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Confidential Presentation by Karan Aneja Aileen DeSoto 4/16/2008
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Confidential Agenda Background The Technology and Patents The Case The Result Questions
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Confidential Company Background –Medical device corporation and pioneer in innovative devices and products for interventional vascular medicine and electrophysiology –CYPHER drug-eluting stent Founded 1979, Natick –Worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties –TAXUS drug-eluting stent Founded 1959, Miami, Florida 1996 J&J merger
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Confidential Drug-eluting Stents Used in Coronary Angioplasty to reduce restenosis Cordis CYPHER sirolimus- eluting stent approval – 2003 BSC TAXUS paclitaxel-eluting stent approval - 2004 Over one million placed in 2004. Drug-eluting stent is a coronary stent (a scaffold) placed into narrowed, diseased coronary arteries that slowly releases a drug to block cell proliferation – wiki
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Confidential History – BCS TAXUS vs. Cordis CYPHER Started in 2000 June 2005 – Delaware Netherlands Cordis vs. BSC - TAXUS stent infringing BSC accuses Cordis’ CYPHER drug-eluting stent system of infringing October 2005 – San Francisco BSC asserted 4 other patents against the CYPHER system August 2007 – US District Judgment
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Confidential History – August 2007 6 Patents involved 4 Kasterhofer patents 1 Forman patent 1 related to Forman - dropped from case Cordis responds – 5 motions 1.Kastenhofer patents invalid for failure to satisfy the Written Description requirements 2.Kastenhofer patents invalid for Obviousness 3.Forman Patent is invalid for Obviousness 4.Forman Patent is Not Infringed 5.Limit BSCs Damage claims
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Confidential Patents: Gerhard Kastenhofer 3 device patents (5,843,032, 6,027,477, & 6,471,673) and 1 method patent (5,961,765) 3 device patents very similar. All patents contained the same abstract and similar claims to one another. An interventional catheter is a tube used during angioplasty that contains 2 layers of superposed material. The inner layer has low friction coefficient(which prevents the guide wire to get clogged), while the outer layer has a higher friction of coefficient. The balloon is on the placed on the catheter tube which allows for the surrounding catheter tube to expand. The method claim dealt with the actual process of making the catheter itself. The patents is a step by step process that gives a detailed description of how to build the catheter in order to fulfill the device claims for the other 3 device patents.
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Confidential Catheter
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Confidential Patent: Michael R. Foreman Two patents, but one thrown out because too related to other patents. Both of Foreman’s patents dealt with the actual process of making the catheter. Patent 5 in this case deals with the method of creating catheters using lasers to bond the angioplasty balloon to the catheter. The process states that concentrated laser energy along the site where the catheter will bind to the balloon can be done and is more effective because of high absorption of laser energy, minimization of heat transfer and reduction of crystallization near the bond sites. This allows for the production of a simpler, more cost efficient, and more effectively designed catheter for angioplasty balloons.
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Confidential Patent 5
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Confidential The Result 1.Kastenhofer patents invalid for failure to satisfy the Written Description requirements BSC Wins 2.Kastenhofer patents invalid for Obviousness BSC Wins 3.Forman Patent is invalid for Obviousness Cordis Wins 4.Forman Patent is Not Infringed Cordis Wins 5.Limit BSCs Damage claims BSC Wins
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Confidential Questions
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Confidential Bibliography Boston Scientific Website Cordis Website Scientific Evidence and Expert Testimony - Patent Litigation Fall 2007, Prof. Morris Sarasota Memorial Health Care System website (image) Brian Tombaugh, Pictopia (image) Washington University (image)
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