, specifically in a 500 mg capsule form and as a powder, with recommended serving suggestions. | ¶¶30, 42 | col. 5:55-6:1 |
| to increase muscle performance. | Defendant’s marketing materials on Amazon and social media allegedly claim benefits of "Stronger Muscles" and "Increases Muscle Strength and Improves Endurance." An Amazon product image makes these claims explicitly (Compl. p. 12). | ¶¶32, 34, 38 | col. 8:1-4 |
'782 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| administering to a subject in need thereof | Customers, who are human subjects, are instructed via marketing materials to consume the Urolithin A supplement. | ¶¶46, 47 | col. 5:1-4 |
| an effective amount of a urolithin, | Defendant sells and provides serving suggestions for its Urolithin A supplements in capsule and powder form. | ¶¶30, 48 | col. 5:55-6:1 |
| thereby increasing or maintaining mitochondrial function. | Defendant's marketing materials allegedly state the product provides "Mitochondrial Support" and acts as a "cellular energy booster." A promotional graphic touts these benefits (Compl. p. 14). | ¶¶34, 46 | col. 3:28-34 |
Identified Points of Contention
- Scope Questions: The case may present questions regarding the link between Defendant's marketing language and the patent claims. For instance, a potential point of contention could be whether advertising claims such as "Mitochondrial Support" or "Stronger Muscles" are sufficient to establish specific intent to induce infringement of the patented methods of "increasing or maintaining mitochondrial function" or "enhancing muscle performance."
- Technical Questions: The infringement theories are based on indirect infringement, where Defendant's customers are the direct infringers. A key factual question will be what evidence demonstrates that customers follow the alleged instructions and marketing claims to use the product for the patented purposes. Another question concerns the "effective amount" limitation, particularly as the complaint alleges the accused 500 mg capsules contain only approximately 390 mg of Urolithin A (Compl. ¶71).
V. Key Claim Terms for Construction
The Term: "effective amount" (asserted in all three patents-in-suit)
- Context and Importance: The definition of this term is critical for determining infringement. The dispute may turn on whether the dosage of Urolithin A provided in Defendant's products, and consumed according to its instructions, is sufficient to achieve the claimed therapeutic effects. Practitioners may focus on this term because the complaint's allegation of under-dosing directly challenges whether the accused products provide an "effective amount" (Compl. ¶71).
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specifications define the term functionally, such as "an amount that is sufficient to realize a desired biological effect" (’782 Patent, col. 47:46-48). This could support an interpretation where any amount that produces the claimed result infringes.
- Evidence for a Narrower Interpretation: The specifications also provide specific numerical dosage ranges, such as "0.1-150 milligram (mg) of urolithin per kilogram (kg) body weight" (’782 Patent, col. 9:1-3). A party could argue that "effective amount" should be construed to be limited to such explicitly disclosed ranges.
The Term: "increase muscle performance" (’850 Patent, Claim 1)
- Context and Importance: Infringement of the ’850 Patent hinges on whether Defendant's marketing for "Stronger Muscles" and "Improves Endurance" induces customers to practice this claimed method. The construction of "muscle performance" will determine if Defendant's advertising falls within the claim's scope.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent specification explicitly states that "In one embodiment, the muscle performance is selected from the group consisting of strength, speed, and endurance" (’850 Patent, col. 8:2-4). This language provides strong support for Plaintiff's position that Defendant's marketing claims for strength and endurance map directly onto the claim language.
- Evidence for a Narrower Interpretation: A party could argue that "increase muscle performance" should be limited to the types of objective, measurable improvements demonstrated in the patent's own examples, such as performance on a treadmill test (’850 Patent, FIG. 49). This interpretation could frame general marketing statements as mere puffery falling outside the claim scope.
VI. Other Allegations
- Indirect Infringement: The complaint alleges both induced and contributory infringement for all patents-in-suit (Compl. ¶¶ 42-44, 48-50, 54-56). The basis for inducement is Defendant’s alleged marketing, labeling, and promotional materials, which allegedly instruct and encourage customers to use the Urolithin A supplements in a manner that directly infringes the method claims (Compl. ¶43).
- Willful Infringement: Willfulness is alleged based on both pre-suit and post-suit knowledge. The complaint asserts Defendant had actual knowledge of the patents and its infringement since at least April 21, 2023, the date Plaintiff sent a cease and desist letter (Compl. ¶58). It is alleged that Defendant continued its infringing conduct, and launched a new accused product, after acknowledging receipt of the letter (Compl. ¶¶60-61).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of intent and evidence: does the language used in Defendant's marketing materials and product instructions demonstrate the specific intent required to encourage customers to perform the patented methods, thereby establishing induced infringement? The screenshots of marketing materials provided in the complaint will be central to this factual determination.
- A key question will be one of definitional scope and fact: can the term "effective amount" be met by the quantity of Urolithin A in the accused products? This analysis may be influenced by the complaint's allegations that the products contain significantly less active ingredient than advertised, raising the question of whether an under-dosed supplement can be legally "effective" for infringement purposes.
- A significant question for damages will be one of willfulness: did Defendant's alleged decision to continue selling its products and launch a new capsule product after receiving notice from Plaintiff constitute objective recklessness? The answer will likely depend on the substance of the communications between the parties and the reasonableness of any non-infringement or invalidity positions Defendant may have developed.