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MEDINOL LTD. v. GUIDANT CORP.

June 4, 2004.

MEDINOL LTD., Plaintiff, -against- GUIDANT CORP. and ADVANCED CARDIOVASCULAR SYSTEMS, INC., Defendants


The opinion of the court was delivered by: SHIRA SCHEINDLIN, District Judge

OPINION AND ORDER

Medinol Ltd. ("Medinol") brings this action for damages and declaratory and permanent injunctive relief relating to the alleged infringement by Guidant Corp. ("Guidant") and its subsidiary Advanced Cardiovascular Systems, Inc. ("ACS") (collectively "defendants") of certain of Medinol's patents.*fn1 Guidant now moves for summary judgement on the basis of collateral estoppel, arguing that Medinol's prior litigation over three of its patents — the `303/120, and `018 — in the Cordis case*fn2 precludes Medinol from asserting claims associated with Medinol's `303, `018, `120, `381, and `982 patents.*fn3 For the following reasons, Guidant's motion is granted in part and denied in part.

 I. FACTS

  A. The Parties

  Medinol, which has its principal place of business in Tel Aviv, Israel, designs and manufactures coronary stents.*fn4 Guidant develops, markets, and sells cardiovascular medical products and has its principal place of business in Indiana. ACS has its principal place of business in California.*fn5

  B. Background

  At the heart of this litigation are patent rights directed to various balloon stent designs. "Stents" are "medical device[s] much like [] miniature scaffolding that physically hold[] open a diseased artery into which [they are] inserted."*fn6 They are "used to treat diseased blood vessels in the heart (`coronary arteries') and in other areas of the body (`peripheral arteries')."*fn7 Stents are introduced into the blood vessel on a balloon catheter in a procedure during which the catheter is "maneuver[ed] into the blocked artery [where the balloon is inflated, causing the stent to expand against the vessel wall]. . . . Once the balloon has been deflated and withdrawn, the stent stays in place permanently, holding the blood vessel open and improving blood flow."*fn8

  1. Prior Art

  Prior to Medinol's development of its catheter-delivered coronary stents, various patents had been issued that the parties agree are "prior art" to the asserted claims of the Medinol patents for purposes of section 103(a).*fn9 These patents include U.S. Patent Nos.: (1) 4,739,762 ("Palmaz `762 Patent") [assigned to Expandable Grafts P'ship];*fn10 (2) 5,102,417 ("Palmaz `417 Patent") [Expandable Grafts P'ship];*fn11 (3) 5,104,404 ("Wolff' 404 Patent") [Medtronic, Inc.];*fn12 (4) 5,195,984 ("Palmaz-Schatz `984 Patent") [Expandable Grafts P'ship];*fn13 (5) 5,421,955 ("Lau `955 Patent") [ACS];*fn14 and (5) 5,879,370 ("Fischell `370 Patent").*fn15

  The origins of the modern stent trace back to the 1980s. In April 1988, a patent was issued to Palmaz for an "expandable intraluminal graft, and method and apparatus for implanting an expandable intraluminal graft," i.e., a "stent," which Johnson & Johnson commercialized in 1991. The Palmaz `762 Patent described the first stent to "include a plurality of closed cells" that, upon expansion, "transformed [from slot-shaped cells] into diamond-shaped cells, resulting in an expanded stent with a honeycomb appearance."*fn16 At approximately the same time, in furtherance of this design, Palmaz patented a stent (Palmaz `417 Patent) "combining slot-shaped cells with flexible connectors to increase longitudinal flexibility."*fn17 In 1992, Wolff designed a stent for Medtronic, Inc. that uses "coil connectors" to impart flexibility (Wolff `404 Patent). In 1995, Schatz developed a new variation of the Palmaz stent, involving "straight flexible connectors between tube sections" (Palmaz-Schatz `984 Patent).*fn18 In the early 1990s, Guidant developed its stent design based on "connecting single serpentine rings with flexible connectors," for which it obtained the Lau `955 Patent.*fn19 The designs disclosed in the Lau `955 Patent "illustrate two different ways of connecting the rings, `in-phase' or `out-of-phase.'"*fn20 Guidant commercialized the "in-phase" design as the "Multi-Link stent." Finally, in 1999, the Fischell `370 Patent was issued, which discloses a stent with "`undulating,' or looped connectors between rings that become circular when completely expanded."*fn21

