DCT

2:26-cv-01758

Thorne Research Inc v. Niagen Biosciences Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:26-cv-01758, D.S.C., 04/28/2026
  • Venue Allegations: Venue is alleged to be proper in the District of South Carolina because Defendants purposefully directed patent enforcement activities, including cease-and-desist letters and an Amazon APEX evaluation, toward Plaintiff, a South Carolina entity with headquarters and manufacturing facilities in the state.
  • Core Dispute: Plaintiff seeks a declaratory judgment that its nutritional supplement products containing nicotinamide riboside do not infringe Defendant's patent related to methods for preparing nicotinamide riboside and its derivatives.
  • Technical Context: The technology concerns chemical synthesis methods for nicotinamide riboside (NR), a precursor to the coenzyme NAD+ that is a popular ingredient in dietary supplements aimed at supporting cellular metabolism and healthy aging.
  • Key Procedural History: The complaint describes a history of litigation between the parties, noting a prior case where patents asserted by ChromaDex against Thorne were invalidated or found unpatentable. The current action was precipitated by a series of cease-and-desist letters from ChromaDex and the initiation of an Amazon Patent Evaluation Express (APEX) procedure seeking the removal of Plaintiff's products from Amazon's marketplace.

Case Timeline

Date Event
2013-07-29 '506 Patent Priority Date
2021-05-12 Prior "Failed ChromaDex Litigation" filed
2022-05-31 PTAB finds claims of a prior patent ('086) unpatentable
2023-02-07 Federal Circuit affirms invalidity of a prior patent ('807)
2024-01-04 Prior litigation against Thorne dismissed
2024-09-20 ChromaDex sends first letter to Thorne regarding NR Malate
2024-10-25 Thorne responds to ChromaDex's letter
2025-03-18 '506 Patent Issues
2025-05-13 ChromaDex sends second letter, providing notice of the newly issued '506 Patent
2025-07-17 Thorne responds to second letter
2025-07-22 ChromaDex sends third letter, alleging infringement of the '506 Patent
2025-12-22 Niagen announces acquisition of the patent portfolio including the '506 Patent
2026-04-10 Thorne's partner receives notice of APEX evaluation initiated by ChromaDex
2026-04-28 Complaint for Declaratory Judgment filed

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

U.S. Patent No. 12,252,506 - Methods of Preparing Nicotinamide Riboside and Derivatives Thereof

  • Patent Identification: U.S. Patent No. 12,252,506, issued March 18, 2025 Compl. ¶12

The Invention Explained

  • Problem Addressed: The patent's background section describes prior art methods for synthesizing nicotinamide riboside (NR) as having significant disadvantages for commercial production Compl. Ex. 1, p. 10 '506 Patent, col. 1:50-53 These methods allegedly used catalysts that resulted in toxic, non-nutritionally suitable salt forms of NR, requiring additional, complex purification steps that were inefficient and difficult to scale up '506 Patent, col. 1:53-2:10
  • The Patented Solution: The invention claims to provide a novel and efficient method for preparing NR and its derivatives with a desired, nutritionally suitable counter-ion '506 Patent, col. 2:29-37 The process involves reacting a reduced form of NR with a nitrogen-containing proton source in the presence of a carbon-containing catalyst, such as activated charcoal, which facilitates an oxidation reaction and introduces the desired counter-ion in a single, efficient step '506 Patent, col. 3:1-14 '506 Patent, Fig. 2
  • Technical Importance: This process is presented as a commercially viable pathway to produce pure, stable, and nutritionally appropriate forms of nicotinamide riboside, a key ingredient in the growing market for NAD+ boosting supplements '506 Patent, col. 1:36-43

Key Claims at a Glance

  • The complaint references a cease-and-desist letter that asserted claims 1 and 26 Compl. ¶28 The complaint seeks a declaratory judgment of non-infringement for all claims Compl. prayer (a) Independent claim 1 is representative of the composition claims.
  • Independent Claim 1 elements:
    • A compound of formula (IV) or the beta-anomer thereof
    • where: n is 0 and Y is absent; m is 1
    • R₁ is a substituted or unsubstituted primary amino
    • R₂-R₅ are each H
    • R₆, R₇, and R₈... are each independently H or a hydroxyl-protecting group; or where R₆ is a phosphate
    • X⁻ is an anion selected from a specific list (which excludes certain anions like formate)
  • The complaint does not explicitly reserve the right to assert dependent claims, but its request for relief covers any claim of the '506 Patent Compl. prayer (a)

III. The Accused Instrumentality

Product Identification

The complaint identifies the accused products as the "Thorne NR Products," which are dietary supplements containing nicotinamide riboside malate Compl. ¶41 Specific examples cited are ResveraCel®, SynaQuell®, and NiaCel® 400 Compl. ¶36

