UC Berkeley IEOR 190G Fall08 Patent Engineering

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UC BerkeleyIEOR 190G Fall08 Patent
Engineering

• MONTIGNY Marie 2008, Dec 8.
• École des Ponts (Engineering Business School)

And other patent disputes related to Palmaz
ballon expandable stent technology
VS.
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Agenda

• Companies background
• Products involved the bare-metal and
  drug-eluting stents
• Overview of the cases
• Focus on the first case technical perspectives
• Result of the case and timeline
• A few words about the other cases
• Bibliography

IEOR 190G Boston Scientific vs Cordis
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The companies

• Boston Scientific is a worldwide developer,
  manufacturer and marketer of less-invasive
  medical devices, providing medical devices and
  associated concentrates for use in surgical
  procedures.
• Medical fields vascular surgery, radiology,
  pulmonary medicine and urology,
• 2 business groups Cardiovascular and Endosurgery
  

• Johnson Johnson is a global manufacturer of
  health care products as well as a provider of
  related health service.
• Cordis is a worldwide leader in developing and
  manufacturing interventional vascular technology,
  and providing physicians with breakthrough
  treatment solutions for peripheral vascular
  disease as weel as innovative solutions for
  neurovascular therapies.
• 3 business groups Cardiology, Endovascular and
  Neurovascular

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The products bare-metal and drug-eluting stents

• A stent a tube that is inserted into a natural
  conduit of the body to prevent or counteract a
  disease-induced localized flow constriction
• Stents involved in our cases Coronary stent

2nd generation Drug-eluting stent a coronary
stent (a scaffold) placed into narrowed, diseased
coronary arteries that slowly releases a drug to
block cell proliferation.
1st generation Bare-metal stent a vascular
stent without a coating
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Overview of some cases
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Why so many cases ?

• Every year new cases, trials, verdicts, appeals
• So patent disputes are very common in the field.
• They often involve small differences in the
  design of the stents or the drugs theyare coated
  with (for DES).
• The medical market related to interventional
  cardiology is very lucrative -gt billions dollars
  in damage
• Our detailed example

IEOR 190G Boston Scientific vs Cordis
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The technology the Palmaz ballon expandable stent

• Cordis is the owner of the 762 patent (also
  called the Palmaz balloon expandable stent
  patent, or simply the Palmaz patent)
• The 762 patent discloses a coronary stent that
  can be mounted on an angioplasty balloon and
  delivered to a target location intraluminally
  (i.e. through the vascular system) by a catheter.
  Once the stent and balloon reach the targeted
  location, the balloon is inflated to expand the
  stent to a desired size.

 expandable prosthesis 
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The technology the stent placement (A)

• A the catheter is inserted across the lesion.

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The technology the stent placement (B)

• B the balloon is inflated, expanding the stent
  and compressing the plaque.

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The technology the stent placement (C)

• C The catheter and deflated balloon have been
  removed..

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• Cross-sectional view of the prosthesis for a body
  passage-way
• - Fig3 having a first diameter which permits
  delivery of the prosthesis into a body passageway

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• Perspective view of the prosthesis for a body
  passage-way
• - Fig1A having a first diameter which permits
  delivery of the prosthesis into a body passageway
• - Fig1B in its expanded configuration when
  disposed within a body passageway

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The technology the issue

• Cordis asserts that BSCs NIR stent infringes
  claim 23 of the 762 patent.
• Claim 23 The expandable intraluminal vascular
  graft of claim 13, wherein the outside of the
  wall surface of the tubular member is a smooth
  surface, when the tubular member has the first
  diameter.
• Claim 13 A expandable intraluminal vascular
  graft, comprising
• a thin-walled tubular member having first and
  second ends and a wall surface disposed between
  the first and second ends, the wall surface
  having a substantially uniform thickness and a
  plurality of slots formed therein, the slots
  being disposed substantially parallel to the
  longitudinal axis of the tubular member
• the tubular member having a first diameter
  which permits intraluminal delivery of the
  tubular member into a body passageway having a
  lumen and
• the tubular member having a second, expanded
  and deformed diameter, upon the application from
  the interior of the tubular member of a radially,
  outwardly extending force, which second diameter
  is variable and dependent upon the amount of
  force applied to the tubular member, whereby the
  tubular member may be expanded and deformed to
  expand the lumen of the body passageway.

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The technology the issue
Palmaz ballon expandable stent
NIR BSCs stent
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The technology the issue

• The NIR stent manufactured from a stainless steel
  sheet.
• Slots are formed in the steel sheet by chemical
  etching.
• The stent disclosed in the 762 patent are
  rectangular.
• The slots in the NIR stent rounded at the ends,
  and each slot contains a U-shaped curve in the
  middle.
• The U-shaped portions protrude slightly when the
  stent is in its collapsed form.
• BSC refers to the U-shaped portions along the
  stents surface as U-loops. BSCs central
  argument is that those U-loops prevent the NIR
  stent from infringing claim 23.
• At the 2000 trial the jury returned a verdict
  against BSC, finding that BSC infringed claim 23
  under the doctrine of equivalents.

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The technology what about Medtronic infringement?

