Ethicon Endo-Surgery v. US Surgical Corp.

Decision Date03 June 1994
Docket NumberNo. C-1-94-74.,C-1-94-74.
Citation855 F. Supp. 1500
CourtU.S. District Court — Southern District of West Virginia
PartiesETHICON ENDO-SURGERY, Plaintiff, v. UNITED STATES SURGICAL CORP., Defendant.

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COPYRIGHT MATERIAL OMITTED

Robert Alexander Pitcairn, Jr., Katz, Teller, Brant & Hild Co., Cincinnati, OH, for plaintiff.

Daniel Jerome Buckley, Vorys, Sater, Seymour & Pease, Cincinnati, OH, for U.S. Surgical Corp.

ORDER DENYING PLAINTIFF'S MOTION FOR A PRELIMINARY INJUNCTION

SPIEGEL, District Judge.

This matter is before the Court on Plaintiff, Ethicon Endo-Surgery's Motion For a Preliminary Injunction (doc. 2) to which the Defendant, United States Surgical Corp. has responded (doc. 11), the Plaintiff has twice replied (docs. 15 & 22) and the Defendant has provided a Surreply Response (doc. 26).

On March 21 and 22, 1994, the Court held a Hearing on the Plaintiff's motion. Final arguments were heard on April 4, 1994. In rendering our decision of this matter, we have considered the testimony of the witnesses, the documents admitted into evidence, the Plaintiff's proposed findings of fact and conclusions of law (doc. 24, 37), and the Defendant's proposed findings of fact and conclusions of law (doc. 27, 38), and joint proposed findings of fact and conclusions of law (doc. 42).

In weighing the testimony of the witnesses, we considered each witness' relationship to the Plaintiff or to the Defendant; their interest, if any, in the outcome of the trial; their manner of testifying; their opportunity to observe or acquire knowledge concerning facts about which they testified; and the extent to which they were supported or contradicted by other credible evidence.

This is a dispute concerning surgical linear cutter-staplers. These instrument are used by surgeons to simultaneously cut and staple tissue. In particular the Plaintiff, Ethicon, asserts that the linear cutter-staplers which are marketed by the Defendant, U.S. Surgical, infringe one of the Plaintiff's patents. The patent in question covers a lockout device. This device prevents a surgeon from inadvertently cutting tissue without having the cutter loaded with staples. The Defendant denies that its product infringes the Plaintiff's patent, and further argues that the balance of equities weighs against the issuance of a preliminary injunction.

Under Fed.R.Civ.P. 52, we set forth our findings of fact and conclusions of law.

FINDINGS OF FACT
I. The Parties

1. Plaintiff Ethicon Endo-Surgery ("Ethicon") is a general partnership formed under the laws of the State of New Jersey with its principal place of business in Cincinnati, Ohio. Both the general partners are subsidiaries of Johnson & Johnson, Inc. Ethicon develops, manufactures and sells mechanical wound-management products.

2. Defendant United States Surgical Corporation ("U.S. Surgical") is a Delaware corporation with its principal place of business in Norwalk, Connecticut. U.S. Surgical is doing business in Ohio. U.S. Surgical develops, manufactures and sells mechanical wound-management products.

3. U.S. Surgical began selling mechanical wound-management products before Ethicon. U.S. Surgical first began selling surgical staplers in the late 1960's. The company has devoted significant resources to research and development and has regularly improved its products over the years. In addition U.S. Surgical has sponsored surgical training programs, in which surgeons learn to use their surgical staplers. U.S. Surgical has been a pioneer in the development of endoscopic surgery, a technique for minimally intrusive surgery, which allows speedy recovery and reduces hospital stays. U.S. Surgical was the first to market a linear cutter with a lockout device.

4. Ethicon, though second in the market has become a vigorous competitor of U.S. Surgical. Ethicon is a subsidiary of Johnson & Johnson, Inc. which manufactures among its many products, surgical sutures and other products used in surgery.

5. Together U.S. Surgical and Ethicon account for the entire market for surgical liner cutter-staplers.

II. The Parties' Patents
A. The Fox Patent.

6. The earliest embodiment of the patented Fox lockout mechanism was conceived in November 1987.

7. In November 1988, Ethicon filed the application which led to the issuance of the original Fox patent in the names of William D. Fox, Rudolph H. Nobis, Richard P. Nuchols and Mark S. Zeiner.

8. On January 9, 1990, the United States Patent and Trademark Office (the "PTO") issued to Ethicon, Inc. United States Letters Patent No. 4,892,244 (the original "Fox Patent"), for an invention entitled "SURGICAL STAPLER CARTRIDGE LOCKOUT DEVICE." The original Fox patent included claim 6 which is now at issue in this suit.

