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Case 1:22-cv-00239-UNA Document 1 Filed 02/25/22 Page 1 of 15 PageID #: 1
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`EXTREMITY MEDICAL, LLC, a New Jersey
`limited liability company,
`
`
`
`Plaintiff,
`
`
`
`
`
`C.A. No.
`
`
`JURY TRIAL DEMANDED
`
`)
`
`))))))))
`
`
`)
`)
`)
`)
`)
`)
`
`v.
`
`
`NEXTREMITY SOLUTIONS, INC., a
`Delaware corporation,
`
`ZIMMER BIOMET HOLDINGS, INC., a
`Delaware corporation, and
`
`ZIMMER, INC., a Delaware corporation,
`
`
`
`
`Defendants.
`
`COMPLAINT
`
`Plaintiff Extremity Medical, LLC (“Extremity Medical” or “Plaintiff”), for its Complaint
`
`against Defendants Nextremity Solutions, Inc. (“Nextremity”), Zimmer Biomet Holdings, Inc.
`
`(“Zimmer Biomet”), and Zimmer, Inc. (“Zimmer”), (collectively, “Defendants”), hereby alleges
`
`as follows:
`
`NATURE OF THE ACTION
`
`1.
`
`This is a civil action for patent infringement of U.S. Patent No. 8,303,589 (“the
`
`’589 Patent”) in violation of the patent laws of the United States, 35 U.S.C. § 1, et seq., arising
`
`from Defendants’ unauthorized manufacture, use, offer to sell, sale and/or importing into or in the
`
`United States its InCore Lapidus System (“the Infringing System”).
`
`THE PARTIES
`
`2.
`
`Extremity Medical is a limited liability company formed in the State of New Jersey
`
`and having its principal place of business at 300 Interpace Parkway, Suite 410, Parsippany, NJ
`
`07054.
`
`
`
`
`

`

`Case 1:22-cv-00239-UNA Document 1 Filed 02/25/22 Page 2 of 15 PageID #: 2
`
`3.
`
`Upon information and belief, Nextremity is a corporation organized under the laws
`
`of the State of Delaware and has its principal place of business at 1195 Polk Drive, Warsaw,
`
`Indiana 46582.
`
`4.
`
`Upon information and belief, Zimmer Biomet is a corporation organized under the
`
`laws of the State of Delaware and has its principal place of business at 345 East Main Street,
`
`Warsaw, Indiana 46580.
`
`5.
`
`Upon information and belief, Zimmer is a corporation organized under the laws of
`
`the State of Delaware and has its principal place of business at 345 East Main Street, Warsaw,
`
`Indiana 46580.
`
`JURISDICTION AND VENUE
`
`6.
`
`This Court has subject matter jurisdiction pursuant to 28 U.S.C. §§ 1331 and
`
`1338(a) because this is an action arising under the patent laws of the United States, 35 U.S.C. § 1,
`
`et seq.
`
`7.
`
`This Court has personal jurisdiction over Defendants because, upon information
`
`and belief, each Defendant: (a) was incorporated in the state of Delaware, (b) transacts business in
`
`Delaware through the sale of products from and/or into Delaware and therefore has substantial and
`
`continuous contacts within this judicial district; and (c) has committed, and continues to commit,
`
`tortious acts within the state of Delaware giving rise to this action. In short, each Defendant has
`
`purposely availed itself of the privileges and benefits of the laws of the State of Delaware, each
`
`Defendant derives benefits from its presence in this Judicial District, and each Defendant should
`
`reasonably expect its actions to have consequences within this Judicial District.
`
`8.
`
`Venue is proper under 28 U.S.C. §§ 1391(b), 1391(c) and/or 1400(b).
`
`
`
`
`2
`
`

`

`Case 1:22-cv-00239-UNA Document 1 Filed 02/25/22 Page 3 of 15 PageID #: 3
`
`THE PATENT-IN-SUIT
`
`9.
`
`On November 6, 2012, U.S. Patent No. 8,303,589, entitled “Fixation System, an
`
`Intramedullary Fixation Assembly and Method Of Use”, was duly and legally issued by the United
`
`States Patent and Trademark Office (“USPTO”). A true and correct copy of the ’589 Patent is
`
`attached hereto as Exhibit A. The ’589 Patent is valid, enforceable and currently in full force and
`
`effect.
`
`10.
`
`Plaintiff is the owner and assignee of all rights, title, and interest in the ’589 Patent,
`
`including the full and exclusive right to bring this action and enforce the ’589 Patent against
`
`infringers, and the right to recover damages for all relevant time periods, including for past
`
`infringement.
`
`11.
`
` The ’589 Patent discloses, inter alia, bone fixation systems comprising
`
`intramedullary fixation assemblies for treating and fixating deteriorated, damaged and/or fractured
`
`bones, such as bones in the human foot. For example, assemblies disclosed in the ’589 Patent may
`
`be used to restore the arch in a human foot by coupling the assembly to the medullary canals of
`
`the first metatarsal, medial cuneiform, navicular and/or talus bones in the foot.
`
`12.
`
`An exemplary figure, Figure 18, from the ’589 Patent is provided below:
`
`
`
`
`3
`
`

