UNITED STATES DISTRICT COURT DISTRICT OF MINNESOTA

COLOPLAST A/S, Plaintiff, v.

Civil No: COMPLAINT FOR PATENT INFRINGEMENT JURY DEMAND

C.R. BARD, INC., Defendant.

Plaintiff Coloplast A/S, for its Complaint against C.R. Bard, Inc., alleges as follows: PARTIES 1. Plaintiff Coloplast A/S (Coloplast) is a Danish corporation headquartered

in Humlebaek, Denmark. Coloplast has a subsidiary, Coloplast Corp., which operates in the United States and is headquartered in Minneapolis, Minnesota. 2. Defendant C.R. Bard, Inc. (Bard) is a corporation organized and existing

under the laws of the state of New Jersey, with its principal offices at 730 Central Avenue, Murray Hill, New Jersey 07974. JURISDICTION AND VENUE 3. This is an action for patent infringement arising under the patent laws of the

United States, 35 U.S.C. 1, et seq. 4. This Court has subject matter jurisdiction over this action pursuant to 28

U.S.C. 1331 and 1338(a).

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This Court has personal jurisdiction over Bard because, on information and

belief, Bard transacts business and has continuous and systematic contacts in this district, maintains an ongoing presence within this district, has purposefully availed itself of the privileges and benefits of the laws of the state of Minnesota, and has engaged in acts causing injury to Coloplast in Minnesota. 6. Venue is proper in this judicial district pursuant to 28 U.S.C. 1391(b)

and (c), and 1400(b). PATENTS-IN-SUIT 7. On February 28, 2012, United States Patent No. 8,123,673 (the 673

patent), entitled Adjustable Surgical Implant for Treating Urinary Incontinence, was duly and legally issued by the United States Patent and Trademark Office. Coloplast was assigned and continues to hold all right, title, and interest in the 673 patent. A true and correct copy of the 673 patent is attached as Exhibit A to this Complaint. 8. On April 17, 2012, United States Patent No. 8,157,821 (the 7821

patent), entitled Surgical Implant, was duly and legally issued by the United States Patent and Trademark Office. Coloplast was assigned and continues to hold all right, title, and interest in the 7821 patent. A true and correct copy of the 7821 patent is attached as Exhibit B to this Complaint. BARDS INFRINGING PRODUCTS 9. On information and belief, Bard makes, offers to sell, and/or sells within

the United States and/or imports into the United States AJUST Adjustable SingleIncision Sling Systems (Bard AJUST Sling Systems). Bard specifically markets and

sells AJUST Sling Systems to medical professionals in the United States for the purpose of treating stress urinary incontinence in women. The instructions for use furnished by Bard for the Bard AJUST Sling Systems (Bard AJUST Sling Systems Instructions for Use) state that the Bard AJUST Sling Systems include an adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer designed to anchor the sling through the obturator internus muscle/membrane at the superiormedial aspect of the obturator foramen (due to its curvature and length), and a flexible stylet for advancing [a] sling lock used to lock the sling after adjustment. (See Exhibit C.) Components of the Bard AJUST Sling Systems are shown in the Bard AJUST Sling Systems Instructions for Use as well as in a product brochure entitled AJUST Adjustable Single-Incision Sling, which is available at

http://www.bardmedical.com/AJUSTAdjustableSingle-Incision Sling.

(See Exhibit D

(Bard AJUST Sling Systems Product Brochure).) Excerpts from the Bard AJUST Sling Systems Instructions for Use and the Bard AJUST Sling Systems Product Brochure are reproduced below:

Bard AJUST Sling Systems Instructions for Use Exhibit C 10.

Bard AJUST Sling Systems Product Brochure Exhibit D

On information and belief, Bard makes, offers to sell, and/or sells in the

United States and/or imports into the United States ALYTE Y-Mesh Grafts (Bard ALYTE Grafts). Bard specifically markets and sells ALYTE Grafts to medical

professionals in the United States for the purpose of treating pelvic organ prolapse in women. Components of the Bard ALYTE Grafts are shown in a product brochure entitled ALYTE Y-MESH GRAFT, which is available at

http://www.bardmedical.com/ALYTEYMeshGraft.

