US v. Telectronics, Inc., Civ. A. No. 80-M-981.

Decision Date07 April 1987
Docket NumberCiv. A. No. 80-M-981.
Citation3 USPQ 2d 1571,658 F. Supp. 579
PartiesUNITED STATES of America, Plaintiff, and Zimmer, Inc., Involuntary Plaintiff and Counterclaim Defendant, v. TELECTRONICS, INC. and BGS Medical, Inc., Defendants and Counterclaim-Plaintiffs.
CourtU.S. District Court — District of Colorado

COPYRIGHT MATERIAL OMITTED

John Fargo, Commercial Litigation Branch, Civ. Div., Dept. of Justice, Washington, D.C., Henry Solano, Asst. U.S. Atty., Denver, Colo., for plaintiff.

James D. Hinga, Baker & Hostetler, Denver, Colo., for involuntary plaintiff and counterclaim defendant.

Bruce G. Klaas, Klaas & Law, Denver, Colo., Michael I. Rackman, Gottlieb, Rackman & Reisman, New York City, William C. Nealon, Suffield, Conn., Charles Goldberg, Peter L. Edwards, Rothgerber, Appel, Powers & Johnson, Denver, Colo., for defendants.

FINDINGS OF FACT, CONCLUSIONS OF LAW, AND ORDER

MATSCH, District Judge.

This is an action for patent infringement under 35 U.S.C. § 271. The court has jurisdiction under 28 U.S.C. § 1338. Plaintiff United States owns Patent No. 3,842,841, entitled "Constant Current Power Pack For Bone Healing And Method Of Use," issued on October 22, 1974 on an application filed on October 29, 1971 in the names of Drs. Carl T. Brighton, Zachary B. Friedenberg, and William Redka, as inventors. For convenience, this patent will be referred to as the '841 patent, or Brighton patent. The plaintiff alleges infringement of claims 1, 3, 4 and 5. The patent resulted from work done in performing a contract between the Office of Naval Research and the University of Pennsylvania. The named inventors were all employed by the University of Pennsylvania.

Involuntary plaintiff Zimmer, Inc. was granted a limited exclusive license in the Brighton patent by the Navy on or about October 31, 1977, for a term of ten years.

The patented invention is a device for expediting the healing of fractures and other bone defects. The devices involved are generally known as bone growth stimulators, and Zimmer's is sold under the trademark Zimmer DCBGS. The Zimmer device is quite similar to the preferred embodiment of the invention shown in the patent.

Defendant Telectronics, Inc. is an Australian-owned medical technology company whose main place of business is in Englewood, Colorado. Defendant BGS Medical, Inc. is a related corporation, also located in Englewood, and is the entity under whose name the business is now conducted. The trademark used by defendants for their product is OSTEOSTIM. While the Model 2000 is now being sold, earlier models were the S-12, HS-12 and XM-12. The OSTEOSTIM-2000 is the same in all relevant respects to all single-anode bone growth stimulator devices designed to expedite the healing of long bone fractures previously manufactured or sold by defendants Telectronics and BGS Medical Corporation, or their predecessors, or Telectronics Proprietary, Limited. The accused device in this case will be referred to as the OSTEOSTIM.

The Brighton patent is directed toward a device for expediting the healing of a fracture or bone defect through the use of a low level constant direct current applied to the site of the fracture via a cathode placed internally at the site of the fracture. Such devices are sometimes referred to as direct current ("DC") bone growth stimulators. The only direct current bone growth stimulators approved for use in the United States are the Zimmer DCBGS (or Quadpak) and the OSTEOSTIM made by defendants.

Normally fractures of bones heal naturally as a result of the body's own reparative process in several stages. First, inflammation occurs at the point of injury followed by the formation of soft callus, which is cartilage. This gives way to hard callus formation, in which the soft cartilaginous tissue is replaced with fiber bone. Finally, remodelling occurs in which the fiber bone is replaced with lamellar bone. In bridging the fracture, the first bone formed is subperiosteal, i.e., below the periosteum which is the outer surface of the cortex of the bone. Endosteal bone also forms to bridge the fracture on the inside of the bone. Then the interfragmentary gap is filled with new bone, uniting the cortices.

