Extremity Medical LLC v. Paragon 28 Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Extremity Medical, LLC (New Jersey)
  • Defendant: Paragon 28, Inc. (Colorado)
  • Plaintiff’s Counsel: Kelley Drye & Warren LLP
• Case Identification: Extremity Medical, LLC v. Paragon 28, Inc., 1:21-cv-02117, D. Colo., 08/04/2021
• Venue Allegations: Venue is alleged to be proper in the District of Colorado because Defendant is incorporated in Colorado, has its principal place of business in the district, and has therefore established a regular and established place of business.
• Core Dispute: Plaintiff alleges that Defendant’s Phantom Intramedullary Nail System, a medical device for foot surgery, infringes a patent related to an intraosseous fixation assembly for bone fusion.
• Technical Context: The technology concerns orthopedic implants used to fuse bones, particularly in complex joints like those in the human foot, where maintaining anatomical structure and providing stable compression are critical.
• Key Procedural History: The complaint alleges that Plaintiff sent Defendant a letter in January 2018 identifying a parent patent to the patent-in-suit and accusing the same product of infringement. It further alleges that Defendant cited publications related to the parent patent in its own patent prosecution filings in July and August 2018, which may be relevant to the question of pre-suit knowledge and willfulness.

Case Timeline

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

U.S. Patent No. 10,751,097 - "Intraosseous Intramedullary Fixation Assembly and Method of Use"

• Patent Identification: U.S. Patent No. 10,751,097, "Intraosseous Intramedullary Fixation Assembly and Method of Use," issued August 25, 2020 (Compl. ¶7).

The Invention Explained

• Problem Addressed: The patent describes drawbacks of prior orthopedic implants for foot bone fusion, such as plates and screws, which can cause skin irritation due to surface prominence, add difficulty to wound closure, and provide inadequate compression or restoration of the foot's natural arch (’097 Patent, col. 1:36-65).
• The Patented Solution: The invention is an intramedullary (i.e., placed inside the bone) assembly composed of multiple interlocking components. As depicted in figures like FIG. 18, a primary nail-like member accepts one or more screw-like members at specific angles, allowing a surgeon to "hook" into separate bone fragments and apply uniform compression to achieve stable fusion deep within the bone structure (’097 Patent, col. 2:27-40; FIG. 18).
• Technical Importance: This intramedullary approach is intended to provide robust, multi-point fixation while minimizing the device's external profile, thereby reducing tissue tension and the risk of post-operative complications (’097 Patent, col. 2:5-8).

Key Claims at a Glance

• The complaint asserts independent claim 12 (Compl. ¶21).
• The essential elements of independent claim 12 are:
  • An assembly for bone fusion, comprising: a "first member", a "second member", and a "third member".
  • The "first member" and "second member" are described as elongated bodies with a shaft, a head, and a thread.
  • The "third member" is an elongated body with a main longitudinal axis. It features a "first bore" that passes through it at a "first angle" relative to the main axis and a "second bore" that passes through it at a "second angle".
  • The "first member" is designed to couple to the "third member" by passing through the "first bore".
  • The "second member" is designed to couple to the "third member" by passing through the "second bore".
  • The geometry is further defined such that the "second angle" is between 0 and 90 degrees, and the "second bore axis" is "substantially perpendicular" to the "third member's" longitudinal axis.

III. The Accused Instrumentality

Product Identification

• The "Phantom Intramedullary Nail System" ("the Infringing Product") (Compl. ¶1).

Functionality and Market Context

• The complaint describes the accused product as an assembly for bone fusion used in foot surgery (Compl. ¶24). It is alleged to comprise at least three primary components: a "Phantom Nail," one or more "threaded pegs," and a "locking screw" (Compl. ¶19). The complaint references the Defendant's "Surgical Technique Guide," which allegedly instructs surgeons on how to assemble these components inside a patient's foot to achieve fixation, for example, by inserting the locking screw and threaded pegs through bores in the Phantom Nail (Compl. ¶¶19, 30, 31). An annotated image from the defendant's marketing materials shows the main components of the accused system. (Compl. ¶19, p. 6).

IV. Analysis of Infringement Allegations

’097 Patent Infringement Allegations

• Identified Points of Contention:
  • Scope Questions: A potential dispute may arise over whether the accused "Phantom Nail" meets all the geometric and structural limitations of the claimed "third member." For instance, the claim requires "no threads adjacent to the second aperture on the exterior surface of the third member," a specific negative limitation that will require factual evidence to verify on the accused device (Compl. ¶28).
  • Technical Questions: The infringement analysis will likely focus on the claim that the "second bore axis is "substantially perpendicular" to the third longitudinal axis." The complaint provides an annotated diagram from Defendant's materials to support this (Compl. ¶32, p. 19). The defense, however, may argue that the actual angle of its device falls outside a proper construction of "substantially perpendicular," raising a question that will likely require expert testimony and precise measurements.

V. Key Claim Terms for Construction

• The Term: "substantially perpendicular"
  • Context and Importance: This term is critical as it defines the spatial relationship between the second screw-like member and the main nail-like member. Infringement of this limitation will depend entirely on how much, if any, deviation from a true 90-degree angle is permitted. Practitioners may focus on this term because terms of degree like "substantially" are frequently litigated.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent does not provide an explicit numerical definition. A party may argue that its use alongside other flexible terms, such as "about 90 degrees" (Claim 12), suggests the patentee did not intend a rigid, exact 90-degree angle but rather one that is functionally perpendicular to achieve the desired fixation.
    • Evidence for a Narrower Interpretation: A party may point to patent drawings, such as FIG. 18, where the relationship between the members (e.g., 1810 and 1815) appears to be depicted as almost exactly 90 degrees, and argue that "substantially" should be construed narrowly to mean only minor deviations due to manufacturing tolerances.

VI. Other Allegations

• Indirect Infringement: The complaint alleges inducement to infringe by asserting that Defendant provides a "Surgical Technique Guide" that "teach surgeons how to assemble the Infringing Product" in an infringing manner (Compl. ¶22). It also alleges contributory infringement, stating that the "Phantom Nail" is a material part of the invention, is not a staple article of commerce, and is especially adapted for use in an infringing manner (Compl. ¶23).
• Willful Infringement: Willfulness is alleged based on pre-suit knowledge. The complaint cites a January 2018 letter sent to Defendant that identified a parent patent and accused the same product of infringement (Compl. ¶14). The complaint further alleges that Defendant cited Plaintiff’s technology in Information Disclosure Statements submitted to the USPTO during its own patent prosecution, suggesting actual awareness of the technology family prior to the lawsuit (Compl. ¶¶17-18).

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

• A central question will be one of claim construction: How will the court define "substantially perpendicular"? The outcome of this construction will likely determine whether a key geometric limitation of the asserted claim reads on the accused product.
• A key evidentiary question will be one of factual proof: Can Plaintiff demonstrate, likely through expert testimony and analysis beyond the marketing materials cited in the complaint, that the physical geometry of the accused Phantom Nail System meets the specific angular and structural limitations of Claim 12?
• A significant issue for damages will be willfulness: Did Defendant's alleged continued sale of the accused product after receiving a detailed notice letter regarding a parent patent and after citing Plaintiff's technology in its own patent prosecution constitute objectively reckless behavior sufficient to support a finding of willful infringement and potential enhanced damages?