DCT
8:18-cv-00156
Vireo Systems Inc v. GNC Holdings Inc
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Vireo Systems, Inc. (Tennessee) and NE Enterprises Inc. (Nebraska)
- Defendant: GNC Holdings, Inc. (Delaware)
- Plaintiff’s Counsel: Kutak Rock LLP; Cline Williams Wright Johnson & Oldfather, L.L.P.
- Case Identification: 8:18-cv-00156, D. Neb., 04/09/2018
- Venue Allegations: Venue is alleged to be proper in the District of Nebraska because Defendant GNC operates multiple "regular and established places of business" (i.e., retail stores) within the district and has allegedly committed acts of patent infringement there.
- Core Dispute: Plaintiffs allege that Defendant’s creatine hydrochloride (C-HCl) nutritional supplements infringe three patents related to C-HCl formulations with improved solubility and purity.
- Technical Context: The technology concerns chemical formulations of creatine, a dietary supplement popular for athletic performance, designed to improve aqueous solubility and bioavailability over older forms like creatine monohydrate.
- Key Procedural History: The patents-in-suit are co-owned by Plaintiff Vireo and the Board of Regents of the University of Nebraska, with rights licensed to Plaintiffs. The complaint alleges that Defendant GNC had pre-suit knowledge of the patent family as early as November 2010, when it allegedly received a licensing invitation for the application that would become the ’450 Patent, and subsequently rebuffed multiple licensing overtures.
Case Timeline
| Date | Event |
|---|---|
| 2003-05-15 | Priority Date for '450, ’685, and ’424 Patents |
| 2010-11 | Alleged licensing invitation sent to GNC for '450 Patent application |
| 2013-01-15 | U.S. Patent No. 8,354,450 Issue Date |
| 2015-02-24 | U.S. Patent No. 8,962,685 Issue Date |
| 2016-11-08 | U.S. Patent No. 9,486,424 Issue Date |
| 2018-04-09 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,354,450 - "Creatine Oral Supplementation Using Creatine Hydrochloride Salt"
- Patent Identification: U.S. Patent No. 8,354,450, "Creatine Oral Supplementation Using Creatine Hydrochloride Salt," issued January 15, 2013 (Compl. ¶23).
- The Invention Explained:
- Problem Addressed: The patent's background section describes how prior creatine supplements, particularly creatine monohydrate, suffer from low aqueous solubility, which necessitates large doses and can lead to gastrointestinal side effects like bloating and cramps (’450 Patent, col. 1:63-col. 2:2).
- The Patented Solution: The invention is a creatine supplement using a creatine hydrochloride (HCl) salt, which is described as having significantly higher aqueous solubility and improved bioavailability compared to creatine monohydrate (’450 Patent, Abstract). This improved solubility allows for smaller, more efficient doses that are better absorbed by the body, solving the problems associated with the prior art (’450 Patent, col. 2:8-15).
- Technical Importance: This technical approach offered a way to achieve the athletic performance benefits of creatine supplementation with greater convenience and fewer of the common negative side effects that limited the use of earlier creatine forms (’450 Patent, col. 2:2-8).
- Key Claims at a Glance:
- The complaint asserts independent claims 1 and 19 (Compl. ¶46).
- Independent Claim 1: The essential elements are: (1) a supplement comprising creatine HCl, (2) where the creatine HCl possesses a solubility of at least 600 mg/mL in water at 25°C, (3) after a time period of about 1.5 hours (’450 Patent, col. 13:10-14).
- Independent Claim 19: The essential elements are: (1) a supplement comprising creatine HCl, (2) where the creatine HCl is at least 95 percent free of contaminants (’450 Patent, col. 14:17-19).
U.S. Patent No. 8,962,685 - "Creatine Oral Supplementation Using Creatine Hydrochloride Salt"
- Patent Identification: U.S. Patent No. 8,962,685, "Creatine Oral Supplementation Using Creatine Hydrochloride Salt," issued February 24, 2015 (Compl. ¶24).
- The Invention Explained:
- Problem Addressed: Similar to the ’450 Patent, the background identifies the low oral bioavailability and gastrointestinal side effects of creatine monohydrate as the key technical hurdle to be overcome (’685 Patent, col. 2:2-8).
- The Patented Solution: The invention is a formula that contains a specific dose range of creatine HCl (from about 500 mg to 2000 mg) that exhibits significantly improved aqueous solubility—at least 15 times greater than creatine monohydrate (’685 Patent, col. 13:9-15). The detailed description emphasizes that this enhanced solubility is the basis for its improved performance as a supplement (’685 Patent, col. 4:16-28).
