DCT
4:23-cv-10299
New Amsterdam LLC v. MTD Micro Molding Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: New Amsterdam LLC (Delaware)
- Defendant: MTD Micro Molding, Inc. (Massachusetts)
- Plaintiff’s Counsel: Donovan Hatem LLP; Garteiser Honea, PLLC
- Case Identification: 4:23-cv-10299, D. Mass., 02/06/2023
- Venue Allegations: Venue is alleged to be proper in the District of Massachusetts because the Defendant is a Massachusetts corporation with a regular and established business presence in the district.
- Core Dispute: Plaintiff alleges that Defendant’s bioresorbable, drug-eluting medical implants infringe a patent related to modular drug delivery devices designed for orthopedic surgical sites.
- Technical Context: The technology concerns implantable medical devices made from biodegradable polymers that are designed to release therapeutic agents in a controlled manner at a surgical site over a specific period.
- Key Procedural History: The complaint details a series of assignments of the patent-in-suit, from the original inventors to OsetoTools, LLC, then to BioDynamics, LLC, then to First Commerce Bank, and finally to the Plaintiff, New Amsterdam LLC. The complaint also notes that the patent may have expired but asserts the right to seek damages for past infringement.
Case Timeline
| Date | Event |
|---|---|
| 2002-07-22 | ’483 Patent Priority Date |
| 2003-06-30 | ’483 Patent assigned by inventors to OsetoTools, LLC |
| 2005-04-01 | ’483 Patent assigned by OsetoTools, LLC to BioDynamics, LLC |
| 2005-07-12 | ’483 Patent Issue Date |
| 2021-06-15 | ’483 Patent assigned by BioDynamics LLC to First Commerce Bank |
| 2021-09-28 | ’483 Patent assigned by First Commerce Bank to New Amsterdam LLC |
| 2023-02-06 | Complaint Filing Date |
| 2023-06-09 | Alleged Expiration Date of ’483 Patent |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 6,916,483 - “Bioabsorbable Plugs Containing Drugs”
The Invention Explained
- Problem Addressed: The patent’s background section states that prior art bioabsorbable implants were generally "isotropic," meaning their uniform composition resulted in a drug release rate determined only by the material's degradation and the implant's surface area (Compl. ¶19; ’483 Patent, col. 2:51-59). This uniformity made it difficult to achieve a "controlled or phased release of active agents," such as a rapid initial dose of an antiseptic followed by a slower, sustained release of wound healing factors (’483 Patent, col. 2:59-67).
- The Patented Solution: The invention is a modular drug delivery system designed to be inserted into an orthopedic prosthesis, such as a femoral pin or bone plate (’483 Patent, col. 4:15-18). The system uses "modular plugs" of various shapes (e.g., cylinders, disks, tiles as shown in Figs. 1A-J) that are comprised of a bioabsorbable polymer and a therapeutic agent (’483 Patent, Abstract). By combining different modules with varied compositions and degradation rates, a custom, "controllable release of the therapeutic agent over a predefined dosing period" can be achieved (’483 Patent, col. 4:10-12).
- Technical Importance: This modular approach provided a method for creating customized drug-release profiles tailored to specific therapeutic needs at a surgical site, moving beyond the monolithic release characteristics of earlier implants (Compl. ¶20; ’483 Patent, col. 4:5-14).
Key Claims at a Glance
- The complaint asserts infringement of independent claims 1 and 20 (’Compl. ¶32).
- Essential elements of independent claim 1 include:
- An implantable prosthetic device having a surface contour, and comprising a solid modular implantable drug delivery device within a shaped recess within the outer surface of an implantable prosthesis
- said device being operable for releasing a therapeutic agent into the body of an animal following implantation of the prosthesis within the body of the animal, the device comprising:
- (a) a solid module comprising a biodegradable polymer dimensioned to fit snugly within the shaped recess in the prosthesis; and
- (b) a therapeutic agent that is released into the body of the animal during biodegration of said biodegradable polymer over a predefined dosing period.
- The complaint reserves the right to assert additional claims (’Compl. ¶26).
III. The Accused Instrumentality
Product Identification
The Accused Instrumentalities are identified as Defendant MTD’s "(1) Drug Delivery Straws; (2) Ultra-Thin Wall Cannulas for Wearable Bolus Injectors or Drug Infusion Sets; (3) Single-Use, Time-Release Pharmaceutical Implants; and (4) Permanent Refillable Drug-Eluting Implants" (Compl. ¶25).
Functionality and Market Context
The complaint alleges these are "drug eluting implants" made from bioabsorbable materials like PLDL and PLG that are operable to release a therapeutic agent into an animal's body (Compl. ¶¶24, 29). The complaint includes a screenshot from Defendant's website depicting a purple, translucent "Drug Eluting Implant" described as having ".003" tolerances" and being used for "neurological implants" (Compl. p. 8). A table from the website lists "Bioabsorbable polymer drug-eluting implants" as a drug delivery application (Compl. ¶29).
