Boston Scientific Corp.. v. Cordis Corp..

• Decision Date: 13 April 2011
• Docket Number: Civ. No. 10–315–SLR.
• Citation: 777 F.Supp.2d 783
• Parties: BOSTON SCIENTIFIC CORPORATION and Boston Scientific Scimed, Inc., Plaintiffs,v.CORDIS CORPORATION, Defendant.
• Court: U.S. District Court — District of Delaware

777 F.Supp.2d 783

BOSTON SCIENTIFIC CORPORATION and Boston Scientific Scimed, Inc., Plaintiffs,

v.CORDIS CORPORATION, Defendant.

Civ. No. 10–315–SLR.

United States District Court, D. Delaware.

April 13, 2011.

John W. Shaw, Esquire and Karen L. Pascale, Esquire of Young Conaway Stargatt & Taylor LLP, Wilmington, DE, Of Counsel Paul A. Bondor, Esquire of Desmarais LLP, and Young J. Park, Esquire of Kirkland & Ellis LLP, New York, NY, for Plaintiffs.Steven J. Balick, Esquire, Tiffany Geyer Lydon, Esquire and Andrew C. Mayo, Esquire of Ashby & Geddes, Wilmington, DE, Of Counsel Gregory Diskant, Esquire, Eugene Gelernter, Esquire, Kathleen M. Crotty, Esquire, and Diana Breaux, Esquire of Patterson Belknap Webb & Tyler LLP, New York, NY, for Defendant.

MEMORANDUM OPINION

SUE L. ROBINSON, District Judge.I. INTRODUCTION

Plaintiffs Boston Scientific Corporation and Boston Scientific Scimed, Inc. (together, “BSC”) filed this action in the United States District Court for the District of Minnesota on December 4, 2009, alleging that defendant Cordis Corporation (“Cordis”) willfully infringed claim 36 of United States Patent No. 5,922,021 (“the '021 patent”) by manufacturing its 2.25 mm Cypher stent. (D.I. 1) On April 16, 2010, the District of Minnesota transferred the case to this court. (D.I. 46) Currently before the court are: (1) Cordis' motion to stay the trial on damages and willfulness pending reexamination of the '021 patent (D.I. 90); (2) Cordis' motion to submit a supplemental brief in support of its motion to stay pending reexamination (D.I. 153); (3) BSC's motion for summary judgment of infringement of the '021 patent (D.I. 111); (4) Cordis' motion for partial summary judgment on the date of hypothetical negotiation (D.I. 108); (5) Cordis' motion to exclude BSC's expert from relying on the outcome of the 03–027 case in her reasonable royalty analysis (D.I. 106); and (6) BSC's motion to preclude damages testimony from Cordis' expert based on incorrect hypothetical negotiations dates (D.I. 114). This matter is currently scheduled for trial commencing on May 5, 2011.

II. BACKGROUNDA. The Parties and the Technology at Issue

Boston Scientific Corporation is a Delaware corporation with a principal place of business in Natick, Massachusetts. (D.I. 1 at ¶ 1) Boston Scientific Scimed, Inc. is a Minnesota corporation with a principal place of business in Maple Grove, Minnesota. ( Id. at ¶ 2) Cordis is a Florida corporation with a principal place of business in Bridgewater, New Jersey. ( Id. at ¶ 3) The parties compete in the field of cardiovascular stents. ( Id. at ¶ 4)

A cardiovascular stent functions as scaffolding that is placed into a blocked artery in a crimped state on a balloon catheter. ('021 patent at col. 1:42–52, 3:13–20) The stent is then expanded by the balloon to either reopen the blocked artery or maintain the lumen of an artery that has previously been reopened by a balloon angioplasty procedure. ( Id.) In the past, cardiovascular stenting procedures were performed with stents made of bare metal without any drug-polymer coating. (D.I. 1 at ¶ 5) Drug-eluting stents, which are bare metal stents with a drug-polymer coating intended to inhibit the re-growth of cells in the reopened vessel passageway, improved treatment dramatically by reducing the need for patients to receive repeated stenting procedures. ( Id. at ¶ 6)

On July 13, 1999, the United States Patent and Trademark Office (the “PTO”) issued the '021 patent, titled “Intravascular Stent,” to G. David Jang, M.D. Claim 36 of the '021 patent claims a pattern of struts arranged in a specific manner on a stent, which provides the stents with their flexibility and scaffolding characteristics. (D.I. 1 at ¶ 19) Specifically, claim 36 of the '021 patent states:

The stent of claim 24, wherein the first connecting strut proximal section is coupled to the second corner of the second expansion strut pair of the first expansion strut column, and the first connecting strut distal section is coupled to the first corner of the first expansion strut pair of the second expansion strut column, and the second connecting strut proximal section is coupled to the second corner of the fourth expansion strut pair of the first expansion strut column, and the second connecting strut distal section is coupled to the first corner of the third expansion strut pair of the second expansion strut column.

