DCT
2:25-cv-00652
OmniActive Health Tech Ltd v. Bio Gen Extracts Pvt Ltd
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: OmniActive Health Technologies Ltd. (India)
- Defendant: Bio-gen Extracts Pvt. Ltd. (India)
- Plaintiff’s Counsel: Covington & Burling LLP; Roth & Abraham, PLLC
- Case Identification: 2:25-cv-00652, E.D. Tex., 06/23/2025
- Venue Allegations: Plaintiff alleges venue is proper because Defendant is a foreign company, and further alleges Defendant has continuous and systematic contacts with Texas, including selling and inducing the use of the accused product in the state.
- Core Dispute: Plaintiff alleges that Defendant actively induces infringement of a patent covering methods for improving human visual function by marketing and selling a key ingredient for nutritional supplements.
- Technical Context: The technology relates to nutritional supplements, specifically the use of carotenoid compounds (lutein and zeaxanthin) to mitigate visual fatigue and protect the eyes from blue light, a field of growing consumer interest due to increased screen time.
- Key Procedural History: The complaint alleges that Defendant has been aware of Plaintiff's patent rights since at least August 2023, following correspondence between the parties. Plaintiff also alleges it sent a cease and desist letter regarding the patent-in-suit on April 1, 2025, which it claims did not result in a substantive response or cessation of the accused activity. These allegations form the basis for the claim of willful infringement.
Case Timeline
| Date | Event |
|---|---|
| 2015-03-26 | Priority Date for ’035 Patent |
| 2020-01-14 | ’035 Patent Issued |
| 2023-07-26 | Plaintiff sent letter to Defendant regarding "misleading claims" |
| 2023-08-21 | Defendant responded, stating it was "aware" of Plaintiff's IP rights |
| 2024-10-30 | Defendant hosted presentation at SupplySide West tradeshow |
| 2025-04-01 | Plaintiff sent cease and desist letter to Defendant |
| 2025-05-13 | Defendant provided response to letter |
| 2025-06-23 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 10,532,035 - "Methods for Improvement of Visual Function and Compositions Used Therein", issued January 14, 2020
The Invention Explained
- Problem Addressed: The patent describes the problem of "visual fatigue" caused by prolonged exposure to light from sources like electronic device screens, which emit high-energy blue light (’035 Patent, col. 1:56-2:5). This exposure can lead to symptoms like eye discomfort, headaches, and difficulty focusing, and may disrupt sleep patterns (’035 Patent, col. 2:7-14).
- The Patented Solution: The invention is a method for improving visual function in individuals suffering from this fatigue. The method involves administering a daily dose of a specific composition of macular carotenoids, namely lutein and zeaxanthin isomers, derived from marigold flowers (’035 Patent, Abstract; col. 20:25-41). The patent asserts that this administration improves key metrics like contrast sensitivity, critical flicker fusion frequency, and macular pigment optical density (MPOD), which in turn alleviates visual fatigue (’035 Patent, col. 19:30-34).
- Technical Importance: The claimed method provides a nutritional, non-pharmaceutical approach to mitigating the negative effects of modern light exposure by supplementing the body's natural macular pigments, which act as filters for harmful blue light (’035 Patent, col. 7:17-25).
Key Claims at a Glance
- The complaint asserts infringement of at least Claim 1 of the ’035 Patent (Compl. ¶68).
- Independent Claim 1 is a method claim with the following essential elements:
- (a) identifying a subject who is exposed to light of varying wavelengths and is suffering from visual fatigue (including visual discomfort, stress, and affected sleep quality);
- (b) administering to the subject a daily dose of macular carotenoids (at least 1mg of lutein and 0.2mg of zeaxanthin isomers, including meso-zeaxanthin and R,R zeaxanthin, in a 5:1 ratio derived from marigold);
- (c) measuring at least one parameter of the subject from a specified group (contrast sensitivity, disability glare, visual processing speed, photostress recovery); and
- (d) evaluating an improvement in the subject's visual function.
