DCT

1:18-cv-00691

Wright Medical Technology Inc v. Paragon 28 Inc

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Key Events
Amended Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:18-cv-00691, D. Colo., 04/30/2018
  • Venue Allegations: Venue is alleged to be proper in the District of Colorado because Defendant is a Colorado corporation with its principal place of business in the district, and is therefore deemed to reside there.
  • Core Dispute: Plaintiff alleges that Defendant’s orthopedic plating systems and related surgical instruments infringe ten patents related to orthopedic plates for bone repair and an orthopedic compression/distraction device.
  • Technical Context: The technology at issue involves orthopedic plates, screws, and instruments used in surgical procedures to repair bone fractures, particularly in the foot and ankle.
  • Key Procedural History: The complaint alleges that Defendant, in a 2014 Section 510(k) premarket notification to the FDA, identified Plaintiff’s commercial products as predicate devices for its own ParaLock Plating System, which was later renamed the Gorilla Plating System. The complaint also notes that a number of former employees of Plaintiff are now employed by Defendant, alleging this as a basis for pre-suit knowledge of the patents-in-suit.

Case Timeline

Date Event
2005-01-28 Priority Date for ’457, ’954, ’846, ’848, ’443, ’251, ’252, ’253, and ’278 Patents
2010-08-10 U.S. Patent No. 7,771,457 Issues
2012-01-24 U.S. Patent No. 8,100,954 Issues
2012-02-21 U.S. Patent No. 8,118,846 Issues
2012-02-21 U.S. Patent No. 8,118,848 Issues
2012-12-12 Priority Date for ’710 Patent
2014-03-04 Paragon 28 files FDA 510(k) submission for ParaLock Plating System
2014-04-17 FDA approves Paragon 28's 510(k) submission
2015-07-14 U.S. Patent No. 9,078,710 Issues
2015-09-29 U.S. Patent No. 9,144,443 Issues
2016-02-16 U.S. Patent No. 9,259,251 Issues
2016-02-16 U.S. Patent No. 9,259,252 Issues
2016-02-16 U.S. Patent No. 9,259,253 Issues
2017-01-17 U.S. Patent No. 9,545,278 Issues
2018-04-30 Complaint Filed

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

U.S. Patent No. 7,771,457 - "Orthopedic plate for use in small bone repair"

  • The Invention Explained:
    • Problem Addressed: The patent’s background section identifies a need for specialized orthopedic implants for small bones (e.g., in the foot and ankle), noting that existing products were often merely scaled-down versions of plates designed for large bones, which are inadequate for the delicate procedures and anatomical variability of smaller bones (ʼ457 Patent, col. 1:15-40).
    • The Patented Solution: The invention is an orthopedic plate system featuring a "bilaterally asymmetrical" plate with a central trunk and divergent arms extending from one or both ends (ʼ457 Patent, Abstract; col. 2:18-21). This design is intended to facilitate three-dimensional contouring to match individual bone shapes and to enable "bi-planar screw fixation"—where screws are inserted at different angles—to enhance stability and pull-out strength while minimizing the risk of screws interfering with one another (ʼ457 Patent, col. 2:21-25, 63-67).
    • Technical Importance: The technology provides surgeons with specialized, anatomically considerate plating systems for small bones, intended to improve upon the fit and stability offered by generic, non-specialized plates (ʼ457 Patent, col. 1:57-62).
  • Key Claims at a Glance:
    • The complaint asserts independent claims 1, 10, 11, and 19 (Compl. ¶36).
    • Essential elements of independent claim 1 include:
      • A Y-shaped plate with an inferior surface and a concentric superior surface forming a portion of a cylinder.
      • The plate consists of a trunk and a pair of a first arm and a second arm.
      • The first arm and second arm are attached to the trunk via linking sections and have different angles and lengths relative to the trunk's longitudinal axis.
      • Each arm has a screw hole defining a screw axis, whereby the first and second screw axes converge toward the inferior side of the plate but do not intersect.
    • The complaint reserves the right to assert additional claims (Compl. ¶1).

