DCT
3:26-cv-02808
Genomatica Inc v. Ketoneaid Inc
Key Events
Complaint
Table of Contents
complaint Intelligence
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Genomatica, Inc. (Delaware)
- Defendant: KetoneAid, Inc. (Delaware)
- Plaintiff's Counsel: Greenberg Traurig, LLP
- Case Identification: 3:26-cv-02808, S.D. Cal., 05/01/2026
- Venue Allegations: Plaintiff alleges venue is proper in the Southern District of California because Defendant is subject to personal jurisdiction in the district, has directed patent enforcement activities there, and a substantial part of the events giving rise to the dispute occurred there, including the design and development of the at-issue ingredient by the Plaintiff, which is headquartered in the district.
- Core Dispute: Plaintiff seeks a declaratory judgment that its (R)-1,3-butanediol ingredient product does not infringe Defendant's patents related to ketogenic beverage compositions and methods of their use.
- Technical Context: The technology involves the use of specific chemical compounds, such as stereoisomers of 1,3-butanediol, in beverages as an alternative to ethanol to help consumers initiate or maintain a metabolic state of ketosis.
- Key Procedural History: The complaint describes a history of interactions beginning in 2019, with Defendant KetoneAid allegedly engaging in a "years-long campaign of threats, demands and patent infringement accusations" against Plaintiff Genomatica. This culminated in a demand letter, cease and desist letters to Genomatica's customers, and notices of infringement, which Plaintiff asserts creates a justiciable controversy warranting a declaratory judgment of non-infringement.
Case Timeline
| Date | Event |
|---|---|
| 2017-08-23 | Priority Date for '963 and '567 Patents |
| 2019-08-22 | First documented communication event between parties |
| 2019-12-03 | Communication event between parties |
| 2019-12-06 | Communication event between parties |
| 2020-01-13 | Communication event between parties |
| 2020-01-15 | Communication event between parties |
| 2020-01-29 | Communication event between parties |
| 2020-02-04 | Communication event between parties |
| 2020-03-17 | Communication event between parties |
| 2020-03-23 | Communication event between parties |
| 2020-05-06 | KetoneAid provides Genomatica a copy of the application for the '963 Patent |
| 2020-06-17 | Communication event between parties |
| 2020-06-19 | Communication event between parties |
| 2020-07-30 | Communication event between parties |
| 2020-08-18 | Communication event between parties |
| 2020-09-18 | Communication event between parties |
| 2020-12-10 | Communication event between parties |
| 2023-05-19 | Communication event between parties |
| 2023-07-10 | Communication event between parties |
| 2023-08-02 | Communication event between parties |
| 2023-09-19 | U.S. Patent No. 11,760,963 issues |
| 2023-10-17 | Communication event between parties |
| 2023-12-15 | Communication event between parties |
| 2024-01-18 | KetoneAid informs Genomatica its lawyer will send cease and desist letters |
| 2024-04-25 | KetoneAid sends notice to a Genomatica customer alleging infringement |
| 2024-07-16 | U.S. Patent No. 12,037,567 issues |
| 2024-10-01 | Communication event between parties |
| 2024-11-25 | Communication event between parties |
| 2025-01-20 | Communication event between parties |
| 2025-09-16 | KetoneAid sends notice of infringement to another Genomatica customer |
| 2026-04-14 | KetoneAid sends Demand Letter to Genomatica |
| 2026-05-01 | Complaint for Declaratory Judgment filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 11,760,963 - "Ketogenic Beer and Alcoholic Beverage Mixture Containing Non-Racemic Ethyl 3-Hydroxybutyrate and/or 1,3 Butanediol," issued September 19, 2023 ('963 Patent)
The Invention Explained
- Problem Addressed: The patent identifies a problem for individuals on a ketogenic diet: the consumption of traditional alcoholic beverages, which contain carbohydrates and ethanol, can prevent the initiation of ketosis or disrupt an existing ketogenic state '963 Patent, col. 3:21-24
- The Patented Solution: The invention proposes a beverage that replaces or supplements traditional ethanol with specific chemical compounds, namely the D-isomer of 1,3-butanediol ("D-1,3-butanediol") or related molecules '963 Patent, col. 3:29-34 These compounds can be metabolized into ketone bodies, thereby providing an intoxicating or relaxing effect without disrupting, and potentially even facilitating, a state of ketosis '963 Patent, abstract '963 Patent, col. 3:17-20 The patent notes that the D-form (non-racemic) may be more bioavailable and beneficial than the racemic mixture '963 Patent, col. 2:27-30
