DCT

5:25-cv-00271

Nanjing Nutrabuilding Bio Tech Co Ltd v. Bonerge Lifescience Hunan Co Ltd

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 5:25-cv-00271, C.D. Cal., 01/31/2025
  • Venue Allegations: Plaintiff alleges venue is proper in the Central District of California because Defendant Bonerge maintains a regular and established place of business at a physical address in Ontario, California, and has committed acts of infringement in the district, including attending a trade show in Anaheim to promote the accused product.
  • Core Dispute: Plaintiff alleges that Defendant’s sale of a dihydroberberine ingredient for use in dietary supplements infringes a patent related to methods of using berberine metabolites to manage glucose tolerance.
  • Technical Context: The technology concerns the use of dihydroberberine, a metabolite of berberine, as a more bioavailable and effective compound for managing blood glucose levels in dietary supplements.
  • Key Procedural History: Plaintiff alleges it provided Defendant with written notice of infringement via letters delivered on or about September 25, 2024, and October 29, 2024. Plaintiff also alleges Defendant received notice via a customer, Nature's Fusions, on November 6, 2024. The complaint states Defendant did not respond to the letters.

Case Timeline

Date Event
2016-04-19 ’961 Patent Priority Date
2019-05-07 ’961 Patent Issue Date
2024-03-13 Defendant allegedly attended Natural Product Expo West
2024-07-31 Defendant allegedly issued press release with CA contacts
2024-09-12 Plaintiff allegedly sent first notice letter to Defendant
2024-10-29 Plaintiff allegedly sent second notice letter to Defendant
2024-11-06 Defendant allegedly received notice from its customer
2025-01-31 Complaint Filing Date

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

U.S. Patent No. 10,278,961 - "Administration of Berberine Metabolites," issued May 7, 2019

The Invention Explained

  • Problem Addressed: The patent's background section notes that while the naturally occurring substance berberine shows potential for lowering fasting blood glucose, its use is hampered by low bioavailability and adverse gastrointestinal effects at effective dosages (’961 Patent, col. 2:26-40).
  • The Patented Solution: The invention proposes using a metabolite of berberine, specifically dihydroberberine, to manage glucose tolerance. The patent asserts that dihydroberberine is more biologically available than berberine, allowing for similar or better therapeutic effects at a lower dosage, which may reduce side effects (’961 Patent, Abstract; col. 5:6-19). The patent describes administering a "pharmaceutically effective amount" of dihydroberberine, for example between 25 mg and 800 mg, to achieve results such as reducing fasting glucose levels (’961 Patent, col. 2:30-34).
  • Technical Importance: This approach suggests a way to harness the metabolic benefits of berberine while mitigating the practical limitations that had previously constrained its use as a dietary supplement.

Key Claims at a Glance

  • The complaint asserts infringement of independent claim 1, and by extension, dependent claims 2, 5, and 7 (Compl. ¶¶ 24-27).
  • Independent Claim 1 requires:
    • A method of managing glucose tolerance in an individual
    • The method comprises: administering, to an individual, a pharmaceutically effective amount of dihydroberberine
    • The pharmaceutically effective amount comprises approximately 25 mg to 800 mg of dihydroberberine.
  • The complaint reserves the right to assert other claims of the patent (’961 Patent, Compl. ¶24).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is Defendant Bonerge's dihydroberberine product, which it markets and sells in the U.S. as an ingredient for dietary supplements (Compl. ¶¶ 14, 23). The complaint notes the product is marketed under the name GLUCOSOBER (Compl. ¶22).

Functionality and Market Context

  • The complaint alleges that Bonerge sells its dihydroberberine ingredient with the intention that it be compounded into final products (e.g., tablets or capsules) for end-users (Compl. ¶¶ 14-15, 23). These products are marketed for "managing glucose tolerance, managing blood glucose levels, related metabolic benefits, and weight loss" (Compl. ¶23). The complaint includes a screenshot from Bonerge's website stating, "Dihydroberberine(DHB) has better effect than Berberine(BBR)" for reducing blood sugar levels (Compl. p. 10). The complaint further alleges that Bonerge ships this product from a facility in Ontario, California, to customers in the U.S. (Compl. ¶17).

