ORIGINAL COMPLAINT FOR PATENT INFRINGEMENT 1

UNITED STATES DISTRICT COURT 

EASTERN DISTRICT OF TEXAS 

MARSHALL DIVISION 

New Amsterdam LLC,

Plaintiff,

v.

Medtronic plc, Medtronic, Inc., 

Medtronic USA, Inc., Medtronic 

Xomed, Inc., and Intersect ENT, Inc.,

Defendants.

Case No. 2:23-cv-421 

JURY TRIAL DEMANDED

ORIGINAL COMPLAINT FOR PATENT INFRINGEMENT 

New Amsterdam LLC (“Plaintiff”) hereby files this Original Complaint for Patent Infringement 

against Medtronic plc (“Medtronic Ireland”), Medtronic, Inc. (“Medtronic USA Parent”), Medtronic 

USA, Inc. (“Medtronic USA”), Medtronic Xomed, Inc. (“Medtronic Xomed”), and Intersect ENT, Inc. 

(“Intersect”) (collectively, “Medtronic” or “Defendant”), and alleges, upon information and belief, as 

follows: 

THE PARTIES 

1. New Amsterdam LLC is a limited liability company organized and existing under the laws of the 

State of Delaware with its principal place of business at 163 Bogerts Mill Road, Harrington Park, 

New Jersey 07640.

2. Upon information and belief, Defendant Medtronic plc is a corporation organized and existing 

under the laws of Ireland, having its principal office at 20 On Hatch, Lower Hatch Street, Dublin 

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2, Ireland, and its operational office at 710 Medtronic Parkway, Northeast. Minneapolis, MN 

55432.

3. Upon information and belief, and as alleged and shown below, Defendant Medtronic, Inc. is a 

corporation organized and existing under the laws of the state of Minnesota, having its principal 

office at 710 Medtronic Parkway, Northeast. Minneapolis, MN 55432. Defendant, through joint 

enterprise as alleged below, has multiple places of business in this District located in Tyler, 

Longview, Sherman, Texarkana, Beaumont, Frisco, and Plano, Texas. 

4. Upon information and belief, and as alleged and shown below, Defendant Medtronic USA, Inc. 

is a corporation organized and existing under the laws of the state of Minnesota, having its 

principal office at 710 Medtronic Parkway, Northeast. Minneapolis, MN 55432. Defendant, 

through joint enterprise as alleged below, has multiple places of business in this District located 

in Tyler, Longview, Sherman, Texarkana, Beaumont, Frisco, and Plano, Texas. 

5. Upon information and belief, and as alleged and shown below, Defendant Medtronic Xomed, 

Inc. is a corporation organized and existing under the laws of the state of Delaware, and through 

joint enterprise as alleged below, has multiple places of business in this District located in Tyler, 

Longview, Sherman, Texarkana, Beaumont, Frisco, and Plano, Texas. 

6. Upon information and belief, and as alleged and shown below, Defendant Intersect ENT, Inc. is 

a corporation organized and existing under the laws of the state of Delaware, and through joint 

enterprise as alleged below, has multiple places of business in this District located in Tyler, 

Longview, Sherman, Texarkana, Beaumont, Frisco, and Plano, Texas. As shown and further 

alleged below, Intersect was acquired by Medtronic Ireland in May, 2022, and now holds itself 

out as Medtronic. As shown in the press release, the acquisition was to acquire the Accused 

Intrumentalities, as defined below, and which includes the SINUVA line. 

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See https://news.medtronic.com/2022-05-13-Medtronic-completes-acquisition-of-Intersect-ENT 

See https://www.intersectent.com/ 

7. Upon information and belief, at least since May 2022, Medtronic Ireland makes, uses, sells, 

offers for sale, and/or imports the Accused Products. 

8. Upon information and belief, in acquiring Intersect, Medtronic Ireland assumed all liabilities 

arising from Intersect’s past and present acts and omissions.

9. Upon information and belief, and as shown above, Intersect operates within the “Neuroscience 

Portfolio at Medtronic.” See https://news.medtronic.com/2022-05-13-Medtronic-completesacquisition-of-Intersect-ENT. Upon information and belief, Medtronic Ireland receives revenue 

from Intersect’s actions and products.