9. The Fox Patent describes a lockout device "in a staple cartridge."

10. Ethicon has never practiced the Fox Patent commercially.

11. In testing the prototypes of the Fox Patent, Ethicon did not actually test the lockout under actual conditions of surgery.

B. The Tompkins Patents.

12. The patented Tompkins lockout mechanism was conceived after November 1987, but no later than May/June 1988.

13. In May 1989, U.S. Surgical filed the application which led to the issuance of the first Tompkins patent in the names of Thomas M. Tompkins and Dominic F. Presty.

14. On September 10, 1990, the PTO issued to U.S. Surgical United States Letters Patent No. 4,955,959 (the "Tompkins '959 Patent") for an invention entitled "LOCKING MECHANISM FOR SURGICAL FASTENING APPARATUS."

15. On July 16, 1991, the PTO issued to U.S. Surgical United States Letters Patent No. 5,031,814 (the "Tompkins '814 Patent") upon an application filed in the names of Thomas M. Tompkins and Dominic F. Presty, for an invention entitled "LOCKING MECHANISM FOR SURGICAL FASTENING APPARATUS."

III. The Devices At Issue

16. Ethicon and U.S. Surgical each market surgical devices called linear cutters. In fact these parties are in effect the only manufacturers of the type of cutters which are involved in this suit. Linear cutters are used by surgeons to cut body tissue while simultaneously stapling the tissue closed on both sides of the incision in order to prevent excessive bleeding. After each cut, the staples are depleted so the surgeon must reload the cutter to avoid cutting without the benefit of staples. The particular devices which are the subject of this case are mechanisms for preventing the surgeon from accidentally using the device without staples. This is accomplished by a "lockout" safety device which makes it impossible to reuse the cutter without reloading. Both the parties linear cutters have lockout devices and each are covered by patents.

17. There are two general types of linear cutters, designed for different types of surgery. Open linear cutters are used in conventional surgery, in which the surgeon gains access to body organs through large incisions. Endoscopic linear cutters are used in endoscopic surgical procedures, in which the surgeon makes only a small puncture wound and performs the surgery through a tube (a trocar), using elongated instruments, while viewing the affected area by means of a miniature camera, also inserted through a trocar.

IV. Introduction Of The Devices To The Market

18. U.S. Surgical first introduced its GIA linear cutter/stapler without a lockout mechanism in 1968. In October 1989, U.S. Surgical introduced the first linear cutter with a lockout mechanism (its 60mm cutter). U.S. Surgical introduced its 80mm device with a lockout in early 1990.

19. In August 1991, Ethicon introduced a 75mm open linear cutter with a lockout mechanism. Ethicon introduced a 55mm open cutter with a lockout in December 1991.

20. U.S. Surgical introduced a 30mm endoscopic linear cutter with a lockout mechanism in spring 1991. Ethicon and U.S. Surgical both introduced 60mm endoscopic cutters with lockout mechanisms in fall 1992. Ethicon introduced its 35mm endoscopic cutter in May 1993.

V. The 1990 Meetings Between Ethicon And U.S. Surgical Concerning The Fox Patent

21. In June 1990, Johnson & Johnson's chief patent counsel, Robert Minier, acting on Ethicon's behalf, sent a letter to U.S. Surgical's General Counsel, Thomas Bremer, stating that U.S. Surgical's linear cutters infringed the original Fox patent.

22. Mr. Minier, and another Johnson & Johnson patent lawyer, Paul Coletti, acting on behalf of Ethicon, then met with Mr. Bremer and with U.S. Surgical's in-house patent counsel, John Andres, twice, first in July, 1990 and then again in September, 1990. During the meetings, U.S. Surgical's counsel asserted that the original Fox patent was not infringed and was invalid in view of certain prior art.

23. The parties did not reach agreement in the course of the two meetings. There were no further communications between the parties about the Fox patent.

VI. The Fox Reexamination Proceeding

24. In November 1990, Ethicon requested that the PTO reexamine the original Fox patent.

25. In January 1991, the PTO denied the request for reexamination.

26. The PTO reconsidered its denial of the request for reexamination and on March 16, 1991, granted the request and decided to reexamine the Fox patent.

27. On July 2, 1991, the PTO examiner confirmed the patentability of all claims of the original Fox patent and issued his reasons for confirming the patent.

VII. The Fox Reissue Proceeding

28. 35 U.S.C. § 251 provides for reissuance of a previously issued patent for specified reasons:

"Whenever any patent is, through error without any deceptive intention, deemed wholly or partly inoperative or invalid, by reason of a defective specification or drawing, or by reason of the patentee claiming more or less than he had a right to claim in the patent, the Commissioner shall, on the surrender of such patent and the payment of the fee required by law, reissue the patent for the invention disclosed in the original patent, and in accordance with a new and amended application
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