DCT

7:25-cv-00161

Tiger Medical Holdings LLC v. MiMedx Group Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 7:25-cv-00161, W.D. Tex., 04/11/2025
  • Venue Allegations: Plaintiffs allege venue is proper in the Western District of Texas because Defendant MiMedx is subject to personal jurisdiction there due to substantial activities, including sending a patent infringement accusation letter into the District and previously enforcing its patents there.
  • Core Dispute: Plaintiffs seek a declaratory judgment that their placental allograft products do not infringe six of Defendant's patents and that those patents are invalid.
  • Technical Context: The dispute is in the field of regenerative medicine, specifically concerning tissue grafts derived from human placenta for use in wound care and other surgical applications.
  • Key Procedural History: The action was precipitated by a February 11, 2025 letter from MiMedx accusing Plaintiffs of infringing the patents-in-suit. The complaint alleges this letter followed a failed multi-year lobbying campaign by MiMedx to have the Centers for Medicare and Medicaid Services (CMS) alter reimbursement policies to effectively exclude Plaintiffs' products from the marketplace. The complaint also notes that MiMedx has a history of asserting the patents-in-suit in other litigations.

Case Timeline

Date Event
2006-08-17 Earliest Priority Date for ’494 and ’259 Patents
2007-09-07 Earliest Priority Date for ’701, ’092, ’207, and ’137 Patents
2012-12-04 ’701 Patent Issued
2014-02-04 ’092 Patent Issued
2014-04-22 ’207 Patent Issued
2014-04-29 ’494 Patent Issued
2017-10-17 ’137 Patent Issued
2019-09-10 ’259 Patent Issued
2022-12-XX Plaintiffs begin selling carePATCH™ product
2023-07-XX Plaintiffs begin selling barrera™ product
2023-09-XX Plaintiffs begin selling Restorigin™ product
2024-09-XX Plaintiffs begin selling alloPLY™ and ACApatch™ products
2025-02-11 MiMedx sends letter to Plaintiffs accusing them of infringement
2025-04-11 Complaint for Declaratory Judgment Filed

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

U.S. Patent No. 8,323,701 - "Placental Tissue Grafts"

  • Patent Identification: U.S. Patent No. 8,323,701, "Placental Tissue Grafts," issued December 4, 2012 (’701 Patent).

The Invention Explained

  • Problem Addressed: The patent background describes the long-standing use of human placental membrane for reconstructive surgery but notes a need for improved grafts and methods for their preparation, particularly for applications involving human mucosa tissue. (’701 Patent, col. 1:15-24, 1:55-61).
  • The Patented Solution: The invention provides tissue grafts derived from placenta, specifically from the amnion layer, where the outer epithelium cell layer has been substantially removed. (’701 Patent, Abstract). This removal is intended to expose the underlying basement membrane, which contains cell-adhesion factors, allowing host cells to more readily interact with the graft. (’701 Patent, col. 2:1-6). The patent also describes multi-layered grafts created by laminating additional membranes to the first, creating thicker and more robust structures. (’701 Patent, col. 2:20-24).
  • Technical Importance: By modifying the natural amnion structure to expose the basement membrane, the invention purports to enhance the graft's integration with host tissue and improve healing outcomes. (’701 Patent, col. 2:1-6).

Key Claims at a Glance

  • The complaint asserts non-infringement of independent claim 1. (Compl. ¶58).
  • Claim 1 of the ’701 Patent requires:
    • A tissue graft consisting of:
    • a first membrane comprising modified amnion,
    • wherein the modified amnion has a first side which is an exposed basement membrane and a second side which is an exposed jelly-like fibroblast cellular layer; and
    • one or more additional membranes sequentially layered adjacent to the exposed fibroblast layer of the first membrane,
    • wherein the additional membrane(s) are selected from a specified group including amnion, chorion, and others.
  • The complaint does not explicitly reserve the right to assert non-infringement of dependent claims for this patent.

