Medical Device Link.

Originally Published MX November/December 2003

COVER STORY

Experts in international intellectual property litigation are traditionally cautious about predicting the ultimate outcome of IP disputes, since rulings that seem to be running in one direction can too readily be overturned in other courts. Whatever the ultimate outcome of current disputes over IP for the design and manufacturing of cardiac stents, Medinol has enjoyed a remarkable run of favorable decisions in European courts and patent offices. Following is a synopsis of the key court decisions issued since the middle of 2003.

June 24: The patent chamber of the district court in Düsseldorf, Germany, rules in favor of Medinol in a suit against Boston Scientific alleging patent infringement of Medinol's German patent EP 0 762 856 and utility model 295 21 206. The court orders Boston Scientific to withdraw its Express-design stents from the German market, and to open its books to Medinol in order to determine the amount of further damages to be paid.

In a press release, Boston Scientific initially maintains that the decision relates only to its Express stent, not to the Taxus stent; and that it applies only to its German subsidiary, not to other subsidiaries or to the parent company. In a letter to Medinol on July 18, however, Boston Scientific acknowledges that the court ruling applies to the parent company and to all Express-design stents—including the Taxus stent. The court subsequently issues a clarification, confirming that its original decision covers all of Boston Scientific's stents, including the Express, Express², and Taxus models; and that the decision applies to all Boston Scientific companies.

July 3: The court of appeals in The Hague, The Netherlands, rules in favor of Medinol in a suit alleging that Johnson & Johnson's BX Velocity stent infringes Medinol's intellectual property. The court orders Cordis B.V. and Cordis Europe N.V. to cease all infringing activity in The Netherlands within 48 hours and sets penalties of approximately $45,900 per breach.

In a follow-up to this decision, J&J asks the court to remove the Cypher stent from its earlier action, arguing that it should not be included in the injunction. On August 26 the court denies J&J's request, ruling that the Cypher is included and barring J&J from conducting any infringing activity related to that stent.

July 9: The cancellation division of the German Patent and Trademark Office (Munich) rules in favor of Medinol, in an action originally filed by J&J (joined by Boston Scientific) to invalidate Medinol's German utility model 295 21 206. When Boston Scientific had the license to market Medinol's stents, in May 2001, it won a similar case against J&J based on the same utility model. The July ruling permits the utility model and pertinent claims to stand.

September 10: The district court in The Hague, The Netherlands, rejects a suit by Scimed Life Systems, a Boston Scientific subsidiary, alleging that Medinol had infringed its balloon catheter patents. The decision also invalidates the Boston Scientific patent on which the suit was based.

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