Medtronic Inc. v. Boston Scientific Corp..

Decision Date30 March 2011
Docket NumberCiv. No. 07–823–SLR.
Citation777 F.Supp.2d 750,2011 Markman 1193381
PartiesMEDTRONIC, INC., Plaintiff,v.BOSTON SCIENTIFIC CORPORATION, Guidant Corporation, and Mirowski Family Ventures L.L.C., Defendants.
CourtU.S. District Court — District of Delaware

OPINION TEXT STARTS HERE

Arthur G. Connolly III, Esquire of Connolly Bove Lodge & Hutz LLP, Wilmington, DE, of Counsel: Martin R. Lueck, Esquire, Jan M. Conlin, Esquire and Stacie E. Oberts, Esquire of Robins, Kaplan, Miller & Ciresi L.L.P., Minneapolis, MN, for Plaintiff.Richard L. Horowitz, Esquire, David Ellis Moore, Esquire of Potter Anderson & Corroon, LLP, Wilmington, DE, of Counsel: Arthur J. Neustadt, Esquire, Thomas J. Fisher, Esquire and John F. Presper, Esquire of Oblon, Spivak, McClelland, Maier & Neustadt, L.L.P., Alexandria, VA, for Defendant Mirowski Family Ventures, L.L.C.Frederick L. Cottrell, III, Esquire and Anne Shea Gaza, Esquire of Richards, Layton & Finger, Wilmington, DE, of Counsel: J. Michael Jakes, Esquire and Naveen Modi, Esquire of Finnegan Henderson Farabow Garrett & Dunner LLP, Washington, District of Columbia, for Defendants Boston Scientific Corporation and Guidant Corporation.

OPINION

SUE L. ROBINSON, District Judge.I. INTRODUCTION

Plaintiff Medtronic, Inc. (“Medtronic” or plaintiff) filed this complaint on December 17, 2007, against Boston Scientific Corporation (BSC), Guidant Corporation (Guidant), and Mirowski Family Ventures LLC (“MFV,” collectively defendants) for declaratory judgment of non-infringement and invalidity of United States Reissued Patent Nos. RE 38,119 (“the '119 patent”) and RE 39,897 (“the '897 patent,” collectively “the reissue patents”). (D.I. 1) Thereafter, plaintiff amended its complaint twice, first to add a defense of prosecution laches, and then to assert non-infringement of two new products. (D.I. 84; D.I. 108) BSC and Guidant filed an answer on February 2, 2008, and thereafter amended it twice. (D.I. 18; D.I. 88; D.I. 115) MFV also filed an answer on February 2, 2008 and amended it twice. (D.I. 20; D.I. 89; D.I. 114) On December 2, 2009, the parties submitted their joint claim construction chart. (D.I. 144) The court conducted a Markman hearing on January 7, 2010.

A bench trial was held January 25–28 and March 13, 2010 on validity and enforceability of the reissue patents and whether any of the accused products infringe any valid asserted claim. On March 30, 2010, the parties stipulated that in post-trial briefing, plaintiff would file opening and reply briefs, and defendants would file only an answering brief. (D.I. 187) On February 7, 2011, the court ordered that defendants may file a sur-reply brief addressing only the issue of infringement as discussed in plaintiffs reply post-trial brief. (D.I. 253) Pursuant to the court's order, defendants filed a sur-reply brief on February 22, 2011. (D.I. 254) The issues at bar have been fully briefed post-trial. The court has jurisdiction pursuant to 35 U.S.C. §§ 1 et seq. and 28 U.S.C. §§ 1331, 1338(a), 1400(b) and 2201. Having considered the documentary evidence and testimony, the court makes the following findings of fact and conclusions of law pursuant to Fed.R.Civ.P. 52(a).

II. FINDINGS OF FACT AND CONCLUSIONS OF LAWA. Background

1. The parties and litigation history

1. Medtronic, BSC, and Guidant are all leading manufacturers and sellers of medical devices. (D.I. 86 at 2) Medtronic is a Minnesota corporation with a principal place of business in Minneapolis, Minnesota. (D.I. 115 at 1) Medtronic is engaged in the business of manufacturing, promoting, offering for sale, and selling certain implantable cardiac stimulation devices that are capable of providing cardiac resynchronization therapy (“CRT”). (D.I. 114 at 1; D.I. 115 at 1) BSC is a Delaware corporation with a principal place of business in Natick, Massachusetts. (D.I. 115 at 1) Guidant is an Indiana corporation with a principal place of business in Carmel, Indiana, and is a wholly-owned subsidiary of BSC. ( Id.) Guidant is the exclusive licensee of the reissue patents. ( Id.) MFV is a Maryland limited liability company which holds the patent rights of Michel Mirowski, M.D., inventor of the implantable cardiac defibrillator (“ICD”), and is the assignee of the reissue patents. (D.I. 86 at 2; D.I. 114 at 1)

2. There is a long history of litigation involving the parties in the case at bar. ( See D.I. 86 at 1–8) Ely Lilly & Co. (“Lilly”), Guidant's predecessor-in-interest to the reissue patents, entered into a sublicense agreement (“Lilly agreement”) with Medtronic in 1991 covering, inter alia, the '119 patent. (DTX–87 at 1) The Lilly agreement gave Medtronic the right to challenge allegations of infringement of the '119 patent as well as the validity and enforceability of the '119 patent through one or more declaratory judgment actions. ( Id.)

