Cordis Corp. v. Medtronic Ave, Inc., s. CIV.A.97-550-SLR, CIV.A.97-700-SLR, CIV.A.98-19-SLR, CIV.A.98-197-SLR.

Page 323

194 F.Supp.2d 323

CORDIS CORPORATION, Plaintiff, v. MEDTRONIC AVE, INC., Boston Scientific Corporation and Scimed Life Systems, Inc., Defendants.

Medtronic AVE, Inc., Plaintiff, v. Cordis Corporation, Johnson & Johnson and Expandable Grafts Partnership, Defendants.

Boston Scientific Corporation, Plaintiff, v. Ethicon, Inc., Cordis Corporation and Johnson & Johnson Interventional Systems Co., Defendants.

Cordis Corporation, Plaintiff, v. Boston Scientific Corporation and Scimed Life Systems, Inc., Defendants.

Nos. CIV.A.97-550-SLR, CIV.A.97-700-SLR, CIV.A.98-19-SLR, CIV.A.98-197-SLR.

United States District Court, D. Delaware.

March 28, 2002.

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Steven J. Balick, Esquire and Steven T. Margolin, Esquire of Ashby & Geddes, Wilmington, Delaware. Counsel for Cordis Corporation, Johnson & Johnson, Johnson & Johnson Interventional Systems Co., Ethicon, Inc. and Expandable Grafts Partnership. Of Counsel: Gregory L. Diskant, Esquire and William F. Cavanaugh, Jr., Esquire of Patterson, Belknap, Webb & Tyler, LLP, New York, New York. Theodore B. Van Italie, Jr., Esquire and Eric I. Harris, Esquire of Johnson & Johnson, New Brunswick, New Jersey.

Patricia Smink Rogowski, Esquire and Francis DiGiovanni, Esquire of Connolly Bove Lodge & Hutz LLP, Wilmington, Delaware. Counsel for Medtronic AVE, Inc. Of Counsel: William E. Wallace, III, Esquire and D. Michael Underhill, Esquire of Morgan, Lewis & Bockius LLP, Washington, D.C. Raphael V. Lupo, Esquire and Donna M. Tanguay, Esquire of McDermott, Will & Emery, Washington, D.C.

Josy W. Ingersoll, Esquire and Christian Douglas Wright, Esquire of Young Conaway Stargatt & Taylor, LLP, Wilmington, Delaware. Counsel for Boston Scientific Corporation and Scimed Life Systems, Inc. Of Counsel: George E. Badenoch, Esquire and Charles R. Brainard, Esquire of Kenyon & Kenyon, New York, New York.

OPINION

SUE L. ROBINSON, Chief Judge.

I. INTRODUCTION

Plaintiffs Expandable Grafts Partnership and Cordis Corporation, a division of Johnson & Johnson (collectively, "Cordis"), originally filed this patent infringement action on October 3, 1997 against defendants Medtronic AVE, Inc., Boston Scientific Corporation and Scimed Life Systems, Inc.¹ Cordis alleges that AVE infringed certain claims of United States Patent Nos. 4,739,762 (the "'762 patent") and 5,195,984 (the "'984 patent"). Cordis accuses BSC of infringing certain claims of the '762 patent and United States Patent Nos. 5,902,332 (the "'332 patent"), 5,643,312 (the "'312 patent"), and 5,879,370 (the "'370 patent"). The court held a seven-week bifurcated jury trial on the issues of infringement and invalidity, and a four-day bench trial on the issue of unenforceability. Currently before the court are the parties' motions for judgment as a matter of law and a new trial, and proposed findings of fact and conclusions of law regarding inequitable conduct.

II. BACKGROUND

A. The Technology

The dispute relates to balloon expandable stents. Balloon expandable stents and other types of stents are used to treat diseased blood vessels in the heart ("coronary arteries") and in other areas of the body ("peripheral arteries"). Coronary artery disease is caused by the buildup of fatty deposits on the inner lining of the coronary arteries. Known as atherosclerosis, this buildup narrows coronary arteries and may eventually block the flow of blood to the heart. Untreated coronary disease can have serious consequences, including angina, heart attack or even death. Similar narrowing in arteries away from the heart causes problems for people with peripheral artery disease.

Until about twenty-five years ago, the primary treatment for coronary lesions was medication or coronary artery bypass graft surgery. In approximately 1975, physicians began to use a non-surgical treatment called percutaneous transluminal coronary angioplasty, commonly known as "balloon angioplasty." During this procedure, a balloon attached to a wire catheter is snaked through a diseased artery until it reaches the site of blockage. A physician inflates the balloon, which compresses the fatty deposits against the vessel wall to open the artery and restore blood flow. The balloon and catheter are then removed from the body. Although balloon angioplasty represented a major advancement in combating artery disease, blood vessels often closed again within several months of the procedure. This recurrence of blockage is called "restenosis."

