DCT
2:23-cv-00479
LifeNet Health v. Zimmer Biomet Holdings Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: LifeNet Health (Virginia)
- Defendant: Zimmer Biomet Holdings, Inc. (Delaware) and Embody, Inc. (Virginia)
- Plaintiff’s Counsel: McGuireWoods LLP
- Case Identification: 2:23-cv-00479, E.D. Va., 02/02/2024
- Venue Allegations: Venue is asserted on the basis that both Plaintiff LifeNet Health and Defendant Embody, Inc. reside in the district. It is further alleged that Defendant Zimmer has a regular and established place of business in the district through its direct operation of Embody, as well as other facilities, and has committed the alleged acts of infringement within the district.
- Core Dispute: Plaintiff alleges that Defendants’ biointegrative implant and suture products infringe two patents related to electrospun scaffolds with highly aligned fibers for promoting tissue repair.
- Technical Context: The technology concerns the field of regenerative medicine, specifically creating biocompatible scaffolds with a controlled, aligned fiber micro-architecture that mimics native tissue to enhance and accelerate the healing of soft-tissue injuries.
- Key Procedural History: The complaint alleges that a co-inventor of the patents-in-suit, Dr. Michael Francis, left LifeNet to join Embody, a direct competitor, in violation of an employment agreement requiring the assignment of inventions to LifeNet. The complaint further alleges that Defendants had pre-suit knowledge of the patents through the prosecution of their own patent applications, during which LifeNet’s antecedent patent application was cited and discussed. The complaint includes a state law claim for tortious interference with contract related to the alleged actions of Dr. Francis and another former LifeNet employee. Zimmer acquired Embody in 2023.
Case Timeline
| Date | Event |
|---|---|
| 2013-03-14 | Priority Date for '223 and '227 Patents (Provisional Filing) |
| 2014-03-07 | N. Kemper (LifeNet employee) signs IP Agreement with LifeNet |
| 2014-04-11 | Embody, Inc. founded |
| 2015-01-01 | Dr. Francis and N. Kemper leave LifeNet and join Embody (approx.) |
| 2018-11-09 | Francis/Kemper allegedly assign invention rights to Embody |
| 2018-11-27 | '223 Patent Issued |
| 2019-03-15 | Embody discusses LifeNet's tech in USPTO filing |
| 2020-10-09 | Embody receives FDA clearance for TAPESTRY implant |
| 2021-01-01 | Embody begins selling TAPESTRY in the U.S. (approx.) |
| 2022-05-03 | '227 Patent Issued |
| 2022-01-01 | Embody launches TAPESTRY RC product (approx.) |
| 2023-01-05 | Zimmer announces agreement to acquire Embody |
| 2023-02-14 | Zimmer completes acquisition of Embody |
| 2023-06-02 | Defendants receive FDA approval for ActivBraid |
| 2024-02-02 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 10,137,223 - "Aligned Fiber and Method of Use Thereof" (Issued Nov. 27, 2018)
The Invention Explained
- Problem Addressed: The patent addresses the need for improved biocompatible scaffolds for tissue repair. The complaint suggests that conventional electrospinning techniques produce fibers with random orientation, which are less effective for repairing tissues that have a naturally aligned structure, such as tendons (Compl. ¶21, ¶23).
- The Patented Solution: The invention is an electrospinning apparatus and resulting scaffold that produces highly aligned fibers. The process uses a collector with at least two parallel, charged rods that create a split electric field, causing extruded polymer fibers (e.g., collagen) to align as they are collected between the rods ('223 Patent, col. 2:32-41; Compl. ¶17). The resulting scaffold has a micro-architecture that can be precisely controlled, with the degree of alignment being quantifiable through a Fast Fourier Transform (FFT) analysis ('223 Patent, Abstract).
- Technical Importance: By creating scaffolds with highly aligned fibers, the invention purports to better mimic the structure of native tissues like tendons, which the complaint alleges "greatly enhanced and accelerated" the recovery and tissue remodeling process (Compl. ¶23).
Key Claims at a Glance
- The complaint asserts at least independent Claim 1 (Compl. ¶66).
- The essential elements of Claim 1 are:
- A scaffold comprising one or more electrospun fibers comprising collagen.
- Wherein a fast Fourier transform (FFT) analysis result of the fibers have adjacent major peaks with about 180° apart from each other.
- The prayer for relief seeks judgment of infringement on "one or more claims" of the patent (Compl. p. 31, ¶a).
U.S. Patent No. 11,318,227 - "Aligned Fiber and Method of Use Thereof" (Issued May 3, 2022)
The Invention Explained
- Problem Addressed: The patent addresses the need for an effective method of treating specific tissue defects, namely in a tendon, a ligament, or a nerve ('227 Patent, col. 23:36-37).