IV. Analysis of Infringement Allegations

'961 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of managing glucose tolerance in an individual, the method comprising: administering, to an individual, a pharmaceutically effective amount of dihydroberberine... Defendant is alleged to induce its customers and end-users to perform this method by marketing and selling its dihydroberberine product specifically for "manag[ing] glucose tolerance" and "blood sugar control." A product label for a supplement containing Defendant's ingredient explicitly lists "BLOOD SUGAR CONTROL" as a use. ¶23, ¶28, ¶31; p. 9 col. 2:18-23
...wherein the pharmaceutically effective amount of dihydroberberine comprises approximately 25 mg to approximately 800 mg of dihydroberberine. A supplement from Defendant's customer, Nature's Fusions, is alleged to contain Defendant's ingredient and is labeled as providing "200 mg per serving" of dihydroberberine, which is within the claimed range. ¶24; p. 9 col. 11:31-34
  • Identified Points of Contention:
    • Indirect Infringement: The complaint focuses on a theory of induced infringement, as Defendant Bonerge sells an ingredient rather than the final consumer product. A central question will be whether Plaintiff can prove Bonerge acted with the specific intent to encourage its customers and end-users to perform the patented method. The complaint's evidence, such as marketing materials that state dihydroberberine is for "Blood Sugar Standard" and "Weight Loss" (Compl. p. 10), and the product's trade name "GLUCOSOBER" (Compl. ¶22), will be central to this inquiry.
    • Technical Questions: The complaint alleges that the "Nature's Fusions" product, which contains 200mg of dihydroberberine per serving (Compl. p. 9), infringes. A factual question for the court will be whether the dihydroberberine in that final product is supplied by the Defendant, Bonerge. The complaint alleges that Nature's Fusions has admitted Bonerge is its manufacturer (Compl. ¶29).

V. Key Claim Terms for Construction

  • The Term: "managing glucose tolerance"
  • Context and Importance: This term defines the purpose of the claimed method. Its scope is critical because infringement hinges on whether the Defendant's marketing and its customers' use of the accused product fall within this definition. Practitioners may focus on this term to determine if general wellness claims (e.g., "healthy metabolism") meet the claimed therapeutic purpose.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification lists several examples of "managing glucose tolerance," including to "decrease and/or maintain blood glucose level, decrease and/or maintain fasting blood glucose, [and] increase ability to process glucose" (’961 Patent, col. 2:20-23). This suggests the term could encompass a range of related metabolic benefits.
    • Evidence for a Narrower Interpretation: A defendant might argue the term should be limited to treating a specific diagnosed condition, such as "Type 2 Diabetes" or "metabolic syndrome," which are explicitly mentioned in the background and detailed description (’961 Patent, col. 2:31-32; col. 3:62-64). The claims, however, do not appear to contain such a limitation.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges inducement by asserting that Bonerge sells its dihydroberberine product with full knowledge and intent for it to be used by customers and end-users for the patented purpose of managing glucose levels (Compl. ¶¶ 23, 31). The complaint cites Bonerge's own marketing materials, website content, and the product's trade name ("GLUCOSOBER") as evidence of intent to encourage infringement (Compl. ¶¶ 22, 28; p. 10).
  • Willful Infringement: The complaint alleges willful infringement based on Defendant's alleged knowledge of the ’961 Patent since at least September 25, 2024, from direct notice letters sent by Plaintiff's counsel, and subsequent notice from a customer on November 6, 2024 (Compl. ¶¶ 16, 22, 33). The complaint alleges that Bonerge continued its infringing activities despite this knowledge (Compl. ¶33).

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

  • A core issue will be one of intent for indirect infringement: can Plaintiff prove that Defendant, by selling a chemical ingredient, specifically intended to induce its customers and end-users to perform the patented method? The case will likely turn on evidence of Defendant's marketing, its product branding (GLUCOSOBER), and its alleged knowledge of the patent.
  • A key evidentiary question will be one of sourcing: can Plaintiff definitively trace the dihydroberberine in the final consumer products, such as the Nature's Fusions supplement cited in the complaint, back to the Defendant? The complaint's allegation that Nature's Fusions admitted Bonerge is its manufacturer will be a critical fact to establish.
  • A final question will be one of damages and willfulness: assuming infringement is found, the court will need to determine the extent of damages, which will depend on the volume of Defendant's sales. The alleged pre-suit notice letters will be central to the analysis of whether any infringement was willful, potentially exposing Defendant to enhanced damages.