`

`Case 1:22-cv-00239-UNA Document 1 Filed 02/25/22 Page 4 of 15 PageID #: 4
`
`FACTUAL BACKGROUND
`
`
`
`13.
`
`Extremity Medical was founded in 2008 by Matthew Lyons. Mr. Lyons graduated
`
`from Syracuse University in 1986 with a Bachelor of Science in Mechanical Engineering,
`
`specializing in biomechanics. Mr. Lyons has over 30 years of experience in the medical device
`
`industry and is named as inventor on numerous patents directed to orthopedics and medical
`
`devices.
`
`14.
`
`Extremity Medical is a global medical engineering company, dedicated to creating
`
`innovative solutions for the challenges that extremity surgeons face. Extremity Medical develops
`
`next-generation products for fusion, fixation and motion-preserving systems for the upper and
`
`lower extremities of the human body, including the hands and feet. Plaintiff proudly manufactures
`
`its products in the United States, and sells and promotes them throughout the United States and
`
`worldwide.
`
`
`
`
`4
`
`

`

`Case 1:22-cv-00239-UNA Document 1 Filed 02/25/22 Page 5 of 15 PageID #: 5
`
`15.
`
`Extremity Medical has invested substantial time and resources into the research,
`
`design and development of its products, and secures intellectual property rights to protect them.
`
`The company has obtained 39 patents in the United States, Australia, Canada, the European Union,
`
`and Japan, and currently has seven additional patent applications pending.
`
`16.
`
`On November 23, 2021, Extremity Medical, by its counsel, sent a letter to
`
`Defendants Nextremity and Zimmer Biomet. The letters explained that Extremity Medical has
`
`obtained over 20 patents on its inventions in the United States, and several others in foreign
`
`countries. The letters further explained that the ’589 Patent is owned by Extremity Medical, and
`
`that the Infringing System contains all of the elements recited in Claim 59 of the ’589 Patent, and
`
`is therefore infringing at least this claim.
`
`17.
`
`On December 15, 2021 and January 14, 2022, Defendants Nextremity and Zimmer
`
`Biomet sent letters to Extremity Medical, confirming receipt of Extremity Medical’s November
`
`23, 2021 letter and acknowledging the notice provided by Extremity Medical regarding the ’589
`
`Patent.
`
`18.
`
`The Infringing System includes at least: (1) an “InCore Post”, (2) a “Targeting
`
`Guide,” and (3) a screw. Below are annotated images of the Infringing System. The images
`
`(without annotations) are depicted on the cover and page 3 of product materials for the Infringing
`
`System, identified on Nextremity’s website and Zimmer Biomet’s website as the “InCore®
`
`Lapidus System Surgical Technique” Guide (the “Surgical Guide”). A copy of the Surgical Guide
`
`is attached hereto as Exhibit B. The Surgical Guide is available for download from Defendants’
`
`websites (See https://www.nextremity.com/portfolio-items/incore-lapidus-system/ and
`
`https://www.zimmerbiomet.com/en/products-and-solutions/specialties/foot-and-ankle/incore-
`
`lapidus-system.html#07-education).
`
`
`
`
`5
`
`

`

`Case 1:22-cv-00239-UNA Document 1 Filed 02/25/22 Page 6 of 15 PageID #: 6
`
`Targeting Guide
`
`InCore Post
`
`
`
`
`
`Exhibit B at 3;
`
`InCore Post
`
`screw
`
`Exhibit B, cover.
`
`
`
`
`
`
`
`
`
`
`6
`
`