- Technical Importance: The invention provided a defined dosage form of a highly soluble creatine salt, aiming to provide a reliable and more tolerable alternative to existing creatine supplements (’685 Patent, col. 2:8-18).
- Key Claims at a Glance:
- The complaint asserts independent claims 8 and 14 (Compl. ¶55).
- Independent Claim 8: The essential elements are: (1) a formula comprising a first creatine, (2) which has a solubility of at least about 150 mg/mL in water at 25°C after about 1.5 hours, (3) where the first creatine comprises creatine HCl, (4) in an amount of about 500 mg to about 2000 mg (’685 Patent, col. 14:3-8).
- Independent Claim 14: The essential elements are: (1) a formula comprising creatine HCl, (2) in an amount of about 500 mg to about 2000 mg, (3) where the creatine HCl is at least 95 percent free of contaminants (’685 Patent, col. 14:21-25).
U.S. Patent No. 9,486,424 - "Creatine Oral Supplementation Using Creatine Hydrochloride Salt"
- Patent Identification: U.S. Patent No. 9,486,424, "Creatine Oral Supplementation Using Creatine Hydrochloride Salt," issued November 8, 2016 (Compl. ¶25).
- Technology Synopsis: The patent addresses the known technical problems of prior art creatine supplements, namely low solubility and the resulting need for large doses that cause side effects (’424 Patent, col. 1:65-col. 2:10). The patented solution is a formula based on creatine HCl, which possesses substantially greater aqueous solubility, allowing for effective supplementation with smaller, better-tolerated doses (’424 Patent, Abstract; col. 2:10-18).
- Asserted Claims: The complaint asserts independent claim 8 (Compl. ¶64).
- Accused Features: The complaint alleges that Defendant's products are formulas containing creatine HCl that meets the specific solubility limitation recited in claim 8 (Compl. ¶37).
III. The Accused Instrumentality
- Product Identification: The accused instrumentalities are a line of GNC-branded nutritional supplements, including "Amplified Creatine 189," "AMP Creatine HCl 189," "GNC Pro Performance Creatine Complex Chew," "Beyond Raw® Chemistry Labs® Creatine HCl," and "GNC Pro Performance XR Series Creatine Advance XR" (collectively, the "Accused Products") (Compl. ¶29).
- Functionality and Market Context: The complaint alleges these products are creatine HCl nutraceuticals that are marketed as having superior absorption compared to "Ordinary Creatine" (Compl. ¶¶30-31). The complaint alleges, on information and belief, that the creatine HCl in these products possesses specific chemical properties, including a solubility of at least 650 mg/mL and a purity of at least 95% (Compl. ¶34). It is also alleged that GNC provides financial incentives to its sales associates to divert customers from Plaintiffs' competing CON-CRET® product to GNC's Accused Products (Compl. ¶44).
No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint's infringement allegations are made on "information and belief" and largely recite the language of the asserted claims.
’450 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A supplement comprising: creatine HCl | The Accused Products contain creatine HCl. | ¶32 | col. 2:20-22 |
| wherein the creatine HCl possesses a solubility of at least 600 mg/mL in water at 25 °C. after a time period of about 1.5 hours. | The Accused Products allegedly possess a creatine HCl solubility of at least 600 mg/mL under the claimed conditions. | ¶35 | col. 13:12-14 |
| Claim Element (from Independent Claim 19) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A supplement comprising: creatine HCl | The Accused Products contain creatine HCl. | ¶32 | col. 2:20-22 |
| wherein the creatine HCl is at least 95 percent free of contaminants. | The Accused Products allegedly possess creatine HCl that is at least 95 percent free of contaminants. | ¶35 | col. 14:18-19 |
’685 Patent Infringement Allegations
| Claim Element (from Independent Claim 8) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A formula comprising: a first creatine having a solubility of at least about 150 mg/mL in water at 25° C. after a time period of about 1.5 hours | The Accused Products allegedly possess creatine HCl having a solubility of at least 150 mg/mL under the claimed conditions. | ¶36 | col. 14:3-6 |
| wherein the first creatine comprises creatine HCl in an amount of about 500 mg to about 2000 mg. | The Accused Products allegedly contain creatine HCl in an amount between 500 mg and 2000 mg. | ¶36 | col. 14:6-8 |
- Identified Points of Contention:
- Technical Questions: The complaint's allegations regarding the specific solubility and purity values of the Accused Products are made "on information and belief" (Compl. ¶¶34-37). A primary point of contention will be factual. What evidence, such as third-party laboratory testing or internal GNC specifications, can Plaintiffs produce to prove the Accused Products meet the quantitative thresholds required by the claims (e.g., "at least 600 mg/mL," "at least 95 percent free")?
