DCT

2:18-cv-06608

Solutions LLC v. Vitajoy USA Inc

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:18-cv-06608, C.D. Cal., 08/01/2018
  • Venue Allegations: Venue is alleged to be proper as Defendants have committed acts of infringement in the district, have a regular and established place of business in the district, and reside there or in a foreign country.
  • Core Dispute: Plaintiffs allege that Defendants’ sale of beta-hydroxybutyrate (BHB) chemical compounds for use in weight loss products infringes a patent related to compositions and methods for appetite suppression.
  • Technical Context: The technology involves the use of butyrate salts and their derivatives, which are compounds naturally occurring in the body, as orally administered agents to cause weight loss or prevent weight gain.
  • Key Procedural History: The complaint alleges pre-suit notice was provided to Defendants on July 27, 2017. Significantly, subsequent to the filing of this complaint, the asserted patent was subject to an Inter Partes Review (IPR) proceeding (IPR2019-01141). The resulting IPR certificate, issued September 2, 2021, indicates that all three claims specifically identified in the complaint (Claims 1, 14, and 17) were cancelled. Several other claims not asserted in the initial complaint survived the IPR. This development fundamentally impacts the viability of the infringement contentions as originally pleaded.

Case Timeline

Date Event
2000-10-10 '356 Patent Priority Date (Filing Date)
2003-09-02 '356 Patent Issue Date
2017-07-27 Plaintiffs send notice letter to Defendants
2018-08-01 Complaint Filing Date
2019-06-03 IPR Proceeding (IPR2019-01141) Filed
2021-09-02 IPR Certificate Issued, Cancelling Claims 1, 14, 17

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

U.S. Patent No. 6,613,356 - "Weight Loss Medication and Method"

  • Issued: September 2, 2003.

The Invention Explained

  • Problem Addressed: The patent's background describes the increasing prevalence of obesity and notes that prior weight loss medications suffered from significant disadvantages, such as addiction potential, undesirable side effects (e.g., nervousness, insomnia, gastrointestinal issues), or were based on chemicals that were not naturally occurring in the body. (’356 Patent, col. 1:16 - col. 2:16).
  • The Patented Solution: The invention proposes a method and composition for weight loss based on the oral administration of butyrate and its related chemical compounds. The patent theorizes that the presence of these compounds in the stomach signals to receptors that there is stagnant food, which in turn suppresses appetite. (’356 Patent, col. 3:9-35). The invention also discloses formulations, such as capsules containing sodium bicarbonate, to facilitate the rapid dispersion of the active ingredient in the stomach. (’356 Patent, col. 5:45-58).
  • Technical Importance: The invention is presented as a weight loss solution that is inexpensive, easy to manufacture, and based on a substance that occurs naturally in mammals, which is expected to result in minimal toxicity and side effects. (’356 Patent, col. 2:32-40).

Key Claims at a Glance

  • The complaint asserts independent claims 1 (a process), 14 (a composition in a capsule), and 17 (a composition in a tablet). (Compl. ¶14). As noted, all three of these claims were subsequently cancelled during IPR proceedings.
  • Independent Claim 1 (Cancelled): The essential elements included:
    • A process for causing weight loss or avoidance of weight gain in mammals.
    • Comprising the step of oral administration to said mammals.
    • Of a "pharmaceutically cally effective" amount of a salt or derivative of butyric acid.
    • Selected from a specific list of compounds including sodium, calcium, potassium, and magnesium betahydroxybutyrate.
  • The complaint states infringement of claims "including but not limited to" the identified claims. (Compl. ¶14).

III. The Accused Instrumentality

Product Identification

  • Defendants' "BHB Products," which are identified as "sodium betahydroxybutyrate, calcium betahydroxybutyrate, potassium betahydroxybutyrate, and magnesium betahydroxybutyrate products." (Compl. ¶15).

