FDAnews Drug Daily Bulletin

Daiichi Sankyo lost an appeals court ruling that invalidated its patent, allowing competitors to market generic versions of Floxin Otic, an antibiotic to treat bacterial ear infections.

The U.S. Court of Appeals for the Federal Circuit ruled in favor of Apotex, reversing a U.S. District Court for the District of New Jersey decision that said Daiichi Sankyo’s ’741 patent was not invalid for obviousness.

The ’741 patent covers a method for treating bacterial ear infections by topically administering Floxin Otic (ofloxacin otic) solution. The district court relied on other decisions involving patents for a method of treating a physical condition to make its decision, the Federal Circuit court said in the ruling. However, the district court’s reliance on other cases was “improper,” the court of appeals said.