A Medical Device Daily

Medtronic (Minneapolis) reported that its spinal business, Medtronic Sofamor Danek (Memphis, Tennessee), has filed suit against Biomet (Warsaw, Indiana) and its EBI Spine (Guaynabo, Puerto Rico) subsidiary in the U.S. District Court for the District of New Jersey, charging patent infringement.

The suit involves seven Medtronic patents and seeks injunctive relief and monetary damages. Three of the patents (U.S. nos. 6,916,320; 6,592,586 and 6,428,542) were purchased by Medtronic last year from Gary Michelson, MD (Medical Device Daily, April 25, 2005), involving single-lock anterior cervical plating systems used in cervical spinal fusions.

Medtronic claims that a cervical plate marketed by Bio-met under the trade name VueLock Anterior Cervical Plate System, and openly promoted, Sofamor Danek said, as a plate that has a Secure One Step Locking mechanism feature, infringes these Michelson patents, now owned by Medtronic.

Sofamor Danek said that in previous litigation Biomet and its subsidiary, Cross Medical (Irvine, California), were found to infringe two different Medtronic cervical plate patents.

The other patents (nos. 5,810,878; 6,036,692; 6,440,133; and 6,790,209) involve rod reducer instruments and surgical implantation methods commonly used in spinal surgeries to implant pedicle screws. Biomet s pedicle screw systems utilize a rod reducer instrument in a variety of lumbar and thoracic spinal fusion surgeries.

Rod reducers are integral to modern spinal surgery, reducing operating room time, improving efficiency and enabling surgical corrections that would be unattainable without the device, Sofamor Danek said.

Medtronic has invested heavily in money, time and resources to develop and incorporate our intellectual property into our commercial products, said Pete Wehrly, Medtronic senior vice-president and president of the company s Spine and Navigation business.

In other legalities, the Securities and Exchange Commission (SEC) reported that William Duffey Jr., U.S. District Judge for the Northern District of Georgia, entered a judgment concerning Mark Kishel, a director of Immucor (Norcross, Georgia), enjoining him from future violations of SEC rules.

The court ordered disgorgement against Kishel of $13,650, plus interest of $1,117.48. He also was ordered to pay a civil penalty of $13,650. Kishel consented to the entry of the judgment without admitting or denying the allegations.

The complaint alleges that on March 25, 2004, when Immucor announced its fiscal 3Q04 results, the company informed investors that it believed it would receive FDA clearance to market its Galileo blood analysis system in the fall of 2004. On April 16, 2004, Kishel and Immucor s board of directors were informed that the company expected early FDA approval to market Galileo, constituting material non-public information.

Shortly after leaving that meeting, Kishel purchased Immucor securities. After the close of the markets on April 26, 2004, Immucor reported FDA approval of the Galileo system.

On April 27, 2004, Immucor s stock traded up $4.18 (19.19%) to close at $25.96 on heavy trading volume, with Kishel receiving $13,650 in unrealized gain as a result.

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