U.S. Patent No. 8,100,954 - "Orthopedic plate for use in small bone repair"

  • The Invention Explained:
    • Problem Addressed: The patent addresses the same technical problem as the '457 Patent: the lack of specialized, anatomically appropriate plating systems for small bone repair (ʼ954 Patent, col. 1:21-49).
    • The Patented Solution: The invention builds on the concept of an asymmetrical plate by disclosing a system of plates that includes "alpha" and "beta" versions, which are mirror images (or enantiomorphs) of each other (ʼ954 Patent, col. 2:50-58). This system allows a surgeon to select a plate specifically contoured for either the left or right side of the body, enhancing the anatomical fit for a given procedure (ʼ954 Patent, col. 2:58-63). The asserted claim is a method of using such a plate, including the step of bending it with a "plate bender" to achieve a final contour (ʼ954 Patent, cl. 4).
    • Technical Importance: This system provides surgeons with pre-contoured, handed (left/right) plates, potentially reducing the need for extensive intraoperative bending and improving the procedural efficiency and anatomical fit for small bone surgeries (ʼ954 Patent, col. 2:58-63).
  • Key Claims at a Glance:
    • The complaint asserts at least independent claim 4 (Compl. ¶49).
    • Essential elements of independent claim 4 (a method claim) include:
      • Accessing a bone by opening a wound.
      • Selecting a pre-contoured, Y-shaped plate with asymmetrical arms.
      • Using a plate bender to bend a linking section of the plate without deforming the screw hole.
      • Attaching the bent plate to the bone.
    • The complaint reserves the right to assert additional claims (Compl. ¶1).

Multi-Patent Capsule: U.S. Patent No. 8,118,846

  • Patent Identification: "Orthopedic plates for use in clavicle repair and methods for their use," issued February 21, 2012 (Compl. ¶11).
  • Technology Synopsis: The patent describes a series of orthopedic plates specifically designed for the repair or reconstruction of the clavicle (collarbone), addressing the unique anatomical shape and challenges of that bone (’846 Patent, col. 2:13-15). The plates feature complex contours and asymmetrical arms to match the clavicle's anatomy and provide stable fixation (’846 Patent, Abstract).
  • Asserted Claims: At least independent claims 7 and 14 are asserted (Compl. ¶¶ 59-60).
  • Accused Features: The complaint alleges that the PROMO Triplanar Hallux Valgus Correction System and the Gorilla R3CON Plating Systems, including their respective plates and screws, infringe the ’846 Patent (Compl. ¶¶ 59-60).

Multi-Patent Capsule: U.S. Patent No. 8,118,848

  • Patent Identification: "Orthopedic plate for use in fibula repair," issued February 21, 2012 (Compl. ¶12).
  • Technology Synopsis: The patent discloses an orthopedic plate specifically designed for the repair of the fibula, particularly for transsyndesmotic fractures near the ankle (’848 Patent, col. 2:5-9). The plate has a Y-shaped profile with the contour of a spoon, where the "bowl" includes terminal arms designed to cup and wrap around the ankle bone for multiplanar fixation (’848 Patent, Abstract; col. 9:15-22).
  • Asserted Claims: At least independent claim 1 is asserted (Compl. ¶¶ 71-72).
  • Accused Features: The PROMO Triplanar Hallux Valgus Correction System and the Gorilla R3CON Plating Systems, including their respective plates and screws, are accused of infringement (Compl. ¶¶ 71-72).

Multi-Patent Capsule: U.S. Patent No. 9,144,443

  • Patent Identification: "Orthopedic plates for use in clavicle repair and methods for their use," issued September 29, 2015 (Compl. ¶13).
  • Technology Synopsis: This patent is related to the ’846 Patent and similarly describes orthopedic plates designed for clavicle repair. The technology focuses on plates with specific contours (e.g., c-shape, fishtail, S-curve) and asymmetrical arms to fit different aspects of the clavicle, such as the superior or anterior/inferior surfaces (’443 Patent, col. 5:4-14, 46-51).
  • Asserted Claims: At least independent claims 1, 22, and 26 are asserted (Compl. ¶83).
  • Accused Features: The Gorilla R3CON Plating Systems, including Lapidus and NC Fusion plates, TUFFNEK screws, and a drill guide, are accused of infringement (Compl. ¶83).

Multi-Patent Capsule: U.S. Patent No. 9,259,251

  • Patent Identification: "Orthopedic plate for use in small bone repair," issued February 16, 2016 (Compl. ¶14).
  • Technology Synopsis: Related to the ’457 and ’954 patents, this patent also describes orthopedic plates for small bone repair featuring a central trunk and asymmetrical arms. The claims focus on a pre-contoured Y-shaped plate where the arms are attached via a "waist" designed to facilitate bending (’251 Patent, cl. 1).
  • Asserted Claims: At least independent claims 1, 4, and 19 are asserted (Compl. ¶¶ 94-96).
  • Accused Features: The PROMO Triplanar Hallux Valgus Correction System, the Gorilla R3CON Plating Systems, and the Baby Gorilla Mini Plating Systems are accused of infringement (Compl. ¶¶ 94-96).