3. In 2003, by agreement of the parties, Medtronic began paying royalties into escrow on sales of certain products, while at the same time challenging the validity of the '119 patent (2003 litigation”).1 ( Id.) In 2004, the validity and enforceability of the '119 patent was also placed at issue in litigation between Guidant and St. Jude Medical, Inc. (“St. Jude litigation”).2 ( Id.)

4. In 2006, Medtronic, Guidant, and MFV entered into a “Litigation Tolling Agreement” (“LTA”). (DTX–87) The LTA recognized that “an actual controversy exists ... as to the scope, validity and enforceability of the '119 patent, and whether or not any valid and enforceable claims thereof cover Medtronic products, and consequently the proper distribution of substantial monies residing in or to be paid into various escrow accounts.” ( Id. at 2) The LTA tolled and suspended various litigation and defenses thereto pending the conclusion of the “DJ Suspension Period” and for ninety (90) days after receipt by Medtronic of a notice of infringement from Guidant or MFV. ( Id. at 5) The “DJ Suspension Period” was defined to be “the later of: (a) final resolution of the St. Jude Litigation (including settlement thereof), or (b) October 1, 2007.” ( Id. at 2) The LTA provided that, within 60 days after the DJ Suspension Period, defendants could provide written notice to Medtronic of infringement of the '119 patent or subsequent reissue patents claiming priority to the '119 patent. ( Id. at 5) The LTA further provided that, within 90 days after such notice, Medtronic could initiate a final declaratory judgment, in this court, challenging infringement, unenforceability and/or validity of the asserted claims of the '119 patent and any asserted claims of any subsequent reissue patent(s). ( Id. at 6) The declaratory judgment complaint in the present action was filed pursuant to the LTA. (D.I. 1)

2. The heart, its maladies and treatment

5. The human heart is divided into four chambers. (D.I. 154, ex. 1 at ¶ 22; D.I. 146 at 3) The two upper chambers of the heart are called the left and right atria and receive blood from the body or lungs. (D.I. 154, ex. 1 at ¶¶ 22, 23; D.I. 146 at 3) “One upper chamber is called an ‘atrium,’ while both upper chambers together are called the ‘atria.’ (D.I. 154, ex. 1 at ¶ 22) The two lower chambers in the heart are called the left and right ventricles and are the pumping chambers of the heart. ( Id.; D.I. 146 at 3) When the ventricles contract, blood is pumped out of the heart with enough force to push blood through the lungs and entire body. ( Id.)

6. The left and right sides of the heart are separated by a wall, called the septum. (D.I. 154, ex. 1 at ¶ 23; D.I. 146 at 3) Deoxygenated blood (blood with no oxygen) returning to the heart from the body moves through the right side of the heart. ( Id.) Oxygenated blood (blood with oxygen) returning from the lungs moves through the left side of the heart. ( Id.)

7. The right atrium receives deoxygenated blood from the body. (D.I. 154, ex. 1 at ¶ 22; D.I. 146 at 3) When the right atrium contracts, blood is pushed into the right ventricle. ( Id.) Once the right ventricle has filled, it contracts and pumps blood to both lungs. ( Id.) Blood is circulated through the lungs where carbon dioxide is removed and oxygen is absorbed. (D.I. 146 at 3)

8. Oxygenated blood returns to the heart into the left atrium. ( Id.) When the left atrium contracts, blood is pushed into the left ventricle. ( Id.) When the left ventricle contracts, blood is pushed on to the rest of the body. ( Id.) The circulatory cycle then begins again. ( Id.)

9. A variety of problems can cause the heart to behave abnormally. (D.I. 148, ex. 1 at 5–6) One problem involves the heart's electrical system, which can affect the timing of the heart, resulting in arrhythmias (rhythm disorders). ( Id.) One such disorder is bradycardia, a condition in which the heart beats too slowly. ( Id.) Tachycardia, on the other hand, is a condition in which the heart beats too rapidly. ( Id. at 7) Fibrillation is a condition in which the heartbeat is chaotic, or irregular, and the heart may skip beats. ( Id.)

10. Treatment of these electrical disorders usually involves an implantable electronic device for stimulating the heart. ( Id.) Bradycardia is treated using a pacemaker, a device that sends electrical impulses to the heart through electrical leads (wires) in the right atrium and right ventricle to maintain a suitable heart rate. ( Id. at 6–7) Tachycardia and fibrillation are usually treated using an implantable cardioverter defibrillator (“ICD”). ( Id. at 7) Compared to pacemakers, ICDs deliver a massive high-energy pulse (shock) to the heart through electrical leads to stop the arrhythmias. ( Id.)

11. Separate from the timing problem of arrhythmias, a heart may also suffer from structural problems that affect its pumping ability, such as heart failure. ( Id. at 8) Heart failure is a disease in which the heart progressively loses its ability to effectively pump blood. ( Id.)

12. Pacing of the heart, using a pacemaker, is performed in various modes described by a shorthand...

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