(See Exhibit E (Bard ALYTE

Grafts Product Brochure).) Bard also specifies in product comparisons available at http://www.bardmedical.com/ALYTEYMeshGraft that Bard ALYTE Grafts include mesh having a density of 17.67 g/m2. (See Exhibit F, (Bard Competitive

Comparison).)

Excerpts from the Bard ALYTE Grafts Product Brochure and

Competitive Comparison are reproduced below:

Bard ALYTE Grafts Product Brochure Exhibit E

Bard Competitive Comparison Exhibit F

NOTICE OF RELATED PATENTS: BARD AJUST SLING SYSTEMS

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On February 21, 2012, United States Patent No. 8,118,728 (the 728

patent), entitled Method for Implanting an Adjustable Surgical Implant for Treating Urinary Incontinence, was duly and legally issued by the United States Patent and Trademark Office. Coloplast was assigned and continues to hold all right, title, and 5

interest in the 728 patent. A true and correct copy of the 728 patent is attached as Exhibit G to this Complaint. 12. On August 30, 2011, United States Patent No. 8,007,430 (the 430

patent), entitled Apparatus and Method for Treating Female Urinary Incontinence, was duly and legally issued by the United States Patent and Trademark Office. Coloplast was assigned and continues to hold all right, title, and interest in the 430 patent. A true and correct copy of the 430 patent is attached as Exhibit H to this Complaint. 13. On September 7, 2010, United States Patent No. 7,789,821 (the 9821

patent), entitled Apparatus and Method for Treating Female Urinary Incontinence, was duly and legally issued by the United States Patent and Trademark Office. Coloplast was assigned and continues to hold all right, title, and interest in the 9821 patent. A true and correct copy of the 9821 patent is attached as Exhibit I to this Complaint. 14. On information and belief, Bard AJUST Sling Systems are used by

medical professionals to perform the method of at least one claim of the 728 patent, at least one claim of the 430 patent, and at least one claim of the 9821 patent in the United States. 15. On information and belief, Bard, in offering to sell and selling Bard

AJUST Sling Systems, is actively inducing, encouraging, teaching, and/or instructing medical professionals to use Bard AJUST Sling Systems to perform the method of at last one claim of the 728 patent, at least one claim of the 430 patent, and at least one claim of the 9821 patent in the United States, with the intent to cause such medical professionals to perform such methods using Bard AJUST Sling Systems. For example,

the Bard AJUST Sling Systems Instructions for Use specifically state that the Bard AJUST Sling Systems are to be used as follows: 1. Insert the introducer into the vaginal dissection laterally through one of the dissected planes toward the cephalad aspect of the ischiopubic ramus. 2. Angle the introducer towards the superior-medial aspect of the obturator foramen. . 3. Pivot the handle towards the obturator internus muscle/membrane. 4. Push the fixed anchor through the obturator intern us muscle/membrane at the superior-medial aspect of the obturator foramen 5. Release the fixed anchor. 6. After releasing the fixed anchor, apply gentle traction to the sub-urethral sling to confirm secure fixation in the tissue. 7. Place the adjustable anchor into the introducer. 8. Insert the adjustable anchor in the contralateral dissection plane and orient the introducer towards the superior-medial aspect of the obturator foramen. [T]hen pivot the handle and push to insert the adjustable anchor through the obturator internus muscle/ membrane in the superiormedial aspect of the obturator foramen. 9. Release the adjustable anchor. 10. After releasing the adjustable anchor, apply gentle traction to the 1) suburethral sling, followed by 2) the adjustment mesh in order to confirm secure fixation in the tissue. 11. Gently pull on the adjusting tab to adjust the sub-urethral sling. 12. Once proper tensioning is achieved, insert the flexible stylet into the adjusting tab opening and slide it up the adjustment mesh to push the sling lock into place at the adjustable anchor.

