Medtronic, Inc. v. Guidant Corp.

• Decision Date: 19 July 2005
• Docket Number: No. CIV.03-848-SLR.,CIV.03-848-SLR.
• Citation: 378 F.Supp.2d 503
• Parties: MEDTRONIC INC., Plaintiff, v. GUIDANT CORPORATION, Guidant Sales Corporation, Eli Lilly & Company, Mirowski Family Ventures L.L.C., Defendants.
• Court: U.S. District Court — District of Delaware

Page 503

378 F.Supp.2d 503

MEDTRONIC INC., Plaintiff, v. GUIDANT CORPORATION, Guidant Sales Corporation, Eli Lilly & Company, Mirowski Family Ventures L.L.C., Defendants.

No. CIV.03-848-SLR.

United States District Court, D. Delaware.

July 19, 2005.

Karen Jacobs Louden, Philip Bangle, of Morris, Nichols, Arsht & Tunnell, Wilmington, DE, Fitch, Even, Tabin & Flannery, Boulder, CO (Steven C. Schroer, of counsel), Fitch, Even, Tabin & Flannery, Chicago, IL (Timothy E. Levstik, Mark A. Borsos, of counsel), for plaintiff.

Federick L. Cottrell, III, Anne Shea Gaza, of Richards, Layton & Finger, Wilmington, DE, Oblon, Spivak, McClelland, Maier & Neustadt, Alexandria, VA (Arthur I. Neustadt, of counsel), Finnegan Henderson Farabow Garrett & Dunner, Washington, DC (J. Michael Jakes, Kathleen A. Daley, Kara F. Stoll, of counsel), for defendants.

OPINION

SUE L. ROBINSON, Chief Judge.

I. INTRODUCTION

On August 29, 2003, plaintiff Medtronic, Incorporated filed this declaratory judgment action against defendants Guidant Corporation, Guidant Sales Corporation, Eli Lilly and Company and Mirowski Family Ventures. (D.I.1) Plaintiff's complaint alleges that claims 15-26 of U.S. Patent No. RE38,119 ("the RE'119 patent") are invalid.¹ (Id.) On September 12, 2003, plaintiff filed an amended complaint, which was answered by defendants on September 23, 2003. (D.I.4, 11) Defendants amended their answer on September 25, 2003. (D.I.12)

The parties have agreed that the issues in this case are limited and involve only the validity of the RE'119 patent and whether the RE'119 patent improperly recaptures subject matter. (PX 69.5) The court has jurisdiction over this matter pursuant to 28 U.S.C. §§ 1331, 1338(a), 2201 and 2202. A three day bench trial commenced on November 1, 2004. The following are the court's findings of fact and conclusions of law pursuant to Fed.R.Civ.P. 52(a).²

II. FINDINGS OF FACT

A. The Parties

1. Plaintiff is a medical device manufacturer and competitor of Guidant. (D.I. 4 at ¶¶ 1, 3, D.I. 12 at ¶ 3) Defendant Mirowski Family Ventures is the assignee of the RE'119 patent. (PX 2) Defendant Eli Lilly is the exclusive licensee of the RE'119 patent with an obligation to enforce the patent. (D.I. 4 at ¶ 2; D.I. 12 at ¶ 2) Defendant Guidant is a medical device manufacturer that was formed in 1994 when Eli Lilly divested certain assets. (D.I. 4 at ¶ 3) Defendant GSC is a wholly owned subsidiary of defendant Guidant. (D.I. 4 at ¶ 4, D.I. 12 at ¶ 4)

2. In 1991, plaintiff, defendant Eli Lilly and defendant Guidant's wholly-owned subsidiary, Cardiac Pacemakers, Inc. ("CPI"), entered into a Settlement and License Agreement ("the Agreement") to settle several lawsuits with respect to numerous patents relating to implantable pacemakers and defibrillators. (PX 69.1) Under the Agreement, any infringement of a covered patent by a party, without the payment of royalties, can be the subject of litigation.³ (Id.)

B. Dr. Mower's Invention

3. Dr. Morton Mower, at a time when he was employed by CPI, invented a device to treat ventricular asynchrony, a condition in which the patient has a conduction defect in his ventricles causing the ventricles to contract at different times. (D.I. 122 at 89; PX 77; PX 80)

4. The heart is made up of four chambers, two atria and two ventricles. (D.I. 122 at 78-80) Electrical stimulations, also known as depolarizations, within these chambers cause contractions within the heart which result in pumping. (Id.) This electrical activity arises in the sinoatrial node ("the SA node") in the right atrium. (Id.) It passes through the atrium to the atrial ventricular node ("the A-V node") and is then transmitted to the ventricles. (Id.) The period of time from depolarization of the atria to depolarization of the ventricles is called the "A-V delay period" and it usually lasts about 150 milliseconds. (D.I. 122 at 82-83)

