“Stent Wars” – Will the Federal Circuit Decision in Cordis Corp. v. Boston Scientific Corp. Finally End Fourteen Years of Patent Litigation?

California – The Federal Circuit affirmed the Delaware district court’s grant of judgment as a matter of law in favor of noninfringement and conclusion that the patents at issue were not unenforceable due to inequitable conduct.

In the court’s opinion, the justices describe the case as, “but one installment – albeit, at nearly fourteen years, perhaps the longest – in an ongoing and epically expensive saga known as the ‘Stent Wars.'”

On October 3, 1997, Cordis filed suit against multiple defendants for patent infringement of its heart stents for coronary artery disease. The heart stents can be deployed by inflatable balloon to clogged arteries to expand and open up the artery. When Cordis named Boston Scientific Corp. as one of the defendants, the company probably did not foresee itself engaging in over a decade of legal battle.

Particular to BSC’s case, Cordis alleged that BSC’s NIR stent infringed Patents 5,643,312 (‘312 patent) and 5,879,370 (‘370 patent). Five years later in 2002, a jury found that BSC’s NIR stent did not infringe the ‘312 patent, but did infringe the ‘370 patent. Thereafter, the district court judge granted JMOL that the NIR stent did not infringe the ‘370 patent. Additionally, the court held a bench trial on the issue of unenforceability due to inequitable conduct. The court ultimately held that both patents were unenforceable because the patentees “purposefully neglected their responsibility of candor to the PTO by ‘putting their heads in the sand'” with respect to known prior art references and for disclosing prior art references “in the midst of numerous other references and without identifying it as being of particular interest.”

When the case reached the Federal Circuit on appeal in 2006, the Federal Circuit declined to address the issues of infringement, and remanded to the district court for further evidence regarding intent to deceive. By 2010, the district court made additional findings and, surprisingly, reversed its earlier decision on inequitable conduct. The court held that there was not clear and convincing evidence of deceptive intent and that each of the parties’ arguments was equally persuasive. Therefore, contrary to its earlier ruling, the court held that both patents were enforceable.

Renewing their initial appeals, the parties brought the suit to the Federal Circuit a second time. This time, the Federal Circuit construed the claim construction given to the jury to determine whether the decision of noninfringement was proper. Ultimately the Federal Circuit agreed that with the correct jury instruction construction, that the decision of noninfringement was proper because a reasonable jury would not be able to find infringement. Additionally, the Federal Circuit affirmed the district court’s decisions on no inequitable conduct.