  2. Medinol's Patents

  Medinol also successfully applied for patent protection of its stent design. In 1995, U.S. Patent No. 5,449,373 ("Pinchasik `373 Patent") was issued to Pinchasik et al. and assigned to Medinol.*fn22 A series of stents, described as continuations or continuations-in-part of the Pinchasik `373 Patent, were invented by Henry Israel and Gregory Pinchasik and assigned to Medinol. These patents — the `303, `018, `120, `381, and `982 — describe a family of flexible, expandable stents. Specifically, the Cordis court noted that Medinol's patents:
share the same drawings, and essentially the same specification, and are described as continuations of a series of applications beginning with Application Serial No. 282, 181 . . ., filed on July 28, 1994, and continuations-in-part of Application Serial No. 213,272 . . ., which was filed on March 17, 1994, and issued as [the Pinchasik `373 Patent]. The Medinol patents generally describe and illustrate stent designs that achieve the objectives and flexibility during delivery, compensation for foreshortening, continuous uniform scaffolding, and resistance to radial deformation and collapse upon expansion.*fn23
a. The `303 Patent
  The `303 Patent was issued on March 31, 1998 and contains thirty-one claims. Two are alleged to be infringed by defendants' products — 24 and 28. Claim 24 reads as follows:
 
A flexible connector for connecting the apices of cells included in a stent, including: a flexible member having a first end and a second end with an area of inflection disposed between said first end and said second end, a portion of said flexible member having a width smaller than the width of said apices to which said first end and said second end are connected.*fn24
Claim 28 refers to:
An expandable stent, including:
a plurality of connected cells having a longitudinal axis defining a substantially uniform structure of flexible cells having a longitudinal axis and a circumferential axis substantially perpendicular to said longitudinal axis;
each of said flexible cells having apices disposed apart and generally opposite to one another along said longitudinal axis of each of said cells;
each of said flexible cells having apices disposed apart and generally opposite to one another about the circumferential extension of the cell, each of said flexible links including at least two portions of an area of inflection therebetween.*fn25
b. The `120 Patent
  Eight months after the issuance of the `303 Patent, the `120 Patent was issued. Five of the claims are asserted in this action — 13, 16, 18, 27, and 28, which, in seriatim, state:
 
13. An expandable stent formed of an elongated cylindrical unitary tube suitable for insertion into a lumen or blood vessel in which it may be expanded, comprising: a plurality of first meanders extending in a first direction on the cylinder of the tube and a plurality of second meanders extending in a second direction, on the cylinder of the tube, wherein the first and second meanders are formed with loops and are interconnected such that at least one of the loops of each of the first meanders is disposed between each consecutive second meander to which the first meander is connected, and at least one of the loops of each of the second meanders is disposed between each consecutive first meander to which it is connected; the first and second meanders defining a plurality of enclosed spaces.
16. A stent according to claim 13, wherein the first and second meanders are connected together such that the loops thereof cooperate so that upon bending of the stents the loops change shape to compensate for the difference in length between the inside and outside curves.
18. A stent according to claim 13, wherein the stent can bend in any direction and in more than one direction at any time.
27. A stent according to claim 21 wherein said second meander patterns intersect with said first meander patterns so as to leave at least one loop of said first meander patterns between each pair of adjacent second meander patterns.
28. A stent according to claim 21 wherein said second meander patterns intersect with said first meander patterns at common members which are shared by said first and said second meander patterns.*fn26 c. The `018 Patent
  The `018 Patent, issued on October 26, 1999, is comprised of sixty-four claims. Medinol is asserting claims 51 and 64, which disclose:
 
51. A generally longitudinally extending tubular stent which is substantially uniformly flexible with respect to its longitudinal axis, said stent consisting essentially of: a plurality of flexible cells, each having a longitudinal extension parallel to said longitudinal axis and a circumferential extension parallel to an arc of a circle around the circumference of the stent,
(a) wherein each of said flexible cells comprises apices disposed apart and generally opposite to one another along said longitudinal extension of the cell,
(b) wherein each of said flexible cells comprises at least first and second flexible links, wherein prior to expansion of the stent, the first and second flexible links are disposed apart and generally opposite to one another along the circumferential extension of the cell, and
(c) wherein each of said flexible links comprises a first attachment point and a second attachment point, the first and second attachment points being on a line segment that extends substantially parallel to said longitudinal axis prior to expansion of the stent, wherein each of said flexible links has a bend in it such that the length of said flexible link is greater than the distance between said first and second attachment points, whereby the flexible link can change shape to allow the distance between the attachment points to become longer or shorter to facilitate bending of the stent.
64. A stent formed of a tube having a patterned shape, the patterned shape comprising:
a. first meander patterns having axes extending in a first direction;
b. second meander patterns having axes extending in a second direction, different than said first direction, wherein said second meander patterns intersect with said first meander patterns;
c. wherein said first meander patterns have loops;
d. wherein said first meander patterns are spaced apart to leave a portion of said second meander patterns between each pair of adjacent first meander patterns;
e. wherein each of said second meander patterns has at least one loop between at least one pair of adjacent first meander patterns, and
f. wherein at least one of said loops is provided with a width that is smaller than the width of the meander pattern on which said [sic] at least one of said loops is disposed.*fn27
d. The `982 Patent
  On September 3, 2002, the Patent and Trademark Office ("PTO") issued the `982 Patent. Claims 1, 2-15, and 17 read as follows:
 