U.S. Patent No. 8,642,092 - "Placental Tissue Grafts"

  • Patent Identification: U.S. Patent No. 8,642,092, "Placental Tissue Grafts," issued February 4, 2014 (’092 Patent).

The Invention Explained

  • Problem Addressed: As with the related ’701 Patent, the technology addresses the need for improved placental tissue grafts for surgical use. (’092 Patent, col. 1:21-24).
  • The Patented Solution: The patent describes a multilayered tissue graft made from isolated and dehydrated layers of chorion and amnion tissue. (’092 Patent, Abstract). The key structural arrangement involves layering at least one chorion layer directly over the fibroblast component of an amnion layer, which itself has an exposed basement layer and an intact fibroblast component. (’092 Patent, col. 13:8-15). This specific layering claims to create a unique composite graft.
  • Technical Importance: The invention provides a specific laminated structure of amnion and chorion tissues, aiming to combine the properties of both placental layers into a single, multilayered graft for therapeutic use. (’092 Patent, col. 8:20-24).

Key Claims at a Glance

  • The complaint asserts non-infringement of independent claim 1. (Compl. ¶64).
  • Claim 1 of the ’092 Patent requires:
    • A multilayered tissue graft comprising:
    • at least one layer of isolated dehydrated chorion tissue; and
    • at least one layer of isolated dehydrated amnion tissue,
    • provided that at least one of said amnion layers has an exposed basement layer and an intact fibroblast component,
    • wherein at least one chorion layer is layered directly over the fibroblast component of said amnion layer.
  • The complaint does not explicitly reserve the right to assert non-infringement of dependent claims for this patent.

U.S. Patent No. 8,703,207 - "Placental Tissue Grafts"

  • Patent Identification: U.S. Patent No. 8,703,207, "Placental Tissue Grafts," issued April 22, 2014 (’207 Patent).
  • Technology Synopsis: This patent, part of the same family as the ’701 and ’092 patents, is also directed to multilayered tissue grafts. The claimed solution involves a graft with at least one layer of isolated amnion tissue (having an exposed basement layer and intact fibroblast component) laminated with at least one additional layer selected from a broad group of biological and synthetic materials, such as chorion, collagen, or biocellulose polymers. (’207 Patent, col. 13:1-21).
  • Asserted Claims: The complaint asserts non-infringement of independent claim 1. (Compl. ¶70).
  • Accused Features: Plaintiffs state their products do not infringe because they lack the claimed element of "at least one of said amnion layers has an exposed basement layer and an intact fibroblast component." (Compl. ¶71).

U.S. Patent No. 8,709,494 - "Placental Tissue Grafts"

  • Patent Identification: U.S. Patent No. 8,709,494, "Placental Tissue Grafts," issued April 29, 2014 (’494 Patent).
  • Technology Synopsis: This patent is directed to a dehydrated, laminated tissue graft made of washed and/or cleaned amnion and chorion layers. A key feature is that at least one of the amnion layers "contains its fibroblast cell layer," and the amnion and chorion layers are directly laminated to each other. (’494 Patent, col. 11:32-38).
  • Asserted Claims: The complaint asserts non-infringement of independent claims 1, 6, 9, and 10. (Compl. ¶76).
  • Accused Features: Plaintiffs allege non-infringement based on the absence of numerous claimed elements, including "washed and/or substantially cleaned amnion layers," "at least one of the amnion layers contains its fibroblast cell layer," and that the layers are "directly laminated." (Compl. ¶77).

U.S. Patent No. 9,789,137 - "Placental Tissue Grafts and Improved Methods of Preparing and Using the Same"

  • Patent Identification: U.S. Patent No. 9,789,137, "Placental Tissue Grafts and Improved Methods of Preparing and Using the Same," issued October 17, 2017 (’137 Patent).
  • Technology Synopsis: This patent claims a dehydrated, laminated placental tissue graft that is a laminate of two layers. The first layer is a washed amnion layer with an exposed basement membrane on one side and a fibroblast layer on the other, while the second layer is a washed amnion or chorion. The layers are dehydrated and laminated directly without sutures. (’137 Patent, col. 14:8-18).
  • Asserted Claims: The complaint asserts non-infringement of independent claim 1. (Compl. ¶82).
  • Accused Features: Plaintiffs allege their products do not infringe because they do not have "a washed amnion layer which has a first side which is an exposed basement membrane and a second side which is a fibroblast layer" or "a second layer which is a washed amnion or a washed chorion." (Compl. ¶83).

