Follea Intl Ltd v. CosmoGene Skincare Pvt Ltd

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Follea International Ltd. (British Virgin Islands)
  • Defendant: CosmoGene Skincare Pvt. Ltd. (India) and Regaliz Medicare Ltd. (India)
  • Plaintiff’s Counsel: Scott D. Olson
• Case Identification: 8:24-cv-00769, S.D. Cal., 04/09/2024
• Venue Allegations: Venue is alleged based on Defendants having committed acts of infringement in the district by selling the accused product to the public via a website and directly to doctors within the district for use or resale.
• Core Dispute: Plaintiff alleges that Defendants’ “Minoxidil Response Test” infringes a patent related to methods for predicting a patient's response to minoxidil-based hair loss treatments.
• Technical Context: The technology concerns diagnostic methods in the field of dermatology, specifically predicting the efficacy of androgenetic alopecia (hair loss) treatments.
• Key Procedural History: The complaint alleges that Plaintiff, via counsel in India, sent a cease and desist letter to Defendants on March 6, 2024, putting them on notice of the patent and the alleged infringement.

Case Timeline

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

U.S. Patent No. 8,691,518 - "Systems and methods for predicting response to minoxidil for the treatment of androgenetic alopecia", issued April 8, 2014

The Invention Explained

• Problem Addressed: The patent's background section describes the broad variability in patient response to minoxidil for hair loss, noting that a "one-size-fits-all approach" is difficult and that few diagnostic tests exist to predict treatment efficacy, often requiring prolonged use before effectiveness is known (’518 Patent, col. 1:49-62).
• The Patented Solution: The invention provides a method to predict whether a patient will respond to minoxidil by directly measuring the biochemical activity of an enzyme, minoxidil sulfotransferase, in plucked hair follicles (’518 Patent, col. 3:36-45). The method uses a colorimetric assay where a higher level of enzyme activity results in a more significant color change, which in turn indicates a higher likelihood that the patient will benefit from minoxidil treatment (’518 Patent, col. 4:46-60). This allows for the selection of patients who are likely to respond to the therapy before they begin a lengthy treatment regimen (’518 Patent, col. 1:62-col. 2:2).
• Technical Importance: The method provides a personalized medicine approach, aiming to replace trial-and-error with a biochemical-based prediction of therapeutic response for a widely used hair loss treatment (’518 Patent, col. 3:34-36).

Key Claims at a Glance

• The complaint asserts one or more claims of the patent, focusing on the method outlined in independent Claim 1 (Compl. ¶¶17, 25).
• Essential elements of independent Claim 1 include:
  • Obtaining a sample of one or more plucked hairs containing hair follicles.
  • Performing a colorimetric assay to measure minoxidil sulfotransferase activity in the sample, where the assay involves placing the sample in a reaction mixture with an indicator dye and minoxidil.
  • Generating an activity value based on a color change in the indicator dye, which correlates to the level of enzyme activity.
  • Comparing the activity value to standardized values to produce an indication of high or low expected response to minoxidil.
  • Presenting the indication to the human subject.
• The complaint does not explicitly reserve the right to assert dependent claims, but the general allegation of infringing "one or more claims" leaves this possibility open (Compl. ¶25).

III. The Accused Instrumentality

Product Identification

The accused instrumentality is the "Minoxidil Response Test" manufactured, marketed, and sold by the Defendants (Compl. ¶¶19, 25).

Functionality and Market Context

The complaint alleges the accused product is a test to help users determine if minoxidil treatment will be effective for them (Compl. ¶19). Marketing materials for the test ask, "Are You Genetically Wired to Respond to Minoxidil?" and state the test is "Grounded in the latest research connecting SULT1A1 genes and minoxidil efficacy" (Compl. p. 6). A screenshot of the accused product packaging describes it as a "DNA TEST KIT" (Compl. p. 7). The product is marketed as a way for users to "Understand if minoxidil is likely to work for you, tailored to your unique DNA" (Compl. p. 6).

