DCT

1:22-cv-02446

Intellectual Wellness LLC v. IronMag Labs LLC

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:22-cv-02446, N.D. Ga., 11/01/2022
  • Venue Allegations: Venue is alleged to be proper based on a forum selection clause in a "Current License Agreement" between the parties, as well as on the basis of Defendants committing alleged tortious acts (patent infringement) and transacting business within the Northern District of Georgia.
  • Core Dispute: Plaintiffs allege that Defendants’ topical sports supplements infringe patents related to methods of using specific dehydroepiandrosterone (DHEA) derivatives for enhancing physical performance.
  • Technical Context: The technology concerns chemical derivatives of the steroid DHEA, formulated to improve bioavailability and efficacy for use in dietary supplements aimed at increasing muscle mass and reducing body fat.
  • Key Procedural History: The complaint details a significant history between the parties, including a cease and desist letter in 2012, a 2014 lawsuit in the Eastern District of Michigan, and a 2015 lawsuit in the Northern District of Georgia. These prior actions allegedly resulted in settlement and license agreements, which form the basis for the current breach of contract claims and allegations of willful infringement.

Case Timeline

Date Event
2005-04-26 Earliest Priority Date for Patents-in-Suit ('399, '774, '918)
2012-05-01 Defendants allegedly first put on notice of patent rights
2012-12-25 U.S. Patent No. 8,338,399 Issued
2013-11-12 U.S. Patent No. 8,580,774 Issued
2014-07-15 U.S. Patent No. 8,778,918 Issued
2014-09-25 "First Action" filed by Intellectual Wellness against IronMag
2014-12-12 "First Action" resolved via Settlement and "Prior License Agreement"
2015-11-06 "Second Action" filed by Plaintiffs against Defendants
2015-11-30 "Second Action" resolved via "Current License Agreement"
2022-11-01 Amended Complaint Filing Date

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

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

The Invention Explained

  • Problem Addressed: The patent's background describes how orally administered DHEA is rapidly metabolized by the liver into DHEA sulfate, a less effective compound, and can also be converted to estrogen, leading to undesirable side effects. This results in poor bioavailability, requiring frequent, high doses to achieve a therapeutic effect. (’399 Patent, col. 2:1-24).
  • The Patented Solution: The invention claims a method of administering specific DHEA derivatives that are designed to be more resistant to liver metabolism. By modifying the base DHEA structure, the patented method purports to provide the benefits of DHEA supplementation—such as decreased body weight and increased endurance—for longer periods while reducing negative side effects. (’399 Patent, Abstract; col. 3:5-14).
  • Technical Importance: This approach sought to create more effective and safer DHEA-based supplements by improving their metabolic stability and pharmacokinetic profile. (’399 Patent, col. 2:25-28).

Key Claims at a Glance

  • The complaint asserts independent Claim 1. (Compl. ¶82).
  • 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," "reduction of adipose tissue," "increased endurance," "skeletal muscle growth," and "increased production of red blood cells";
    • Of a specific general chemical formula (representing androst-1-ene structures);
    • Wherein specific chemical groups (R3, R5, and R7) are selected from a defined list. (’399 Patent, col. 5:56–col. 6:14).

U.S. Patent No. 8,580,774 - "Use of DHEA Derivatives For Enhancing Physical Performance," issued Nov. 12, 2013

The Invention Explained

  • Problem Addressed: The patent addresses the same technical problem as its parent patents: the rapid metabolism and poor bioavailability of conventional DHEA supplements. (’774 Patent, col. 2:1-24).
  • The Patented Solution: This patent claims a method of administering a different class of DHEA derivatives (androst-4-ene structures) via a specific delivery route: transdermally. Transdermal administration allows the compound to enter the bloodstream directly through the skin, bypassing the "first-pass metabolism" in the liver that degrades oral DHEA. (’774 Patent, Claim 1; col. 5:20-25).
  • Technical Importance: The use of transdermal delivery for these specific DHEA derivatives represents an alternative strategy to overcome the metabolic issues associated with oral administration. (’774 Patent, col. 5:20-25).

