Stent Wars: Boston Scientific and Cordis Both Get Victories

Watching the latest court rulings in the coronary-stent patent infringement suits brought by Boston Scientific Corp. (Natick, MA) and Cordis Corp. (Miami Lakes, FL), a Johnson & Johnson company, is a little like watching a tennis match with no end. There have been lots of volleys, and games have been won and lost, but the final outcome is far from settled.

In mid-June, the U.S. district court in Wilmington, DE, found that Boston Scientific's Taxus drug-eluting stent and two of the company's bare-metal stent platforms—the Taxus Express and its next-generation counterpart, Liberté—infringe on patents held by Cordis. Specifically, the jury ruled that Taxus infringes Cordis's Palmaz patent for balloon-expandable stents, while Liberté infringes Cordis's Gray patent relating to flexible stent technology. Liberté is currently undergoing clinical trials and is expected to be approved for sale in Europe later this year, with U.S. market entry expected in mid-2006.

The ruling in favor of Cordis was widely expected. Last March, Cordis won a similar patent infringement case involving the Nir stent, which Boston Scientific formerly marketed under license from Medinol Ltd. (Tel Aviv, Israel). Due to a dispute with Medinol, Boston Scientific no longer sells Nir stents.

Nicholas Valeriani, worldwide chairman for cardiovascular devices and diagnostics at Cordis, commented that “Today's findings of infringement against the Taxus, Liberté, and Express stents—together with previous findings of infringement by Boston Scientific's Nir stent—reinforce the strength of Cordis's deep patent estate on balloon expandable stents. We are confident that the finding of infringement of the Gray patent by the bare-metal Liberté stent will also apply to the drug-eluting version of Liberté, and Cordis will strongly assert its patent claim against it if and when the product is launched.”

Cordis will reportedly seek $844 million in “lost profit damages.” Boston Scientific vigorously maintained the validity of its patents and announced plans to appeal the verdict.

But just nine days after the jury verdict in its favor, Cordis found itself on the losing end of a decision from the same Delaware court. The court ruled that the company's Cypher drug-eluting stent infringes on Boston Scientific's drug-coating technology patent. The court also ruled that Cypher and Cordis's Bx Velocity, Bx Sonic, and Genesis stents violate Boston Scientific's stent-design patents.

The ruling upheld the validity of Boston Scientific's Ding and Jang patents, which respectively cover the company's two-layer drug coating technology and the specific geometry of its stent designs.

Paul A. LaViolette, Boston Scientific's chief operating officer, expressed the company's satisfaction with the verdict. “We are very pleased with the jury's verdict. It confirms our belief that we have fundamental intellectual property covering drug-eluting stent technology and stent design.”

Medtech analysts generally viewed the favorable decision for Boston Scientific as something of a surprise. Cordis said it would seek to have Delaware district court judge Sue Robinson reverse the most recent ruling and, if it was not overturned, would take its case to the court of appeals for the federal circuit, in Washington, DC.

Although Cordis's Cypher was the first drug-eluting coronary stent approved for the U.S. market, Boston Scientific's Taxus controls approximately 60–65% of the American market. Global sales of drug-eluting coronary stents are expected to reach $5 billion this year.

So far, the court rulings have only involved issues of liability. Trials relating to respective damages are expected to take place in August.