Hi Tech Pharma v. Vintage Muscle

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Hi-Tech Pharmaceuticals, Inc. (Georgia) and Intellectual Wellness, LLC (Michigan)
  • Defendant: Vintage Muscle, LLC (Utah)
  • Plaintiff’s Counsel: Hillyer Legal, PLLC
• Case Identification: 2:24-cv-00208, D. Utah, 03/19/2024
• Venue Allegations: Venue is alleged to be proper in the District of Utah because the Defendant is domiciled there, maintains a regular and established place of business in the district, and distributes and sells the accused products within the district.
• Core Dispute: Plaintiffs allege that Defendant’s dietary supplement products infringe three patents related to methods of using specific dehydroepiandrosterone (DHEA) derivatives to enhance physical performance.
• Technical Context: The technology concerns chemical compounds used in the sports supplement industry, which are designed to provide anabolic effects, such as increased muscle mass and strength, while mitigating undesirable side effects associated with traditional hormone precursors.
• Key Procedural History: The patents-in-suit share a common priority application. Plaintiff Intellectual Wellness, LLC is the owner of the patents and has granted Plaintiff Hi-Tech Pharmaceuticals, Inc. a license with the right to enforce the patents against third parties. The complaint alleges that Plaintiffs provided Defendant with notice of the patents-in-suit in September 2023, approximately six months prior to filing the lawsuit.

Case Timeline

Date	Event
2005-04-26	Priority Date for ’446, ’399, and ’918 Patents
2011-12-27	U.S. Patent No. 8,084,446 Issued
2012-12-25	U.S. Patent No. 8,338,399 Issued
2014-07-15	U.S. Patent No. 8,778,918 Issued
2023-09-XX	Plaintiffs allegedly sent notice letter to Defendant
2024-03-19	Complaint Filed

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

U.S. Patent No. 8,084,446 - "Use of DHEA Derivatives For Enhancing Physical Performance," issued Dec. 27, 2011

The Invention Explained

• Problem Addressed: The patent’s background section explains that when DHEA is used as a dietary supplement, it is often rapidly metabolized by the liver into either an ineffective, quickly excreted compound (DHEA sulfate) or into estrogen, which can cause undesirable side effects in males ('446 Patent, col. 2:1-19). This requires frequent, large doses to achieve any beneficial effect.
• The Patented Solution: The invention proposes methods of administering specific DHEA derivatives that are designed to be more resistant to metabolic conversion to estrogen and to last longer in the body ('446 Patent, col. 3:1-9). This allows a user to obtain the desired performance-enhancing benefits—such as decreased body weight, reduced adipose tissue, and increased endurance—while minimizing negative side effects.
• Technical Importance: By creating more stable derivatives, the invention sought to improve the therapeutic window and efficacy of DHEA-related compounds for performance enhancement and anti-aging applications ('446 Patent, col. 2:5-22).

Key Claims at a Glance

• The complaint asserts at least independent claim 1 (Compl. ¶44).
• The essential elements of Claim 1 are:
  • A method of administering a DHEA derivative or a physiologically acceptable salt, ester or ether thereof;
  • as a compound that provides at least one of a list of benefits including anti-aging adrenal hormonal balance, decreased body weight, skeletal muscle growth, and others;
  • of a specific general chemical formula wherein a substituent R3 is one of α-OH and β-OH;
  • wherein the DHEA derivative is administered orally.

U.S. Patent No. 8,338,399 - "Use of DHEA Derivatives For Enhancing Physical Performance," issued Dec. 25, 2012

The Invention Explained

• Problem Addressed: Similar to the '446 Patent, the '399 Patent addresses the problem of conventional DHEA supplements being rapidly metabolized into less effective or undesirable compounds, limiting their benefits and causing side effects like gynecomastia in men ('399 Patent, col. 2:1-24).
• The Patented Solution: The patent describes methods of using a different class of DHEA derivatives, specifically androst-1-ens, which are also intended to be more metabolically stable and resistant to estrogen conversion ('399 Patent, col. 3:15-42). The goal is to provide the benefits of high DHEA levels for extended periods without the associated drawbacks.
• Technical Importance: This patent expanded the family of protected DHEA derivatives to a different structural class, aiming to provide alternative chemical pathways to achieve similar performance-enhancing goals with improved safety and efficacy profiles ('399 Patent, col. 2:18-24).