- Scope Questions: The term "about" is used in relation to key limitations, including dosage ("about 500 mg") and time ("about 1.5 hours"). The interpretation of the breadth of "about" will be critical. The case raises the question of whether the properties of the Accused Products fall within a reasonable interpretation of these ranges, a determination that will be central to the infringement analysis.
V. Key Claim Terms for Construction
The Term: "solubility"
Context and Importance: The asserted claims are defined by specific, quantitative solubility thresholds (e.g., "at least 600 mg/mL"). The definition of this term and, critically, the protocol used to measure it, will be central to determining infringement. Practitioners may focus on this term because the patent discloses a specific experimental protocol for its measurement, creating a potential dispute over whether that protocol is definitional.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party could argue that the term should be given its plain and ordinary meaning to one of skill in the art, measured under the conditions explicitly stated in the claim itself ("in water at 25 °C. after a time period of about 1.5 hours"), without being limited to a single measurement technique (’450 Patent, col. 13:12-14).
- Evidence for a Narrower Interpretation: The specification provides a detailed "Saturation Solubility Determination" protocol in Example 2, including steps such as using a "shaking water bath," centrifugation at "3900 rpm for 10 minutes," and assaying the result "spectrophotometrically at 210 nm" (’450 Patent, col. 11:56-65). A party could argue this disclosure implicitly defines the required method for measuring the claimed "solubility."
The Term: "contaminants"
Context and Importance: Several asserted claims require the creatine HCl to be "at least 95 percent free of contaminants." The meaning of "contaminants" is critical to assessing purity. Practitioners may focus on this term because its scope is undefined in the claims, raising the question of whether it refers to any substance other than creatine HCl or only to specific, undesirable manufacturing byproducts.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claim language itself offers no limitation, which may support an interpretation where "contaminants" means any and all substances other than creatine HCl present in the tested material.
- Evidence for a Narrower Interpretation: The specification explicitly identifies certain impurities, stating, "The main impurities typically detected in the composition are creatine ethyl ester hydrochloride and creatinine hydrochloride" (’450 Patent, col. 9:62-65). A party could argue that "contaminants" should be construed more narrowly to refer to such unintended byproducts of the synthesis process, rather than other substances like excipients that may be intentionally added to a final consumer product.
VI. Other Allegations
- Indirect Infringement: The complaint does not plead a separate count for indirect infringement but includes allegations that may support such a theory. It alleges that GNC "intended that its affiliates, suppliers, and manufacturers would make, sell, offer to sell, distribute, and/or use" infringing products (Compl. ¶¶48, 57, 66). It also alleges GNC encourages its sales associates to divert customers to the Accused Products (Compl. ¶44).
- Willful Infringement: The complaint alleges that GNC's infringement has been "knowing, willful, and egregious" (Compl. ¶38). This allegation is primarily based on alleged pre-suit knowledge of the patent family. The complaint asserts that GNC was notified of the application leading to the ’450 Patent via a licensing invitation sent to its COO in November 2010 (Compl. ¶41) and that GNC also had knowledge of the patents because it sells Plaintiffs' own CON-CRET® product, which is marked with the patent numbers (Compl. ¶40).
VII. Analyst’s Conclusion: Key Questions for the Case
The resolution of this case will likely depend on the answers to a few central questions:
- A core issue will be one of evidentiary proof: given that the complaint's technical allegations are made "on information and belief," can the Plaintiffs develop and present sufficient factual evidence (e.g., through chemical analysis) to prove that the accused GNC supplements meet the specific, quantitative limitations for solubility and purity recited in the patent claims?
- The case will also turn on a question of claim construction: will the term "solubility" be defined by its plain meaning under the conditions listed in the claim, or will it be limited to the specific measurement protocol detailed in the patent's examples? The outcome of this dispute could be dispositive for infringement.
- Finally, a key question for damages will be one of willfulness: do the allegations of a 2010 licensing overture to a GNC executive and GNC's own sales of patent-marked products establish pre-suit knowledge sufficient to support a finding of willful infringement and potential exposure to enhanced damages?