Functionality and Market Context

  • The complaint alleges Defendants make, sell, use, offer for sale, or import these BHB compounds. (Compl. ¶15). It further alleges that in conjunction with these compounds, Defendants provide tablets, capsules, and softgels for products "designed for weight loss or avoidance of weight gain." (Compl. ¶15). The alleged function is that these products are incorporated into formulations intended for oral administration for the purpose of weight loss. (Compl. ¶16).
  • No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

'356 Patent Infringement Allegations

Claim Element (from Independent Claim 1 - Cancelled) Alleged Infringing Functionality Complaint Citation Patent Citation
A process for causing weight loss, or avoidance of weight gain, in mammals Defendants provide tablets, capsules, and softgels for products "designed for weight loss or avoidance of weight gain." ¶15 col. 8:65-67
comprising oral administration to said mammals The BHB products are allegedly incorporated into products intended to be "orally administered for the purpose of weight loss or avoidance of weight gain." ¶16 col. 2:21-23
of butyric acid or one or more pharmaceutically cally effective and acceptable salts or derivatives of butyric acid selected from the group consisting of...betahydroxybutyric acid, sodium betahydroxybutyrate, calcium betahydroxybutyrate, potassium betahydroxybutyrate, magnesium betahydroxybutyrate... Defendants are alleged to make, sell, and import products named "sodium betahydroxybutyrate, calcium betahydroxybutyrate, potassium betahydroxybutyrate, and magnesium betahydroxybutyrate products." ¶15 col. 9:8-12
  • Identified Points of Contention:
    • Procedural Question: The primary issue is the legal status of the asserted claims. Given that claims 1, 14, and 17 were cancelled by the USPTO, the complaint as written does not state a viable claim for relief. The central question is whether Plaintiffs can amend their allegations to target claims that survived the IPR.
    • Scope Questions: Assuming the case were to proceed on surviving claims, a point of contention would be whether the act of selling bulk chemical compounds ("BHB Products") constitutes direct infringement of a process claim, which requires administration. The complaint's allegations of direct infringement may be more suited to the cancelled composition claims (14 and 17).
    • Technical Questions: The complaint makes conclusory allegations by mapping the names of the accused products directly to the language of the claim's Markush group. A key factual question for the court would be whether the accused products are administered in a "pharmaceutically cally effective" amount for weight loss, as required by the patent. The complaint does not provide detail on dosages or formulations.

V. Key Claim Terms for Construction

  • The Term: "pharmaceutically cally effective" (appears in cancelled Claim 1; note apparent typographical error in patent text)
  • Context and Importance: This term is critical as it sets the quantitative threshold for infringement. The sale or administration of an amount of a claimed compound that is not "effective" for the claimed purpose (weight loss) would not infringe. Practitioners may focus on this term to determine if the amounts used in Defendants' products meet the patented dosage requirements.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent specification describes a wide range of dosages used in human trials, from a low of "23 mg twice a day" to a high of "1150 mg three times a day," suggesting a broad understanding of what might be considered effective. (’356 Patent, col. 6:65, col. 7:50-51).
    • Evidence for a Narrower Interpretation: The patent also provides more specific dosage limitations in its claims, such as in cancelled claim 5, which recites administration of "at least 60 milligrams per square meter of body surface area per day." (’356 Patent, col. 9:35-38). A party could argue that an "effective" dose must meet or exceed such specified minimums.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement by stating that Defendants "know or should have known, and specifically intend, for the BHB Products to be used to infringe" the patent. (Compl. ¶16). This intent is allegedly shown by the compounds being incorporated into tablets and capsules intended for oral administration for weight loss. (Compl. ¶16).
  • Willful Infringement: The willfulness allegation is based on alleged pre-suit knowledge. The complaint states that Plaintiffs provided Defendants with notice of their infringing activities via a letter dated July 27, 2017, and that Defendants continued their activities without response. (Compl. ¶13).

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

The complaint, as filed, faces a fundamental challenge that will likely dictate the course of the litigation. The key questions for the case are:

  1. A central procedural question: Given that all specifically asserted claims (1, 14, and 17) were cancelled in a post-filing IPR proceeding, can the Plaintiffs successfully amend their complaint to assert one or more of the surviving claims, and if so, do the original factual allegations support infringement of those claims?
  2. A key evidentiary question: Assuming the case proceeds on surviving claims, what evidence will show that Defendants' accused BHB products are formulated and administered in a manner that satisfies the specific compositional and dosage limitations of those claims, particularly the requirement that the compound be present in a "pharmaceutically effective" amount for weight loss?