American Cyanamid Co. v. US Surgical Corp., Civ. No. 5:91CV-352(FBB).

• Decision Date: 30 November 1992
• Docket Number: Civ. No. 5:91CV-352(FBB).
• Citation: 833 F. Supp. 92
• Parties: AMERICAN CYANAMID CO. v. UNITED STATES SURGICAL CORP.
• Court: U.S. District Court — District of Connecticut

833 F. Supp. 92

AMERICAN CYANAMID CO. v. UNITED STATES SURGICAL CORP.

Civ. No. 5:91CV-352(FBB).

United States District Court, D. Connecticut.

November 30, 1992.

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William H. Prout, William J. Doyle, Wiggin & Dana, New Haven, CT, Berj A. Terzian, John J. Lauter, Victor Balancia, Pennie & Edmonds, New York City, for plaintiff.

Ann H. Rubin, Anthony M. Fitzgerald, J. Christopher Rooney, Carmody & Torrance, New Haven, CT, Jay Paul McGrath, Clark E. Walter, Bradford J. Badke, Dewey Ballantine, New York City, for defendant.

RULING ON MOTION FOR PRELIMINARY INJUNCTION

ELLEN B. BURNS, Senior District Judge.

This infringement action involves United States Patent No. 4,135,622 ("the '622 patent"), entitled "Packaged, Desiccated Surgical Elements," which was issued on January 23, 1979 to American Cyanamid Company ("Cyanamid") as assignee of the inventor, Arthur Glick. This Court has jurisdiction over the subject matter under 28 U.S.C. § 1338(a), and venue is proper under 28 U.S.C. § 1400(b).

Cyanamid has moved for an order enjoining United States Surgical Corporation ("U.S. Surgical") pendente lite from making, using, or selling packaged synthetic absorbable sutures that infringe the '622 patent, which are marketed by U.S. Surgical under the brand name Polysorb. After an eight-day hearing to the Court, the parties' filing of post-hearing memoranda with proposed findings of fact and conclusions of law, and oral argument, and after considering the sufficiency, weight, and credibility of the testimony of the witnesses,¹ their demeanor on the stand, the documentary evidence admitted at the hearing,² and the post-hearing memoranda, the Court enters the following findings of fact and conclusions of law, which are embodied in this opinion as permitted by Fed.R.Civ.P. 52(a). For the reasons that follow, the Plaintiff's motion for a preliminary injunction is denied.

FINDINGS OF FACT

I. BACKGROUND

A. The Parties

1. Plaintiff American Cyanamid Company is a corporation organized and existing under the laws of the State of Maine with a place of business at Stamford, Connecticut. Cyanamid manufactures and sells a variety of chemical, agricultural, and medical products with sales in 1990 of $4.5 billion. (Compl. ¶ 3; DX BT).

2. Cyanamid, through its Davis & Geck division, manufactures and sells a competitive full-line of sutures used in medical surgical procedures. Cyanamid also markets other wound closure products, including external skin staplers and stainless steel needles. (Clifford Tr. 1188, 1190, 1192; PX 75 (IMS Market Data for Fixed Head and Rotating Head Skin Staplers); PX 83, at 20 (Cyanamid Annual Report (1990))). Davis & Geck's worldwide sales in 1990 were approximately ^* (Clifford Tr. 1191).

3. U.S. Surgical is a corporation organized and existing under the laws of the State of Delaware with its principal place of business in Norwalk, Connecticut. U.S. Surgical manufactures and sells a variety of competitive wound closure products and endoscopic instruments, including internal and external surgical stapling instruments, surgical clips, clip appliers, and trocars. (Knarr Tr. 1757-58; PX 82 (U.S. Surgical Annual Report (1990))). In March 1991 U.S. Surgical introduced a full-line of suture products, which are manufactured at its principal manufacturing facility in North Haven, Connecticut. (Knarr Tr. 1758, 1762-62; DX BQ).

4. U.S. Surgical has grown rapidly in recent years. From 1987 to 1990, its annual sales doubled from $252 million to $514 million, and sales for the first three quarters of 1991 exceeded $600 million. (Knarr Tr. 1758-59; PX 82, at 43).

B. The Witnesses

5. The following witnesses testified in behalf of Cyanamid in its case-in-chief or in rebuttal: Gabor B. Levy, Ph.D., a consultant in the scientific instruments field and editor of American Laboratory and Biotechnology Lab (PX 9); Elvira Longordo, Ph.D., an employee in the physical chemistry laboratory of the Scientific Services Department of Cyanamid; A. Charles Tanquary, Ph.D., a polymer chemist with over 35 years of experience in the field of polymer research and technology (PX 62); William K. Brandt, Ph. D., a marketing and sales management consultant (PX 74); John F. Clifford, Division Vice President of the Davis & Geck division of Cyanamid; Leo Gaudette, a Regional Sales Manager of the Davis & Geck division of Cyanamid; Dean Gulezian, a Sales Representative for the Davis & Geck division of Cyanamid; Martin Adelman, Professor of Law at the Wayne State University School of Law and editor of Patent Law Perspectives (PX 73); Michael Zeide, M.D., an orthopedic surgeon practicing in West Palm Beach, Florida; Chermeine Rivera, a chemist employed by Cyanamid; and Peter K. Jarrett, Ph.D., Associate Research Fellow of the Polymer Technology Group of Cyanamid.

