American Standard Inc. v. Pfizer Inc.

• Citation: 722 F. Supp. 86
• Decision Date: 10 October 1989
• Docket Number: Civ. A. No. 83-834 LON.
• Parties: AMERICAN STANDARD INC., Plaintiff, v. PFIZER INC. and Howmedica, Inc., Defendants.
• Court: U.S. District Court — District of Delaware

722 F. Supp. 86

AMERICAN STANDARD INC., Plaintiff, v. PFIZER INC. and Howmedica, Inc., Defendants.

Civ. A. No. 83-834 LON.

United States District Court, D. Delaware.

October 10, 1989.

COPYRIGHT MATERIAL OMITTED

COPYRIGHT MATERIAL OMITTED

Douglas E. Whitney, and Mary B. Graham of Morris, Nichols, Arsht & Tunnell, Wilmington, Del., for plaintiff; Jules P. Kirsch, Robert D. Katz, and Mavis K. Fowler of Cooper & Dunham, New York City.

Harold Pezzner of Connolly, Bove, Lodge & Hutz, Wilmington, Del., for defendants; John E. Kidd and Leora Ben-Ami of Anderson Russell Kill & Olick, and Gidon D. Stern and Stephen J. Harbulak, of Pennie & Edmonds, New York City.

LONGOBARDI, Chief Judge.

This patent infringement suit was brought by American Standard Inc. ("American Standard") against Pfizer Inc. ("Pfizer") and Howmedica, Inc. ("Howmedica"). Docket Item ("D.I.") 27. American Standard charges Pfizer with willful and literal infringement of United States Letters Patent No. 3,605,123 ("the '123 Patent") and seeks damages, treble damages and attorneys' fees pursuant to 35 U.S.C. ?? 284, 285. The Defendants deny the allegations of willful and literal infringement and filed a declaratory judgment counterclaim asserting that the '123 Patent is invalid in light of the prior art and unenforceable due to inequitable conduct before the United States Patent and Trademark Office ("PTO"). D.I. 34. The case was bifurcated such that damages will be the subject of a separate proceeding.

This Opinion represents the Court's findings of fact and conclusions of law. Because the parties raise a large number of separate and distinct issues, the Court's findings will be integrated and organized by issue.

I. BACKGROUND

Plaintiff American Standard is a corporation of the State of Delaware and has its principal place of business in New York, New York. Pretrial Order, D.I. 324, ? 3B. At the time the suit was filed, Howmedica was a wholly owned subsidiary of Pfizer, which subsequently became a division of Pfizer Hospital Products Group, Inc. and which is also a subsidiary of Defendant Pfizer, Inc. D.I. 324, ? 3C.

Plaintiff American Standard is the owner of the entire right, title and interest in the '123 Patent. D.I. 324, ? 3D. The '123 Patent issued to Plaintiff on September 21, 1971, based upon an application (Serial No. 820,184) filed April 29, 1969, naming Henry Hahn as inventor. D.I. 324, ? 3E; Plaintiff's Exhibit ("PX") 28. The '123 Patent contains 31 claims and was originally assigned to Melpar, Inc., Hahn's employer in 1969. When American Standard acquired the Westinghouse Airbrake Company in 1968, it also acquired its partially owned subsidiary, Melpar, Inc. Transcript, D.I. 340, Volume ("Vol.") G at 1621. American Standard subsequently merged Melpar, Inc. into American Standard in 1969 and assumed the rights to the '123 Patent when it issued in 1970. PX-30.

After American Standard divested itself of the Melpar business in several stages, mostly in 1970, Hahn resigned from Melpar and founded Artech, Inc. ("Artech"), which then acquired the Materials Laboratory assets of Melpar. D.I. 340, Vol. F at 1189, Vol. G at 1623. Hahn is President and Chairman of the Board of Artech and owns 15% of its common stock. D.I. 340, Vol. F at 1189-90. Although it has never manufactured any products under the '123 Patent, American Standard granted an exclusive license of the '123 Patent to Artech even before the '123 Patent was issued on September 21, 1971. D.I. 340, Vol. G at 1629. In 1980, the Bristol-Myers Company ("Bristol-Myers) approached American Standard inquiring about an exclusive license of the '123 Patent. Id. at 1630-31. On October 7, 1980, American Standard entered into a license agreement with Artech and Bristol-Myers in which Artech gave up its exclusive license in return for a percentage of the royalties that were to be collected from the exclusive license granted to Bristol-Myers and its subsidiary Zimmer Corp. ("Zimmer"). Id. at 1631; DX-275; PX-138. In 1984, Bristol-Myers' exclusive license was changed to a non-exclusive one at the request of American Standard so that it would have the authority to settle several lawsuits brought for infringement of the '123 Patent. D.I. 340, Vol. G at 1634-36.