`

`Case 1:22-cv-00239-UNA Document 1 Filed 02/25/22 Page 7 of 15 PageID #: 7
`
`CLAIMS FOR RELIEF
`
`FIRST CLAIM FOR RELIEF
`(INFRINGEMENT OF THE ’589 PATENT)
`
`19.
`
`Plaintiff hereby incorporates by reference paragraphs 1-18 as if fully set forth
`
`herein.
`
`20.
`
`Defendants have infringed and continue to infringe, either literally or under the
`
`doctrine of equivalents, at least Claim 59 of the ’589 Patent in violation of 35 U.S.C. § 271(a) by
`
`making, using, offering for sale, selling and/or importing into or in the United States the Infringing
`
`System, without a license or permission from Plaintiff.
`
`21.
`
`Upon information and belief, Defendants have also infringed and continue to
`
`infringe at least Claim 59 of the ’589 Patent in violation of 35 U.S.C. § 271(b) by inducing vendors,
`
`customers and others to make, use, sell, or offer for sale within the United States, systems that
`
`practice inventions of the ’589 Patent with knowledge of and intent that such vendors, customers
`
`and others infringe the ’589 Patent. Defendants have intentionally caused, urged, encouraged, or
`
`aided in the actions—including the direct infringement of the ‘589 Patent—that induced
`
`infringement of the ’589 Patent by vendors, customers and others. Upon information and belief,
`
`such intentional actions include, for example, inducing Defendants’ customers to infringe the ’589
`
`Patent by making available on their website surgical guides that teach surgeons how to assemble
`
`and use the Infringing System. As a result of Defendants’ conduct, Defendants have induced and
`
`are inducing such vendors, customers and others to make or use systems, such as the Infringing
`
`System, to infringe at least Claim 59 of the ’589 Patent. Additionally and in the alternative,
`
`Defendants have induced and are inducing their vendors, customers and others to implement and
`
`utilize parts of the Infringing System to infringe at least Claim 59 of the ’589 Patent. Defendants
`
`
`
`
`7
`
`

`

`Case 1:22-cv-00239-UNA Document 1 Filed 02/25/22 Page 8 of 15 PageID #: 8
`
`have engaged and are engaging in this conduct while aware of the ’589 Patent and with the intent
`
`to infringe, at least as of the filing of the Complaint.
`
`22.
`
`Upon information and belief, with knowledge of the ’589 Patent, Defendants have
`
`also contributed to the infringement of the ’589 Patent by offering for sale or selling within the
`
`United States or importing into the United States the InCore Post, which constitutes a material part
`
`of the Infringing System. Defendants know the InCore Post is especially made or especially
`
`adapted for use in the Infringing System, and that the InCore Post is not a staple article or
`
`commodity of commerce suitable for substantial noninfringing use. By contributing to the use of
`
`the Infringing System by their vendors, customers and others, Defendants have been indirectly
`
`infringing under 35 U.S.C. § 271(c) one or more claims of the ’589 Patent, either literally or under
`
`the doctrine of equivalents.
`
`23.
`
`Claim 59 of the ’589 Patent recites: “[a] fixation system for compressing bone,
`
`comprising” certain elements. The Infringing System is a fixation system for compressing bone.
`
`Below is an annotated image of the InCore Post and screw of the Infringing System:
`
`InCore Post
`
`screw
`
`
`
`
`
`
`
`
`8
`
`

`

`Case 1:22-cv-00239-UNA Document 1 Filed 02/25/22 Page 9 of 15 PageID #: 9
`
`See Exhibit B, cover. Below is an image of the Targeting Guide and InCore Post of the Infringing
`
`System:
`
`
`
`See Exhibit B at 2; see also id. at 1 (“Targeting Guide includes built-in Compression-Distraction
`
`Fixture providing compression parallel to the long axis of the first metatarsal”).
`
`24.
`
`Claim 59 further recites: “a first screw member comprising a head portion and a
`
`first shaft extending along a first longitudinal axis . . . .” The screw of the Infringing System is a
`
`first screw member comprising a head portion and a first shaft extending along a first longitudinal
`
`axis. An annotated image of a screw of the Infringing System is shown below.
`
`
`
`screw
`
`head portion
`
`See Exhibit B at 1.
`
`first shaft
`
`
`
`first longitudinal axis
`
`
`
`25.
`
`Claim 59 further recites: “a second member comprising a second shaft extending
`
`along a second longitudinal axis and a bore extending through said second shaft along a bore axis
`
`. . . .” The InCore Post of the Infringing System is a second member comprising a second shaft
`
`
`
`
`9
`
`

`

`Case 1:22-cv-00239-UNA Document 1 Filed 02/25/22 Page 10 of 15 PageID #: 10
`
`extending along a second longitudinal axis and a bore extending through said second shaft along
`
`a bore axis. An annotated image of the InCore Post of the Infringing System is shown below:
`InCore Post
`
`
`
`second shaft
`
`bore
`
`bore axis
`
`
`
`second longitudinal axis
`
`See Exhibit B at 1.
`
`
`
`26.
`
`Claim 59 further recites: “an instrument adapted for coupling said first screw
`
`member to said second member . . . .” The Targeting Guide of the Infringing System is an
`
`instrument adapted for coupling the screw of the Infringing System to the InCore Post. Annotated
`
`images of the Targeting Guide as part of the Infringing System are shown below:
`
`
`
`
`10
`
`