• The second patent involved, the 984 patent,
  discloses a flexible stent manufactured by
  joining tubular members, such as those disclosed
  in the 762 patent, by a connector that provides
  the necessary flexibility to negociate the bends
  and curves in tortuous body passageways, such as
  the vascular system.

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The technology what about Medtronic infringement?

• Cordis alleges that Medtronic stents (the
  Microstent II and the GFX) infringe the 762 and
  984 patents. Those stents are made from rounded
  lengths of stainless steel formed into rings. The
  rings are heated to a temperature sufficient to
  permit them to be formed, and they are then
  folded into sinusoidal structures. Each
  sinusoidal ring has straight portions (struts)
  and curved portions at the ends of the struts
  (crowns). To create the complete stent,
  adjacent sinusoidal rings are welded together at
  a point between one of the crowns of each ring.

A weld point between 2 crowns
762, Claim 13 a substantially uniform
thickness and a plurality of slots formed
therein 984, Claim 1 and 3 a plurality of
thin-walled tubular members The jury finds that
Medtronics stents infringes the 762 and 984
patents under the doctrine of equivalents.
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Result of the case and timeline

• 1997 Cordis files a patent infringement action
  against Medtronic and BSC.
• 2000 Juries find that Boston Scientific's and
  Medtronic's bare metal stents infringe Cordis'
  patent .
• Cordis wins 324 million against Boston
  Scientific and 271 million against Medtronic,
  prior to the addition of interest.
• 2005, Mar Both cases are retried with Cordis
  winning the verdict again.
• The jury finds that BSC stent infringes claim
  23 of the 762 patent, which jury conclues was
  non obvious.
• 2007 Jan A federal circuit court in Washington,
  D.C., upholds the jury verdicts
• 2008 September a Delaware federal judge granted
  the company's motion for final judgment against
  Medtronic and Boston Scientific in the patent
  litigation.
• The court awards about 1.2 billion, including
  accrued interest, to Cordis against the two
  companies. Medtronic was ordered to pay about
  521 million and Boston Scientific about 703
  million.

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A few words about the other cases

• In June 2005, the following verdicts are returned
  
• BSC Express stents as well as the Liberty stents
  literally infriges claim 23 of the 762 patent.
• BSC has induced literal infringement of claim 1
  of the 762 patent with respect to those stents.
• The Liberty stent literally infriges claim 2 of
  the 406 patent
• Claim 2 of the 406 patent is neither anticipated
  nor rendered obvious by the prior art.

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A few words about the other cases

• In July 2005, the following verdicts are returned
  
• Cordiss Cypher stent infringes claim 8 of the
  536 patent.
• The claim 8 of the 536 patent is not invalid for
  obviousness.
• Cordis Cypher, BX velocity, BX Sonic and Genesis
  stents do not literally infrige claim 36 of the
  021 patent.
• The Cypher, BX velocity, BX Sonic and Genesis
  stents infringe the corners limitation of claim
  36 of the 021 patent under the doctrine of
  equivalent.
• Claim 36 of the 021 patent is not invalid for
  obviousness.

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The other cases - Conclusion

• a tubular member having a wall surface, the
  wall surface having a substantially uniform
  thickness and a plurality of slots formed
  therein
• the wall surface of the tubular member is a
  smooth surface
• Always the same technology

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Bibliography

• Patents
• U.S. Patents 4,739,762 (Palmaz), 5,195,984
  (Schatz), 5,895,406 (Gray), 5,922,021 (Jang),
  6,120,536 (Ding).
• Websites
• Boston Scientific and Cordis websites
• Wikipedia stent and coronary stent
• http//www.ideasforsurgery.com/2008/10/13/johnson-
  johnson-jnj-cordis-awarded-12-bln-final-judgment-a
  gainst-medtronic-and-boston-scientific-in-the-pate
  nt-litigation-patent-litigation-against-medtronic-
  boston-scientific-palmaz/
• http//depatentlaw.morrisjames.com/03200272020.p
  df
• http//depatentlaw.morrisjames.com/032028320137.
  pdf
• http//depatentlaw.morrisjames.com/97205502022.p
  df
• http//depatentlaw.morrisjames.com/uploads/file/97
  -550_98-1920218(2).pdf
• http//www.cordis.com/active/crdus/en_US/html/cord
  is/downloads/press/Cordis_InfBy_BSC_PR_062105a.pdf
  
• http//www.kenyon.com/pubs/detail_press.aspx?news_
  id321405705
• http//www.law.com/jsp/article.jsp?id120281525104
  2
• http//jnj.v1.myvirtualpaper.com/report/2008030701
  /?page69
• http//www.pharmaceutical-business-review.com/comp
  anyprofile.asp?guidAE9B6B3B-5CCC-4915-B1E5-AC61C3
  060CD9CTypeBackground
• http//www.pharmaceutical-business-review.com/comp
  anyprofile.asp?guidDDE623F4-24CB-41C6-9B74-AEBC6C
  EF6369CTypeBackground
• http//www.ptca.org/press_rel/20031122pr_boston.ht
  ml
• http//www.smalltimes.com/articles/article_display
  .cfm?SectionARCHICBioARTICLE_ID269270p109

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Thank you

• Any question ?