Key Claims at a Glance

• The complaint asserts at least independent claim 1 (Compl. ¶52).
• The essential elements of Claim 1 are:
  • A method of administering a DHEA derivative or a physiologically acceptable salt, ester or ether thereof;
  • as a compound that provides at least one of a list of benefits including anti-aging adrenal hormonal balance, decreased body weight, skeletal muscle growth, and others;
  • of a specific general chemical formula wherein R3 is one of α-OH and β-OH, R5 is one of α-H and β-H, and R7 is one of α-H and β-H.

U.S. Patent No. 8,778,918 - "Use of 19 Nor DHEA Derivatives For Enhancing Physical Performance," issued July 15, 2014

• Technology Synopsis: This patent addresses the same technical problem of poor bioavailability and negative side effects from standard DHEA supplementation (’918 Patent, col. 2:1-28). The patented solution is a method of administering a different class of compounds, namely 19-nor-DHEA derivatives, which are alleged to provide enhanced physical performance benefits more effectively by being more resistant to metabolism (’918 Patent, col. 4:21-30).
• Asserted Claims: The complaint asserts at least independent Claim 1 (Compl. ¶60).
• Accused Features: The accused features are Defendant's "19Nor Vial" and "19Nor Stack" products, which are alleged to contain 19-Nor-DHEA, a compound that allegedly falls within the scope of the patent's claims (Compl. ¶58, ¶64).

III. The Accused Instrumentality

Product Identification

• The accused instrumentalities are six dietary supplement products: "RAD-Mass Vial," "RAD-Mass Stack," "1-Androl Vial," "1-Androl Stack," "19Nor Vial," and "19Nor Stack" (Compl. ¶37).

Functionality and Market Context

• The accused products are orally administered supplements marketed for bodybuilding and fitness (Compl. ¶43, ¶51, ¶59).
• The "RAD-Mass" products contain the ingredient 4-DHEA and are promoted as a "muscle-building supplement" for "Faster Muscle Gains" and "More Brute Strength" (Compl. ¶46, ¶48). A screenshot from Defendant's website describes RAD-Mass as a "cutting-edge muscle-building supplement featuring 4-DHEA" (Compl. ¶46).
• The "1-Androl" products contain the ingredient 1-DHEA and are promoted for "Drastic Strength and Lean Gains" and to "Improve Fat Loss" (Compl. ¶54, ¶56). A product description for '1-Androl Stack' identifies its key ingredient as 1-DHEA and claims it "Promotes Anabolic Activity" (Compl. p. 11).
• The "19Nor" products contain the ingredient 19-Nor-DHEA and are promoted as a "muscle-building and recovery supplement" (Compl. ¶62, ¶64). A screenshot of Defendant's marketing material describes 19Nor as featuring "19Nor-DHEA, a 2-step precursor to Deca" (Compl. ¶63).
• The complaint alleges that these products compete directly with Plaintiffs' products in the bodybuilding and fitness market (Compl. ¶41).

IV. Analysis of Infringement Allegations

8,084,446 Infringement Allegations

Claim Element (from Independent Claim 1)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
A method of administering a DHEA derivative... wherein the DHEA derivative is administered orally.	The "RAD-Mass" products are "orally administered dietary supplement[s]" that are "promoted to be consumed orally by the user."	¶43, ¶46	col. 2:46-56
as a compound that provides at least one of... skeletal muscle growth...	The "RAD-Mass" products are promoted as increasing "muscle mass," for "Faster Muscle Gains," and for "More Brute Strength."	¶46	col. 6:5-10
of the general formula: [formula depicted] wherein R3 is one of α-OH and β-OH	The "RAD-Mass" products contain 4-DHEA, a compound that the complaint alleges has a chemical structure corresponding to the general formula recited in the claim.	¶48	col. 6:11-18

8,338,399 Infringement Allegations

Claim Element (from Independent Claim 1)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
A method of administering a DHEA derivative...	The "1-Androl" products were "designed and... promoted to be consumed orally by the user."	¶51, ¶54	col. 2:50-60
as a compound that provides at least one of... reduction of adipose tissue, ... skeletal muscle growth...	The "1-Androl" products are promoted for "Drastic Strength and Lean Gains" and to "Improve Fat Loss."	¶54, p. 11	col. 6:3-8
of the general formula: [formula depicted] wherein R3 is one of α-OH and β-OH, R5 is one of α-H and β-H, and R7 is one of a-H and β-H	The "1-Androl" products contain 1-DHEA, a compound that the complaint alleges has a chemical structure corresponding to the general formula recited in the claim.	¶56	col. 6:9-17

