A Medical Device Daily
A U.S. District Court judge enforced a settlement between Abbott Laboratories (Abbott Park, Illinois) and Israeli company Medinol (Tel Aviv) that removed an entanglement for a key drug-coated stent heart device Abbott plans to bring to the U.S.
Tuesday's ruling involves a settlement that was reached in mid-2006 but became the subject of disagreement over how broadly Abbott could use a license for a stent patent held by Medinol. The Israeli company felt the license should be restricted to Abbott's Vision and Xience stents, while Abbott felt it had agreed to unrestricted use of the license for any present or future stents.
Judge Shira Scheindlin of the U.S. District Court for the Southern District of New York backed Abbott, granting Abbott's motion to enforce the settlement. She argued that if Medinol had wanted to restrict the license to two products, it should have said so on the record, even if the parties had discussed that issue.
"I decline to add a material term to an agreement that was never expressed on the record," Scheindlin said in the order.
At issue are stents that Abbott acquired through last year's purchase of Guidant's (Indianapolis) vascular business. Vision is a bare-metal device already on sale in the U.S., while Xience is a closely watched drug-coated stent that's now on sale internationally. Abbott plans to launch Xience in the U.S. in the first half of 2008 pending regulatory approval.
"We're pleased the court affirmed Abbott's view of the settlement terms, granting us unrestricted use of Medinol stent patents involved in the case on all present and future stents," Scott Stoffel, a senior manager at Abbott, told Medical Device Daily in an email.
Coated stents use medication to combat re-narrowing, and are the most popular type of stent in the U.S., although usage has been hurt by concerns about links between first-generation devices and a slightly elevated risk for dangerous clots, compared with bare-metal stents. Boston Scientific (Natick, Massachusetts) bought the bulk of Guidant and struck a deal with Abbott to market the Xience stent under a different name — Promus — while sharing profits with Abbott.
Medinol in 2003 sued Guidant alleging that Guidant products infringed upon certain Medinol patents. A ruling in early 2006 that Guidant infringed upon one patent preceded the settlement, through which Abbott agreed to pay an undisclosed amount to license the patent.