6. The following witnesses testified in behalf of U.S. Surgical in opposition to the motion for a preliminary injunction: John R. Schaefgen, Ph.D., a consultant in the field of polymer chemistry with over 30 years of experience (DX T); David M. Wiles, Ph.D., a consultant and former head of the Division of Chemistry of the National Research Council of Canada with over 30 years of experience studying the kinetics of polymer reactions (DX U); Richard R. Geoffroy, an engineer with over 25 years of experience in test method development (DX S); John D. Corbitt Jr., M.D., Chairman of the Department of Surgery at J.F.K. Medical Center (DX Q); Donald S. Chisum, Professor of Law at the University of Washington School of Law and author of a seven-volume treatise on patent law (DX R); Donald Kaplan, Ph.D., U.S. Surgical's Vice President of Materials Research who developed the accused product, Polysorb; and Robert Knarr, U.S. Surgical's Vice President of Marketing.

C. General Information — Sutures

7. There are seven types of sutures: catgut, silk, nylon, polypropylene, steel, Dacron, and synthetic absorbable. Sutures are manufactured in many different sizes and are typically dyed, coated, and needled. (Tanquary Tr. 541-42; Knarr Tr. 1760-61; DX BQ).

8. A synthetic absorbable suture is made principally of a synthetic polymer, which is designed to hold tissue together for only a few weeks while healing occurs. Body moisture then breaks down the synthetic absorbable suture into components that the body can metabolize. (Tanquary Tr. 541; Kaplan Tr. 820; Wiles Tr. 1377-78; Knarr Tr. 1780). As such, synthetic absorbable sutures must retain stability and in vivo strength, yet deteriorate after the critical wound healing process. (Wiles Tr. 1378; Tanquary Tr. 550).

9. The term "synthetic polymer" refers to a long chain of material comprising small chemical building blocks usually made from petrochemical sources. (Tanquary Tr. 541; Kaplan Tr. 731; Wiles Tr. 1376-77).

10. Synthetic absorbable sutures are broken down in the body by a process called hydrolytic degradation. In this process, water attacks and breaks the ester linkages in the polymer chain to facilitate absorption into the body. (Tanquary Tr. 541, 549-50; Wiles Tr. 1378-79).

D. The '622 Patent

11. The '622 patent relates to packaged synthetic absorbable surgical elements. Claim 1 of the '622 patent provides:

A package comprising an air-tight sealed container fabricated from a material which is substantially impervious to water vapor, said container having therein a storage stable sterile synthetic surgical element of a polymer subject to hydrolytic degradation to non-toxic, tissue-compatible absorbable components, said polymer having glycolic acid ester linkages, said storage stable sterile synthetic surgical element further characterized in that the absorbed water moisture in the sterile surgical element is at or less than 0.25% by weight of the sterile surgical element, in the sterile enclosure.

(PX 1, col. 21, 11.15-27; DX DP).

E. Polysorb

12. Dr. Donald S. Kaplan, Vice President of Research at U.S. Surgical, developed the Polysorb synthetic absorbable suture. (Kaplan Tr. 745, 772-73).

13. Polysorb is packaged in an airtight, water impervious foil package. (Kaplan Tr. 815; Tanquary Tr. 554; PX 64; PX 65).

14. Polysorb is a sterile synthetic absorbable suture composed primarily of a 90/10 copolymer of glycolic and lactic acids. (Kaplan Tr. 809, 828; Wiles Tr. 1376-77; Tanquary Tr. 555; PX 64).

15. Polysorb has glycolic acid ester linkages, (Wiles Tr. 1496), and also contains glycerin, a terpolymer coating, and water.

16. Polysorb is storage stable and subject to hydrolytic degradation to non-toxic tissue compatible absorbable components. (Tanquary Tr. 555-56; Wiles Tr. 1495; PX 64; PX 65).

17. After interpreting the meaning of surgical element, a principal issue is thus whether "the absorbed water moisture in the sterile surgical element is at or less than 0.25% by weight of the sterile surgical element."

18. The filaments in Polysorb are more numerous and smaller in diameter than those in competitive products, and they are braided differently, with an inner core of filaments and an outer braided portion. (Kaplan Tr. 750-59; Tanquary Tr. 562; Wiles Tr. 1376; PX 66; DX DU; DX DV; DX DW).

19. The glycerin, water, and 90/10 copolymer are in dynamic equilibrium within the Polysorb package. (Wiles Tr. 1393; DX FY). These components move rapidly throughout the system and hydrogen bond³ with each other in multiple configurations. (Wiles Tr. 1389, 1391-93, 1403, 1408-11, 1434-36, 1450-51).

20. This equilibrium and interaction "no longer allows you to differentiate between water that's part of glycerin or water that's part of the polymer or water that's part of itself." (Wiles Tr. 1403, 1451, 1480-81). Consequently, the relative hygroscopicity of water, glycerin, and the 90/10 copolymer, standing alone, will not apply in a system where water, glycerin, and the 90/10 copolymer are mixed together. (Wiles Tr. 1402-03, 1479-82).

21. The 90/10 copolymer of...