Identified Points of Contention

• Scope Questions: The infringement analysis for all patents will raise the question of whether the active ingredients in the accused products (4-DHEA, 1-DHEA, and 19-Nor-DHEA) fall within the structural definitions of the general formulas recited in the respective asserted claims. The complaint alleges a direct correspondence, but the structural details could be a point of dispute.
• Technical Questions: The asserted claims are method claims that require the administered compound to "provide" a physiological benefit (e.g., "skeletal muscle growth"). A key technical question is what evidence the complaint provides to show this requirement is met. The complaint relies on Defendant's marketing claims (e.g., Compl. ¶46, ¶54), which raises the question of whether such claims are sufficient to prove the compound actually causes the claimed effect.

V. Key Claim Terms for Construction

The Term: "DHEA derivative"

• Context and Importance: This term appears in the preamble of the asserted claims and is foundational to the scope of the patents. The definition of "DHEA derivative" will determine whether the specific chemical compounds in Defendant's products are subject to the patent claims at all. Practitioners may focus on this term because its construction could resolve the infringement question for all accused products.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The specifications provide an explicit definition, stating a "derivative... refers to a species having a chemical structure that is similar to the compound, yet containing a chemical group not present in the compound and/or deficient of a chemical group that is present in the compound" ('446 Patent, col. 2:57-63). This language could support a broad reading encompassing a wide range of structurally related steroids.
  • Evidence for a Narrower Interpretation: The specifications also provide a finite number of general formulas and specific examples of derivatives ('446 Patent, col. 3-4). A party could argue that the term "DHEA derivative" should be construed as being limited to the classes of compounds explicitly disclosed and exemplified in the patent.

The Term: "provides at least one of [anti-aging adrenal hormonal balance, decreased body weight, reduction of adipose tissue, increased endurance, skeletal muscle growth, and increased production of red blood cells]"

• Context and Importance: This functional language in the body of the claims requires that the accused method achieve a specific result. The interpretation of what it means for a compound to "provide" one of these benefits is critical for determining infringement.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The patents' background sections discuss the "beneficial effects of high DHEA levels" in general terms, such as stimulating "skeletal muscle anabolism" ('446 Patent, col. 1:59-62). A party might argue that any compound designed and marketed for these known DHEA-related effects inherently "provides" them for purposes of the claim.
  • Evidence for a Narrower Interpretation: The claims recite specific, measurable physiological outcomes. A party could argue that this language requires objective scientific proof that the administration of the compound causes a cognizable and demonstrable effect, and that marketing claims alone (e.g., "Faster Muscle Gains," Compl. ¶46) are insufficient to meet this limitation.

VI. Other Allegations

Indirect Infringement

• The complaint alleges both induced and contributory infringement (Compl. ¶72). Inducement is based on allegations that Defendant's labels, instructions, and advertising encourage and instruct end users to administer the products in a manner that directly infringes the method claims (Compl. ¶79-80). Contributory infringement is based on allegations that the accused products are "special purpose products" that are not "staple articles of commerce," have no substantial non-infringing use, and are especially designed to practice the patented methods (Compl. ¶86-89).

Willful Infringement

• The complaint alleges willful infringement based on pre-suit knowledge. It specifically claims that Defendant has known of the patents-in-suit "at least as early as September, 2023 when Plaintiffs sent a letter informing Vintage Muscle of their patent rights" (Compl. ¶71, ¶75, ¶99). The complaint further alleges that Defendant "turned a blind eye" to a high probability of infringement (Compl. ¶77).

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

• A core issue will be one of claim construction: can the term "DHEA derivative," as defined and used in the patents, be construed to cover the specific 4-DHEA, 1-DHEA, and 19-Nor-DHEA compounds contained in Defendant's products, particularly in light of the specific chemical formulas recited in the claims?
• A key evidentiary question will be one of functional proof: for the asserted method claims, what level of evidence is required to demonstrate that the administration of Defendant's products "provides" the claimed physiological benefits? The case may turn on whether Defendant's own marketing claims are sufficient to meet this limitation or if objective, scientific data is necessary.
• Finally, a central question for damages will be willfulness: given Plaintiffs' allegation of a pre-suit notice letter, the court will likely examine whether Defendant's continued sales after September 2023 constituted objectively reckless conduct, which could depend on what, if any, good-faith efforts Defendant made to assess its non-infringement or the patents' invalidity upon receiving notice.