Amazentis SA v. Cognishield Global LLC

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Amazentis SA (Switzerland) and Timeline Longevity, Inc. (Delaware)
  • Defendant: CogniSHIELD Global LLC (Delaware) and Acta Pharmaceuticals, Inc. (Delaware)
  • Plaintiff's Counsel: Foley Hoag LLP
• Case Identification: 1:26-cv-11015, D. Mass., 03/11/2026
• Venue Allegations: Venue is based on allegations that both Defendants reside in the District of Massachusetts, maintain a regular and established business in the district, and have committed acts of infringement within the district.
• Core Dispute: Plaintiff alleges that Defendant's CogniSHIELD dietary supplement, which contains urolithin A, infringes patents related to methods of using urolithin to improve mitochondrial and cognitive function and to treat neurodegenerative diseases.
• Technical Context: The dispute centers on urolithin A, a metabolic compound that can be produced in the human gut after consuming certain foods and is marketed as a supplement for promoting cellular health and healthy aging, particularly by supporting mitochondrial function.
• Key Procedural History: The complaint alleges that the parties discussed the patents-in-suit in 2022, prior to the launch of the accused product. It further alleges that Plaintiffs sent Defendants an email and a formal letter in August 2025 identifying the infringing product and the patents-in-suit. These pre-suit communications are cited as the basis for allegations of willful infringement.

Case Timeline

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

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: The patent background describes how declining mitochondrial energy production, coupled with increased oxidative stress, is a significant factor in the aging process and in degenerative diseases, including metabolic disorders, neurodegeneration, and cognitive decline ʼ782 Patent, col. 2:10-18
• The Patented Solution: The invention proposes using urolithins-metabolites of compounds like ellagitannins found in fruits such as pomegranates-to treat or prevent disorders related to inadequate mitochondrial activity ʼ782 Patent, abstract The specification suggests that these compounds can induce mitochondrial function, thereby improving conditions like metabolic disorders, cognitive decline, or mood disturbances ʼ782 Patent, col. 3:20-44
• Technical Importance: This approach provided a method for directly supplementing a subject with a specific bioactive metabolite (urolithin) to counter age-related cellular decline, bypassing the inefficiencies and individual variations of gut microflora in producing it from dietary precursors ʼ782 Patent, col. 2:51-56

Key Claims at a Glance

• The complaint asserts independent claim 1 Compl. ¶42
• Claim 1 of the '782 Patent contains the following essential elements:
  • 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 claims 3, 5, 7, 21-23, 25-26, and 28-29 Compl. ¶44

U.S. Patent No. 10,857,126 - "Compositions and Methods for Improving Mitochondrial Function and Treating Neurodegenerative Diseases and Cognitive Disorders"

The Invention Explained

• Problem Addressed: The patent identifies cognitive decline as being characterized by a decrease in performance in thinking, learning, and memory, which can be impaired by factors including aging and stress ʼ126 Patent, col. 2:50-54 This decline is linked to the high energy demands of neurons and their exposure to oxidative stress ʼ126 Patent, col. 2:45-49
• The Patented Solution: The invention provides for the administration of urolithins and their precursors to improve cognitive function ʼ126 Patent, abstract The detailed description posits that these compounds can stimulate neuronal plasticity, promote neurite outgrowth, and exhibit neuroprotective properties, which are key processes for memory and cognitive functions ʼ126 Patent, col. 4:5-20
• Technical Importance: The invention claims a method to directly address cognitive decline by using specific metabolites to support neuronal plasticity, offering a potential therapeutic pathway for age- or stress-related cognitive impairment ʼ126 Patent, col. 7:3-6

Key Claims at a Glance

• The complaint asserts independent claim 1 Compl. ¶48
• Claim 1 of the '126 Patent contains the following essential elements:
  • A method of improving a cognitive function, comprising:
  • administering to a subject in need thereof an effective amount of a urolithin
  • thereby improving the cognitive function.
• The complaint reserves the right to assert dependent claims, including claims 2-7, 9-10, and 17-18 Compl. ¶50

U.S. Patent No. 11,234,960 - "Compositions and Methods for Improving Mitochondrial Function and Treating Neurodegenerative Diseases and Cognitive Disorders"

• Technology Synopsis: The patent addresses neurodegenerative diseases such as Alzheimer's, Parkinson's, and dementia with Lewy bodies ʼ960 Patent, col. 8:49-54 It proposes a method of treating these diseases by administering a specific dosage range of urolithin A to a subject in need thereof ʼ960 Patent, claim 1
• Asserted Claims: The complaint asserts independent claim 1 Compl. ¶54
• Accused Features: The complaint alleges that Defendants' marketing of the CogniSHIELD product, including claims related to clearing beta-amyloid, is meant to convey that the product treats neurodegenerative diseases like Alzheimer's disease Compl. ¶9 Compl. ¶55 Compl. ¶81

III. The Accused Instrumentality

Product Identification

• The accused instrumentality is the "CogniSHIELD" dietary supplement Compl. ¶34

Functionality and Market Context

• CogniSHIELD is a dietary supplement for humans, sold in capsule form with instructions to take two capsules daily Compl. ¶36 A key ingredient is urolithin A, with each serving containing 200 mg Compl. ¶36 The product label, depicted in the complaint, shows the product contains a "CogniSHIELD™ Blend" including Ipriflavone, Urolithin A, Quercetin, and Fisetin (Compl. ¶36, image).
• The complaint alleges Defendants market the product through their website and on Amazon.com with claims that it provides "Science-Backed Brain Health," supports brain function, and benefits cognitive function Compl. ¶35 Compl. ¶40 A screenshot from the product website claims that "Urolithin A Studies show contributions to beta-amyloid clearance" (Compl. ¶35, image). Other marketing materials allegedly promote benefits such as "Protection against normal age-related decline," "Maximized neural function," and "Support memory and recall" (Compl. ¶40, image).