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10. Upon information and belief, Medtronic USA Parent, and along with its subsidiaries Medtronic 

USA, Medtronic Xomed and Intersect, are all subsidiaries of Medtronic Ireland. 

11. Upon information and belief, Intersect has at all times been the manufacturer of the Accused 

Instrumentalities, and since May 2022, Medtronic USA and Medtronic Xomed sell and offer to 

sell the Accused Instrumentalities. 

12. Upon information and belief, Medtronic Ireland directs and controls the decisions of Medtronic 

USA Parent, Intersect, Medtronic USA, and Medtronic Xomed regarding the Accused 

Instrumentalities. Indeed, two executive officers of Medtronic Ireland, CEO Geoff Martha and 

CFO Karen Parkhill, are the same as Medtronic USA Parent. 

See https://www.wsj.com/market-data/quotes/MDT/company-people (screenshot of key people 

of Medtronic plc from Wall Street Journal) and https://www.medtronic.com/us-en/ourcompany/leadership.html (Medtronic website of leadership for Medtronic USA Parent). 

13. Upon information and belief, Defendants are engaged in a joint enterprise to exploit and 

monetize the Accused Instrumentalities in the United States, including within this Judicial 

District, and are jointly and severally liable to Plaintiff for all damages resulting therefrom. By 

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way of example, and on information and belief, Defendant Medtronic USA Parent is the owner 

in all rights to the trademark “Medtronic” with the USPTO. Moreover, Medtronic patent rights 

appear to be spread across a variety of Medtronic subsidiaries, but under common control and 

direction. Indeed, Medtronic Ireland, Medtronic USA Parent, Medtronic Xomed and other 

Medtronic subsidiaries have all, at different occasions, brought IPR proceedings on behalf of 

Medtronic. Further, Medtronic USA Parent, Medtronic USA and other Medtronic subsidiaries 

have also brought enforcement actions on behalf of Medtronic numerous times in District Courts, 

for example, Medtronic, Inc., Medtronic USA, Inc. et al v. Axonics Modulation Technologies, 

Inc., Case No. 8-19-cv-02115 (C.D. Cal. Nov. 9, 2019). Further, as noted above, the business 

headquarters for Defendants Medtronic Ireland, Medtronic USA Parent and Medtronic USA are 

the same. Stull further, the Accused Instrumentalities are marketed in the same form, under the 

same names (e.g., Medtronic), by all Defendants. On information and belief, there exists written 

agreement(s) among and between Defendants governing the rights, duties, and responsibilities of 

each entity in their collective effort to exploit and monetize the Accused Instrumentalities in the 

United States, including within this Judicial District, all to the harm of Plaintiff. 

14. Upon information and belief, Defendants therefore sell and offer to sell products and services 

throughout the United States, including in this judicial district, and introduce products and 

services into the stream of commerce that incorporate infringing technology, knowing that they 

would be sold in this judicial district and elsewhere in the United States. 

JURISDICTION AND VENUE 

15. This Court has subject matter jurisdiction over this case under 28 U.S.C. §§ 1331 and 1338(a). 

16. This Court has personal jurisdiction over Defendant. Defendant has continuous and systematic 

business contacts with the State of Texas. Defendant transacts business within this District and 

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elsewhere in the State of Texas. Further, this Court has personal jurisdiction over Defendant 

based on its commission of one or more acts of infringement of patent-in-suit in this District and 

elsewhere in the State of Texas. 

17. Upon information and belief, Defendant transacts substantial business in the State of Texas and 

this Judicial District. Defendant has committed acts of infringement in this District by, among 

other things, offering to sell and selling products that infringe the asserted patents, including the 

accused products as alleged herein, as well as providing service and support to its customers in 

this District. Upon information and belief, Defendant, directly or indirectly, participates in the 

stream of commerce that results in products, including the accused products, being made, used, 

offered for sale, and/or sold in the State of Texas and/or imported into the United States to the 

State of Texas. 

18. Defendant maintains regular, physical, continuous, and established places of businesses, 

including places of business for numerous employees in this District, which Defendant has 

established, ratified, and controlled; have employed people to conduct their business from this 

District; and from which they have willfully infringed the Asserted Patents in order to benefit 

themselves in this District. Defendant commits acts of infringement in this District, including as 

explained further below by making and using the infringing systems in, and performing at least 

one step of the accused methods of the Asserted Patents, at their regular and established places of 

business in this District. 