- The Patented Solution: The invention is a surgical method that involves implanting a specific type of scaffold at the site of a tissue defect. The claimed scaffold must contain "crosslinked fibers comprising collagen" that exhibit the characteristic high alignment, as demonstrated by an FFT analysis showing major peaks approximately 180° apart ('227 Patent, col. 23:31-37). The specification notes that crosslinking can be performed by various conventional methods to form covalently crosslinked fibers ('227 Patent, col. 12:30-36).
- Technical Importance: The invention provides a specific method for applying the aligned-fiber scaffold technology to surgical repair, leveraging the scaffold's native-tissue-mimicking structure to treat specific soft-tissue injuries (Compl. ¶33).
Key Claims at a Glance
- The complaint asserts at least independent Claim 1 (Compl. ¶75).
- The essential elements of Claim 1 are:
- A method of treating a tissue defect in a subject comprising:
- implanting at the tissue defect a scaffold comprising crosslinked fibers comprising collagen;
- wherein a result of a fast Fourier transform (FFT) analysis of the fibers demonstrates that the fibers have major adjacent peaks that are about 180° apart from each other; and
- applying the scaffold to the tissue defect to repair a tendon, a ligament or a nerve defect.
- The prayer for relief seeks judgment of infringement on "one or more claims" of the patent (Compl. p. 31, ¶b).
III. The Accused Instrumentality
Product Identification
- The accused instrumentalities are the TAPESTRY Biointegrative Implant (including the TAPESTRY RC system) and the ActivBraid Collagen Suture (Compl. ¶¶49, 56, 58).
Functionality and Market Context
- The TAPESTRY implant is described as a "bioengineered collagen implant with a highly aligned & highly porous architecture specifically designed to support tendon and ligament healing" (Compl. ¶49). Defendants' promotional materials, cited in the complaint, state that the implant's "highly aligned and consistent micro-architecture mimics native tendon" (Compl. p. 18, Fig. at top). This visual shows an outer layer of unaligned fibers for suture retention and an inner structure of highly aligned fibers. The complaint alleges TAPESTRY is used for rotator cuff, ACL, and Achilles tendon injuries (Compl. ¶54).
- The ActivBraid suture is described as a suture using "novel cross-linking" and comprising "highly aligned, crosslinked collagen microfibers" (Compl. ¶¶58-59). It is marketed for "high demand applications" in orthopedics, such as rotator cuff repair (Compl. p. 22, Fig. at top).
- The complaint alleges that these two product lines constitute "Embody's complete portfolio of collagen-based biointegrative solutions" and were the basis for Zimmer's acquisition of Embody for $155 million, with up to an additional $120 million in milestone payments (Compl. ¶¶61-62).
IV. Analysis of Infringement Allegations
'223 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A scaffold comprising one or more electrospun fibers comprising collagen | The TAPESTRY implant is described as a "bioengineered collagen implant" with a "micro-architecture" of fibers (Compl. ¶49). | ¶49 | col. 1:10-12 |
| wherein a fast Fourier transform (FFT) analysis result of the fibers have adjacent major peaks with about 180° apart from each other. | The complaint alleges TAPESTRY has a "highly aligned" fiber architecture (Compl. ¶49). It presents a side-by-side visual comparison of magnified images of "Defendants' 'Highly Aligned' Electrospun Fibers" and "LifeNet's Patented Electrospun Fibers" to assert their similarity (Compl. p. 20, Fig. at top). | ¶49, ¶52 | col. 1:13-16 |
'227 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method of treating a tissue defect in a subject comprising implanting at the tissue defect a scaffold... | Defendants are accused of inducing infringement by instructing customers on how to use ActivBraid for its intended purpose, which requires it to be "implanted at a tissue defect" (Compl. ¶77). | ¶77 | col. 18:35-39 |
| ...comprising crosslinked fibers comprising collagen... | The ActivBraid suture is described as using "novel cross-linking" and being composed of "crosslinked collagen microfibers" (Compl. ¶¶58-59). Promotional materials for the product, included in the complaint, explicitly mention "Biocompatible: Novel cross-linking has no associated inflammatory response" (Compl. p. 22, Fig. at top). | ¶58, ¶59 | col. 12:30-36 |
| ...wherein a result of a fast Fourier transform (FFT) analysis of the fibers demonstrates that the fibers have major adjacent peaks that are about 180° apart from each other... | The complaint alleges that ActivBraid uses "highly aligned...collagen microfibers" (Compl. ¶59). | ¶59 | col. 13:21-27 |
| ...and applying the scaffold to the tissue defect to repair a tendon, a ligament or a nerve defect. | Defendants' marketing materials allegedly promote ActivBraid for repairing tendon and ligament injuries, such as "RCR [rotator cuff repair], M/L Instability, etc." (Compl. p. 22, Fig. at top). The complaint alleges ActivBraid must be applied to a tissue defect to perform its intended function (Compl. ¶77). | ¶77 | col. 23:36-37 |
- Identified Points of Contention:
- Scope Question: A potential dispute for the ’227 patent is whether the accused ActivBraid "suture" falls within the scope of the term "scaffold" as used in the patent. The defense may argue that a linear suture is distinct from the sheet-like matrix structures described and depicted in the specification (e.g., '227 Patent, Figs. 9A-9C).
