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This article was originally published in The Gray Sheet

Executive Summary

BECTON DICKINSON APPEAL OF SAFETY CATHETER PRELIMINARY INJUNCTION is being considered by the U.S. Court of Federal Claims. The injunction was ordered on July 16 as part of a patent infringement suit between Johnson & Johnson subsidiary Critikon and B-D. Issued by U.S. District Court for the District of Delaware, the order enjoins B-D from "making, using, or selling" its Insyte Saf-T-Cath intravenous catheter. However, on July 26 B-D was granted a stay of the injunction pending a decision on the appeal, which is expected this week. The litigation dates back to March, when Critikon, which manufactures and markets the Protectiv safety catheter, filed suit against B-D alleging that Insyte infringes patent 4,952,207 (the "Lemieux" patent). The patent covers technology involving a needle guard that automatically caps the tip of a needle emerging from an IV catheter. The complaint was amended April 1 to include patent 4,978,344 (the "Dombrowski" patent), which also covers safety catheter technology. B-D maintains that its device does not infringe the two Critikon patents and "avers that both patents are invalid and unenforceable," according to the order for the preliminary injunction. The court explained that it granted Critikon's motion for injunction because the firm "demonstrated a likelihood of success on the merits, and that it [would] suffer irreparable harm" if the injunction was not granted. Critikon "made a clear showing" that the B-D safety catheter bears the design claims in the Lemieux patent, the ruling states. In addition, Critikon has "a reasonable likelihood of succeeding" in the case based on "the doctrine of equivalents," under which B-D's catheter would be held to infringe the Lemieux patent if the device "performs the same function, in the same manner, to obtain substantially the same result" as a catheter "disclosed" in the Lemieux patent. The ruling comments that "if courts refuse to grant preliminary injunctions where the infringement is as clear as it is in this case, the rights of patent holders will become diluted, and potential infringers will be encouraged to play the odds." The court also found that Critikon is likely to succeed on other issues, such as B-D's allegation that the Lemieux patent is inoperable, which would render the patent non- enabling. According to B-D, the Lemieux patent does not describe the technology used in Critikon's Protectiv. That technology was invented by Luther Medical Products, which licenses the technology to Critikon. B-D says that it has offered to resolve the patent dispute by taking a license from Critikon, but that Critikon has not responded to the offer.

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