(See Exhibit C.)

On information and belief, Bard also has its employees and/or

representatives attend surgeries to provide support for medical professionals using Bard 7

AJUST Sling Systems, provides product literature describing the use of Bard AJUST Sling Systems, and provides training to medical professionals on the use of Bard AJUST Sling Systems. (See e.g., Exhibit D.) 16. On information and belief, Bard AJUST Sling Systems are especially

made for use in performing a method that is covered by at least one claim of the 728 patent, at least one claim of the 430 patent, and at least one claim of the 9821 patent and do not have any substantial uses that do not infringe at least one claim of the 728 patent, at least one claim of the 430 patent, and at least one claim of the 9821 patent. 17. On information and belief, as a result of Bards conduct, Bard will be

actively inducing and/or contributing to the performance of the methods of at least one claim of the 728 patent, at least one claim of the 430 patent, and at least one claim of the 9821 patent in the United States by medical professionals using Bard AJUST Sling Systems, and with knowledge that the performance of such methods will infringe such claims, all in violation of 35 U.S.C. 271(b) and (c). 18. Coloplast reserves its right to amend its Complaint to assert that Bard is

inducing infringement of or contributing to the infringement of at least one claim of the 728 patent, at least one claim of the 430 patent, and at least one claim of the 9821 patent in violation of 35 U.S.C. 271(b) and (c).
NOTICE OF RELATED PATENTS: BARD ALYTE GRAFTS

19.

On April 17, 2012, United States Patent No. 8,157,822 (the 822 patent),

entitled Surgical Implant and Methods of Use, was duly and legally issued by the United States Patent and Trademark Office. Coloplast was assigned and continues to

hold all right, title, and interest in the 822 patent. A true and correct copy of the 822 patent is attached as Exhibit J to this Complaint. 20. On January 24, 2012, United States Patent No. 8,100,924 (the 924

patent), entitled Surgical Implant, was duly and legally issued by the United States Patent and Trademark Office. Coloplast was assigned and continues to hold all right, title, and interest in the 924 patent. A true and correct copy of the 924 patent is attached as Exhibit K to this Complaint. 21. On September 29, 2009, United States Patent No. 7,594,921 (the 921

patent), entitled Surgical Implant, was duly and legally issued by the United States Patent and Trademark Office. Coloplast was assigned and continues to hold all right, title, and interest in the 921 patent. A true and correct copy of the 921 patent is attached as Exhibit L to this Complaint. 22. On information and belief, Bard ALYTE Grafts are used by medical

professionals to perform the method of at least one claim of the 822 patent, at least one claim of the 924 patent, and at least one claim of the 921 patent in the United States. 23. On information and belief, Bard, in offering to sell and sell Bard ALYTE

Grafts, is actively inducing, encouraging, teaching, and/or instructing medical professionals to use Bard ALYTE Grafts to perform the method of at last one claim of the 822 patent, at least one claim of the 924 patent, and at least one claim of the 921 patent in the United States, with the intent to cause such medical professionals to perform such methods using Bard ALYTE Grafts. Bard, for example, states in its marketing materials for the Bard ALYTE Grafts that they are made with lightweight mesh and

designed specifically for sacrocolposuspension/sacrocolpopexy procedures, which are surgical methods of treating pelvic organ prolapse. (See Exhibit E.) In addition, Bard specifies in product comparisons available at http://www.bardmedical.com/ALYTEYMeshGraft that Bard ALYTE Grafts include mesh having a density of 17.67 g/m2. (See Exhibit F.) On information and belief, Bard also has its employees and/or representatives attend surgeries to provide support for medical professionals using Bard ALYTE Grafts to treat pelvic organ prolapse in women, provides product literature describing the use of Bard ALYTE Grafts, and provides training to medical professionals on the use of Bard ALYTE Grafts. 24. On information and belief, Bard ALYTE Grafts are especially made for