IV. Analysis of Infringement Allegations
’483 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| An implantable prosthetic device having a surface contour, and comprising a solid modular implantable drug delivery device within a shaped recess within the outer surface of an implantable prosthesis... | The complaint alleges MTD's products are "drug eluting implants," and references "Osteoplug" products that include biodegradable polymer dimensions to fit snugly within a shaped recess in a prosthesis. | ¶27 | col. 4:15-18 |
| a solid module comprising a biodegradable polymer dimensioned to fit snugly within the shaped recess in the prosthesis; | MTD's products allegedly include "biodegradable polymer dimensions to fit snugly within the shaped recess in the prosthesis." The website screenshot shows an implant made of "bioabsorbable materials." | ¶27, ¶29 | col. 9:5-7 |
| a therapeutic agent that is released into the body of the animal during biodegration of said biodegradable polymer over a predefined dosing period. | MTD's products are alleged to be "drug eluting implants" that release a "therapeutic agent... during biodegration of the biodegradable polymer over a predefined dosing period." | ¶24, ¶27 | col. 9:8-10 |
Identified Points of Contention
- Structural Questions: A primary issue is whether the Accused Instrumentalities, identified as "drug eluting implants," constitute the "solid modular implantable drug delivery device" of the claim, and if so, what separate "implantable prosthetic device" with a "shaped recess" they are allegedly used with. The complaint alleges the accused products have dimensions to "fit snugly within the shaped recess in the prosthesis" (Compl. ¶27), but does not explicitly identify this separate prosthesis. The claim language suggests a two-component system (a plug within a larger prosthesis), raising the question of whether the complaint has adequately pleaded infringement of this structural arrangement.
- Scope Questions: Does the term "solid module" as required by Claim 1 read on the accused "Drug Delivery Straws" and "Ultra-Thin Wall Cannulas" (Compl. ¶25), which may have hollow features?
- Technical Questions: What evidence does the complaint provide that the release of the therapeutic agent from the accused products occurs over a "predefined dosing period" as required by the claim, beyond the general allegation that they are "Time-Release" implants? The complaint's visual evidence describes the "Drug Eluting Implant" (Compl. p. 8) but does not specify its release characteristics.
V. Key Claim Terms for Construction
"An implantable prosthetic device... comprising a solid modular implantable drug delivery device within a shaped recess within the outer surface of an implantable prosthesis"
Context and Importance
The construction of this limitation is central to the dispute. The language appears to describe a two-component system: a drug delivery "device" (or "module") that is placed within a recess of a separate "prosthesis." The infringement case may depend on whether the Accused Instrumentalities are the "device" component, and whether Plaintiff can show they are used with a separate "prosthesis." Practitioners may focus on whether this limitation can be met by a single, integrated product or if it unambiguously requires two distinct articles.
Intrinsic Evidence for Interpretation
- Evidence for a Narrower Interpretation: The specification consistently describes the drug delivery device as being affixed to or inserted into a separate prosthesis, stating it is "preferable that the drug delivery device be in the form of a rigid, preshaped polymeric plug that can be readily affixed to an orthopaedic prosthesis such as a femoral pin or a bone plate" (’483 Patent, col. 4:14-18). This supports a construction requiring two separate components.
- Evidence for a Broader Interpretation: The complaint does not appear to present evidence from the patent to support a broader interpretation where a single device could satisfy both the "prosthesis" and "drug delivery device" limitations.
"solid module"
Context and Importance
This term appears in Claim 1 and its construction will be important for determining whether products like "Drug Delivery Straws" and "Ultra-Thin Wall Cannulas" (Compl. ¶25) can infringe. Practitioners may focus on this term because if "solid" is construed to mean having no hollow parts, it could create a straightforward non-infringement argument for some of the accused products.
Intrinsic Evidence for Interpretation
- Evidence for a Narrower Interpretation: The claim itself recites a "solid module." Claim 15, which depends from claim 7 (which in turn depends from claim 1), adds the limitation that "one of the solid modules is hollowed out," suggesting that the baseline "solid module" of claim 1 is not hollow.
- Evidence for a Broader Interpretation: The patent specification discloses embodiments that are tubular or have an axial bore (e.g., "tubular embodiments 10i," ’483 Patent, col. 6:7-9). However, these are not explicitly described as satisfying the "solid module" limitation of Claim 1, which may limit their relevance to its construction.
VI. Other Allegations
Indirect Infringement
The complaint alleges induced infringement based on Defendant's distribution of "the Osteo Video, brochures, manuals, instructional documents" with the specific intent to cause infringement (Compl. ¶33). Contributory infringement is alleged on the basis that Defendant provides material parts that are not staple articles of commerce and are especially adapted for infringing use (Compl. ¶34).
Willful Infringement
Willfulness is alleged based on knowledge of the ’483 Patent obtained "at least as early as the date it received service of the Original Complaint in this litigation" (Compl. ¶35).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of structural scope: Does Claim 1 require a two-component system where a drug-delivery module is inserted into a recess of a separate, larger prosthesis? If so, the case may turn on whether Plaintiff can identify both components in Defendant’s accused system, an element not explicitly detailed in the complaint.
- A second key issue will be one of definitional scope: Can the claim term "solid module" be construed to read on the accused "Drug Delivery Straws" or "Ultra-Thin Wall Cannulas," or does the patent’s language and claim structure limit the term to non-hollow structures?
- An important evidentiary question will be one of functional performance: Beyond general marketing claims, what technical evidence will be presented to demonstrate that the accused products release a therapeutic agent over a "predefined dosing period" as specifically required by the patent claim?