coloplast a/s v. c.r. bard

7/31/2019 Coloplast A/S v. C.R. Bard

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UNITED STATES DISTRICT COURT

DISTRICT OF MINNESOTA

COLOPLAST A/S,

Plaintiff,

v.

C.R. BARD, INC.,

Defendant.

Civil No:

COMPLAINT FOR PATENT

INFRINGEMENT

JURY DEMAND

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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5. 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 Single-

Incision Sling Systems (Bard AJUST

Sling Systems). Bard specifically markets and


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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 superior-

medial 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:


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10. 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

Bard AJUST

Sling Systems

Instructions for Use

Exhibit C

Bard AJUST

Sling Systems

Product Brochure

Exhibit D
http://www.bardmedical.com/ALYTEYMeshGrafthttp://www.bardmedical.com/ALYTEYMeshGraft


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Comparison).) Excerpts from the Bard ALYTE

Grafts Product Brochure and

Competitive Comparison are reproduced below:

NOTICE OF RELATED PATENTS: BARD AJUST

SLING SYSTEMS

11. 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

Bard ALYTE

Grafts Product Brochure

Exhibit E

Bard Competitive Comparison

Exhibit F


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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,


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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 superior-

medial 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


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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


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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



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



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


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


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

and proper.

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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coloplast a/s v. c.r. bard

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