Amneal, Hanmi get favorable court ruling in esomeprazole strontium case

BRIDGEWATER, N.J. — A federal court decision paves the way for Amneal Pharmaceuticals and its South Korean partnering company to market a drug for treating gastroesophageal reflux disease, the companies said Monday.

Amneal Pharmaceuticals and Hanmi Pharmaceutical announced that the U.S. