DCT

9:24-cv-80198

Loria Pharmaceutical LLC v. Mezzancello

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Key Events
Amended Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 9:24-cv-80198, S.D. Fla., 01/07/2025
  • Venue Allegations: Venue is alleged to be proper based on a substantial part of the events giving rise to the claims occurring in the district, as well as venue selection clauses in various agreements between the parties.
  • Core Dispute: Plaintiffs allege that Defendants' male enhancement procedures and associated filler compositions infringe a patent related to injectable silicone oil-in-water emulsions used for soft tissue augmentation.
  • Technical Context: The technology involves injectable cosmetic fillers designed to provide permanent soft tissue augmentation by stimulating the body's own production of high-quality collagen in a controlled manner.
  • Key Procedural History: The complaint describes a soured business relationship, beginning with a 2021 agreement for Defendants to offer male enhancement procedures using Plaintiffs' intellectual property, followed by training of Defendant physicians. The relationship was formally altered by a March 2023 Separation Agreement, which Plaintiffs allege Defendants subsequently breached, leading to the unauthorized use of Plaintiffs' patented technology and trade secrets.

Case Timeline

Date Event
2017-01-12 ’578 Patent Priority Date
2018-06-12 ’578 Patent Issue Date
2019 (Summer/Fall) Defendant Dr. Dellinger undergoes training with Dr. Loria
2019 Dr. Loria begins licensing the Male Enhancement IP Portfolio
2021-12-20 NY Business Agreement signed between Loria Pharmaceutical and Mark Mezzancello
2022-02-01 Defendant Dr. Aman undergoes training in Florida
2022-02-22 Dr. Aman signs training and equipment agreements with Loria Medical
2022-04-05 Defendant Dr. Goldsmith undergoes training in Florida
2022-04-22 Dr. Goldsmith signs training and equipment agreements with Loria Medical
2022-04-27 Physician Defendants sign Physician Independent Contractor Services Agreements
2022-08-15 Addendum to NY Business Agreement entered
2022-09-11 Dr. Goldsmith begins performing male enhancement procedures in New York
2022-09-23 Samantha Harrison signs Nondisclosure Agreement with Loria Medical
2023-01-31 Start of period during which LMNY ordered filler
2023-03-17 Business Separation Agreement executed by Dr. Loria and Mark Mezzancello
2023-06-06 End of period during which LMNY ordered filler
2023-09-06 Dr. Loria emails Defendants regarding lack of contact and filler orders
2023-10-03 Counsel for Mark Mezzancello sends letter terminating Separation Agreement
2025-01-07 Second Amended Complaint Filing Date

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

U.S. Patent No. 9,993,578 - "SILICONE OIL-IN-WATER COMPOSITION USEFUL AS AN INJECTABLE FILLER AND AS A SCAFFOLD FOR COLLAGEN GROWTH"

  • Issued: June 12, 2018

The Invention Explained

  • Problem Addressed: The patent’s background section describes a need for safe and effective methods for soft tissue augmentation to treat conditions like facial wrinkles, scars, and for cosmetic enhancement (’578 Patent, col. 2:13-25). It notes that prior uses of injectable silicone oil have been associated with adverse reactions like granuloma formation and migration, potentially due to impurities, injection technique, or the physical properties of the silicone oil itself (’578 Patent, col. 3:3-14). A key challenge is stimulating the production of high-quality, uniform collagen to achieve a permanent and aesthetically pleasing result (’578 Patent, col. 2:11-25).
  • The Patented Solution: The invention is a specific silicone oil-in-water emulsion designed to be injected into soft tissue. It comprises silicone oil of a specific high viscosity, dispersed as droplets within a precise size range (30 to 2000 microns), and suspended in water using a biodegradable thickening agent (’578 Patent, Abstract). This thickening agent acts as a "temporary scaffold" that initially separates the silicone droplets, allowing the body to build a uniform matrix of new collagen around them before the scaffold dissolves (’578 Patent, col. 6:55-65). The specific droplet size is described as critical to avoid being engulfed by the body's immune cells (phagocytes) before collagen production can be stimulated (’578 Patent, col. 3:51-58).
  • Technical Importance: The claimed technical approach seeks to provide a permanent soft tissue augmentation by using a carefully formulated composition to control the body's own biological response, thereby generating high-quality native collagen while mitigating the safety risks of earlier, less-controlled silicone injection methods (’578 Patent, Abstract; col. 4:1-10).

Key Claims at a Glance

  • The complaint asserts independent Claim 1 (’578 Patent; Compl. ¶94). It also references "one or more claims," reserving the right to assert others (Compl. ¶142.d).
  • The essential elements of independent Claim 1 are:
    • A filler composition comprising:
    • (a) 1% to 80% of a silicone oil having a viscosity from 12500-30000 centistokes (cSt);
    • (b) 20% to 99% of water; and
    • (c) 0.005% to 10% of a thickening agent,
    • wherein the composition is a pharmaceutically acceptable oil-in-water emulsion,
    • the silicone oil is dispersed as droplets with an average diameter from 30 to 2000 microns, and
    • the thickening agent is sufficiently biodegradable when implanted to provide a temporary scaffold for collagen growth between the silicone droplets.

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are the "filler composition" and methods of "performing male enhancement procedures" by the Physician and Corporate Defendants (Compl. ¶¶ 40, 43, 98). The complaint alleges that Defendants are compounding a filler that is "consistent with the claims" of the ’578 Patent (Compl. ¶43).

Functionality and Market Context

  • The complaint alleges that after being trained by Plaintiffs, Defendants began offering male enhancement procedures using what they market as the "Loria Method" and "Loria formula" to achieve "permanent" results (Compl. ¶¶ 40, 97). The core of the allegation is that Defendants are leveraging confidential information and patented technology gained through their prior business relationship with Plaintiffs to offer competing services (Compl. ¶95). The procedures are allegedly performed by the Physician Defendants at facilities operated by the Corporate Defendants (Compl. ¶98).
  • No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not contain a formal claim chart. The infringement theory is based on allegations that Defendants, having been trained on Plaintiffs' proprietary and patented methods, are now using a filler composition that infringes the ’578 Patent (Compl. ¶¶ 95, 98).

U.S. Patent No. 9,993,578 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A filler composition comprising: (a) 1% to 80% of a silicone oil having a viscosity from 12500-30000 centistokes (cSt); (b) 20% to 99% of water; and (c) 0.005% to 10% of a thickening agent... Based on information and belief, Defendants use a filler composition for male enhancement procedures that allegedly infringes the ’578 Patent. ¶¶ 96, 98 col. 16:45-51
wherein the filler composition is a pharmaceutically acceptable oil-in-water emulsion... Defendants are alleged to be "compounding filler consistent with the claims" of the patent for use in medical procedures. ¶43 col. 16:51-53
...the silicone oil is dispersed in the water as droplets having an average diameter from 30 microns to 2000 microns... The complaint alleges Defendants learned the characteristics of the patented composition from Plaintiffs and have not conducted their own research to create a non-infringing alternative. ¶¶ 95-96 col. 16:53-56
...and the thickening agent is sufficiently biodegradable when implanted subcutaneously in a human to provide a temporary scaffold for collagen growth between silicone oil droplets. Defendants are alleged to be using the "Loria Method," which is described as utilizing Plaintiffs' IP Portfolio to achieve permanent results, implying a mechanism of stimulating collagen growth as taught by the patent. ¶¶ 40, 97 col. 16:56-61
  • Identified Points of Contention:
    • Evidentiary Question: The complaint's infringement allegations are made "upon information and belief" (Compl. ¶98). A central dispute will be an evidentiary one: what is the actual composition of the filler Defendants are using? Plaintiffs will need to prove through discovery and testing that the accused filler meets every numerical and functional limitation of Claim 1.
    • Technical Question: Even if the composition is identified, a potential point of contention is the functional requirement that the thickening agent provides a "temporary scaffold for collagen growth." This raises the question of whether the accused product's mechanism of action is the same as that required by the claim, or if it achieves its results through a different technical pathway.

