DCT
2:23-cv-08378
Genexa Inc v. KinderFarms LLC
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Genexa, Inc. (Delaware)
- Defendant: KinderFarms, LLC. (Delaware)
- Plaintiff’s Counsel: Cooley LLP
- Case Identification: 2:23-cv-08378, C.D. Cal., 10/04/2023
- Venue Allegations: Venue is asserted on the basis that Defendant resides and has its principal place of business within the Central District of California, and the alleged infringing acts occurred in the district.
- Core Dispute: Plaintiff alleges that Defendant’s over-the-counter children's pain and fever medications infringe a patent related to pharmaceutical syrup formulations that use agave syrup and natural ingredients in place of artificial fillers.
- Technical Context: The lawsuit concerns formulations for over-the-counter (OTC) liquid medicines, a market segment where palatability and the composition of inactive ingredients are significant consumer-facing features.
- Key Procedural History: The complaint does not mention any prior litigation, Inter Partes Review (IPR) proceedings, or licensing history related to the patent-in-suit. The allegations focus heavily on a market narrative of Genexa creating the "clean medicine" category, which KinderFarms allegedly copied.
Case Timeline
| Date | Event |
|---|---|
| 2017-11-02 | '795 Patent Priority Date |
| 2020 (late) | Genexa launches "Kids' Pain & Fever" product |
| 2021 | Genexa launches "Infants' Pain & Fever" product |
| 2022-11-15 | KinderFarms announces launch of accused "KinderMed" product line |
| 2023-04-04 | '795 Patent Issued |
| 2023-09-25 | Date of Defendant's alleged knowledge of the '795 Patent |
| 2023-10-04 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 11,617,795 - Pharmaceutical Syrup Formulation or Suspension, issued April 4, 2023
The Invention Explained
- Problem Addressed: The patent's background section notes that liquid pharmaceutical formulations containing active agents like analgesics often "taste terrible," leading chemists to use "unnatural and artificial ingredients to mask the taste" ('795 Patent, col. 1:21-25). The complaint characterizes this problem as the traditional OTC market consisting of products with "a host of artificial fillers" such as "dyes, preservatives, sweeteners, and a plethora of other artificial substances" (Compl. ¶1).
- The Patented Solution: The invention proposes a pharmaceutical syrup formulation that uses agave syrup as its base, combined with an active pharmaceutical ingredient, a diluent, and other natural components like an acidic preservative and flavoring agent ('795 Patent, col. 2:1-7). This formulation is designed to be stable, palatable, and have a specific viscosity ("less than 1500 centipoise") while suspending the active ingredient, which can help mask undesirable taste ('795 Patent, col. 2:58-63). The stated goal is to provide pharmaceutical suspensions "made with the same active ingredients needed for a treatment, but without the artificial ingredients" ('795 Patent, col. 2:36-38).
- Technical Importance: This approach provides a method for creating "clean" OTC liquid medicines that avoid a list of common artificial ingredients (e.g., parabens, artificial dyes, sweeteners) while maintaining the necessary stability and palatability for consumer products (Compl. ¶5; '795 Patent, col. 2:30-38).
Key Claims at a Glance
- The complaint asserts infringement of at least independent claim 18 (Compl. ¶31).
- The essential elements of independent claim 18 are:
- A stable, palatable pharmaceutical syrup formulation for oral administration
- consisting essentially of:
- (a) a therapeutically effective amount of acetaminophen;
- (b) agave syrup;
- (c) acidic preservative;
- (d) a flavoring agent, and
- (e) a diluent,
- wherein the syrup formation has a viscosity of less than 1500 centipoise at about 22 degrees and the acetaminophen is suspended in the syrup.
- The complaint reserves the right to assert additional claims (Compl. ¶13).
III. The Accused Instrumentality
Product Identification
- The accused products are "KinderMed™ Kids' Pain & Fever" and "KinderMed™ Infants' Pain & Fever" (Compl. ¶14-15).
Functionality and Market Context
- The accused products are over-the-counter liquid medications containing acetaminophen as the active ingredient for pain and fever relief in children (Compl. ¶22). The complaint alleges the products are marketed as being "made with only 2-5 recognizable inactive ingredients" and specifically identifies the formulation as consisting of five total ingredients: acetaminophen, organic agave syrup, organic cherry flavor, non-GMO citric acid, and purified water (Compl. ¶23-24, ¶36). A photograph of the accused product's packaging highlights these "5 Ingredients" (Compl. p. 7). The complaint positions the products as direct competitors to Genexa's own "clean medicine" line, alleging KinderFarms launched its brand more than two years after Genexa's similar products were on the market (Compl. ¶27).