IV. Analysis of Infringement Allegations

'518 Patent Infringement Allegations

Identified Points of Contention

• Technical Questions: A central question is whether the accused "DNA TEST KIT" performs the claimed "colorimetric assay to measure... activity." The complaint's evidence describes the accused product as a genetic test ("Decode Your DNA," "SULT1A1 genes") (Compl. p. 6). This raises the question of whether a genetic test, which typically identifies the presence of a gene or genetic variant, can be considered to "measure" the activity of the corresponding enzyme as required by the claim. The claim appears to recite a functional, biochemical process, whereas the accused product is marketed as a genetic analysis.
• Scope Questions: What evidence does the complaint provide that the accused test generates an "activity value" based on a "color change" from an "indicator dye"? The complaint does not detail the specific laboratory process used by the Defendants, instead relying on marketing language that focuses on genetics rather than a colorimetric chemical reaction.

V. Key Claim Terms for Construction

• The Term: "performing a colorimetric assay to measure minoxidil sulfotransferase activity"

  • Context and Importance: This term defines the core technical step of the claimed method. The outcome of the case may depend on whether this term can be construed to cover a genetic test that predicts enzyme activity, versus being limited to a biochemical test that directly measures it. Practitioners may focus on this term because the accused product is marketed as a "DNA test," which may not literally perform a "colorimetric assay" to "measure activity."
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent states that "variations in hair follicle minoxidil sulfotransferase activity may be used to predict the efficacy of minoxidil" without limiting the prediction method exclusively to the described assay in all contexts (’518 Patent, col. 2:10-14).
    • Evidence for a Narrower Interpretation: The specification repeatedly describes a specific chemical process: converting p-nitrophenyl sulfate to a colorimetric product (p-nitrophenolate), which is then measured with a spectrophotometer at a specific wavelength (’518 Patent, col. 4:24-28, 51-53). Dependent claim 12 further specifies that the indicator dye is p-nitrophenyl sulfate. This explicit embodiment could be used to argue that "colorimetric assay" is not a generic term but refers to this type of chemical reaction.

• The Term: "activity value"

  • Context and Importance: This term is the direct output of the claimed "assay." Its definition is critical because if the accused "DNA test" does not generate a value corresponding to enzyme activity in the manner claimed, there can be no infringement. The dispute will be whether a genetic result (e.g., "possesses gene variant X") qualifies as an "activity value."
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The term itself is not explicitly defined, which could support an argument that any numerical or qualitative output that indicates the level of enzyme activity meets the limitation.
    • Evidence for a Narrower Interpretation: The claim links the "activity value" directly to the "color change" of the indicator dye (’518 Patent, col. 5:18-21). The detailed description further clarifies this by referencing an absorbance reading from a spectrophotometer, which is a quantitative measurement of a chemical reaction's result (’518 Patent, col. 4:51-53). This suggests the "activity value" is a measured quantity from a biochemical reaction, not a pre-determined value associated with a genetic marker.

VI. Other Allegations

• Indirect Infringement: The complaint alleges that Defendants have induced infringement (Compl. ¶2). The specific facts alleged to support the required elements of knowledge and intent appear to be tied to the Defendants' marketing of the test and the cease and desist letter (Compl. ¶¶19, 21).
• Willful Infringement: The willfulness allegation is based on Defendants' alleged continued infringement after receiving a cease and desist letter on March 6, 2024, which allegedly provided actual notice of the patent and the infringing nature of their activities (Compl. ¶¶21-22).

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

• A core issue will be one of technical operation: does the accused "DNA TEST KIT" actually perform a "colorimetric assay to measure... activity" as required by Claim 1? The case may turn on evidence revealing the precise laboratory steps of the accused test and whether those steps align with the patent's description of a functional, biochemical measurement rather than a purely genetic analysis.
• A related key question will be one of definitional scope: can the claim term "activity value," which the patent links to a measured "color change" in a chemical reaction, be construed to read on a predictive result from a genetic test? The answer will likely depend on whether the court views the claim as being tied to a specific method of measuring a real-time chemical process or more broadly to any method of determining a patient's likely enzyme function.