Key Claims at a Glance

  • The complaint asserts independent Claim 1. (Compl. ¶100).
  • 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 the same list of benefits as in the ’399 Patent;
    • Of a specific general chemical formula (representing androst-4-ene structures);
    • Wherein the chemical group R3 is α-OH or β-OH;
    • And wherein the DHEA derivative is "administered transdermally." (’774 Patent, col. 6:1-41).

Multi-Patent Capsule

  • Patent Identification: U.S. Patent No. 8,778,918, "Use of 19 NOR DHEA DERIVATIVES FOR ENHANCING PHYSICAL PERFORMANCE," issued Jul. 15, 2014. (Compl. ¶39).
  • Technology Synopsis: This patent also addresses the problem of DHEA metabolism and side effects. (’918 Patent, col. 2:1-30). Its claimed solution is a method of administering a distinct class of DHEA derivatives known as "19-nor-DHEA derivatives," which lack a methyl group at the C-19 position, to achieve physical performance benefits such as skeletal muscle growth and increased endurance. (’918 Patent, Abstract; col. 3:39-45).
  • Asserted Claims: Independent Claim 1. (Compl. ¶116).
  • Accused Features: The accused product "Lean AF Cream" is alleged to infringe the ’918 Patent because it is allegedly formulated with "Nor-DHEA," a 19-nor-DHEA derivative. (Compl. ¶¶112, 120-121).

III. The Accused Instrumentality

Product Identification

The complaint names four accused products: "Super 1-Andro Cream," "Super 4-Andro Cream," "Gear Cream," and "Lean AF Cream" (collectively, the "Infringing Products"). (Compl. ¶68).

Functionality and Market Context

The accused instrumentalities are described as topical creams formulated with DHEA derivatives (1-DHEA, 4-DHEA, and Nor-DHEA) and marketed as sports supplements. (Compl. ¶¶86, 104, 120). They are designed to be applied to the skin to deliver their active ingredients, with the promoted purpose of increasing lean muscle mass, strength, and power, and promoting fat loss. (Compl. ¶¶79, 84, 97, 113). The complaint alleges these products are sold nationwide through Defendants' website and other retailers and compete directly with Plaintiffs' products. (Compl. ¶¶76-77).

IV. Analysis of Infringement Allegations

’399 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of administering a DHEA derivative... Defendants market and sell products such as "Super 1-Andro Cream" and instruct users on how to apply them. ¶78, ¶79 col. 5:56-58
...that provides at least one of...skeletal muscle growth... The product "Super 1-Andro Cream" is promoted as providing benefits including "Increases Lean Muscle Mass." A product page screenshot shows this advertised benefit. (Compl. p. 16). ¶84 col. 6:3-7
...of the general formula: [depicting an androst-1-ene structure] The accused products "Super 1-Andro Cream" and "Gear Cream" allegedly contain the active ingredient 1-DHEA, whose chemical structure is depicted in product marketing materials and falls within the claimed formula. A screenshot shows the product's active ingredient as 1-DHEA with its chemical structure. (Compl. p. 17). ¶86, ¶94 col. 3:15-28
...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. The chemical structure provided by Defendants for 1-DHEA allegedly meets the substituent requirements of the claim. ¶86, ¶94 col. 6:8-14

’774 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of administering a DHEA derivative... Defendants market and sell products such as "Super 4-Andro Cream" and instruct users on how to apply them. ¶96, ¶97 col. 6:1-3
...that provides at least one of...skeletal muscle growth... The product "Super 4-Andro Cream" is promoted as providing benefits including "Increases Muscle Mass." A product page screenshot shows this advertised benefit. (Compl. p. 20). ¶102 col. 6:7-12
...of the general formula: [depicting an androst-4-ene structure] The accused product allegedly contains the active ingredient 4-DHEA, whose chemical structure is depicted in product marketing and falls within the claimed formula. A screenshot shows the active ingredient as 4-DHEA with its chemical structure. (Compl. p. 21). ¶104, ¶110 col. 3:45-58
...wherein the DHEA derivative is administered transdermally. The product is a topical cream and is sold with instructions for users to apply it to the skin on various parts of the body, constituting transdermal administration. A screenshot shows the "Suggested Use" instructions with application areas. (Compl. p. 21). ¶106, ¶111 col. 6:39-41
  • Identified Points of Contention:
    • Technical Questions: A primary factual question will be whether the chemical composition of the accused products as sold actually matches the ingredients listed on their labels. The complaint's allegations rely heavily on Defendants' own marketing materials; the case may turn on extrinsic evidence, such as chemical analysis of the products, to confirm the presence and structure of the alleged DHEA derivatives.
    • Scope Questions: The asserted claims are for a "method of administering" a compound. Infringement is therefore carried out by the end-user. The complaint addresses this by alleging indirect infringement. A point of contention may be whether Defendants' marketing and instructions rise to the level of specific intent required to prove inducement to infringe the patented methods.

V. Key Claim Terms for Construction

  • The Term: "DHEA derivative"

  • Context and Importance: This term is foundational to all asserted patents, as its scope defines which chemical compounds are covered. Practitioners may focus on this term because the infringement analysis for all accused products depends on whether 1-DHEA, 4-DHEA, and Nor-DHEA fall within its definition as used in the patents.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification provides a general definition of "derivative" as a species with a similar chemical structure but with added or removed chemical groups, with DHEA being the "parent" substance. (’399 Patent, col. 2:62-65). This could support a broad reading covering a range of related steroid structures.
    • Evidence for a Narrower Interpretation: The claims themselves narrow the universe of "DHEA derivatives" to those falling within the specific Markush groups depicted in the general formulas. A party could argue that the term should be strictly limited to the structures explicitly defined by the claims and their substituents (e.g., R3, R5, R7), and not to a broader, undefined class of "similar" compounds. (’399 Patent, col. 6:8-14).

  • The Term: "administered transdermally" (’774 Patent, Claim 1)

  • Context and Importance: This limitation is the key distinguishing feature of the asserted claim of the ’774 Patent. Its construction is critical for determining infringement by products like "Super 4-Andro Cream."

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification mentions administering the derivatives "transdermally using acceptable liquid vehicles." (’774 Patent, col. 5:20-22). This language may support an interpretation that covers any application of a cream or liquid to the skin that results in the active ingredient passing into the body.
    • Evidence for a Narrower Interpretation: The complaint does not provide sufficient detail for analysis of potential narrower interpretations. A party might argue that "transdermally" implies a specific formulation designed for skin penetration beyond a simple topical cream, though the patent specification does not appear to impose such a limitation.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both inducement and contributory infringement. The inducement claim is based on allegations that Defendants, with knowledge of the patents from prior litigation, provide products with instructions and advertisements that specifically direct and encourage end-users to perform the infringing methods. (Compl. ¶¶131, 134-135). The contributory infringement claim is based on allegations that the accused products are "special purpose products" containing ingredients material to the invention and have no substantial non-infringing uses. (Compl. ¶¶141-144).
  • Willful Infringement: The complaint makes detailed allegations to support willfulness. It points to a history beginning with a 2012 notice letter, two prior lawsuits, and two separate license agreements. (Compl. ¶¶47-61). This history is alleged to establish that Defendants had pre-suit knowledge of the patents and their infringement, and that any ongoing infringement constitutes a deliberate and willful disregard of Plaintiffs' patent rights. (Compl. ¶¶130, 149, 160).

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

  1. Contract vs. Patent: Given the extensive history of licensing agreements between the parties, a central issue will be the interplay between the breach of contract claims and the patent infringement claims. The resolution may depend more on the interpretation and alleged breach of the "Current License Agreement" than on a de novo patent analysis.
  2. Willfulness and Intent: The complaint presents a detailed factual predicate for willfulness based on years of prior dealings and litigation. A key question for the court will be whether Defendants’ alleged conduct, particularly the alleged violation of a license agreement, demonstrates the specific intent required for induced infringement and the deliberate or reckless disregard required for a finding of willfulness, which could expose them to enhanced damages.
  3. Evidentiary Link: The infringement allegations rely on connecting the marketing claims on Defendants’ product labels to the technical limitations in the patent claims. A core evidentiary question will be one of compositional identity: does the actual chemical makeup of the accused creams, as proven through discovery and expert testing, correspond to the DHEA derivatives covered by the patents' specific chemical formulas?