U.S. Patent No. 10,406,259 - "Placental Tissue Grafts and Improved Methods of Preparing and Using the Same"

  • Patent Identification: U.S. Patent No. 10,406,259, "Placental Tissue Grafts and Improved Methods of Preparing and Using the Same," issued September 10, 2019 (’259 Patent).
  • Technology Synopsis: This patent is directed to a final packaged product. It claims a package containing a sealed, deoxygenated container which holds a dehydrated placental tissue graft. The graft itself is described as having a first separated and washed amnion layer (with an epithelial cell layer) and a second separated and washed amnion or chorion layer, with the two layers directly laminated. The patent further claims the graft has a shelf-life of at least 5 years. (’259 Patent, col. 12:1-12).
  • Asserted Claims: The complaint asserts non-infringement of independent claim 1. (Compl. ¶88).
  • Accused Features: Plaintiffs allege non-infringement because their products purportedly do not meet the 5-year shelf-life limitation, do not have the specific layered structure claimed, and are not directly laminated as required. (Compl. ¶89).

III. The Accused Instrumentality

Product Identification

  • Plaintiffs' "Placental Allografts," sold under the trademarks Restorigin™, barrera™, carePATCH™, alloPLY™, and ACApatch™. (Compl. ¶20).

Functionality and Market Context

  • The accused products are described as wound care products, including skin grafts, made from donated human placental tissue. (Compl. ¶20). The complaint alleges that RegenTX Partners, LLC manufactures and processes the allografts, and Extremity Care, LLC distributes them. (Compl. ¶21). The complaint does not provide further technical detail regarding the specific structure or manufacturing process of the accused products, focusing instead on identifying which claim elements are allegedly not met. No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

’701 Patent Infringement Allegations

As this is a complaint for declaratory judgment of non-infringement, the following table summarizes Plaintiffs' stated basis for why their products do not meet the limitations of the asserted claim.

Claim Element (from Independent Claim 1) Plaintiffs' Stated Basis for Non-Infringement Complaint Citation Patent Citation
a first membrane comprising modified amnion wherein the modified amnion has a first side which is an exposed basement membrane and a second side which is an exposed jelly-like fibroblast cellular layer Plaintiffs' Placental Allografts do not infringe because this claim element is not present, literally or under the doctrine of equivalents. The complaint does not specify which sub-part of this limitation is absent or why. ¶59 col. 13:10-14

’092 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Plaintiffs' Stated Basis for Non-Infringement Complaint Citation Patent Citation
at least one layer of isolated dehydrated amnion tissue provided that at least one of said amnion layers has an exposed basement layer and an intact fibroblast component Plaintiffs' Placental Allografts do not infringe because this claim element is not present, literally or under the doctrine of equivalents. The complaint does not specify which sub-part of this limitation is absent or why. ¶65 col. 13:11-13

Identified Points of Contention

  • Factual Questions: A central point of contention for both the ’701 and ’092 patents will be the actual physical structure of Plaintiffs' allografts. The dispute will require factual evidence, likely through expert analysis of the products, to determine if they possess the specific layered amnion structures recited in the claims (e.g., an "exposed basement membrane" and an "exposed jelly-like fibroblast cellular layer" or "intact fibroblast component").
  • Scope Questions: The non-infringement arguments presented in the complaint are conclusory and do not elaborate on why the elements are absent. This suggests a potential dispute over the a proper interpretation of key claim terms. For example, a core question may be whether Plaintiffs' manufacturing process results in an amnion layer that falls within the scope of the term "modified amnion" as used in the ’701 patent, or whether their products contain what would be legally construed as an "intact fibroblast component" under the ’092 patent.