19. As shown below, but only as limited examples, Defendant has employees in the Eastern District 

of Texas, including in Tyler, Longview, Sherman, Texarkana, Beaumont, Frisco, and Plano, 

Texas: 

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20. Venue is proper in the District of Texas as to Defendant pursuant to at least 28 U.S.C. §§ 

1391(c)(2) and 1400(b). As noted above, Defendant maintains a regular and established business 

presence in this District. As noted above, Defendant maintains a regular and established business 

presence in this District. See In re Monolithic Power Sys., Inc., 50 F.4th 157, 160 (Fed. Cir. 

2022); see also AGIS Software Dev. LLC v. Google LLC, No. 2:19-CV-00361-JRG, 2022 WL

1511757, at *9 (E.D. Tex. May 12, 2022).

21. Furthermore, venue is proper in this Judicial District pursuant to 28 U.S.C. §§ 1391(b), 1391(c) 

and 1400(b) because, among other things, Defendant Medtronic Ireland is subject to personal 

jurisdiction in this Judicial District, it has regularly conducted business in this Judicial District, 

certain of the acts complained of herein occurred in this Judicial District, and it is not a resident 

in the United States and may be sued in any judicial district. 

BACKGROUND AND PATENTS-IN-SUIT 

22. Plaintiff is the sole and exclusive owner, by assignment, of U.S. Patent Nos. 6,916,483 (“the 

’483 Patent”) titled “Bioabsorbable Plugs Containing Drugs” relating to controllably delivering 

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therapeutic agents to an orthopaedic surgical site that requires the implantation of a prosthesis 

within the site. 

23. By operation of law, the ’483 Patent was originally issued and exclusively vested to the named 

inventors, James Ralph and Steven Tater, as of the issue date of the ’483 Patent. See 35 U.S.C. § 

261; Schwendimann v. Arkwright Advanced Coating, Inc., 959 F.3d 1065, 1072 (Fed. Cir. 2020); 

Suppes v. Katti, 710 Fed. Appx. 883, 887 (Fed. Cir. 2017); Taylor v. Taylor Made Plastics, Inc., 

565 Fed. Appx. 888, 889 (Fed. Cir. 2014). The inventors, in a written instrument dated June 30, 

2003, and filed with the United States Patent and Trademark Office on June 9, 2005, assigned all 

rights, title, and interest in the ’483 Patent to OsetoTools, LLC. 

24. OsteoTools, LLC, in a written instrument dated April 1, 2005, and filed with the United States 

Patent and Trademark Office on April 2, 2005, assigned all rights, title, and interest in the ’483 

Patent to BioDynamics, LLC. 

25. Formed in May 2004, BioDynamics, LLC is a medical design company dedicated to the 

development of new surgical implants, instruments and techniques that are reliable and less 

intrusive, that allow a surgeon to be more efficient, and which speed a patient's recovery. Their 

team of engineers has several decades of combined medical design experience and over 150 

patents in the medical arena, ranging from orthopedic implants to biologics. 

26. Thereafter, in a written instrument dated June 15, 2021, and filed with the United States Patent 

and Trademark Office on July 8, 2021, BioDynamics LLC assigned all rights, title, and interest 

in the ’483 Patent to First Commerce Bank related to settling litigation claims. 

27. Thereafter, in a written instrument dated September 28, 2021, and filed with the United States 

Patent and Trademark Office on November 17, 2021, First Commerce Bank assigned all rights, 

title, and interest in the ’483 Patent to the Plaintiff New Amsterdam LLC. As such, Plaintiff New 

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Amsterdam LLC has sole and exclusive standing to assert the ’483 Patent and to bring these 

causes of action. 

28. The ’483 Patent is valid, enforceable, and was duly issued in full compliance with Title 35 of the 

United States Code. 

29. The inventions described and claimed in the ’483 Patent were invented individually and 

independently by James Ralph and Steven Tater. 

