FDAnews Device Daily Bulletin

INSULIN DEVICES FOCUS OF ITC SECTION 337 INVESTIGATION

June 13, 2006
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The International Trade Commission (ITC) is initiating an investigation of patent infringement for insulin delivery devices under section 337 of the Tariff Act of 1930, the Commission announced recently.

Three Novo Nordisk companies filed a complaint May 8 against three sanofi-aventis firms, alleging patent infringement of a pen-shaped delivery device and disposable insulin-filled cartridges with adapters. Supplemental letters were filed on May 11 and 23 for the complaint, which seeks to restrict the U.S. importation and sale of the infringing sanofi-aventis devices.

The case will be referred to ITC administrative law judge Sidney Harris, who will make an initial determination in the case, the Commission said.

The ITC announcement can be viewed at http://www.usitc.gov/ext_relations/news_release/2006/er0607dd1.htm (http://www.usitc.gov/ext_relations/news_release/2006/er0607dd1.htm).