Functionality and Market Context

These products are nutritional supplements marketed for benefits such as promoting healthy aging, supporting cellular metabolism, and enhancing NAD+ production Compl. ¶¶37-39 The complaint alleges they contain "nicotinamide riboside malate" Compl. ¶28 Compl. ¶41 The products are sold through various channels, including directly from Thorne's website and via third-party sellers on Amazon.com Compl. ¶40 The dispute arises from Defendants' alleged efforts to remove these products from the market through infringement allegations Compl. ¶2

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

This is a declaratory judgment action where the Plaintiff, Thorne, alleges non-infringement. The following table summarizes Thorne's primary argument for why its products do not infringe the patent, as articulated in the complaint.

'506 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Non-Infringing Functionality Complaint Citation Patent Citation
A compound of formula (IV) The Thorne NR Products do not contain a compound of formula (IV). ¶53 col. 18:21
wherein... R₆, R₇, and R₈... are each independently H or a hydroxyl-protecting group The Thorne NR Products do not contain a compound where each of R₆, R₇, and R₈ are a hydroxyl-protecting group, which the complaint argues is required by the specification's definition of formula (IV). ¶53 col. 7:14-17

Identified Points of Contention

  • Scope Questions: The complaint raises a central claim construction question. While the plain language of claim 1 recites compounds where the R₆, R₇, and R₈ positions can be either hydrogen ("H") or a "hydroxyl-protecting group," the complaint alleges that the patent's specification defines "formula (IV)" more narrowly to require the presence of hydroxyl-protecting groups Compl. ¶53 This raises the question of whether the specification contains a clear disavowal of claim scope that would override the explicit "H or" language present in the claim itself.
  • Technical Questions: The complaint asserts that the Thorne NR Products contain nicotinamide riboside malate Compl. ¶41 A factual question for the court may be to confirm the precise chemical structure of the compound in Thorne's products and whether it corresponds to a compound of formula (I) (the final product) or formula (IV) (an intermediate, as claimed).

V. Key Claim Terms for Construction

  • The Term: "a compound of formula (IV)"
  • Context and Importance: The construction of this term appears to be the crux of the non-infringement argument presented in the complaint. Thorne's position is that its products, which contain nicotinamide riboside (where R₆, R₇, and R₈ would be hydrogens), do not meet this limitation because, it argues, the specification defines "formula (IV)" as an intermediate that must have hydroxyl-protecting groups Compl. ¶53 Practitioners may focus on this term because if it is construed narrowly as Thorne proposes, Thorne's non-infringement argument may have merit; if construed more broadly to match the plain language of the claim, Thorne's pleaded theory may fail.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The plain language of claim 1 itself explicitly recites that R₆, R₇, and R₈ can be "H or a hydroxyl-protecting group" '506 Patent, claim 1 This language on its face appears to encompass both unprotected nicotinamide riboside (where R groups are H) and its protected precursors.
    • Evidence for a Narrower Interpretation: The complaint's argument relies on interpreting the role of formula (IV) within the synthetic schemes shown in the patent. The specification describes a process where a protected intermediate, formula (III), is deprotected to form formula (II) '506 Patent, col. 7:1-12, and formula (III) is in turn made from formula (IV) '506 Patent, col. 8:16-49 Thorne may argue that this process description defines "formula (IV)" contextually as a required intermediate that must bear protecting groups, thereby constituting a definitional statement or disavowal that limits the scope of the claims.

VI. Other Allegations

  • Indirect Infringement: The complaint seeks a declaratory judgment of non-infringement for direct, induced, and contributory infringement Compl. prayer (a) The complaint's factual allegations focus on the composition of its products to rebut direct infringement and do not provide a detailed basis for its non-liability for indirect infringement.
  • Willful Infringement: This allegation is not applicable, as the complaint is filed by the accused infringer seeking a declaratory judgment of non-infringement. However, the complaint does request that the case be judged exceptional under 35 U.S.C. § 285, seeking attorneys' fees based on the allegation that Defendants' infringement claims are "baseless" Compl. prayer (c)

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

  • A central issue will be one of claim construction: Can the term "compound of formula (IV)" be limited by statements in the specification to require the presence of hydroxyl-protecting groups, thereby disavowing the explicit "H or" language recited in the asserted independent claim? The resolution of this question may determine the viability of the primary non-infringement theory advanced in the complaint.
  • A second key question involves enforcement conduct: separate from the technical patent questions, the court will likely need to evaluate whether Defendants' enforcement activities-particularly the cease-and-desist letters and the Amazon APEX complaint-were good-faith efforts to protect patent rights or constituted tortious interference and unfair competition as alleged by Thorne.
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