('021 patent at col. 22:42–52) Claim 36 depends on claims 23 and 24, which are directed at the design of the stent but do not reference the drug-polymer coating or the characteristics of the balloon attached to the stent. ( Id. at col. 19:53–21:23)B. The 03–027 Case

On January 13, 2003, Cordis filed a patent infringement action against BSC and BSC counterclaimed, alleging that the Cordis Cypher and BX Velocity stents infringed claim 36 of the '021 patent. (D.I. 109 at 2; D.I. 129 at 4) The Cypher and BX Velocity stents have the same six-cell design which comes in 2.5 mm, 2.75 mm and 3.0 mm sizes,¹ but the Cypher stents have a drug-polymer coating which is not present in the BX Velocity stents. (D.I. 109 at 4–6; D.I. 129 at 6) In both the Cypher and the BX Velocity stent systems, a stent is mounted on a balloon that inflates to the various nominal diameters. (D.I. 109 at 6) Cordis first manufactured the BX Velocity stent in the United States in 1999 and received FDA approval to sell the Cypher stents in sizes ranging from 2.5 mm to 3.5 mm in 2003. ( Id. at 5; D.I. 129 at 6)

In July 2005, the jury returned a verdict in favor of BSC, finding that Cordis' Cypher and BX Velocity stents infringed claim 36 of the '021 patent and that claim 36 was valid. (D.I. 1 at ¶ 11; D.I. 129 at 5) On September 24, 2007, this court upheld the jury verdict and entered judgment in favor of BSC. (D.I. 109 at 2–3) The Federal Circuit affirmed the judgment in March 2009, ² and this court scheduled a jury trial on damages and willfulness for February 2010. ( Id. at 3) Under a settlement agreement reached by the parties prior to the damages trial, Cordis received a license from BSC to make and sell the BX Velocity and Cypher stents at issue in the 03–027 case. ( Id.; D.I. 129 at 5)

C. Prosecution History of the '021 Patent

On October 13, 2009, Cordis applied for ex parte reexamination of the '021 patent, which was granted by the PTO on December 17, 2009 based on substantial new questions as to the effect of various prior art references on the patentability of claims 23, 24 and 36 of the '021 patent.³ (D.I. 109 at 3) On September 10, 2010, the examiner issued a non-final initial office action rejecting claims 23, 24 and 36 as obvious over the prior art. ( Id. at 4) BSC responded to the rejection on December 10, 2010 and overcame it with no amendment to the claim language. (D.I. 151) Cordis filed a second request for reexamination on January 17, 2011. ( Id.) On February 18, 2011, the PTO issued a non-final office action in the second reexamination proceeding, rejecting claim 36 as anticipated by U.S. Patent No. 5,807,404 (“the '404 patent”) and as an obvious combination of the ' 404 patent and U.S. Patent No. 5,733,303. (D.I. 153, Ex. A)

D. The Accused Product

Only Cordis' 2.25 mm Cypher stent is at issue in the instant case. Cordis' 2.25 mm Cypher stent was first manufactured for commercial use on August 18, 2009. (D.I. 113, Ex. 6 at 52:3–18) Cordis obtained FDA approval and began selling the 2.25 mm Cypher stent in the United States in September 2009. (D.I. 109 at 5; D.I. 113, Ex. 6 at 49:14–50:3, 52:3–18; D.I. 126 at 5) The stent used in the 2.25 mm Cypher stent system is identical to the six-cell stent used in most of the Cypher stents accused of infringement in the 03–027 case, but it is mounted on a balloon that inflates to a nominal diameter of only 2.25 mm. (D.I. 109 at 5–6; D.I. 129 at 8–9)

Although Cordis submitted its application for FDA approval of all of the Cypher stents at the same time in June 2002, the FDA required Cordis to submit a supplemental application for the 2.25 mm stent with additional clinical data. (D.I. 109, Ex. 8 at 35:20–36:9; D.I. 130, Ex. G at 6–7) Experts for both parties testified as to the unique role that 2.25 mm drug-eluting stents play in the treatment of coronary artery disease. (D.I. 129 at 7) Specifically, Dr. Steven Goldberg explained that 2.25 mm drug-eluting stents “provide an important option for the treatment of small coronary arteries” because of the particular challenges that treating small coronary arteries present. (D.I. 130, Ex. N at ¶ 33) Dr. Daniel Simon likewise testified that he would prefer to use a 2.25 mm Cypher stent in treating 2.0 mm vessels. ( Id., Ex. P at 126:3–11; 139:17–19) BSC and Cordis are the only suppliers of 2.25 mm drug-eluting stents on the market. (D.I. 129 at 7)

III. STANDARD OF REVIEW

A court shall grant summary judgment only if “the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to judgment as a matter of law.” Fed.R.Civ.P. 56(c). The moving party bears the burden of proving that no genuine issue of material fact exists. See Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 586 n. 10, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986). “Facts that could alter the outcome are ‘material,’ and disputes are ‘genuine’ if evidence exists from which a rational person could conclude that the position of the person with the burden of proof on the disputed issue is correct.” Horowitz v. Fed. Kemper Life Assurance Co., 57 F.3d 300, 302 n. 1 (3d Cir.1995) (internal citations omitted). If the moving party has demonstrated an absence of material fact, the nonmoving party then “must come forward with ‘specific facts showing that there is a genuine issue for trial.’ ” Matsushita, 475 U.S. at 587, 106 S.Ct. 1348 (quoting Fed.R.Civ.P. 56(e)). The court will “view...