Untitled case

This patent infringement case, 1:25-cv-00592, was filed on May 12, 2025, in the District of Delaware by Treace Medical Concepts, Inc. ("Treace") against Zimmer Biomet Holdings, Inc. and Paragon 28, Inc.. Treace Medical Concepts is an operating company specializing in medical devices, particularly for bunion correction surgery. The defendant, Zimmer Biomet Holdings, Inc., is also a prominent medical device company, which finalized its acquisition of Paragon 28, Inc. in April 2025 for approximately $1.2 billion, shortly before this lawsuit was filed. The lawsuit accuses Zimmer Biomet and Paragon 28 of infringing four patents, including US Patent No. 12,268,397, all related to Treace's Lapiplasty® system for three-dimensional bunion correction. The Lapiplasty® system is designed to improve upon older surgical methods by correcting bunions in three dimensions and guiding surgeons for more consistent results. The asserted patents cover aspects of both the surgical tools and the techniques used in the procedure.

The case is being heard in the U.S. District Court for the District of Delaware, and has been assigned to Judge Gregory B. Williams. The District of Delaware is a common venue for patent litigation, particularly for cases against Delaware-incorporated defendants, which include a large number of major U.S. technology and pharmaceutical companies. The court is known for its experienced patent judges, who have presided over numerous patent trials and claim construction proceedings, and for a mature body of patent-specific precedent. While the district does not have uniform local patent rules, litigation is governed by the individual practices of the judges.

This case is notable due to its timing, having been filed shortly after Zimmer Biomet's acquisition of Paragon 28, suggesting Treace may be challenging a broader range of products now encompassing Paragon's technologies. Treace has emphasized its robust patent portfolio, including 80 granted U.S. patents, 26 international patents, and over 150 pending applications, indicating a strategic effort to protect its innovations in the bunion correction field. Treace is seeking financial damages and an injunction to prevent the defendants from making, using, or selling the allegedly infringing products. The case highlights the competitive landscape within the medical device industry, especially concerning specialized surgical procedures and the protection of intellectual property following significant corporate acquisitions.

Patent Infringement Litigation: Treace Medical Concepts, Inc. v. Zimmer Biomet Holdings, Inc. et al.

Case Number: 1:25-cv-00592
Court: U.S. District Court for the District of Delaware
Patents at Issue: 12,102,368; 12,268,397; 12,268,428; 12,274,481 (initial complaint), with an additional patent added in the amended complaint.
Status: Active

Key Legal Developments and Current Posture:

This patent infringement lawsuit was initiated by Treace Medical Concepts, Inc. against Zimmer Biomet Holdings, Inc. and Paragon 28, Inc. in the U.S. District Court for the District of Delaware. The case centers on alleged infringement of patents related to Treace's Lapiplasty® 3D Bunion Correction system.

Filing & Initial Pleadings:

• Complaint Filed: Treace Medical Concepts, Inc. filed its initial complaint on May 12, 2025, accusing Zimmer Biomet Holdings, Inc. and Paragon 28, Inc. of infringing four patents: U.S. Patent Nos. 12,102,368; 12,268,397; 12,268,428; and 12,274,481. The case was assigned to Judge Gregory B. Williams. Treace seeks financial damages and injunctive relief to prevent the defendants from manufacturing, using, or selling the allegedly infringing products.
• Amended Complaint Filed: On August 5, 2025, Treace filed an amended complaint, alleging infringement of an additional patent.
• Answer and Counterclaims: The defendants, Zimmer Biomet Holdings, Inc. and Paragon 28, Inc., filed their answer to the amended complaint, including defenses and counterclaims seeking declaratory judgments of invalidity and non-infringement, on February 17, 2026.
• Answer to Counterclaims: Treace Medical Concepts, Inc. filed its answer to the defendants' counterclaims on March 10, 2026.

Pre-trial Motions of Substance:

• As of the current date (May 29, 2026), publicly available information indicates that Treace filed motions to sever and consolidate certain patent claims into this case (C.A. No. 25-592-GBW). Details or rulings on these specific motions are not yet available.

Claim Construction (Markman) Outcomes:

• No information regarding a Markman hearing or claim construction order is publicly available at this time.

Discovery Milestones:

• No specific discovery milestones with strategic significance are detailed in the provided search results.

Trial Events, Verdict, and Post-Trial Motions:

• The case is currently active, and there have been no reported trial events, verdicts, or post-trial motions.

Settlement, Dismissal, Judgment, or Appeal:

• The case remains active in the U.S. District Court for the District of Delaware.

Parallel PTAB IPR/PGR Proceedings:

• A search for PTAB (Patent Trial and Appeal Board) IPR (Inter Partes Review) or PGR (Post-Grant Review) proceedings specifically for patent 12268397 did not yield any direct results indicating an active or concluded challenge against this particular patent. While the PTAB generally handles such reviews, and a recent precedential PGR decision highlights the Board's preference for such reviews, there is no public record directly linking these to patent 12268397 in this case.

