Full article reprinted from "The Gray Sheet" - November 3, 2008
Find out how Medtronic finally reentered the U.S. market with popular rapid-exchange (RX) coronary catheter delivery systems Oct. 30 after an eight-year absence, prompting an immediate patent infringement suit from Abbott.
Full article reprinted from "The Gray Sheet" - November 3, 2008
Medtronic finally reentered the U.S. market with popular rapid-exchange (RX) coronary catheter delivery systems Oct. 30 after an eight-year absence, prompting an immediate patent infringement suit from Abbott.
Last week's launches of updated RX versions of Medtronic's Endeavor drug-eluting stent system, MicroDriver bare-metal stent system and NC Sprinter balloon catheter came one day after a California judge dissolved a 2000 injunction blocking Medtronic from selling RX products.
Prior to Medtronic's announcement, the firm was the only one of the four U.S. drug-eluting stent makers to be limited to the older over-the-wire delivery system technology (and an alternate multi-exchange system).
Access to the more user-friendly RX systems, which Medtronic estimates are used in about 70%-80% of U.S. coronary angioplasties, will add market share that translates directly into increased long-term revenue, the company says.
Prior to gaining access to the RX market, Medtronic anticipated reaching a stable market share percentage "in the mid-teens" for its Endeavor drug-eluting stent, launched Feb. 1, according to Medtronic spokesperson Joseph McGrath.
But with the access to RX, "we expect that that market share will stabilize in the high-teens," McGrath said.
Abbott's RX patent, inherited from its 2006 acquisition of Guidant's vascular business, was scheduled to expire on Oct. 29.
But in July, after the firm launched its Xience V everolimus-eluting stent, Abbott requested an extension for the patent (1#5,451,233) under a statute that allows manufacturers to make up for time lost in FDA pre-market review (2"The Gray Sheet" Sept. 1, 2008, p. 3).
FDA has yet to complete its portion of the patent extension review, which has attracted an opposing citizen's petition from AngioScore (Abbott issued a response to this petition Oct. 30). AngioScore wants to launch an RX version of its AngioSculpt balloon catheter. In the meantime, on Oct. 14, the U.S. Patent and Trademark Office granted Abbott's patent an interim one-year extension.
Boston Scientific and Johnson & Johnson sell RX-delivered stents under licensing agreements with Abbott.
In an Oct. 29 3filing with the same California federal court that imposed and recently dissolved the original injunction, Abbott charges Medtronic with infringing its RX patent. The suit requests an injunction until the patent expires, in addition to tripled damages for willful infringement.
But McGrath says that Medtronic is "confident that any appeal by Abbott will lack merit and will not prevent us from offering our angioplasty products on RX." He says the firm does not believe that it will end up being liable for any major damages in the case.
- David Filmore
Sign up for your 30-day, risk-free trial of "The Gray Sheet" today.
"The Gray Sheet" gives you 51 issues per year filled with useful articles that will help you meet your business and regulatory objectives
.jpg)
.jpg)