- Technical Question: For both patents, a central question will be whether the fibers in the accused TAPESTRY and ActivBraid products actually meet the quantitative alignment standard required by the claims—that an FFT analysis shows "adjacent major peaks with about 180° apart." The complaint provides a visual comparison for TAPESTRY but less direct evidence for ActivBraid, raising the question of what technical evidence supports this allegation for both products.
V. Key Claim Terms for Construction
The Term:
"scaffold"(in Claim 1 of both patents)- Context and Importance: The construction of this term is critical, particularly for the infringement allegations against the ActivBraid "suture." Whether a linear product like a suture can be considered a "scaffold" will be a central point of contention.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification describes the scaffold in various forms, including as an implant for use in "tendon and/or ligament in bone tunnels" ('223 Patent, col. 8:57-58), which could imply a flexible, non-sheet form. The general purpose is to provide a support structure for tissue regeneration, a function a suture also performs.
- Evidence for a Narrower Interpretation: The specification's primary embodiments depict the scaffold as an "elongated sheet" or a roll made from such sheets ('223 Patent, Figs. 9A-9C, col. 8:8-10). The term is consistently used in the context of a two- or three-dimensional matrix for cell growth, which could support an interpretation that excludes a one-dimensional suture.
The Term:
"adjacent major peaks with about 180° apart from each other"(in Claim 1 of both patents)- Context and Importance: This phrase quantifies the core inventive concept of high fiber alignment. The definitions of "major peaks" and the degree of variance permitted by "about 180°" will determine the threshold for infringement.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent provides a specific definition: "'major peaks' herein refer to peaks higher than the average of the peaks in the result" ('223 Patent, col. 13:4-6). This objective standard, combined with the flexibility of "about," may support finding infringement even with some deviation from perfect alignment.
- Evidence for a Narrower Interpretation: A defendant may argue that the term "major" implies a qualitative degree of prominence beyond simply exceeding the average. Further, they may argue that the specific deviation from 180° in their products is too great to be considered "about" 180°, pointing to the exemplary aligned FFT graph (Fig. 8A) as the standard.
VI. Other Allegations
- Indirect Infringement: The complaint alleges Defendants actively induce infringement of the ’227 patent method claims by providing promotional materials and instructions that encourage customers to use the ActivBraid suture in an infringing manner (Compl. ¶76). It also alleges contributory infringement, asserting that ActivBraid is a material part of the invention, is not a staple article of commerce, and is sold with knowledge of its special suitability for infringement (Compl. ¶77).
- Willful Infringement: The complaint alleges willful infringement based on extensive pre-suit knowledge. The allegations include Defendants' employment of the patents' co-inventor (Dr. Francis) and their discussion of LifeNet's published patent application (which issued as the '223 Patent) during the prosecution of Defendants' own patents (Compl. ¶¶67-68, ¶¶78-79). The complaint cites a sworn declaration by Dr. Francis acknowledging the LifeNet technology and its assignment to LifeNet, made while he was Chief Scientific Officer at Embody (Compl. ¶45).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of definitional scope: can the term "scaffold," which is primarily described and depicted in the patents as a two-dimensional sheet or three-dimensional matrix, be construed to cover the linear form of the accused ActivBraid "suture"?
- A key evidentiary question will be one of technical proof: does the micro-architecture of the accused TAPESTRY and ActivBraid products, upon testing, demonstrate the specific, quantifiable fiber alignment—an FFT analysis with "adjacent major peaks with about 180° apart"—that is the central limitation of the asserted claims?
- A third critical question concerns intent and conduct: do the detailed allegations regarding the inventor's move to a competitor and Defendants' knowledge of the patented technology during their own patent prosecution provide a sufficient basis for a finding of willful infringement, irrespective of the ultimate outcome on the technical merits of infringement?