DCT
3:23-cv-00491
OrthoPediatrics Corp. v. WishBone Medical, Inc.
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: OrthoPediatrics Corp. (Delaware)
- Defendant: WishBone Medical, Inc. (Indiana)
- Plaintiff’s Counsel: Venable, LLP
- Case Identification: 3:23-cv-00491, N.D. Ind., 05/26/2023
- Venue Allegations: Plaintiff alleges venue is proper because Defendant maintains a principal place of business, an office, and employees in the district, and has committed alleged acts of infringement within the district.
- Core Dispute: Plaintiff alleges that Defendant’s pediatric femoral locking plate system infringes a patent related to orthopedic plates specifically designed to avoid interfering with bone growth in children.
- Technical Context: The technology concerns orthopedic implants for stabilizing long bone fractures in pediatric patients, a field where avoiding damage to the epiphyseal (growth) plates is a critical clinical challenge.
- Key Procedural History: The complaint notes that Defendant announced it received 510(k) clearance from the U.S. Food and Drug Administration for the accused product on or about March 31, 2023.
Case Timeline
| Date | Event |
|---|---|
| 2009-02-23 | ’998 Patent Priority Date |
| 2014-07-15 | ’998 Patent Issue Date |
| 2023-03-31 | Accused Product receives FDA 510(k) clearance |
| 2023-05-26 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,777,998 - "Pediatric Long Bone Support or Fixation Plate"
- Patent Identification: U.S. Patent No. 8,777,998, "Pediatric Long Bone Support or Fixation Plate," issued July 15, 2014.
The Invention Explained
- Problem Addressed: The patent addresses the significant risks of adapting orthopedic plates designed for adults for use in pediatric patients. Modifying adult implants or using straight plates on curved pediatric bones can cause screws to enter and damage the epiphyseal (growth) plate, potentially leading to partial growth arrest and bone deformities. (’998 Patent, col. 1:35-49; Compl. ¶¶ 21-22).
- The Patented Solution: The invention is a one-piece bone plate with a specific geometry: a flat "planar portion" to lie along the bone shaft (diaphysis) and a "curved portion" to fit the bone near a joint (metaphysis). The crucial innovation is the orientation of the screw holes. The axes of the screw holes in both the planar and curved portions are engineered to be parallel to each other. This ensures that all fixation screws are inserted parallel to the epiphyseal plate, thereby avoiding impingement on the growth structure. (’998 Patent, Abstract; col. 7:38-45).
- Technical Importance: This design provides stable fixation for pediatric bone trauma while accommodating a child's growing anatomy, a key challenge not addressed by conventional adult implants. (’998 Patent, col. 2:26-32; Compl. ¶ 25).
Key Claims at a Glance
- The complaint asserts infringement of at least independent Claim 1. (Compl. ¶ 36).
- Independent Claim 1 of the U.S. Patent No. 8,777,998 requires:
- An apparatus for supporting a pediatric bone that would not interfere with growth in the epiphyseal plate.
- An elongated plate with a planar portion for the diaphysis and a curved portion for the metaphysis.
- A top surface that is smoothly continuous between the planar and curved portions, where the surface is in a plane in the planar portion and curved out of that plane in the curved portion.
- A first plurality of holes in the planar portion, with each hole having a central longitudinal axis that is perpendicular to the top surface.
- A second plurality of holes in the curved portion, with each hole having a central longitudinal axis that is not perpendicular to the top surface (of the curved portion).
- The respective axes of the holes of the first and second pluralities are parallel.
III. The Accused Instrumentality
Product Identification
- Defendant’s PRIMA™ Distal Femur Locking Plate System ("the Accused System"). (Compl. ¶ 28).
Functionality and Market Context
- The Accused System is marketed as a medical device for surgeons to address "proximal and distal deformities and trauma applications of the femur in pediatric patients." (Compl. ¶ 29).
- The complaint alleges the system is "specifically designed for pediatric patients" and quotes Defendant’s brochure, which states the system includes "condylar screws [that] are angled 5° away from the physis [to] help[] prevent penetrating the growth plate." (Compl. ¶ 37). The complaint asserts the Accused System is currently being manufactured, sold, or imported by the Defendant. (Compl. ¶ 32).
IV. Analysis of Infringement Allegations
The complaint provides an illustration from a surgical guide showing the Accused System implanted on a femur, alongside standalone views of the plate. (Compl. ¶ 38, p. 10).