Multi-Patent Capsule: U.S. Patent No. 9,259,252

  • Patent Identification: "Orthopedic plate for use in small bone repair," issued February 16, 2016 (Compl. ¶15).
  • Technology Synopsis: This patent is also part of the same family and describes systems of orthopedic plates for small bone repair. The asserted claims are directed to a method of conducting a surgery using a system that includes a plate bender and a pre-contoured plate with asymmetrical arms (’252 Patent, cl. 1).
  • Asserted Claims: At least independent claims 1 and 17 are asserted (Compl. ¶107).
  • Accused Features: The complaint alleges infringement by systems including the PROMO Plates, Gorilla R3CON plates, Baby Gorilla plates, and associated locking screws, which are allegedly used by customers in an infringing manner (Compl. ¶107).

Multi-Patent Capsule: U.S. Patent No. 9,259,253

  • Patent Identification: "Orthopedic plate for use in small bone repair," issued February 16, 2016 (Compl. ¶16).
  • Technology Synopsis: Also from the same family, this patent claims orthopedic plating systems. The asserted claims cover a plate having a trunk and a pair of terminal arms with differing angles and lengths, where the system also includes locking screws that converge but do not impinge (’253 Patent, cl. 46).
  • Asserted Claims: At least claims 1, 13, 20, 37, and 46 are asserted (Compl. ¶¶ 117-119).
  • Accused Features: The PROMO Triplanar Hallux Valgus Correction System, the Gorilla R3CON Plating Systems, and the Baby Gorilla Mini Plating Systems are accused of infringement (Compl. ¶¶ 117-119).

Multi-Patent Capsule: U.S. Patent No. 9,545,278

  • Patent Identification: "Orthopedic plate for use in small bone repair," issued January 17, 2017 (Compl. ¶17).
  • Technology Synopsis: This patent, from the same family as the preceding small bone repair patents, claims an orthopedic plate system that includes a contoured plate with asymmetrical arms and at least one screw with a threaded head that forms a mating interface with the screw hole, allowing for a plurality of angular orientations (’278 Patent, cl. 1).
  • Asserted Claims: At least independent claims 1 and 5 are asserted (Compl. ¶¶ 130-132).
  • Accused Features: The PROMO system, Gorilla R3CON systems, and Baby Gorilla systems, including plates and screws that allegedly allow for variable angle locking, are accused of infringement (Compl. ¶¶ 130-132).

Multi-Patent Capsule: U.S. Patent No. 9,078,710

  • Patent Identification: "Orthopedic compression/distraction device," issued July 14, 2015 (Compl. ¶18).
  • Technology Synopsis: This patent describes a surgical instrument used to apply compressive or distractive forces to bone parts. The device has an elongated body with a stationary arm and a movable arm, each equipped with a locking sleeve to hold surgical pins (e.g., K-wires) that are anchored to the bone (’710 Patent, Abstract).
  • Asserted Claims: At least independent claim 1 is asserted (Compl. ¶145).
  • Accused Features: The complaint accuses the Gorilla® Caspar Device, which is part of the Gorilla R3CON Plating System instrumentation (Compl. ¶143). The complaint includes a side-by-side comparison image alleging that the Gorilla Caspar Device is a "copy" of the instrument patented in the ’710 Patent (Compl. p. 43). This image depicts the accused Gorilla Caspar Device alongside a figure from the ’710 patent, highlighting their structural similarities (Compl. p. 43).

III. The Accused Instrumentality

  • Product Identification: The accused instrumentalities are Defendant’s orthopedic plating systems, including the Gorilla® R3CON Plating Systems, the Baby Gorilla™ Mini Plating Systems, and the PROMO™ Triplanar Hallux Valgus Correction System, as well as the Gorilla® Caspar Device, a surgical instrument (Compl. ¶28).
  • Functionality and Market Context: The accused plating systems are comprised of orthopedic plates, locking screws, non-locking screws, and surgical instruments used for the fixation and repair of bones, particularly in the foot and ankle (Compl. ¶¶ 4, 23, 29, 31). The Gorilla® Caspar Device is identified as a compression/distraction instrument used as part of the Gorilla R3CON Plating System instrumentation (Compl. ¶143). The complaint alleges that Defendant’s business is focused on medical devices for the foot and ankle and that its accused Gorilla Plating System was previously named the ParaLock Plating System (Compl. ¶¶ 23, 27).