- The complaint does not explicitly reserve the right to assert other claims, but the prayer for relief requests judgment on "one or more claims" (Compl. ¶77(a)).
III. The Accused Instrumentality
Product Identification
- The accused product is "Lute-gen®," a compound containing lutein and zeaxanthin isomers that Defendant Bio-gen manufactures, sells, and imports into the United States (Compl. ¶6, ¶26).
Functionality and Market Context
- Lute-gen® is marketed and sold as an ingredient for use in nutritional supplements and nutraceuticals (Compl. ¶27). The complaint alleges that Lute-gen® is derived from marigold and provides lutein and zeaxanthin isomers in a 5:1 ratio, the same as that recited in the patent (Compl. ¶29). Bio-gen is alleged to promote Lute-gen® for its benefits to visual health, including enhancing visual performance, increasing macular pigment optical density, and protecting against blue light (Compl. ¶32). The complaint provides an example of a third-party product, Sports Research Corporation's "Lutein + Zeaxanthin isomers" supplement, which is formulated with Lute-gen® and sold to end-users in the U.S. (Compl. ¶28). The complaint includes a screenshot of a customer review for this supplement, which states the user has "noticed a reduction in eye strain and improved visual clarity, especially during extended periods of screen time" (Compl. ¶47).
IV. Analysis of Infringement Allegations
The complaint alleges active inducement of infringement, asserting that Bio-gen encourages and instructs its customers and end-users to perform the patented method (Compl. ¶66). The complaint references a claim chart in an attached "Exhibit B" (Compl. ¶68); however, this exhibit was not included with the filed complaint. The following summary is based on the narrative allegations.
’035 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| (a) identifying a subject in need thereof, exposed to light of varying wavelengths and intensity and suffering from visual fatigue... | End-users of supplements containing Lute-gen® are individuals who suffer from visual fatigue due to extensive screen time and blue light exposure. | ¶36, ¶50 | col. 19:26-30 |
| (b) administering to the subject a daily dose of macular carotenoids...the macular carotenoids consisting of at least 1mg of lutein and of at least 0.2 mg of zeaxanthin isomers... | Bio-gen promotes and sells Lute-gen® for daily supplementation, and alleges its product contains a 5:1 ratio of lutein to zeaxanthin isomers (e.g., 10 mg lutein, 2 mg zeaxanthin). This is administered by end-users. | ¶29, ¶37, ¶52 | col. 19:34-41 |
| (c) measuring at least one parameter of the subject selected from the group consisting of contrast sensitivity, disability glare, visual processing speed, and photostress recovery... | On information and belief, end-users measure at least one of these parameters to evaluate improvement. This is supported by Bio-gen's promotion of a clinical study (the Lopresti study) that measured these parameters. | ¶38, ¶53 | col. 19:42-46 |
| (d) evaluating an improvement in visual function of the subject. | End-users evaluate improvements in their visual health. This is evidenced by customer reviews stating they "noticed a slight improvement in my vision" or "improved visual clarity." | ¶47, ¶53 | col. 19:47-49 |
- Identified Points of Contention:
- Technical Questions: A primary question is whether the actions of a typical consumer constitute "measuring" and "evaluating" as required by claim limitations 1(c) and 1(d). The complaint cites consumer reviews describing subjective improvements, such as eyes feeling "less tired" (Compl. ¶47). The court may need to determine if such subjective self-assessment meets the technical requirements of "measuring" parameters like "contrast sensitivity" or "photostress recovery," which the patent describes being assessed via specific clinical tests (’035 Patent, col. 18:8-28).
- Scope Questions: The case hinges on a theory of induced infringement, which requires underlying direct infringement by an end-user. A central dispute will be whether the scope of method claim 1 covers the ordinary use of a nutritional supplement by a consumer, or if it is limited to a more clinical or diagnostic setting where objective measurements are taken. As referenced in a customer review, a user notes, "This was recommended by my eye doctor" (Compl. ¶48), which may suggest a more formal evaluation context for at least some users.