A stent improves the success of balloon angioplasty by minimizing the occurrence of restenosis. A stent is a small device that holds open an artery just like scaffolding inside a tunnel keeps the tunnel from collapsing. At issue in this case are balloon expandable stents which are used in conjunction with angioplasty balloons. The stent is placed on a balloon and inserted into an artery via a catheter. Once the balloon is at the area of blockage, it is inflated, which causes the stent to expand and press against the vessel wall, thereby opening the artery. The balloon is then deflated and removed, leaving the expanded stent in the artery to keep the vessel open and allow blood to flow.

B. The Patents in Suit

1. The '762 Patent

The '762 patent, entitled "Expandable Intraluminal Graft, and Method and Apparatus for Implanting an Expandable Intraluminal Graft," is a continuation-in-part of patent application serial no. 796,009 (the "'009 application"), which issued as United States Patent No. 4,733,665 (the "'665 patent"). Dr. Julio C. Palmaz is the named inventor of the '762 patent, and plaintiff Expandable Grafts Partnership ("EGP") is the listed assignee. Dr. Palmaz filed the '009 application on November 7, 1985, and the '762 patent issued on April 26, 1988. A reexamination certificate (the "'762 reexamination certificate") issued on October 27, 1998 with amended and additional claims.

The '762 patent includes both apparatus and method claims. The apparatus claims are directed to an expandable tubular member that serves as vascular scaffolding. Figures 1A and 1B shown below depict the preferred embodiment of the '762 patent in its unexpanded state ("first diameter") and expanded state ("second diameter"), respectively.

NOTE: OPINION CONTAINING TABLE OR OTHER DATA THAT IS NOT VIEWABLE

The method claims of the '762 patent describe the process of implanting the stent into a diseased vessel. As depicted in Figures 3 and 4 below, a stent is mounted upon a catheter and delivered in its first diameter to the diseased vessel. Next, the stent is expanded and deformed radially into contact with the vessel. Finally, the balloon is deflated and removed along with the catheter, leaving the stent in the artery to support the vessel wall.

NOTE: OPINION CONTAINING TABLE OR OTHER DATA THAT IS NOT VIEWABLE

Claim 23 of the '762 patent is an apparatus claim which is dependent upon claim 13.² The claims read:

13. An expandable intraluminal vascular graft, comprising:

a thin-walled tubular member having first and second ends and a wall surface disposed between the first and second ends, the wall surface having a substantially uniform thickness and a plurality of slots formed therein, the slots being disposed substantially parallel to the longitudinal axis of the tubular member;

the tubular member having a first diameter which permits intraluminal delivery of the tubular member into a body passageway having a lumen; and

the tubular member having a second, expanded and deformed diameter, upon the application from the interior of the tubular member of a radially, outwardly extending force, which second diameter is variable and dependent upon the amount of force applied to the tubular member, whereby the tubular member may be expanded and deformed to expand the lumen of the body passageway.

23. The expandable intraluminal vascular graft of claim 13, wherein the outside of the wall surface of the tubular member is a smooth surface, when the tubular member has the first diameter.

('762 patent, col. 11, ln. 63—col. 12, ln. 14; col. 12, lns. 56-59)

Claim 44, a method claim added during reexamination, reads:

44. A method for implanting a balloon expandable stent prosthesis within a passageway of a coronary artery having an area of stenosis, comprising the steps of:

utilizing a thin-walled, tubular member as the stent prosthesis, the tubular member having a plurality of slots formed therein, the slots being disposed substantially parallel to the longitudinal axis of the tubular member;

disposing the stent prosthesis and catheter having an inflatable balloon portion;

inserting the stent prosthesis and catheter within the passageway by percutaneous catheterization;

delivering the catheter and stent prosthesis to the area of stenosis without surgically exposing the area of the passageway; and

expanding and deforming the stent prosthesis at the area of stenosis within the coronary artery passageway by expanding the inflatable balloon portion of the catheter associated with the stent prosthesis to force the stent prosthesis radially outwardly into contact with the area of stenosis in the passageway, the stent prosthesis being controllably deformed beyond its elastic limit.

('762 reexamination certificate, col. 3, lns. 22-44)

Claims 51 and 54, also added during reexamination, read:

51. In combination, a balloon expandable stent prosthesis for implementation in the passageway of a coronary artery having an area of stenosis and a catheter comprising:

an expandable stent prosthesis being a thin-walled tubular member having first and second ends and a wall having an outer wall surface disposed between the first and second ends, the wall surface having a substantially uniform thickness and a plurality of slots formed therein, the slots being disposed substantially parallel to the longitudinal axis of the tubular member;

a catheter having an expandable, inflatable balloon...