IV. Analysis of Infringement Allegations
'795 Patent Infringement Allegations
| Claim Element (from Independent Claim 18) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A stable, palatable pharmaceutical syrup formulation for oral administration consisting essentially of: | The accused KinderMed products are alleged to be shelf-stable, palatable syrup formulations sold at major pharmacy retailers. | ¶34 | col. 6:36-38 |
| (a) a therapeutically effective amount of acetaminophen; | Both accused products are alleged to contain 160 mg of acetaminophen per 5mL dose. | ¶35 | col. 6:39 |
| (b) agave syrup; | The accused products are alleged to contain "organic agave syrup" as a primary inactive ingredient. | ¶36 | col. 6:40 |
| (c) acidic preservative; | The accused products are alleged to contain "non-GMO citric acid," which functions as an acidic preservative. | ¶36 | col. 6:41 |
| (d) a flavoring agent, and | The accused products are alleged to contain "organic cherry flavor" as a flavoring agent. | ¶36 | col. 6:42 |
| (e) a diluent, | The accused products are alleged to contain "purified water" as a diluent. | ¶36 | col. 6:43 |
| wherein the syrup formation has a viscosity of less than 1500 centipoise at about 22 degrees | The complaint alleges "upon information and belief" that the accused products' viscosity is less than 1500 cP, based in part on a visual comparison to Genexa's own product. | ¶37-38 | col. 6:44-46 |
| and the acetaminophen is suspended in the syrup. | The complaint alleges "upon information and belief" that the acetaminophen is suspended, pointing to the product's label which describes it as an "oral suspension." An image of the product boxes confirms the use of the term "Oral Suspension." (Compl. p. 12). | ¶39 | col. 6:47-48 |
- Identified Points of Contention:
- Scope Questions: The claim uses the transitional phrase "consisting essentially of." This raises the question of whether the accused products contain any unlisted ingredients and, if so, whether those ingredients "materially affect the basic and novel characteristics" of the patented invention. The complaint's side-by-side comparison of ingredients suggests a direct overlap. A graphic in the complaint contrasts the five alleged ingredients in the KinderFarms product with the six in Genexa's product, highlighting their similarity (Compl. p. 9).
- Technical Questions: The complaint pleads the viscosity and suspension limitations "upon information and belief" (Compl. ¶37, ¶39). A central factual question will be whether the accused products actually meet these technical requirements. Plaintiff supports its suspension allegation by pointing to the "Oral Suspension" language on the accused product's packaging (Compl. p. 12), but the viscosity allegation relies on a "visual inspection" and comparison (Compl. ¶38). These elements will likely require expert testimony and empirical testing to resolve.
V. Key Claim Terms for Construction
The Term: "consisting essentially of"
- Context and Importance: This transitional phrase is critical to defining the boundaries of infringement. It permits the presence of ingredients not explicitly listed in claim 18, but only if they do not materially alter the "basic and novel characteristics" of the formulation. Practitioners may focus on this term because the case could turn on whether the accused formulation contains any additional, unrecited components and what the "basic and novel characteristics" of an agave-based syrup are.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The standard legal definition of the phrase allows for impurities or other non-material components.
- Evidence for a Narrower Interpretation: The patent repeatedly emphasizes the goal of creating a "clean" formulation by excluding a range of "unnatural ingredients" such as "aspartame, carbomer, EDTA, gelatin, milk, parabens, polyethylene glycol, titanium dioxide, and other unnatural ingredients" ('795 Patent, col. 2:33-38). A party could argue that the "basic and novel characteristic" is this very absence of artificial additives, potentially limiting the scope of permissible unlisted ingredients.
The Term: "suspended in the syrup"
- Context and Importance: This term defines the physical state of the acetaminophen within the liquid. Infringement requires that the drug particles are primarily dispersed as a solid in the liquid, rather than being dissolved. The complaint relies on the defendant's own product labeling ("Oral Suspension") as evidence (Compl. ¶39). The distinction is technically significant, as the patent suggests that keeping the drug in solid form is key to masking its bitter taste ('795 Patent, col. 2:58-63).
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The term could be construed to mean that any non-trivial amount of the acetaminophen exists in a solid, undissolved state.
- Evidence for a Narrower Interpretation: The specification links the suspension to taste-masking, stating that because the "active agent remains in the solid (undissolved) form, the pharmaceutical is less likely to be tasted while in the mouth" ('795 Patent, col. 2:61-63). This could support an interpretation requiring a substantial portion of the drug to be undissolved for the taste-masking benefit to be realized.
VI. Other Allegations
- Indirect Infringement: The complaint alleges inducement under 35 U.S.C. § 271(b), stating that Defendant encourages infringement by its partners, customers, and end users through "advertising and distributing the Accused Products and providing instructions with the Accused Products" (Compl. ¶40-41).
- Willful Infringement: Willfulness is alleged based on the assertion that the "Accused Products are copies of Genexa's products" and that Defendant had knowledge of the infringement (Compl. ¶43). The complaint alleges pre-suit knowledge of the patent as of September 25, 2023 (Compl. ¶32). The "copying" narrative is further supported by allegations that KinderFarms used a similar "founder's story" and nearly identical product names and ingredient profiles (Compl. ¶20, ¶25-26).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of claim scope: does the transitional phrase "consisting essentially of" permit the inclusion of any unrecited ingredients in the accused product, and what are the "basic and novel characteristics" of the patented formulation that define this boundary?
- A key evidentiary question will be one of physical properties: can the plaintiff produce empirical evidence, beyond the initial "information and belief" allegations and visual comparisons, to prove that the accused products meet the specific "viscosity of less than 1500 centipoise" and "acetaminophen is suspended" limitations of claim 18?
- A third question will concern intent and damages: can the plaintiff substantiate its narrative that the defendant engaged in deliberate copying of its product line, founder story, and formulation? The answer will be critical for the claims of willfulness and the potential for enhanced damages.