Friday 16 January, 2009

Sirolimus-Eluting Stent System: Court declared Boston Scientific patent invalid

Boston Scientific Corporation today announced a decision by the Court of Appeals for the Federal Circuit. The case involves a Boston Scientific following patent, which in part is directed to drug-eluting stents and coating systems:
US6120536 (Assignee: Schneider): which covers a medical device having at least a portion which is implantable into the body of a patient, wherein at least a part of the device portion is metallic and at least part of the metallic device portion is covered with a coating for release of at least one biologically active material, wherein said coating comprises an undercoat comprising a hydrophobic elastomeric material incorporating an amount of biologically active material therein for timed release therefrom, and wherein said coating further comprises a topcoat which at least partially covers the undercoat, said topcoat comprising a biostable, non-thrombogenic material which provides long term non-thromobogenicity to the device portion during and after release of the biologically active material, and wherein said topcoat is substantially free of an elutable material.
In the decision, the Court found that the patent was invalid as obvious over the prior art. The case was an appeal by Johnson and Johnson of a 2005 jury verdict in the United States District Court for the District of Delaware that found the patent was valid and infringed by Johnson and Johnson's Cypher(R) Sirolimus-Eluting Stent System.
Link to court opinion Here

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