- Technical Importance: This approach creates a new category of "functional" alcoholic-alternative beverages tailored to the growing market of consumers following ketogenic diets '963 Patent, col. 1:13-18
Key Claims at a Glance
- The complaint states that KetoneAid has alleged infringement of at least claims 1 and 7 Compl. ¶58
- Independent Claim 1: A beverage composition comprising:
- water
- at least 0.5 percent by volume D-1,3-butanediol
- no, or substantially no, L-1,3-butanediol
- optionally comprising one or more other additives (e.g., D ethyl 3-hydroxybutyrate, D beta hydroxybutyrate salts) '963 Patent, col. 6:17-24
- Independent Claim 7: A beverage composition comprising:
- at least 0.5 percent by volume D-1,3-butanediol
- no, or substantially no, L-1,3-butanediol
- one or more additives selected from a specified group (D ethyl 3-hydroxybutyrate, etc.) '963 Patent, col. 6:36-46
U.S. Patent No. 12,037,567 - "Functional Beverage Containing 1,3 Butanediol," issued July 16, 2024 ('567 Patent)
The Invention Explained
- Problem Addressed: As a continuation of the application leading to the '963 Patent, the '567 Patent addresses the same technical problem: the conflict between consuming traditional alcoholic beverages and maintaining a ketogenic diet '567 Patent, col. 3:18-21
- The Patented Solution: The solution is also the same, focusing on beverages containing D-1,3-butanediol to support ketosis '567 Patent, col. 3:26-34 However, the '567 Patent claims are directed to methods of using these beverages rather than the beverage compositions themselves.
- Technical Importance: The patent aims to protect the specific use of such beverages for achieving a physiological outcome (increasing or maintaining ketone levels), expanding protection beyond just the product composition '567 Patent, col. 1:11-15
Key Claims at a Glance
- The complaint alleges that KetoneAid has accused Genomatica of infringing the claims of the '567 Patent Compl. ¶64 The lead independent claims are method claims.
- Independent Claim 1: A method of increasing ketone bodies exposure in a subject, comprising:
- administering a beverage to the subject
- wherein the beverage comprises water and at least 0.5 percent by volume D-1,3-butanediol and no, or substantially no, L-1,3-butanediol
- wherein the blood levels of ketone bodies are increased above 0.5 mmol/L '567 Patent, col. 6:17-31
- Independent Claim 11: A method of maintaining ketone bodies exposure in a subject, comprising administering a similar beverage, wherein blood ketone levels are maintained above 0.5 mmol/L '567 Patent, col. 6:50-68
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is Genomatica's "(R)-1,3-butanediol" ingredient Compl. ¶18
Functionality and Market Context
- Genomatica's product is an ingredient, specifically the (R)-enantiomer of 1,3-butanediol, which corresponds to the "D-1,3-butanediol" specified in the patents-in-suit Compl. ¶18
- The complaint alleges the ingredient is "generally recognized as safe for use in beverages, gels, bars and other products" Compl. ¶56
- A central allegation in the complaint is that Genomatica is an ingredient supplier and "is neither in the business of selling beverages nor the business of administering beverages to a subject" Compl. ¶55 This positions Genomatica's product as a precursor component rather than the finished consumer product described in the patents.
IV. Analysis of Infringement Allegations
This is a complaint for a declaratory judgment of non-infringement. The tables below summarize Genomatica's asserted non-infringing position based on the allegations.
'963 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Asserted Non-Infringing Position | Complaint Citation | Patent Citation |
|---|---|---|---|
| A beverage comprising water and at least 0.5 percent by volume D-1,3-butanediol... | Genomatica alleges it does not sell a "beverage" but rather sells a single chemical ingredient, (R)-1,3-butanediol. | ¶55 | col. 6:17-19 |
| ...and no, or substantially no, L-1,3-butanediol... | The complaint does not provide sufficient detail for analysis of the stereoisomeric purity of Genomatica's (R)-1,3-butanediol product. | col. 6:19-20 |
No probative visual evidence provided in complaint.
- Identified Points of Contention:
- Scope Questions: The primary dispute for the '963 Patent appears to be definitional: does the act of selling a single, bulk chemical ingredient ((R)-1,3-butanediol) constitute selling a "beverage comprising" that ingredient, as required by the claims? Genomatica's position is that it does not Compl. ¶55 This raises the question of whether KetoneAid's infringement theory relies on direct or indirect infringement.