30. The ’483 Patent includes numerous claims defining distinct inventions. As represented in Figs. 

1A-J of the ’483 Patent below, the inventions generally relate to implantable devices and 

methods thereof for dispensing one or more therapeutic agents at a surgical site. More 

particularly, the invention relates to devices and methods for controllably delivering therapeutic 

agents to an orthopaedic surgical site that requires the implantation of a prosthesis within the site. 

31. The priority date of each of the ’483 Patent is at least as early as July 22, 2002. As of the priority 

date, the inventions as claimed were novel, non-obvious, unconventional, and non-routine. 

32. Biodegradable materials are used in medicine for a variety of purposes including drug delivery 

devices and as aids in tissue repair. The physical and chemical properties of such materials can 

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vary as in the case of different polymeric materials, e.g., melting point, degradation rate, 

stiffness, etc. The variability in physical and chemical properties of biodegradable polymeric 

materials allows biodegradable implants made from such materials to be tailored to suit specific 

applications. 

33. At the time of the inventions, the porous bioabsorbable were generally isotropic materials. That 

is to say, the structure and composition of the materials were uniform in all directions. Any 

pharmacological therapeutic agents were generally distributed uniformly in the biodegradable 

carrier materials. This, in turn, means that the active agents were released uniformly into the 

wound site at a rate determined only by the rate at which the implant material biodegrades and 

the surface area of the implant. In practice, it would have been preferable to have controlled or

phased release of active agents. Alternatively, it would sometimes have been desirable to have an 

initial rapid release of antiseptic followed by slower release of wound healing factors such as 

cytokines, EGF, etc.

34. The inventors of the ’483 Patent conceived new a modular drug delivery device and method for 

controllably delivering a therapeutic agent to a surgical site, particularly an orthopaedic surgical 

site into which a prosthesis has been implanted. The bioabsorbable drug delivery devices in 

accordance with the various embodiments of the ’483 Patent include encapsulating the 

therapeutic agent in a bioabsorbable polymer, or a modular plug containing more than one 

bioabsorbable polymer, which will yield a controllable release of the therapeutic agent over a 

predefined dosing period, with residual therapeutic agent being thereafter delivered only until the 

bioabsorable polymer is completely biodegraded.

35. The ’483 Patent is a pioneering patent, and has been cited as relevant prior art in 99 subsequent 

United States Patent Applications, including Applications Assigned to such technology leaders 

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ORIGINAL COMPLAINT FOR PATENT INFRINGEMENT 13

and academia as Tyco Healthcare, MIT, Microchips, Inc., Tyrx Pharma Inc. and Orbusneich 

Medical, Inc. 

36. The claims of the ’483 Patent were all properly issued, and are valid and enforceable for the 

respective terms of their statutory life through expiration, and are enforceable for purposes of 

seeking damages for past infringement even post-expiration. See, e.g., Genetics Institute, LLC v. 

Novartis Vaccines and Diagnostics, Inc., 655 F.3d 1291, 1299 (Fed. Cir. 2011) (“[A]n expired 

patent is not viewed as having ‘never existed.’ Much to the contrary, a patent does have value 

beyond its expiration date. For example, an expired patent may form the basis of an action for 

past damages subject to the six-year limitation under 35 U.S.C. § 286”) (internal citations 

omitted). 

37. The expiration date of the ’483 Patent is no earlier than June 9, 2023.

MEDTRONIC’S INFRINGING PRODUCTS 

38. Upon information and belief, Medtronic makes, sells, advertises, offers for sale, uses, or 

otherwise provides drug eluting implants, including, but not limited to, the SINUVA Sinus 

Implant, that utilize the ’483 Patent’s patented implantable prosthetic designs. On information 

and belief, these drug eluting implants are operable for releasing a therapeutic agent into the 

body of an animal following implantation of the prosthesis within the body of the animal. 

39. On information and belief, Medtronic has manufactured and sold products that infringe the ’483 

Patent and which include at least, but not limited to, its SINUVA Sinus Implant (“Accused 

Instrumentalities”). 

40. As shown in more detail below, Medtronic’s products include each and every limitation of at 

least, but not limited to, claim 1 of the ’483 Patent and therefore literally infringe these claims. 

Plaintiff reserves the right to assert additional claims and to assert infringement under the 

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ORIGINAL COMPLAINT FOR PATENT INFRINGEMENT 14

doctrine of equivalents in light of information learned during discovery or in view of this Court’s 

claim construction order. 