IV. Analysis of Infringement Allegations

10,485,782 Patent Infringement Allegations

10,857,126 Patent Infringement Allegations

• Identified Points of Contention:
  • Scope Questions: The asserted claims are method claims, requiring a specific outcome ("thereby increasing... mitochondrial function," "thereby improving... cognitive function"). A central dispute may be whether marketing a product for general "brain health" or "mitochondrial support" is sufficient to meet the elements of claims directed to specific therapeutic methods.
  • Technical Questions: The "thereby" clause in both asserted claims requires a causal link between the administration of urolithin and the claimed physiological effect. The analysis may raise the question of what evidence, beyond marketing claims, will be required to prove that the administration of the 200 mg urolithin A dose in the CogniSHIELD formulation actually and necessarily results in the claimed functional outcomes in a human subject.

V. Key Claim Terms for Construction

• The Term: "effective amount"

  • Context and Importance: This term appears in the independent claims of both the ʼ782 and ʼ126 patents. Its definition is critical because infringement depends on whether the 200 mg dose of urolithin A in the CogniSHIELD product constitutes an "effective amount" to achieve the claimed functional outcomes. Practitioners may focus on this term to dispute whether the accused dosage falls within the scope of what the patent teaches as being effective.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification of the ʼ782 Patent describes a dosage range "equal or equivalent to 0.1-150 milligram (mg) of urolithin per kilogram (kg) body weight" ʼ782 Patent, col. 9:1-4, which could support a broad interpretation covering a wide variety of doses.
    • Evidence for a Narrower Interpretation: The specification also discloses achieving certain serum levels, such as a "peak serum level of at least 1 µM" ʼ782 Patent, col. 9:20-22 A party could argue that an "effective amount" must be an amount sufficient to achieve such a specified serum concentration, potentially narrowing the term's scope to doses proven to reach that level.

• The Term: "cognitive function"

  • Context and Importance: This term is the central functional goal of claim 1 of the ʼ126 Patent. The infringement analysis will turn on whether the benefits allegedly promoted by CogniSHIELD (e.g., "support memory and recall") are captured by the patent's definition of "cognitive function."
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification provides a broad, non-exclusive list of what constitutes cognitive function, including "perception, memory, attention, speech comprehension, speech generation, reading comprehension, creation of imagery, learning, and reasoning" ʼ126 Patent, col. 7:7-10 This language may support an expansive definition.
    • Evidence for a Narrower Interpretation: A defendant might argue that the term should be limited by the specific examples in the patent, which demonstrate cognitive improvements using particular animal models like the Morris water maze ʼ126 Patent, col. 66:1-6 This could support an argument that "cognitive function" should be construed to mean the types of spatial memory and learning measured in those specific tests.

VI. Other Allegations

• Indirect Infringement: The complaint alleges both induced and contributory infringement for all three patents-in-suit. Inducement allegations are based on Defendants' product labeling, instructions, and promotional materials, which allegedly instruct and encourage customers to use the CogniSHIELD product in an infringing manner Compl. ¶¶45-46 Compl. ¶¶51-52 Compl. ¶¶57-58 Contributory infringement is alleged on the basis that the product contains urolithin A, is especially adapted for use in the infringing methods, and is not a staple article of commerce with substantial non-infringing uses (Compl. ¶¶47; ¶¶53; ¶¶59).
• Willful Infringement: The complaint alleges that Defendants' infringement has been and continues to be willful (Compl. ¶¶103; ¶¶111; ¶¶119). This allegation is based on claims of pre-suit knowledge, citing discussions between the parties in 2022, an email from Plaintiffs to Defendants on August 12, 2025, and a subsequent letter on August 17, 2025, all of which allegedly put Defendants on notice of the patents and their infringement Compl. ¶¶66-71 The complaint further alleges Defendants knew of the patents and their relevance even before launching the accused product Compl. ¶¶61-64

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

• A core issue will be one of causation and proof: what level of scientific evidence is required to satisfy the "thereby" clause in the asserted method claims? The case may turn on whether Plaintiffs can prove, and are required to prove, that the act of a consumer taking the CogniSHIELD supplement as directed necessarily results in a measurable improvement in cognitive function or maintenance of mitochondrial function, or if Defendants' marketing claims alone are sufficient to establish the required link for inducement.
• A second central question will be one of definitional scope: can the therapeutic language of the patent claims, such as "improving a cognitive function" and "treating a neurodegenerative disease," be construed to read on the marketing claims for a general-purpose dietary supplement promoted for "brain health" and "intellectual sharpness"? The outcome may depend on how the court construes the boundary between specific, claimed medical methods and broader wellness claims made for a consumer product.