Medical Device Link.

Originally Published MX January/February 2004

BUSINESS NEWS

The efforts of Boston Scientific Corp. (Natick, MA) to enter the U.S. market for drug-eluting coronary stents took two steps forward in November, when the company received a positive FDA panel recommendation and turned away a legal challenge from rival manufacturer Cordis Corp. (Miami Lakes, FL), a Johnson & Johnson company.

In a meeting held at the end of November, FDA's circulatory system devices panel unanimously recommended approval of Boston Scientific's Taxus Express² coronary stent system. Since the agency generally follows the recommendations of its advisory committees, the paclitaxel-eluting stent could be available in the United States as early as the first quarter of this year.

The court challenge involved motions in the ongoing patent infringement cross-litigation between Cordis and Boston Scientific, each of which had requested a preliminary injunction to keep the other's product off the U.S. market. The Cypher drug-eluting stent manufactured by Cordis was approved by FDA last April, and has been available on the U.S. market since May.

In its recent session, the U.S. District Court in Wilmington, DE, denied both companies' motions. Although both patent infringement cases remain pending, the recent ruling clears the way for Boston Scientific to move forward with market entry and distribution plans for 2004.

U.S. District Judge Sue Robinson ruled that Cordis had failed to meet the necessary criteria for granting an injunction. Her ruling noted that such an injunction would deny U.S. market access to the Taxus system and would likely result in "irreparable harm" to Boston Scientific. Conversely, the ruling noted that Cordis would not incur any significant damages from not receiving the injunction. Robinson also ruled that an injunction was not in the public interest of ensuring both a competitive marketplace and an adequate supply of drug-eluting stents.

In a company news release, Cordis welcomed Judge Robinson's ruling, which acknowledged that the company is "likely to prevail on the merits of its claims that its core patent on balloon expandable stents is valid and infringed by Boston Scientific's Taxus stent." Taking issue with the ruling, however, the release went on to say, "Cordis believes that the public interest favors the enforcement of valid patent rights and disagrees with the decision to deny the injunction." Cordis said it would seek an expedited appeal.

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