41. Images of Medtronic’s drug eluting implants products are shown below. Medtronic’s drug 

eluting implants products include the required (a) biodegradable polymer dimensions to fit 

snugly within the shaped recess in the prosthesis and (2) therapeutic agent that is released into 

the body of the animal during biodegration of the biodegradable polymer over a predefined 

dosing period, all of the same fundamental components claimed in the ’483 Patent. 

42. For example, SINUVA Sinus Implant is shown in the following video from its website 

promoting the Accused Instrumentalities, as last visited on April 6, 2023, at 

SINUVA | Non-Surgical Nasal Polyps Treatment Option

43. Features of the Accused Instrumentalities below describe the functionality as required by the 

’483 Patent are found on Medtronic’s website as last visited on April 6, 2023 at 

https://www.sinuva.com/wp-content/uploads/2021/03/SINUVA-Patient-Brochure-Print.pdf.

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44. On information and belief, Medtronic directs and completely and/or effectively controls, and/or 

instigates, the conduct of its subsidiaries and affiliates, including, but not limited to, Intersect, 

Medtronic USA and Medtronic Xomed, to design, develop, manufacture, market, advertise, 

manufacture, package, brand, offer for sale, and sell the Accused Products in and into the United 

States. 

45. Medtronic exercise complete domination and control over its subsidiaries and affiliates, 

including, but not limited to, Intersect, Medtronic USA and Medtronic Xomed, and/or direct and 

completely and/or effectively control all external and internal workings of those subsidiaries and 

affiliates. 

COUNT I 

Infringement of U.S. Patent No. 6,916,483B2

46. Plaintiff incorporates the above paragraphs by reference. 

47. Medtronic without authority, continues to make, use, sell, offer to sell, and/or import into the 

United States its Accused Instrumentalities as shown above. 

48. Medtronic thus has infringed and continues to infringe at least claims 1 and 20 of the ’483 Patent 

literally and/or under the doctrine of equivalents. 

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49. Medtronic has also actively induced and will continue to actively induce the infringement of at 

least one of claim 1 of the ’483 Patent, in violation of 35 U.S.C. § 271(b), by, among other 

things, actively and knowingly aiding and abetting infringement of others through activities such 

as creating and/or distributing videos of use such as the Osteo Video, brochures, manuals, 

instructional documents, and/or similar materials with instructions on creating, manufacturing, 

designing, assembling and/or implementing infringing products, with the specific intent to 

induce others to directly make, use, offer for sale, sell, and/or import into the United States 

products that fall within the scope of the ’483 Patent, without license or authority from Plaintiff. 

On information and belief, Medtronic knows that the induced acts constitute infringement of the 

’483 Patent. 

50. Medtronic individually, collectively, or through others or intermediaries, has contributorily 

infringed, and/or is contributorily infringing, in violation of 35 U.S.C. § 271(c), at least one 

claim of the ’483 Patent by making, using, offering for sale, selling, and/or importing, material 

parts of the inventions claimed in the ’483 Patent, which are not a staple article or commodity of 

commerce suitable for substantial non-infringing use, and knowing the accused parts to be 

especially made or especially adapted for use in an infringement of the ’483 claims. 

51. Defendant Medtronic’s subsidiaries, including but not limited to Intersect, Medtronic USA and 

Medtronic Xomed, are alter egos of Medtronic, and Medtronic is therefore responsible and liable 

for any activities performed by its subsidiaries on Medtronic’s behalf in offering for sale, testing, 

selling, and/or importing the Accused Products in or into the United States and instructing or 

training end users to use the Accused Products in the United States. Medtronic directs and 

completely and/or effectively controls the conduct of its subsidiaries, including but not limited to 

Intersect, Medtronic USA and Medtronic Xomed. Medtronic controls the internal business 

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operations, workings, and affairs of its subsidiaries and related companies. Medtronic and its 

subsidiaries do not observe and enforce corporate formalities and share common executive level 

leadership. The relationship between Medtronic and its subsidiaries, parents, and related entities 

is a sham at least because Medtronic B directs and controls all external and internal activities of 

its subsidiaries, including but not limited to Intersect, Medtronic USA and Medtronic Xomed. 

