Presentation by

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Presentation by Karan Aneja Aileen
DeSoto 4/16/2008
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Agenda

• Background
• The Technology and Patents
• The Case
• The Result
• Questions

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Company Background
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 JJ
merger

• Medical device corporation and pioneer in
  innovative devices and products for
  interventional vascular medicine and
  electrophysiology
• CYPHER drug-eluting stent

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Drug-eluting Stents

• 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

• 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.

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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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History August 2007

• 6 Patents involved
• 4 Kasterhofer patents
• 1 Forman patent
• 1 related to Forman - dropped from case
• Cordis responds 5 motions
• Kastenhofer patents invalid for failure to
  satisfy the Written Description requirements
• Kastenhofer patents invalid for Obviousness
• Forman Patent is invalid for Obviousness
• Forman Patent is Not Infringed
• Limit BSCs Damage claims

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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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Catheter

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Patent Michael R. Foreman

• Two patents, but one thrown out because too
  related to other patents. Both of Foremans
  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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Patent 5
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The Result

• Kastenhofer patents invalid for failure to
  satisfy the Written Description requirements
• BSC Wins
• Kastenhofer patents invalid for Obviousness
• BSC Wins
• Forman Patent is invalid for Obviousness
• Cordis Wins
• Forman Patent is Not Infringed
• Cordis Wins
• Limit BSCs Damage claims
• BSC Wins

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Questions
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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)