V. Key Claim Terms for Construction
The Term: "evaluating an improvement in visual function" (Claim 1(d))
- Context and Importance: The viability of the inducement claim depends on whether an end-user's subjective perception of improved vision satisfies this limitation. Practitioners may focus on this term because if "evaluating" requires objective, clinical-style testing, then ordinary consumer use would not constitute direct infringement, and the inducement claim would fail.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The body of the claim itself does not specify how the evaluation must be performed, which may suggest any form of evaluation, including subjective assessment, is covered.
- Evidence for a Narrower Interpretation: The patent's detailed description and examples focus on objective measurements using clinical tools and specific tests, such as heterochromatic flicker photometry for MPOD and the Hermann Grid for contrast sensitivity (’035 Patent, col. 14:45-54; col. 16:21-23). This could support a narrower construction limited to quantitative or clinical evaluation.
The Term: "measuring at least one parameter" (Claim 1(c))
- Context and Importance: This term is closely related to "evaluating" and is equally critical. The infringement theory requires that a consumer "measures" a specific parameter like "contrast sensitivity." If this term is construed to require the use of an instrument or a formal test, the infringement case may be significantly weakened.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent does not define "measuring," leaving open the possibility that a layperson's observation (e.g., "I can see more clearly at night") could qualify.
- Evidence for a Narrower Interpretation: The patent consistently discusses the listed parameters (contrast sensitivity, photostress recovery, etc.) in the context of formal, controlled studies and specific testing protocols, not informal user observation (’035 Patent, col. 16:21-41; col. 18:8-18). This context suggests "measuring" implies a more rigorous process than subjective experience.
VI. Other Allegations
- Indirect Infringement: The complaint exclusively pleads induced infringement under 35 U.S.C. § 271(b). It alleges Bio-gen acted with knowledge of the ’035 Patent and with the specific intent to cause infringement by its U.S. customers (Compl. ¶54, ¶60). The alleged inducing acts include marketing Lute-gen® for its patented benefits, promoting clinical studies (the "Lopresti" study) that describe the claimed method, and hosting presentations for industry professionals that detail the product's effects on visual health (Compl. ¶32-33, ¶41-43).
- Willful Infringement: The complaint alleges willful infringement based on both pre-suit and post-suit knowledge of the ’035 Patent. It specifically cites an August 21, 2023, communication in which Bio-gen's counsel allegedly stated Bio-gen was "aware and well informed about the intellectual property rights" of OmniActive (Compl. ¶56). It further alleges that Bio-gen continued its conduct after receiving a formal cease and desist letter on April 1, 2025 (Compl. ¶61, ¶71).
VII. Analyst’s Conclusion: Key Questions for the Case
This case appears to present fundamental questions regarding the scope of method claims in the context of consumer products. The resolution will likely depend on the following:
- A question of claim construction: The central issue will be whether the method steps of "measuring" a specific clinical parameter and "evaluating an improvement" can be construed to cover a consumer's subjective self-assessment of their own vision. The patent's reliance on objective, clinical data in its examples may pose a challenge to the plaintiff's broader interpretation.
- An evidentiary question of direct infringement: Assuming the claim construction is broad enough, the case will turn on whether Plaintiff can prove, on a factual basis, that end-users of Lute-gen® actually perform all steps of the claimed method. The complaint's reliance on "information and belief" and consumer testimonials for the "measuring" and "evaluating" steps highlights a potential evidentiary hurdle.
- A question of specific intent for inducement: If direct infringement is established, the focus will shift to whether Bio-gen's marketing and promotion of clinical studies demonstrate the specific intent to encourage its customers to perform the entire claimed method, including the potentially ambiguous evaluation and measurement steps.