Eli Lilly and Co. v. Medtronic, Inc.

Decision Date21 April 1988
Docket NumberCiv. A. No. 83-5393.
Citation7 USPQ 2d 1447,696 F. Supp. 1033
PartiesELI LILLY AND COMPANY, Plaintiff, v. MEDTRONIC, INC., Defendant.
CourtU.S. District Court — Eastern District of Pennsylvania

Timothy J. Malloy, Lawrence M. Jarvis, Gregory J. Vogler, Chicago, Ill., Richard G. Schneider, Philadelphia, Pa., for plaintiff.

Philip S. Johnson, Albert W. Preston, John J. Mackiewicz, Gary H. Levin, Philadelphia, Pa., for defendant.

MEMORANDUM AND ORDER

DITTER, District Judge.

Plaintiff Eli Lilly and Company brought this suit against defendant Medtronic, Inc. alleging infringement by Medtronic of two United States patents, No. Re. 27,757, reexamined and issued as Bl Re. 27,757 (the 757 patent) and No. 3,942,536, reexamined and issued as Bl 3,942,536 (the 536 patent). At the close of Medtronic's case, with the agreement of the parties, I granted Lilly's motion for a directed verdict with regard to the validity of the 536 patent and its infringement by Medtronic's Model 7210 and its associated leads. The jury subsequently returned a verdict in favor of Lilly, having found Medtronic's devices to infringe the claims of the 757 patent. The jury also decided that Medtronic's infringement of the 757 and 536 patents was willful. The parties agreed to submit for my determination the issue as to whether the alleged inequitable conduct of the patents' inventors,1 Dr. Michel Mirowski and Dr. Morton Mower, before the United States Patent and Trademark Office (PTO) during the prosecution and reexamination of the patents-in-suit renders both patents unenforceable. For the reasons which follow and based upon the findings of fact and conclusions of law made of record on April 15, 1988, I conclude that Medtronic has failed to prove by clear and convincing evidence that the patents-in-suit are unenforceable because of inequitable conduct on the part of their inventors. Since I find that both patents-in-suit are enforceable, I will direct that judgment be entered in favor of Lilly and against Medtronic in accordance with the jury's verdict.

Medtronic contends that Drs. Mirowski and Mower were guilty of certain instances of inequitable conduct with regard to each of the patents in suit. I will discuss each of Medtronic's claims.

A. The 757 Patent
1. Conduct During Initial Prosecution of the 757 Patent

Medtronic argues that, in 1972, during the prosecution of the 757 patent, Dr. Mirowski and his counsel, Ronald Cohn, Esq., were guilty of inequitable conduct because they failed to disclose as prior art to Examiner William E. Kamm, the patent examiner who was reviewing the 757 patent application,2 an article published in 1954, by Dr. John Hopps. Medtronic contends that the Hopps article renders the 757 patent invalid because it specifically teaches the use of an electrode positioned within the heart for defibrillation, one of the features of the claims of the 757 patent.

The patent application for the 757 patent was first filed on February 9, 1970, by Ronald Cohn, Dr. Mirowski's counsel. Medtronic counsel later assumed the prosecution of the 757 patent on behalf of Dr. Mirowski. A reissue application for the 757 patent was filed on February 25, 1972. The application for the 536 patent was filed by Medtronic counsel on behalf of Dr. Mirowski on March 15, 1971, as patent application Serial No. 124,326 (the 326 application). At the time, Medtronic was undertaking prosecution of both Dr. Mirowski's patent applications under an agreement with Dr. Mirowski to develop the invention of the 757 patent application, an automatic defibrillator. Medtronic subsequently decided to discontinue its defibrillation program and its relationship with Dr. Mirowski and assigned the patent rights under the applications back to Dr. Mirowski. Dr. Mirowski's counsel, Mr. Cohn, thereupon undertook prosecution of the patent applications on behalf of Dr. Mirowski.

On May 2, 1972, Examiner Kamm performed a prior art search in connection with the 326 application and found the Hopps article which he cited to Medtronic counsel in a letter of August 3, 1972. Sometime prior to August 7, 1972, however, Medtronic had a copy of the Hopps reference in its corporate library, although Medtronic disputes whether the Medtronic counsel prosecuting the 757 patent were aware of it. In any event, after being informed of the Hopps article by Examiner Kamm with regard to the 326 application, Medtronic failed to cite the article to Kamm with regard to the 757 patent application despite its responsibility under the agreement with Dr. Mirowski for prosecution of the 757 application. Having cancelled its relationship with Dr. Mirowski by a notice dated September 14, 1972, Medtronic, in letters of September 29, 1972, and October 12, 1972, to Mr. Cohn stated that its cancellation of its defibrillation program was based, in part, on its belief that the Hopps article invalidated the 757 patent because it disclosed the use of an electrode positioned within the heart for defibrillation.3

