FDAnews Device Daily Bulletin


May 22, 2006

The U.S. District Court for the Northern District of California recently sided with Huntsville, Ala.-based SourceCF and SourceCF Clinical Research and Development in a patent infringement suit related to a cystic fibrosis (CF) treatment brought by Chiron.

The patent claims a "method of treating" an endobronchial infection using an inhalation device to administer a nebulized dose of tobramycin, an antibiotic. Chiron was issued the '907 patent May 10, 2005, and filed suit against the SourceCF companies and the Respiratory Disease Network Pharmacies (RDN) the same day.

In responding to a physician's prescription, SourceCF could not dispense the eFlow SCF nebulizer after May 10, 2005, the suit alleged. The eFlow SCF nebulizer could also not be prescribed for use with the concentration of tobramycin the RDN Pharmacies had been using before the '907 patent was issued, Chiron said.

The concentrations of tobramycin remaining in dispute -- 50mg/ml and 40mg/ml -- did not infringe the '907 patent, the court ruled May 16. This is the second of two lawsuits filed by Chiron against SourceCF, both concerning the eFlow nebulizer. The first lawsuit was settled.

CF leads to abnormally thick and sticky mucus that clogs the lungs and obstructs the pancreas. The eFlow is designed to reduce treatment time and offer increased portability as compared with traditional jet nebulizers. The device is battery-operated and is small enough to fit in the palm of the hand.