`

`Case 1:22-cv-00239-UNA Document 1 Filed 02/25/22 Page 11 of 15 PageID #: 11
`
`Targeting Guide
`
`See Exhibit B at 3;
`
`
`
`Targeting Guide
`
`
`
`
`
`See Exhibit B at 9. According to the Surgical Guide, “[s]ighting the holes in the Targeting Guide,
`
`alignment can be visualized to ensure proper assembly and left/right foot selection.” Exhibit B at
`
`3.
`
`
`
`
`11
`
`

`

`Case 1:22-cv-00239-UNA Document 1 Filed 02/25/22 Page 12 of 15 PageID #: 12
`
`27.
`
`Claim 59 further recites: “wherein said second longitudinal axis and said bore axis
`
`define an angle, wherein said first screw member is adapted for coupling to said second member
`
`at said angle . . . .” As shown in the following annotated image of the Infringing System, the
`
`second longitudinal axis and bore axis of the InCore Post define an angle, and the screw of the
`
`Infringing System is adapted for coupling to the InCore Post at that angle:
`
`screw
`
`bore axis
`
`InCore Post
`
`angle
`
`See Exhibit B, cover.
`
`second longitudinal axis
`
`
`
`28.
`
`Claim 59 further recites: “wherein each of said first screw member and said second
`
`member is adapted for residing substantially within at least one bone . . . .” As shown in the
`
`following annotated image, the InCore Post and screw are adapted for residing substantially within
`
`at least one bone:
`
`
`
`
`12
`
`

`

`Case 1:22-cv-00239-UNA Document 1 Filed 02/25/22 Page 13 of 15 PageID #: 13
`
`InCore Post
`
`screw
`
`
`
`See Exhibit B at 1.
`
`Claim 59 further recites: “wherein said second member comprises first and second
`
`circumferentially spaced recesses adapted for coupling to said instrument.” As shown in the
`
`following annotated image, the InCore Post includes first and second circumferentially spaced
`
`recesses adapted for coupling to the Targeting Guide:
`
`second recess
`
`first recess
`
`See Exhibit B at 1;
`
`
`
`
`
`
`
`
`
`
`13
`
`

`

`Case 1:22-cv-00239-UNA Document 1 Filed 02/25/22 Page 14 of 15 PageID #: 14
`
`Exhibit B at 2.
`
`
`
`
`
`Exhibit B at 2.
`
`29.
`
`Plaintiff has already been damaged by Defendants’ infringement of the ’589 Patent,
`
`has been irreparably harmed by that infringement, and will suffer additional damages and
`
`irreparable harm for which there is no adequate remedy at law unless and until such infringing
`
`conduct is enjoined pursuant to 35 U.S.C. § 283 and/or the equitable powers of this Court.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Plaintiff respectfully requests the following relief:
`
`A.
`
`Entry of a judgment in favor of Plaintiff on all Counts of the Complaint;
`
`
`
`
`14
`
`

`

`Case 1:22-cv-00239-UNA Document 1 Filed 02/25/22 Page 15 of 15 PageID #: 15
`
`B.
`
`Entry of a judgment that each Defendant has directly and/or indirectly infringed the
`
`’589 Patent and that such infringement has been willful;
`
`C.
`
`Entry of a preliminary and permanent injunction against each Defendant, pursuant
`
`to 35 U.S.C. § 283 and/or the equitable powers of this Court, to prevent further direct and/or
`
`indirect infringement of the ’589 Patent;
`
`D.
`
`An award of damages, in an amount to be determined, adequate to compensate
`
`Plaintiff for the infringement that has occurred, pursuant to 35 U.S.C. § 284;
`
`E.
`
`An Order requiring each Defendant to pay Plaintiff its costs and attorneys’ fees in
`
`this action pursuant to 35 U.S.C. § 285 and/or other applicable laws;
`
`F.
`
`Such other and further relief as the Court may deem just and proper.
`
`JURY DEMAND
`
`Plaintiff hereby demands a trial by jury of all issues so triable.
`
`ASHBY & GEDDES
`
`/s/ Andrew C. Mayo
`____________________________
`Andrew C. Mayo (#5207)
`500 Delaware Avenue, 8th Floor
`P.O. Box 1150
`Wilmington, Delaware 19899
`(302) 654-1888
`amayo@ashbygeddes.com
`
`Attorneys for Plaintiff Extremity Medical, LLC
`
`
`
`
`
`
`
`
`
`Of Counsel:
`
`Michael J. Zinna
`David G. Lindenbaum
`KELLEY DRYE & WARREN LLP
`One Jefferson Road
`2nd Floor
`Parsippany, NJ 07054
`(973) 503-5900
`
`Dated: February 25, 2022
`
`
`
`
`
`
`15
`
`

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