’998 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| an elongated plate having a planar portion for attachment to a diaphysis of a pediatric bone, and a curved portion for attachment to a metaphysis of the pediatric bone... | The Accused System is an "elongated plate" with a "planar portion" for the diaphysis and a "curved portion" for the metaphysis of a pediatric bone. | ¶38 | col. 2:29-32 |
| said plate having a top surface that faces away from the bone...said top surface being smoothly continuous between said planar portion and said curved portion and being in a plane in said planar portion and curved out of said plane in said curved portion | The Accused System's plate has a top surface that faces away from the bone and is smoothly continuous between its planar and curved portions. | ¶38 | col. 2:32-36 |
| wherein said plate has a set of holes, said set including a first plurality of holes in said planar portion, each of said first plurality of holes having a respective central longitudinal axis that is perpendicular to said top surface | The plate of the Accused System has a first plurality of holes in the planar portion with a "respective central longitudinal axis that is perpendicular to said top surface." | ¶¶38-39 | col. 2:36-40 |
| and said set also including a second plurality of holes in said curved portion, each of said second plurality of holes having a respective central longitudinal axis that is not perpendicular to said top surface | The plate includes a second plurality of holes in the curved portion with a "respective central longitudinal axis that is not perpendicular to said top surface." | ¶¶38-39 | col. 2:40-43 |
| and wherein said respective axes of said holes of said first plurality and said second plurality are parallel. | Upon information and belief, the respective axes of the holes of the first and second plurality of holes in the Accused System are parallel. | ¶¶38-39 | col. 2:43-45 |
- Identified Points of Contention:
- Scope Questions: The complaint alleges the Accused System features screws "angled 5° away from the physis" (Compl. ¶ 37), while simultaneously alleging, upon information and belief, that the hole axes are "parallel" as required by the claim (Compl. ¶ 38). This raises a central question of claim scope: does the term "parallel" permit a 5-degree deviation, or does it require strict geometric parallelism? The resolution of this issue may be dispositive for infringement.
- Technical Questions: A key evidentiary question will be whether the axes of the screw holes in the Accused System’s planar and curved portions are, in fact, parallel. The complaint’s allegation is made "upon information and belief" (Compl. ¶ 39), which suggests Plaintiff may not yet have definitive proof. The defendant’s own description of a 5-degree angle may be used to challenge this assertion, requiring factual development and likely expert testimony to resolve the technical discrepancy.
V. Key Claim Terms for Construction
- The Term: "parallel"
- Context and Importance: This term is at the heart of the technical dispute. The patent's inventive concept rests on all screw axes being parallel to avoid the growth plate. The complaint alleges the accused product's screws are "angled 5° away from the physis," creating an immediate tension with the claim requirement that the axes "are parallel." Practitioners may focus on this term because its construction—whether it means strictly parallel or "substantially" parallel—could determine the outcome of the infringement analysis.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party arguing for a broader construction may point to the patent’s stated purpose. The specification describes the screw orientation as being "generally parallel to the epiphyseal plate" (’998 Patent, col. 7:40-41) and "substantially parallel to an epiphyseal plate" (’998 Patent, col. 3:17-19). This language could suggest that the function of avoiding the growth plate is paramount and that absolute geometric parallelism is not required to achieve that function.
- Evidence for a Narrower Interpretation: A party arguing for a narrower, stricter definition may focus on the specific language of Claim 1, which states the axes "are parallel" without any qualification like "substantially" or "generally." The specification also repeatedly uses the unqualified term "parallel" when describing the relationship between the central axes of the different holes. (’998 Patent, col. 2:43-45; col. 8:12-13).
VI. Other Allegations
- Indirect Infringement: The complaint alleges inducement of infringement under 35 U.S.C. § 271(b). It asserts that Defendant provides marketing materials, a brochure, Instructions for Use, and Surgical Technique documents that instruct and encourage orthopedic professionals to use the Accused System in an infringing manner. (Compl. ¶¶ 39, 41-42). The complaint also pleads contributory infringement, alleging the Accused System has no substantial non-infringing uses. (Compl. ¶ 43).
- Willful Infringement: The complaint does not contain a formal count for willful infringement but alleges Defendant "intentionally" infringes and that the case is "exceptional" and warrants attorneys' fees under 35 U.S.C. § 285. (Compl. ¶¶ 7, 45). The complaint does not allege facts indicating Defendant had pre-suit knowledge of the ’998 Patent.
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of definitional scope: can the claim term "parallel", as used in the patent, be construed to read on a device whose screw axes are allegedly "angled 5° away" from a key anatomical feature? The case may turn on whether the patent requires absolute geometric parallelism or allows for functional, substantial parallelism to achieve the goal of avoiding the growth plate.
- A key evidentiary question will be one of technical proof: what evidence will Plaintiff provide to support its "information and belief" allegation that the hole axes in the Accused System are parallel, and how will that evidence reconcile with Defendant's own product description referencing a 5-degree angle? This suggests a potential "battle of the experts" over the precise physical characteristics of the accused device.