DC bone growth stimulators are particularly useful in the treatment of nonunions. A nonunion is a fracture which has not healed naturally within an extended period of time, and in which all natural reparative processes have ceased. Nonunions occur in about 5% of all long bone fractures. Prior to the advent of direct current bone growth stimulators, the conventional treatment for a nonunion was bone grafting, which involved removing a portion of the hip bone of the patient and grafting this portion to the nonunion, in the hope that it will stimulate further bone growth and result in a healed fracture. Bone grafting involves major surgery, is painful to the patient and requires about 4-10 days of hospitalization. If the first bone graft is not successful, another must be tried. If this is not successful, the limb may be amputated.

DC bone growth stimulators have been successful in treating nonunions, even in instances where bone grafting has previously failed. The Zimmer Quadpak and the Telectronics OSTEOSTIM enjoy a success rate of about 70-85% in healing nonunions. This is at least as good as the rate of success using bone grafting and avoids the necessity for removal of a portion of the patient's hip for a graft, along with the attendant pain. Furthermore, use of a bone growth stimulator saves hospitalization time, and its attendant costs, over that required for bone grafting.

The four claims of the patent alleged to be infringed are as follows:

1. A system for expediting the healing of bone fractures and bone defects in a living being comprising:
constant current source means for providing a constant value of current despite changes in load;
means for connecting said constant current means to the living being, such connection acting to produce current flow into said fracture or defect,
said connecting means including further means for application internally of said living being at the fracture or defect site,
said constant current being a selected value within a predetermined microampere range so as to promote bone formation at the fracture or bone defect site and avoid fibrous tissue formation in other areas of the living being.
3. The system as defined in claim 1 wherein said constant current means comprises miniature solid state means suitable for mounting on the living being in close proximity to said fracture or defect.
4. The system as defined in claim 1 wherein said cathodic electrode is positionable within said fracture or defect.
5. The system as defined in claim 1 wherein said current is in the range of from substantially 5 microamperes to substantially 20 microamperes.

Exhibit 1.

The magnitude of the constant current in the embodiment of the invention illustrated in the patent is 10 microamperes, although a range of 5-20 microamperes is said to be useful. Defendants use a constant current of 20 microamperes. When using the product of either party, the cathode (negative terminal) is placed in the defect site. The Zimmer cathode is made of stainless steel, the material described in the patent. The OSTEOSTIM cathode is made of titanium. The major difference between the products of the parties pertains to the anode (positive terminal). As disclosed in the patent drawing and accompanying description, and as marketed by Zimmer, the anode is placed on the skin of the patient. So is the power pack (current source) itself. The only internal element is the cathode — a pin which is inserted through the skin into the defect site. This technique avoids the need for surgery; after several months of treatment, the cathode pin is simply pulled out. The OSTEOSTIM device, on the other hand, is completely implanted, an embodiment which while not shown in the patent drawing is nevertheless described. The power pack and the anode of the OSTEOSTIM are placed in soft tissue near the bone. The original OSTEOSTIM S-12 had a power pack from which two wires extended, the wires terminating respectively at a titanium cathode for placement in the defect site, and a platinum anode for placement in the soft tissue. In all of the later models, including the OSTEOSTIM-2000, the anode wire was omitted. The anode is the case itself—titanium with a patch of platinum.

Literal Infringement

The defendants' denial of infringement in this case is based solely on the defendants' anode and case being used internally. Accordingly, the critical question in the case is whether the language of claim 1 (and with it, the dependent claims) is limited to a skin anode.

The defendants' contention is that an internal anode could not come within the literal language of claim 1 because fibrous tissue formation inevitably results from such an implant. Therefore, fibrous tissue formation could not be avoided in the dictionary sense of "keep away from" or "stay clear of". Webster's Third New International Dictionary, 151 (1971).

The patent is for a medical device — an apparatus which will promote healing. To accomplish that purpose, it must, of course, avoid injury or adverse medical results. It must not do damage. Fibrous tissue forms as a response to a foreign body. That is called encapsulation. Fibrous tissue also results from any trauma. Electrical current produces fibrous tissue. Fibrinoid necrosis is the term used to describe dead fibrous tissue. Fibrinoid necrosis is damage which must be avoided.

The defendants made a conscious decision not to avoid the formation of fibrous tissue, electing to tolerate the amount formed from implanting the case/anode because its effect is not so deleterious as to outweigh the benefit of greater freedom of movement for the patient. Additionally, an implanted case/anode does not have a wire penetrating the skin and thus the risk of infection is reduced. Drs. Brighton and...

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