1. An expandable stent for supporting a vessel, wherein in the expanded and deployed state, the stent consists of:
(a) first meander patterns having loops, the first meander patterns being longitudinally spaced from each other and having axes extending in a first direction; and
(b) second meander patterns having loops, the second meander patterns having axes extending in a second direction, different than the first direction,
(c) wherein the first and second meander patterns are interconnected to form a tubular structure;
(d) wherein the first meander patterns are connected to the second meander patterns so as to leave at least one loop of each of the second meander patterns in the space between each pair of adjacent first meander patterns; and
(e) wherein the second meander patterns are connected to the first meander patterns so as to leave no more than two loops of each of the first meander patterns between each pair of adjacent second meander patterns.
2. The stent according to claim 1, wherein the shape and placement of the loops provides radial strength to the expanded stent to hold the vessel open.
3. The stent according to claim 2, wherein the first direction extends in a circumferential direction.
4. The stent according to claim 3, wherein the second direction extends in a longitudinal direction.
5. The stent according to claim 2, wherein the second direction extends in a longitudinal direction.
6. The stent according to claim 1, wherein the stent defines a plurality of enclosed spaces, with each longitudinal end of each of the enclosed spaces being formed by one or more loops of the first meander pattern.
7. The stent according to claim 6, wherein the enclosed spaces are substantially the same size.
8. The stent according to claim 7, wherein the first direction extends in a circumferential, direction.
9. The stent according to claim 8, wherein the second direction extends in a longitudinal direction.
10. The stent according to claim 7, wherein the second direction extends in a longitudinal direction.
11. The stent according to claim 6, wherein the first direction extends in a circumferential direction.
12. The stent according to claim 11, wherein the second direction extends in a longitudinal direction.
13. The stent according to claim 6, wherein the second direction extends in a longitudinal direction. 14. The stent according to claim 1, wherein the first direction extends in a circumferential direction.
15. The stent according to claim 14, wherein the second direction extends in a longitudinal direction.
17. The stent according to claim 1 wherein the second direction extends in a longitudinal direction.*fn28
e. The `381 Patent
  In October 2002, the `381 Patent was issued. Claims 56-58, 61, 63, 65-66, and 68-70, asserted herein, recite:
 
56. A balloon expandable stent for implantation into a lumen to support the lumen, said stent both in the unexpanded state and in the balloon-expanded state including: a plurality of flexible cells adjacent to one another both circumferentially and longitudinally each of said flexible cells comprising:
a) a first flexible link including an arc, the first flexible link having a first longitudinal end and a second longitudinal end;
b) a second flexible link including an arc, the second flexible link having a first longitudinal end and a second longitudinal end;
c) a first circumferential member disposed between said first longitudinal end of said first flexible link and said first longitudinal end of said second flexible link and;
d) a second circumferential member disposed between said second longitudinal end of said first flexible link and said second longitudinal end of said second flexible link,
e) at least one of said first circumferential member and said second circumferential member in each of said cells having a portion with a substantial longitudinal component that is also a portion with a substantial longitudinal component of a first circumferential member or a second circumferential member in a longitudinally adjacent cell,
wherein in the expanded state the first and second circumferential members have a substantial longitudinal component to provide coverage of the lumen.
57. A stent according to claim 56, wherein in the unexpanded state, a radial plane perpendicular to a longitudinal axis can pass through the flexible links of the flexible cells and not pass through the circumferential members.
58. A stent according to claim 56 wherein each of said first and second flexible links has ends generally aligned with respect to each other along a longitudinal axis of the stent.
61. A stent according to claim 56, wherein the first members of circumferentially adjacent cells are connected in a closed circumferential structure which contains at least five loops and the second members of circumferentially adjacent cells are connected in a closed circumferential structure which contains at least five loops.
63. A stent according to claim 56 wherein said plurality of flexible cells provide substantially all the support for said stent.
68. A stent according to claim 65, wherein the first members of circumferentially adjacent cells are connected in a closed circumferential structure which contains at least five loops and the second members of circumferentially adjacent cells are connected in a closed circumferential structure which contains at least five loops.
69. A stent according to claim 65 wherein each of said first and second flexible links has ends generally aligned with respect to each other along a longitudinal axis of the stent.
70. A stent according to claim 65 wherein said plurality of flexible cells provide substantially all the support for said stent.*fn29
C. Cordis Litigation
  In December 1999, Medinol and its licensee, Scimed Life Systems, Inc. ("Scimed") (collectively "plaintiffs"), filed a patent infringement action in the district of Delaware, alleging that Cordis Corp. ("Cordis"), Johnson & Johnson, and Johnson & Johnson Interventional Systems, Inc. had infringed certain claims of Medinol's `303, `120, and `018 patents.*fn30 Medinol argued that defendants' (1) BX Velocity stent,*fn31 (2) Crown and Mini-Crown stents,*fn32 and (3) Corinthian stent*fn33 infringed specified claims in its patents. After a two-week jury trial on the issues of infringement and invalidity, the jury returned the following verdict:

  (1) BX Velocity Stent

 
(a) Claims 35, 47 and 60 of the `018 patent: no literal infringement; no infringement under the doctrine of equivalents; did not address the reverse doctrine of equivalents
(b) Claim 12 of the `303 patent: no infringement under the doctrine of equivalents.
(2) Crown and Mini-Crown Stents
(a) Claim 13 of the `120 patent: no literal infringement
(3) Corinthian Stent (a) Claim 13 of the `120 patent: literal infringement*fn34
The jury determined that all of the asserted claims were invalid for obviousness and failure to comply with the written description requirement, except for claim 13 of the `120 Patent. The jury found defendants' infringement of claim 13 through the sale and manufacture of the Corinthian stent to be nonwillful and awarded plaintiffs approximately eight million dollars in damages.*fn35

  Medinol and Scimed then moved for judgment as a matter of law ("JMOL") and for a new trial under Rule 59(a).*fn36 Plaintiffs' motion was granted in part and denied in part. The court denied plaintiffs' motion as to infringement by the BX Velocity stent and the Crown and Mini-Crown stents.*fn37 The court also rejected plaintiffs' argument that the asserted claims of the `303 and `018 patents are not invalid for obviousness, finding that "defendants presented substantial evidence to support a reasonable jury's conclusion that claims 12, 35, 47 and 60 would have been obvious to one of ordinary skill in the art in July 1994, the time the inventions described in those claims were made."*fn38 However, finding that defendants failed to present clear and convincing evidence such that a reasonable jury could conclude that the claims are invalid for failure to comply with the written description requirement, the court granted plaintiffs' motion for JMOL as to the "invalidity of claims 12, 35, 47, and 60 [of the `303 and `018 patents] based on failure to comply with the written description requirement."*fn39

  Significantly, the court rejected plaintiffs' argument that they were entitled to a new trial based on an inconsistent jury verdict on obviousness. As the court explained:
Claim 13 of the `120 patent has an additional limitation, i.e., that the stent must have "at least one of the loops of each of the first meanders disposed between each consecutive second meander to which the first meander is connected" over claim 60 of the `018 patent. This supports the jury's verdict that claim 13 is not invalid for obviousness whereas claim 60 is invalid.*fn40
  Medinol and Scimed then unsuccessfully appealed the denial of their post-trial motions to the Federal Circuit, which held that "there was substantial evidence in the record to support the conclusion that the asserted claims of the `303 and `018 patents were obvious over the prior art at the time they were filed with the PTO."*fn41 Specifically, the Federal Circuit cited the testimony of Cordis's trial expert, Dr. Nigel Buller, as evidence of the existence of compensation for foreshortening in the prior art. Dr. Buller testified that stents constructed from combinations of rings and flexible connectors, "as required by the asserted claims of the `303 and `018 patents, were in the prior art."*fn42 In response to plaintiffs' argument that "even if each of the elements of the asserted claims was in the prior art, the record does not demonstrate that there was a motivation to combine" them, the Federal Circuit identified portions of the record that indicated that there was substantial evidence that "a person of ordinary skill in the art did, in fact, combine the elements of the stent design claimed by the `303 and `018 patents prior to July 28, 1994."*fn43 In particular, the court noted that Paul Burmeister, a Scimed engineer, had "evaluated the concept of a hybrid stent that would partially self-expand and then fully expand with a balloon."*fn44 He filed a patent application on May 19, 1994, containing the design aspects of the stents claimed in the `303 and `018 patents. Although he subsequently abandoned the design, the court found:
 
The jury had before it expert testimony that a person of ordinary skill in the art, on July 28, 1994, would inspect the drawings of the Burmeister application and conclude it disclosed a stent design that combined the claimed elements of the balloon expandable stent design taught by the patents-in-suit. This was legally sufficient evidence from which the jury could have found a motivation to combine in the knowledge of one of ordinary skill in the art, a finding of fact we must ...

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