use in performing a method that is covered by at least one claim of the 822 patent, at least one claim of the 924 patent, and at least one claim of the 921 patent and do not have any substantial uses that do not infringe at least one claim of the 822 patent, at least one claim of the 924 patent, and at least one claim of the 921 patent. 25. On information and belief, as a result of Bards conduct, Bard will be

actively inducing and/or contributing to the performance of the methods of at least one claim of the 822 patent, at least on claim of the 924 patent, and at least one claim the 921 patent in the United States by medical professionals using Bard ALYTE Grafts, and with knowledge that the performance of such methods will infringe such claims, all in violation of 35 U.S.C. 271(b) and (c). 26. Coloplast reserves its right to amend its Complaint to assert that Bard is

inducing infringement of or contributing to the infringement of at least one claim of the

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822 patent, at least one claim of the 924 patent, and, at least one claim of the 921 patent in violation of 35 U.S.C. 271(b) and (c). FIRST CAUSE OF ACTION INFRINGEMENT OF U.S. PATENT NO. 8,123,673 27. Coloplast realleges and incorporates by reference paragraphs 1 through 26

as if fully stated herein. 28. On information and belief, Bard makes, uses, offers to sell, and/or sells in

the United States and/or imports into the United States single-incision sling systems for treating stress urinary incontinence in women, including, for example, Bard AJUST Sling Systems, that infringe at least one claim of the 673 Patent. 29. Accordingly, Bard has infringed and is infringing the 673 patent in

violation of 35 U.S.C. 271(a). 30. Bards acts of infringement have caused and continue to cause damage to

Coloplast, and Coloplast is entitled to recover from Bard the damages sustained by Coloplast in an amount subject to proof at trial. Bards acts of infringement will

irreparably injure Coloplast unless and until such infringing activities are enjoined by this Court. SECOND CAUSE OF ACTION INFRINGEMENT OF U.S. PATENT NO. 8,157,821 31. Coloplast realleges and incorporates by reference paragraphs 1 through 30

as if fully stated herein. 32. On information and belief, Bard makes, uses, offers to sell, and/or sells in

the United States and/or imports into the United States lightweight mesh products for

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treating pelvic organ prolapse in women, including, for example, Bard ALYTE Grafts, that infringe at least one claim of the 7821 Patent. 33. Accordingly, Bard has infringed and is infringing the 7821 patent in

violation of 35 U.S.C. 271(a). 34. Bards acts of infringement have caused and continue to cause damage to

Coloplast, and Coloplast is entitled to recover from Bard the damages sustained by Coloplast in an amount subject to proof at trial. Bards acts of infringement will

irreparably injure Coloplast unless and until such infringing activities are enjoined by this Court. PRAYER FOR RELIEF WHEREFORE, Coloplast respectfully requests this Court: A. To enter judgment that Bard has infringed the 673 and 7821 patents in

violation of 35 U.S.C. 271; B. To enter orders preliminarily and permanently enjoining Bard, its officers,

agents, servants, employees, attorneys, and all persons in active concert or participation with any of the foregoing, who receive actual notice by personal service or otherwise of the orders, from infringing the 673 and 7821 patents in violation of 35 U.S.C. 271; C. To award Coloplast its damages in an amount sufficient to compensate it

for Bards infringement of the 673 and 7821 patents, together with pre-judgment and post-judgment interest and costs, pursuant to 35 U.S.C. 284; D. To declare this case to be exceptional under 35 U.S.C. 285 and to

award Coloplast its attorneys fees, expenses, and costs incurred in this action; and

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E. and proper.

To award Coloplast such other and further relief as this Court deems just

DEMAND FOR JURY TRIAL Pursuant to Rule 38(b) of the Federal Rules of Civil Procedure, Coloplast respectfully requests a trial by jury of any and all issues on which a trial by jury is available under applicable law.

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