5. Dr. Mower's device either conditionally or unconditionally paces the ventricles of the heart, so as to cause simultaneous ventricular contractions. The conditional embodiment, which was explicitly claimed in the '688 patent, requires sensing a depolarization in a first ventricle, then waiting for a predetermined period of time to sense a depolarization in the second ventricle. (D.I. 122 at 92; D.I. 123 at 331) If no depolarization is sensed in the second ventricle, then the device electronically paces the second ventricle (i.e., paces the second ventricle). (D.I. 123 at 331) The unconditional embodiment requires sensing depolarization in either ventricle and, as soon as depolarization in one ventricle is sensed, both ventricles are immediately paced. (Id. at 332; D.I. 122 at 105) In the unconditional embodiment, one ventricle will necessarily be paced twice, once naturally and once by the device. However, this does not damage the ventricle because each ventricle has a refractory period. (D.I. 123 at 332)

C. Prosecution Of The '688 Patent

6. In the late 1980's, Dr. Mower contacted Mr. Ron Cohn to draft a patent application for his invention. (D.I. 123 at 245) Mr. Cohn was the attorney who primarily prosecuted patents for the Mirowski Family Ventures. (D.I. 122 at 186)

7. On October 30, 1987, Stuart Rickerson, an agent of CPI, forwarded Mr. Cohn's draft to Thomas Nikolai and requested that Mr. Nikolai review and prepare a final draft application. (PX 74) On December 3, 1987, Mr. Nikolai notified Dr. Mower that CPI had requested that he "assist" Mr. Cohn in preparing the patent application. (PX 75) Attached to this letter was a copy of the application, as drafted by Mr. Cohn and revised by Mr. Nikolai. (PX 75) Mr. Nikolai asked Dr. Mower to review the draft and send any corrections back to him. (PX 75) Mr. Nikolai further inquired about whether the specification accurately described the invention. (PX 75) Specifically, Mr. Nikolai stated that,

[i]n reading through the patent specification, especially the portion relating to the logic diagram of Figure 2, you will note that we have included the concept of a "window of coincidence" which we think is important. It seems to be logically impossible to make a decision about pacing or not pacing unless such a "window of coincidence," however small, is provided in which the circuitry can look for a pulse from the other ventricle. I am further operating on the assumption that the degree of coincidence of the two pulses might very well be a variable which one would want to program in the same way that rate, pulse width, AV delay, etc., are programmed in many present-day pacers.

(PX 75)

8. During the summer of 1988, Dr. Mower and Mr. Cohn discussed the draft application sent to Dr. Mower by Mr. Nikolai. (D.I. 123 at 276; PX 76) Mr. Cohn forwarded Dr. Mower's comments to Mr. Nikolai, instructing him to "use these comments as you see fit and finalize the application for execution...." (PX 77) Mr. Cohn classified Dr. Mower's invention as

continually sens[ing] the activity of both the left and right ventricles, and when activity is sensed in either ventricle the device immediately electrically paces the other or both ventricles. Preferably, both ventricles are paced regardless of which ventricle fails to experience electrical activity, thereby ensuring that simultaneous contraction occurs, and also simplifying the required control and stimulating circuitry. However, for proper functioning of the device, only the non-active ventricle need be stimulated.

(PX 77) (emphasis in original) With respect to Mr. Nikolai's "window of coincidence," or delay between sensing and pacing, Mr. Cohn stated that to have a delay between sensing and pacing would undermine the purpose of the invention, i.e., to cause a simultaneous contraction of the ventricles. (PX 77)

9. On August 31, 1988, Mr. Nikolai responded to Mr. Cohn's letter with a letter to Dr. Mower. (PX 78) Mr. Nikolai expressed his confusion as to how the invention can sense the depolarization of one ventricle and then decide whether to pace the other ventricle without a delay period. (Id.) It seemed to Mr. Nikolai that, without such a delay, "both ventricles would have to be unconditionally stimulated whenever depolarization is detected in either ventricle," but this is not the invention Mr. Nikolai thought was originally described to him. (PX 78)

10. Dr. Mower responded to Mr. Nikolai on September 9, 1988. Dr. Mower stated that, in fact, both ventricles should be" `unconditionally stimulated whenever depolarization is detected in either ventricle.'" (PX 80) This is demand pacemaking "in the sense that the stimulus will cause a depolarization if needed, but if not needed to effect a depolarization, it does not cause the depolarization because it is delivered into the intrinsic deflection." (PX 80)

11. On December 30, 1988, Mr. Nikolai sent a copy of the patent application to Dr. Mower and requested that Dr. Mower review it. If Dr. Mower did not have any comments or corrections, he was introduced to execute the enclosed Declaration and Assignment⁴ and return it to Mr. Nikolai. (PX 82)

12. On January 11, 1989, Dr. Mower sent Mr. Nikolai suggested changes to the application section discussing the background of the invention. (PX 84) His changes were incorporated into the application. (Compare PX 84, with PX 3)

13. Mr. Nikolai sent the patent application to the Patent and Trademark Office ("PTO") on January 19, 1989. (PX 156) On this same day, he sent a copy of the application to Stuart Rickerson at CPI. (PX 35)

14. On January 23, 1989, the patent application was formally filed with the PTO and assigned patent application number 07/299895 ("the '895 application").⁵ (PX 3.02)

15. On June 9, 1989, the PTO examiner issued his first action, rejecting claims 1-14 and 17-22 of the '895 application. (PX 3.04) The examiner allowed claims 15 and 16. (Id.) Claims 2, 3, 8 and 9 were rejected as being obviousness in view of Nappholz⁶ and Cohen.⁷ (Id.) According to the examiner, Cohen showed "a means to...