After Medtronic assigned the patent rights back to Dr. Mirowski in an assignment dated November 14, 1972, Dr. Mirowski executed a power of attorney to Ronald Cohn on November 20, 1972. Mr. Cohn thereupon prosecuted the 757 and 326 applications on behalf of Drs. Mirowski and Mower. In a letter of November 28, 1972, to Examiner Kamm regarding the 757 application, Mr. Cohn cited the Hopps reference and other articles saying that "none of these references is any more pertinent than those already cited in connection with the prosecution of this application." Mr. Cohn did not submit a copy of the Hopps reference to Examiner Kamm.

2. Conduct During the Reexamination of the 757 Patent

Medtronic alleges certain statements made by Dr. Mower during the reexamination of the 757 patent with regard to the teachings of the Hopps article and the possibility of spontaneous defibrillation in small dogs constituted inequitable conduct. Medtronic also alleges that Dr. Mower intentionally withheld certain publications which contradict his statements to Examiner Kamm about spontaneous defibrillation in small dogs and the success of the Hopps experiments. Finally, Medtronic alleges that Dr. Mower intentionally withheld from Examiner Kamm the fact of his professional relationship with Dr. Mirowski.

During the reexamination of the 757 and 536 patents initiated by Medtronic in connection with this litigation, Medtronic submitted a copy of the Hopps reference to Examiner Kamm. All of the claims of the 757 patent were initially rejected by Examiner Kamm on the basis of Hopps teaching of direct application of cardioverting energy to the heart.4 As part of the reexamination proceedings, Dr. Mower was interviewed by Examiner Kamm and submitted an affidavit concerning the Hopps article.

The Hopps reference discloses the findings of Dr. Hopps' attempts in 1954 to defibrillate a number of dogs. In the portion of the reference entitled "Closed Chest Defibrillation", the first attempt discussed involved a "modification of the intracardiac catheter electrodes as they lay in various portions in the right atrium and right ventricle." Trial Exhibit 1172, p. 841. As the article explains,

"in every case but one, fibrillation persisted about the apex, and it was impossible to reach this extremity of the ventricles with the shock. In each instance, there was an area of burnt tissue around the electrodes after three or four shock applications. The one exception was a ten-kilogram dog whose heart was defibrillated on the fifth attempt ..."

Id. The ten-kilogram dog was one of the smallest dogs in Hopps' experiment. Id.

In Dr. Hopps' next experiment, "a single electrode catheter in the heart and a large dispersive electrode on the front of the chest, over the apex of the heart" was used. Id. at 841-43. As explained in the article, "the technique proved fairly satisfactory in five of the eleven dogs." Id. at 843. Two of the five successes, however, were discounted because "the first attempts to defibrillate were unsuccessful, and it was necessary to open the chest, massage, and defibrillate with conventional electrodes before performing further tests with atrium-chest electrodes. Subsequent defibrillations by this method did not constitute valid tests under closed chest conditions." Id. Thus, closed chest defibrillation was successful in only 3 of 11 dogs. Dr. Hopps' report concluded:

5. Shocks applied through an intracardiac catheter were not effective in cardiac defibrillation. It was impossible to arrest the ventricular muscle around the apex by this method.
6. With a single intracardiac electrode and a dispersive electrode on the chest over the heart, closed-chest defibrillation was possible in smaller dogs. As in open-chest technique, there appears to be a relationship between the size of the dog and the ability to defibrillate.

Id.

Dr. Mower's affidavit to Examiner Kamm stated that the first closed chest technique was a failure and discussed this technique. Trial Exhibit 1173, para. 5-6. Dr. Mower noted that the second technique was reported as "fairly satisfactory" in five of the eleven dogs that were tested. Id. at para. 8. Dr. Mower explained that two of the five successes were discounted by Hopps and, thus, that "only three of the eleven dogs were apparently defibrillted in the manner intended." Id. at para. 7-8. Dr. Mower then noted that the three dogs that were defibrillated had weights lower than those dogs that could not be defibrillated. Id. at para. 9. Dr. Mower indicated in his affidavit that Hopps himself reached a similar conclusion that "there appeared to be a definite relationship between the size of the dog and our ability to defibrillate ... with a larger dog, the greater the size of heart and increased current path undoubtedly contribute to the difficulty of defibrillation." Id. at para. 9.

Dr. Mower concluded his affidavit to Examiner Kamm by explaining that the Hopps reference would teach a person of ordinary skill in...

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