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This article was originally published in The Gray Sheet

Executive Summary

ICU CHARGES BAXTER, B-D WITH INFRINGEMENT OF I.V. CONNECTOR PATENT in a suit filed in the U.S. District Court for the Central District of California on April 6. ICU Medical alleges that certain Interlink products manufactured and marketed by Becton Dickinson under license from Baxter, as well as Baxter's Needle Lock device, infringe a patent issued to ICU on April 6. The patent covers "a novel method of infusing two fluids into a patient using a piggyback connector in intravenous (I.V.) tubing," according to the suit. Current ICU products used to practice the patented method include various components of the Click Lock intravenous connection system, such as the Click Lock housing and needle, the matching injection port, I.V. sets with the injection port mounted on them, replacement needles and the Piggy Lock housing, according to the firm. The Click Lock and Piggy Lock are 510(k) cleared and were market launched in 1985 and 1991, respectively. The products that ICU claims infringe the patent include B-D's Interlink y-lock cannula and the Interlink threaded lock cannula. The cannulas constitute male components of a needleless injection technology developed by Baxter, which manufactures and markets the female components of the Interlink system including I.V. sets, adapters for vials, and specially designed patient injection sites. The Interlink system has been marketed in the U.S. and abroad since January 1990 and was cleared for marketing via 510(k) in August 1988. Baxter's Needle Lock device is a separate product consisting of a steel needle with a plastic sheath around it. ICU is seeking the immediate recall and destruction of the allegedly infringing devices, treble damages, and attorney's fees and costs. The suit also seeks "preliminarily and permanently" to enjoin the defendants from manufacturing or selling products that infringe the ICU patent. ICU devices covered by the firm's recent patent constituted 93% of its sales in 1992. Total sales were $10.2 mil., producing net earnings of $4.9 mil., according to the firm. The company estimates that sales of Interlink and Needle Lock products exceeded $35 mil. in 1992. According to ICU, Baxter was once the firm's exclusive distributor under an agreement signed in December of 1987 and terminated in August 1988. The arrangement covered all ICU product lines including the Click Lock housing and related devices, the firm says. Both Baxter and B-D say that they are reviewing the suit. Baxter says that it has patents covering its technology and that further comment is being reserved pending its review. The suit is not the first time Baxter has faced accusations of patent infringement with respect to its Needle Lock device. A January 1990 suit filed by International Medication Systems alleged that the device infringed a patent held by IMS for a recessed needle designed to prevent accidental needle sticks ("The Gray Sheet" Aug. 27, 1990, In Brief). According to IMS, Baxter agreed to pay for a "paid up license under the patent" to settle the suit.

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