IV. Analysis of Infringement Allegations

'457 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A Y-shaped plate... consisting of a trunk and a pair of a first arm and a second arm The accused PROMO, Gorilla R3CON, and Baby Gorilla plates are alleged to be y-shaped plates consisting of a trunk and a pair of arms. ¶36-38 col. 7:26-30
the first arm having... a first angle and a first length... the second arm having... a second angle and a second length... the first angle and the first length being different from the second angle and the second length The complaint alleges that the accused plates include all limitations of the claim, which would require the arms to be asymmetrical with respect to both angle and length. ¶36-38 col. 8:1-12
whereby the first screw axis and the second screw axis converge toward the inferior side of the plate but do not intersect The complaint alleges that the accused systems meet all limitations of the claims, which would require the screw axes to converge without intersecting. ¶36-38 col. 8:12-15

'954 Patent Infringement Allegations

Claim Element (from Independent Claim 4) Alleged Infringing Functionality Complaint Citation Patent Citation
selecting a pre-contoured plate which is a Y-shaped plate... Defendant allegedly induces infringement by providing instructions and teachings that direct customers to select the accused plates for use in surgery. ¶49 col. 12:49-51
using a plate bender to bend the '954 Accused Plates to an appropriate contour Defendant allegedly provides instructions and instruments (e.g., "Gorilla plate benders") for users to bend the accused plates as part of a surgical procedure. ¶49 col. 13:9-12
attaching the bent plate to the bone The infringement allegation is based on the use of the accused systems by Defendant's customers in surgical procedures to repair bones. ¶49 col. 12:45-46
  • Identified Points of Contention:
    • Scope Questions: A central question may be whether the various accused plates, identified by names such as "Universal T-plates," "Universal Dogbone plates," and "Lisfranc Clover plates," fall within the scope of the claim term "Y-shaped plate" (Compl. ¶¶ 37, 49). The infringement allegations group numerous plate geometries under a single claim limitation, which may become a point of dispute over claim scope.
    • Technical Questions: The complaint makes broad allegations that the accused plates meet all claim limitations without providing specific technical details on how they do so (e.g., Compl. ¶36). A key technical question will be what evidence supports the allegation that the screw axes in the accused products converge in the specific manner required by the claims (i.e., toward the inferior side but without intersecting).

V. Key Claim Terms for Construction

  • The Term: "Y-shaped plate" (from ’457 Patent, Claim 1)
    • Context and Importance: The construction of this term is critical because the complaint accuses a wide variety of plate configurations, including "T-plates," "Dogbone plates," and "Clover plates," of infringing claims that explicitly recite a "Y-shaped plate" (Compl. ¶¶ 37, 49). The definition of "Y-shaped" will be central to determining the scope of infringement.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The patent's abstract describes the plate as having a "modified x shape," and the detailed description states the shape "can be thought of as being similar to the Greek letter X with foreshortened opposing diagonal legs" ('457 Patent, Abstract; col. 5:6-9). This language may support an interpretation that is not limited to a literal 'Y' configuration.
      • Evidence for a Narrower Interpretation: The claim language itself explicitly uses the term "Y-shaped plate." Further, the claim recites a structure with a single "trunk" and only one "pair of a first arm and a second arm" extending from one end of that trunk ('457 Patent, cl. 1). This language could be cited to argue for a narrower construction that excludes plates with more complex geometries or arms extending from both ends of the trunk.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement for all asserted patents. The primary basis for inducement is the allegation that Defendant provides customers with products accompanied by instructions, marketing materials, and surgical technique guides that direct users to employ the products in an infringing manner (e.g., Compl. ¶¶ 39, 49, 61).
  • Willful Infringement: Willfulness is alleged for all asserted patents. The complaint alleges pre-suit knowledge based on several grounds: (1) Defendant employs former Wright Medical employees who had knowledge of the asserted patents and corresponding commercial products; (2) Defendant cited Plaintiff's products as predicate devices in an FDA 510(k) submission; and (3) Plaintiff's patents are listed on its virtual marking webpage (e.g., Compl. ¶¶ 43, 53, 65). Post-suit knowledge is alleged based on the service of the complaint (e.g., Compl. ¶44).

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

  • A core issue will be one of definitional scope: can the term "Y-shaped plate," as recited in several asserted claims, be construed broadly enough to encompass the diverse portfolio of accused plate geometries, including those identified as T-plates, Dogbone plates, and Clover plates, or will it be limited to a more literal interpretation?
  • A key evidentiary question will be one of technical proof: can Plaintiff substantiate its broad allegations that the accused products meet every limitation of the asserted claims, particularly for nuanced geometric and functional requirements such as the precise convergence of screw axes without intersection?
  • A central question for willfulness and indirect infringement will be one of scienter: do the allegations regarding Defendant's hiring of former employees and its FDA 510(k) submission provide a sufficient factual basis to establish that Defendant had the requisite knowledge and intent for these claims prior to the lawsuit?