'567 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Asserted Non-Infringing Position | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method of increasing ketone bodies exposure in a subject, the method comprising administering a beverage...to a subject | Genomatica alleges it is not in the "business of administering beverages to a subject." | ¶55 | col. 6:17-20 |
| ...wherein the blood levels of ketone bodies is increased above 0.5 mmol/L | This is a functional limitation describing the result of the method. Genomatica's non-infringement argument focuses on its lack of participation in the active "administering" step. | ¶55 | col. 6:29-31 |
- Identified Points of Contention:
- Functional Questions: For the '567 Patent, the dispute centers on the active step of the method claims. Does Genomatica's role as an ingredient supplier constitute "administering a beverage...to a subject"? Genomatica argues it does not perform this claimed step Compl. ¶55 This suggests any potential liability for Genomatica under the '567 Patent would likely arise from a theory of indirect infringement (i.e., inducing its customers to perform the claimed method).
V. Key Claim Terms for Construction
The Term: "beverage"
- Context and Importance: This term is critical for the '963 Patent. Genomatica's primary defense against direct infringement appears to be that it sells an ingredient, not a finished "beverage" Compl. ¶55 The construction of this term will determine whether the claims read on a raw material supplier or are limited to manufacturers of final consumer drinks.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification defines "beverage" broadly as "consumable liquids including but not limited to water, carbonated water, naturally and/or artificially flavored waters, soft drinks, teas, juices, extractions, alcohol-containing beverages, and other known consumable liquids" '963 Patent, col. 3:35-42
- Evidence for a Narrower Interpretation: The language of the claims themselves, such as "A beverage comprising water and..." suggests a mixture or finished product, not a single, pure ingredient '963 Patent, col. 6:17 A party could argue that a single ingredient is not a "beverage" until it is combined with water and other components.
The Term: "administering"
- Context and Importance: This term is the central verb in the method claims of the '567 Patent. Genomatica denies "administering" its product to a subject Compl. ¶55 Its construction will be key to determining liability for the claimed methods.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent does not explicitly define "administering." A broad reading could be argued to encompass the entire chain of supply that results in a subject consuming the beverage.
- Evidence for a Narrower Interpretation: In the context of a method claim performed "in a subject," "administering" typically implies causing the subject to take in the substance. Parties may argue this requires a more direct action than merely selling an ingredient to a third-party manufacturer.
The Term: "no, or substantially no, L-1,3-butanediol"
- Context and Importance: This negative limitation defines the required stereoisomeric purity of the key ingredient. Practitioners may focus on this term because infringement will depend on the precise chemical makeup of Genomatica's product. The term "substantially no" is a classic source of claim construction disputes.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: "Substantially" could be interpreted to permit trace amounts or commercially acceptable levels of the L-isomer, which may be present as an unavoidable impurity from the manufacturing process.
- Evidence for a Narrower Interpretation: The patent repeatedly emphasizes the "D form" and distinguishes it from the racemic form, suggesting the patentee considered the absence of the L-form to be a critical aspect of the invention '963 Patent, col. 2:27-30 '963 Patent, FIG. 4 This could support a construction requiring a very high degree of purity.
VI. Other Allegations
- Indirect Infringement: While Genomatica's complaint is for a declaratory judgment of its own non-infringement, it lays the groundwork for a dispute over indirect infringement. The complaint notes that KetoneAid has accused Genomatica's customers of infringement Compl. ¶37 Compl. ¶43 Compl. ¶58 These customers would be the alleged direct infringers. The unstated allegation that Genomatica is preemptively countering is that it induces or contributes to its customers' infringement by supplying the key (R)-1,3-butanediol ingredient.
- Willful Infringement: The complaint explicitly states that KetoneAid's Demand Letter raised the issue of willfulness and enhanced damages, constituting "actual notice" Compl. ¶9 The extensive history of communication detailed in the complaint, beginning years before the suit was filed, would be the basis for KetoneAid's allegation of pre-suit knowledge Compl. ¶¶11-45
VII. Analyst's Conclusion: Key Questions for the Case
- Definitional Scope: A core issue will be one of definitional scope: does supplying a bulk chemical ingredient ((R)-1,3-butanediol) constitute direct infringement of claims reciting a "beverage" composition ('963 Patent) or the act of "administering" that beverage to a subject ('567 Patent)?
- Indirect Liability: If Genomatica is not found to be a direct infringer, a central question will become one of indirect liability: do Genomatica's customers directly infringe the patents by creating and/or consuming beverages with the ingredient, and if so, does Genomatica's act of supplying the ingredient, along with its marketing or instructions, rise to the level of specific intent required to prove induced infringement?
- Technical Purity: A crucial evidentiary question will be one of chemical composition: what is the precise meaning of "substantially no, L-1,3-butanediol," and does the chemical analysis of Genomatica's product show a level of the L-isomer that falls within the scope of this limitation?
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