Medtronic, and all key United States activities and decsions are made solely by Medtronic and its 

direct employees. 

52. Medtronic is also liable for the actions of its subsidiaries, including but not limited to Intersect, 

Medtronic USA and Medtronic Xomed, as to the manufacture, use, sale, offer for sale, testing, or 

import in or into the United States of the Accused Products under agency theory and/or because 

its subsidiaries, including but not limited to Intersect, Medtronic USA and Medtronic Xomed, 

function as mere agents of Medtronic as to the Accused Products. Any and all activities taken by 

Medtronic’s subsidiaries, including but not limited to Intersect, Medtronic USA and Medtronic 

Xomed, relating to the development, manufacturing, use, sale, offer for sale, or import in or into 

the United States of the Accused Products are and/or were instigated and directed by Medtronic, 

and are therefore attributable to Medtronic. 

53. Defendant has been on actual notice of the ’483 Patent at least as early as September 8, 2011 

when its subsidiary Medtronic Vascular, Inc. cited to it within its own patent prosecution, as 

shown below.

See https://patents.google.com/patent/US6916483B2/en?oq=6%2c916%2c483#citedBy and 

https://patents.google.com/patent/US20110218606A1/en?oq=6%2c916%2c483#patentCitati

ons

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54. Defendant’s direct and indirect infringement of the ’483 Patent has thus been committed with 

knowledge of the ’483 Patent, making Medtronic liable for direct, indirect, and willful 

infringement. 

55. Medtronic’s infringement of the ’483 Patent will continue to damage Plaintiff, causing 

irreparable harm for which there is no adequate remedy at law, unless it is enjoined by this 

Court. 

56. Plaintiff has been damaged because of the infringing conduct by Medtronic alleged above. Thus, 

Medtronic is liable to Plaintiff in an amount that adequately compensates it for such 

infringement, which, by law, cannot be less than a reasonable royalty, together with interest and 

costs as fixed by this Court under 35 U.S.C. § 284. 

57. Plaintiff and/or its predecessors-in-interest have satisfied all statutory obligations required to 

collect pre-filing damages for the full period allowed by law. 

PRAYER FOR RELIEF 

WHEREFORE, New Amsterdam LLC respectfully requests the Court enter judgment against 

Defendant as follows: 

1. Declaring that Defendant has infringed the ’483 Patent; 

2. Awarding New Amsterdam LLC its damages suffered because of Defendant’s 

infringement of the ’483 Patent; 

3. Awarding New Amsterdam LLC its costs, reasonable attorneys’ fees, expenses, and 

interest; 

4. An award to New Amsterdam LLC of enhanced damages, up to and including trebling of 

Plaintiff’s damages pursuant to 35 U.S.C. § 284 for Medtronic’s willful infringement of

the ’483 Patent; 

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5. Granting a permanent injunction pursuant to 35 U.S.C. § 283, enjoining Defendants from 

further acts of infringement with respect to the ’483 Patent; 

6. Awarding New Amsterdam LLC ongoing post-trial royalties for infringement of the nonexpired ’483 Patent; and 

7. Granting New Amsterdam LLC such further relief as the Court finds appropriate. 

JURY DEMAND 

New Amsterdam LLC demands trial by jury, under Fed. R. Civ. P. 38. 

Respectfully Submitted 

/s/ Christopher A. Honea 

M. Scott Fuller 

 Texas Bar No. 24036607 

 sfuller@ghiplaw.com 

Randall Garteiser 

 Texas Bar No. 24038912

 rgarteiser@ghiplaw.com 

Christopher A. Honea 

 Texas Bar No. 24059967

 chonea@ghiplaw.com 

GARTEISER HONEA, PLLC 

119 W. Ferguson Street 

Tyler, Texas 75702 

Telephone: (903) 705-7420

Hao Ni 

Texas Bar No. 24047205

hni@nilawfirm.com 

Neal Massand

Texas Bar No. 24039038

nmassand@nilawfirm.com 

NI, WANG & MASSAND, PLLC

8140 Walnut Hill Ln., Ste. 615

Dallas, TX 75231>

Tel: (972) 331-4600

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Fax: (972) 314-0900

ATTORNEYS FOR PLAINTIFF

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