V. Key Claim Terms for Construction

  • The Term: "a temporary scaffold for collagen growth"

    • Context and Importance: This term recites the function of the thickening agent and is central to the invention's purported novelty. The infringement analysis will turn on whether the accused product's thickening agent performs this specific biological function. Practitioners may focus on this term because Defendants could argue their formulation's thickening agent serves only as a standard rheology modifier and does not function as a "scaffold" in the claimed manner.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification suggests the function is to provide initial separation for the oil droplets, stating that as the scaffold dissolves, "host tissues (including nascent collagen) [gain] progressively greater access to the silicone oil droplets over time" (’578 Patent, col. 10:55-58). This could support a reading where any biodegradable separating agent meets the limitation.
      • Evidence for a Narrower Interpretation: The patent links the scaffold's performance to specific, preferred timeframes, stating that a "14 to 28-day time frame is most preferred for penile shaft-glans-scrotal enlargement" (’578 Patent, col. 10:60-63). This could support a narrower construction requiring the "temporary" period to fall within a functionally optimal window, rather than just being non-permanent.

  • The Term: "silicone oil having a viscosity from 12500-30000 centistokes (cSt)"

    • Context and Importance: This precise numerical range is presented as a key to the invention's success. The patent's own data tables contrast the "Very Good" results and "Rare" side effects of 12,500 cSt oil with the inferior outcomes of lower-viscosity oils (’578 Patent, Tables 2 & 3, col. 15). Infringement may hinge on whether the accused product's oil falls squarely within this range.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: While the claim provides a hard numerical range, a party might argue for some flexibility based on measurement tolerances or by pointing to language describing the importance of viscosity more generally in preventing migration.
      • Evidence for a Narrower Interpretation: The claim language is unambiguous. The specification heavily reinforces the importance of this specific high-viscosity range for achieving superior clinical outcomes and minimizing adverse events, strongly suggesting the numbers are a critical, non-negotiable aspect of the invention (’578 Patent, col. 15).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that defendants Mark and Patricia Mezzancello induced infringement by being the "motive force" behind the infringing activity. They are accused of "actively encouraging," "directing, controlling, and influencing" the Physician Defendants to use the patented technology with knowledge of the patent and specific intent for infringement to occur (Compl. ¶¶ 109-111).
  • Willful Infringement: Willfulness is alleged against all infringing Defendants. The complaint asserts that the Defendants knew of the ’578 Patent and knew that the materials they were using were covered by its claims, based on their prior business relationship, training, and access to Plaintiffs' intellectual property (Compl. ¶¶ 95, 101, 113).

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

This dispute appears to be driven as much by a breakdown in a business relationship as by a traditional patent conflict. The resolution will likely depend on the following open questions:

  • A primary issue will be one of evidentiary proof: can Plaintiffs, through discovery, obtain evidence demonstrating that the filler material allegedly compounded by Defendants meets every specific quantitative (viscosity, concentration) and qualitative (droplet size, scaffold function) limitation of the asserted patent claim? The complaint's reliance on "information and belief" highlights that this is the central factual hurdle.
  • A secondary issue will be one of functional operation: assuming Plaintiffs can prove the accused product's composition, does its thickening agent actually perform the claimed function of acting as a "temporary scaffold for collagen growth"? The case may evolve into a battle of expert testimony over the precise biological mechanism of the accused product.
  • Finally, a key question involves the interplay of patent and contract law: how do the prior agreements between the parties, particularly the 2023 Separation Agreement with its mutual release clause, affect the patent infringement claims? The court will have to determine whether the alleged infringement constitutes a new tort or is an issue subsumed by the complex contractual history and prior business dealings.