This Court has jurisdiction over the subject matter of the infringement action pursuant to 28 U.S.C. ? 1338(a) and federal jurisdiction over the subject matter of the Defendants' declaratory judgment counterclaims pursuant to 28 U.S.C. ? 2201. D.I. 324, ?? 2, 3A. This Court also has personal jurisdiction over the parties and venue is proper as to the parties under 28 U.S.C. ? 1400(b) and 28 U.S.C. ? 1391(c). D.I. 324, ? 3A.

The relevant history of the invention at issue in this case begins with the use of modern biocompatible materials to replace damaged body parts such as hips and knees. Although wood, ivory and noble metals were initially used as prosthetic devices, they were not very useful because of the biological reaction of the body or the inadequate strength of the implant material. D.I. 340, Vol. A at 72. Metals with a smooth surface, such as Vitallium, titanium, tantalum and stainless steel were then used as prosthetic devices. Although each of these metals are biocompatible and have high strength to withstand the normal load bearing stresses of the body, each has also demonstrated a failure to provide a strong union between the prosthetic device itself and the surrounding bone tissue. PX-28, column ("col.") 2, lines 30-39.

Thus, one of the fundamental problems plaguing the development of prosthetic devices or implants for major joints such as the knee or hip is the attachment or fixation of the implant to the adjacent bone. Defendants' Exhibit ("DX") 102 at 101; DX-101A at 456; PX-28, col. 1, lines 39-53. The most common problem was the fixation of a prosthesis involving replacement of the upper portion of the femur or thigh bone and of the socket or acetabulum in the pelvis in which the upper ball shaped end of the femur rotates. At the time of the invention of the '123 Patent, there were three methods used to anchor a prosthetic device to the surrounding bone surface: (1) impaction of the prosthetic stem into the medullary cavity of the bone and held in place by comprehensive residual stress interaction (i.e., press-fit technique), (2) mechanical internal fixation through the use of screws, pins, nails or plates, and (3) methylmethacrylate polymerizing in situ as a cement or filler between the prosthesis and the bone. DX-102 at 101; DX-101A at 456; PX-28, col. 1, lines 33-38; D.I. 340, Vol. A at 71-72, 81, Vol. B at 249-50. Each one of these techniques, however, had problems that prevented the successful skeletal fixation of the implants. For example, prosthetic devices which were implanted by a press-fit technique could loosen when the areas of stress interaction between the implant and the bone were relaxed. DX-102 at 101. Similarly, mechanical devices used to achieve fixation of the prosthetic device often become loose over an extended period of time. Id. Finally, cemented implants proved not so advantageous because they predominantly fail at the interface between the bone and the outer surface of the cement due to a low level of adhesion strength. D.I. 340, Vol. A at 87, 90. If a prosthetic device or bone implant loosens, the results to the patient can be catastrophic, including failure of the implant or of the remaining bone which would require corrective surgery. D.I. 340, Vol. A at 87-88. Thus, scientists in the 1960's sought to resolve this problem of inadequate fixation of prosthetic devices.

Hahn, a metallurgist, sought to overcome the problem of inadequate prosthetic fixation to bone by proposing what he believed was a novel combination of biological and metallurgical concepts and materials. Hahn's concept was "to stimulate growth of bone tissue into an implant (for improved adhesion)" by using plasma flame spray technology to create a porous metal coating or surface layer into which bone tissue would grow and thereby attach the implant to the contacting bone surface. DX-6. The second concept was "the combination of the plasma flame sprayed coatings and wrought or cast metal substrates in surgical implants." Id. At trial, Hahn admitted that at the time of his invention it was well known that one could plasma flame spray a porous metal coating on metal and that open pores would promote bone ingrowth. Thus, Hahn testified that his invention was only a "combination of these known technologies." D.I. 340, Vol. G at 1571-72.

II. INFRINGEMENT

Prior to trial Plaintiff asserted literal infringement by Defendants' PCA products of claims 1-4, 9-18, 20-22 and 29-31 of the '123 Patent and infringement under the doctrine of equivalents of the remaining claims. D.I. 324, ? 3(F). At trial, however, Plaintiff withdrew sixteen claims and limited its case to proving the literal infringement of claims 1, 2, 10-16, 18, 21, 22 and 29-31 and has expressly not contended infringement by the doctrine of equivalents of those claims.

Section 27 of Title 35 of the United States Code provides that "whoever without authority makes, uses or sells any patented invention, within the United States during the term of the patent therefor infringes the patent." The Federal Circuit has stated that an allegation of literal infringement raises "at least two questions: (1) what is patented, and (2) has what is patented been made, used or sold by another." Fromson v. Advance Offset Plate, Inc., 720 F.2d 1565, 1569 (Fed.Cir.1983); Phillips Petroleum Co. v. U.S. Steel Corp., 673 F.Supp. 1278, 1344 (D.Del.1987), aff'd, 865 F.2d 1247 (Fed.Cir.1989). In other words, the Court's infringement analysis follows a two-step process of first construing the language of the asserted claims of the '123 Patent,¹ and then applying the properly construed claims to Defendants' accused PCA products to determine if they fall within the scope of the asserted...