V. Key Claim Terms for Construction

  • The Term: "modified amnion" (’701 Patent, Claim 1)

  • Context and Importance: This term is foundational to claim 1 of the ’701 Patent, as the subsequent limitations describing the "exposed basement membrane" and "exposed jelly-like fibroblast cellular layer" depend on it. The dispute may turn on whether the process used to create Plaintiffs' allografts results in a structure that meets the definition of "modified amnion."

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification does not appear to provide an explicit definition. A party could argue that any processing that alters the natural state of the amnion, such as cleaning or separation from the chorion, results in a "modified amnion."
    • Evidence for a Narrower Interpretation: The specification describes a specific modification: the substantial removal of the epithelium layer to expose the basement membrane. (’701 Patent, col. 2:1-4). A party could argue "modified amnion" is not just any alteration, but specifically refers to this de-epithelialized structure.

  • The Term: "exposed basement membrane" and "intact fibroblast component" (’701 and ’092 Patents, Claim 1 of each)

  • Context and Importance: Plaintiffs' non-infringement theories for the ’701, ’092, and ’207 patents all rely on the alleged absence of this specific structural arrangement. The viability of these defenses hinges on how these terms are construed and applied to the accused products. Practitioners may focus on these terms because they define the core technical feature that distinguishes the claimed invention from a natural, unprocessed amniotic membrane.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The patents describe the fibroblast layer as the "jelly-like" stromal tissue. (’701 Patent, col. 5:1-3). A party might argue that "intact" does not require a perfectly pristine or complete layer, but merely one that has not been deliberately removed and still performs its structural function. "Exposed" could be argued to mean simply not covered by the epithelium layer.
    • Evidence for a Narrower Interpretation: The description of the cleaning process notes that if the amnion is cleaned too aggressively, the "jelly-like fibroblast layer can be removed." (’701 Patent, col. 5:20-22). A party could argue that any manufacturing process that substantially diminishes or damages this layer would prevent it from being "intact." The term "exposed" could be argued to require complete and direct accessibility, which may not be present in a multi-layered, laminated product.

VI. Other Allegations

  • Indirect Infringement: In this declaratory judgment action, Plaintiffs preemptively deny contributing to or inducing the infringement of any valid and enforceable claim of the patents-in-suit. (Compl. ¶¶57, 63, 69). The complaint does not detail any specific facts MiMedx may have alleged to support such claims.
  • Invalidity: Plaintiffs allege that all claims of the six patents-in-suit are invalid under 35 U.S.C. §§ 101, 102, 103, and 112. (Compl. ¶¶91-144). The invalidity contentions include allegations that the claims are directed to ineligible subject matter (natural phenomena), anticipated or rendered obvious by a list of prior art references, indefinite, and lack adequate written description and enablement. (Compl. ¶¶93-98).

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

  • A core issue will be one of claim construction and factual analysis: What are the precise structural and processing requirements of key claim limitations such as "modified amnion," "exposed basement membrane," "intact fibroblast component," and "directly laminated"? And, as a matter of fact, do Plaintiffs' accused allografts, as manufactured, possess these specific features? The outcome for multiple patents appears to hinge on this fundamental technical comparison.
  • A second key issue will be patent validity: Plaintiffs have asserted that the patents are invalid on multiple grounds, including anticipation and obviousness in light of numerous prior art references related to preparing and using placental grafts. A central question for the court will be whether the specific layered and modified structures claimed by MiMedx represent a patentable advance over the state of the art that existed at the time of the inventions.
  • The extensive background allegations regarding MiMedx's alleged lobbying and market-exclusion efforts raise a potential third theme of inequitable conduct or patent misuse, although not explicitly pled as a separate count. The court will need to determine whether this context is relevant to the core patent disputes of infringement and validity or if it constitutes a separate business tort or antitrust issue.