Boston Scientific Scimed, Inc. v. Cordis Corp.

554 F.3d 982, 89 U.S.P.Q. 2d (BNA) 1704, 2009 U.S. App. LEXIS 588, 2009 WL 89246
CourtCourt of Appeals for the Federal Circuit
DecidedJanuary 15, 2009
Docket2008-1073
StatusPublished
Cited by32 cases

This text of 554 F.3d 982 (Boston Scientific Scimed, Inc. v. Cordis Corp.) is published on Counsel Stack Legal Research, covering Court of Appeals for the Federal Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Boston Scientific Scimed, Inc. v. Cordis Corp., 554 F.3d 982, 89 U.S.P.Q. 2d (BNA) 1704, 2009 U.S. App. LEXIS 588, 2009 WL 89246 (Fed. Cir. 2009).

Opinion

LOURIE, Circuit Judge.

Cordis Corporation and Johnson & Johnson, Inc. (collectively “Cordis”) appeal from the judgment of the United States District Court for the District of Delaware denying a motion for a new trial and judgment as a matter of law (“JMOL”) following a jury verdict of infringement of claim 8 of U.S. Patent 6,120,536 (“the '536 patent”). See Boston Scientific Scimed, Inc. v. Cordis Corp., No. 03-283-SLR, 2005 WL 1322946, 2005 U.S. Dist. LEXIS 10735 (D.Del. June 3, 2005) (“Claim Construction Opinion ”); Boston Scientific Scimed, Inc. v. Cordis Corp., 434 F.Supp.2d 308 (D.Del.2006) (“Opinion Denying JMOL ”); Boston Scientific Scimed, Inc. v. Cordis Corp., Nos. 03-027-SLR, 03-283-SLR, 2007 WL 2775087 (D.Del. Sept. 24, 2007) ^‘Opinion Denying New Trial”). Because the court erred as a matter of law in failing to hold the '536 patent to have been obvious, we reverse the judgment.

BACKGROUND

Boston Scientific Scimed, Inc. and Boston Scientific Corporation (collectively “Boston Scientific”) own the '536 patent, which relates to a drug-eluting expandable stent with a coating that has a non-throm-bogenic surface. Boston Scientific sued Cordis in March 2003, alleging, inter alia, that Cordis’s Cypher stent infringed claim *984 8 of the '536 patent. Claim 8, the only claim on appeal, depends from claim 6, which depends from claim 1. Claims 1, 6, and 8 read as follows:

1. A medical device having at least a portion which is implantable into the body of a patient, wherein at least a part of the device portion is metallic and at least part of the metallic device portion is covered with a coating for release of at least one biologically active material, wherein said coating comprises an undercoat comprising a hydrophobic elas-tomeric material incorporating an amount of biologically active material therein for timed release therefrom, and wherein said coating further comprises a topcoat which at least partially covers the undercoat, said topcoat comprising a biostable, non-thrombogenic material which provides long term nonthromobo-genicity to the device portion during and after release of the biologically active material, and wherein said topcoat is substantially free of an elutable material.
6. The device of claim 1 wherein the medical device is an expandable stent. 8. The device of claim 6 wherein the stent comprises a tubular body having open ends and an open lattice sidewall structure and wherein the coating conforms to said sidewall structure in a manner that preserves said open lattice.

'536 patent col. 13 1.13-col. 14 1.4 (filed June 13,1996).

In June 2005, the district court construed certain limitations of claim 8. The court held that the phrase “non-thrombo-genic material which provides long term non-thrombogenicity to the device portion during and after release of the biologically active material” in claim 1 means “a material that does not promote thrombosis for a period of time that extends both during and after release of the biologically active material.” Claim Construction Opinion, 2005 U.S. Dist. LEXIS 10735, at *3, 2005 WL 1322946 at *1. The court relied on medical dictionary definitions for the meaning of “thrombogenic” (“causing thrombosis or coagulation of the blood”) and “thrombolytic” (“breakfing] up or dissolving] a thrombus”), “thrombolytic” being a term the patentee used in the specification, but not the claims. Id. at *3 n. 6, 2005 WL 1322946 at *1 n. 6. The court rejected Cordis’s proposed definition of “non-thrombogenic,” which required a “significant reduction in thrombogenicity over that experienced with bare metal stents.” Id. at *4 n. 7, 2005 WL 1322946, at *1 n.7. The court also construed the phrase “substantially free of an elutable material” to mean “largely or approximately free of an elutable material.” Id. at *4, 2005 WL 1322946, *1.

Cordis makes the Cypher drug-eluting expandable stent. The Cypher stent has two coatings: an undercoat containing the drug and a topcoat. Early in the manufacturing process, the Cypher stent’s topcoat is drug-free. The topcoat is sprayed on as a solution containing no drug but containing a polymer and two solvents, tetrahy-drofuran (or THF) and toluene, both of which are toxic to humans. The solvents dissolve the drug, allowing it to diffuse from the undercoat into the topcoat. Thus, when the Cypher stent is sterilized, removing any remaining solvent, the drug has moved into the topcoat to such an extent that the topcoat and undercoat contain the same concentration of drug. The topcoat is thinner than the undercoat; it contains about 23% of the total amount of the drug in the stent after sterilization.

At trial, the jury found that claim 8 of the '536 patent would not have been obvious based on, among other prior art references, U.S. Patent 5,545,208 (“Wolff’) and U.S. Patent 5,512,055 (“Domb”). The jury *985 also found that the Cypher stent infringed claim 8. After trial, Cordis filed a renewed motion for JMOL or, in the alternative, a new trial on infringement and validity. The court denied Cordis’s motion.

In doing so, the district court upheld the jury’s nonobviousness finding over Domb, Wolff, and several other references. The court reasoned that Domb, which discloses esophageal stents, does not suggest the use of metal in a stent, and that there was no evidence of motivation to combine Domb with other references. Opinion Denying JMOL, 434 F.Supp.2d at 320. The court reasoned that Wolff, according to one expert, does not teach a metallic stent having a two-layer coating, and the failure of Wolffs assignee to create the claimed stent after more than a decade of work evidenced a lack of motivation to combine the features of its various prior art stents with each other. Id. Finally, as a secondary consideration of nonobviousness, the court found from expert testimony that the praise for and commercial success of the Cypher stent were due to the claimed features and that, even after identifying an appropriate drug and stent, it took Cordis a great deal of time to develop a drug-eluting stent. Id. at 321.

Regarding infringement, the district court reasoned that the jury’s infringement finding was based on substantial evidence because three experts had testified that Cypher was non-thrombogenic. Id. at 316-17. As for the “substantially free” limitation, the court found support for the. jury’s infringement finding in a witness’s testimony that the topcoat is drug-free when applied and “has about 1 to 2% drug ... after manufacturing is completed,” finding that 1 to 2% drug may be considered “substantially free.” Id. at 315. The court also pointed to evidence that a stent need not be sterilized to be implantable and thus that the stent could infringe during manufacture, when the topcoat was first applied and was then drug-free. Id. The court referred to testimony that concluded, after applying the court’s claim construction, that the Cypher stent was substantially free of elutable material. Id.

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554 F.3d 982, 89 U.S.P.Q. 2d (BNA) 1704, 2009 U.S. App. LEXIS 588, 2009 WL 89246, Counsel Stack Legal Research, https://law.counselstack.com/opinion/boston-scientific-scimed-inc-v-cordis-corp-cafc-2009.