Treace Medical Concepts, Inc., the plaintiff in 1:25-cv-00592 in the Delaware District Court, is represented by counsel from Winston & Strawn LLP and Heyman Enerio Gattuso & Hirzel LLP.

The counsel of record for the plaintiff(s) include:

• Nimalka R. Wickramasekera

  • Role: Lead Counsel (Partner, Co-chair of Intellectual Property Practice)
  • Firm: Winston & Strawn LLP, Los Angeles, CA / Silicon Valley, CA
  • Experience Note: Ms. Wickramasekera is a first-chair trial lawyer specializing in high-stakes patent and technology litigation, with a proven track record of wins in federal courts and before the ITC, including medical device litigation. She has secured major jury verdicts, complete defense judgments, and appellate victories.

• Michael A. Meneghini

  • Role: Lead Counsel (Litigator)
  • Firm: Winston & Strawn LLP, Chicago, IL
  • Experience Note: Mr. Meneghini has extensive trial and appellate experience in commercial and patent litigation across a wide range of disputes in federal and state courts.

• Olivia A. Wogon

  • Role: Lead Counsel (Associate)
  • Firm: Winston & Strawn LLP, Houston, TX
  • Experience Note: Ms. Wogon focuses her practice on intellectual property matters, leveraging her mechanical engineering degree to advise clients on a variety of technologies.

• Dominick T. Gattuso

  • Role: Local Counsel (Partner)
  • Firm: Heyman Enerio Gattuso & Hirzel LLP, Wilmington, DE
  • Experience Note: Mr. Gattuso focuses his practice on intellectual property, corporate, and complex commercial litigation, frequently serving as Delaware counsel for leading national law firms in disputes in state and federal court.

While an article from "Indiana Intellectual Property Law News" indicated that "Overhauser Law Offices, LLC" posted the complaint for the case, the listed attorneys appearing in the PacerMonitor docket for Treace Medical Concepts, Inc. primarily show representation by Winston & Strawn LLP and Heyman Enerio Gattuso & Hirzel LLP. Paul B. Overhauser is the founder of Overhauser Law Offices, LLC, and has extensive experience in patent and trademark litigation.

The following attorneys are identified as counsel of record representing the defendant(s), Zimmer Biomet Holdings, Inc. and Paragon 28, Inc., in Treace Medical Concepts, Inc. v. Zimmer Biomet Holdings, Inc. et al, Case No. 1:25-cv-00592, in the District of Delaware. While the specific assignment of each attorney to either Zimmer Biomet Holdings, Inc. or Paragon 28, Inc. is not explicitly detailed in the public search results, they are listed as counsel associated with the defendant side of the case.

• Dominick T. Gattuso

  • Role: Local Counsel
  • Firm: Heyman Enerio Gattuso & Hirzel LLP, Wilmington, Delaware.
  • Note: Mr. Gattuso is a partner who focuses his practice on intellectual property, corporate, and complex commercial litigation, often serving as Delaware counsel for national law firms in patent, trade secret, and trademark cases. His experience spans various technologies, including pharmaceuticals, telecommunications, and computer hardware and software.

• Nimalka R. Wickramasekera

  • Role: Lead Counsel (inferred from experience and firm role)
  • Firm: Winston & Strawn LLP, Los Angeles, California.
  • Note: Ms. Wickramasekera is co-chair of Winston & Strawn's Intellectual Property Practice and a first-chair trial lawyer with a strong record in high-stakes patent and technology litigation, particularly in the medical device, technology, and life sciences sectors. She has secured significant jury verdicts and complete defense judgments, including for medical device companies.

• Michael A. Meneghini

  • Role: Counsel (inferred from association with firm)
  • Firm: Winston & Strawn LLP. (Office location not explicitly found for this case, but Winston & Strawn has multiple offices).
  • Note: Mr. Meneghini has been part of a Winston & Strawn team recognized for successfully defending against patent, unfair competition, and false advertising claims for clients such as Abbott Laboratories.

• Olivia A. Wogon

  • Role: Associate
  • Firm: Winston & Strawn LLP, Houston, Texas.
  • Note: Ms. Wogon is a litigation associate focusing on intellectual property matters, utilizing her mechanical engineering background to advise clients on a variety of technologies.

• Robert T. Vlasis, III

  • Role: Lead Counsel (inferred from experience and firm role)
  • Firm: Mintz, Washington, D.C.
  • Note: Mr. Vlasis is Co-chair of Mintz's International Trade Commission (ITC) Practice and a patent litigator with two decades of experience in complex IP disputes before the ITC and other major patent venues, including medical devices. He has first-chair ITC trial experience and is recognized for his strategic counsel.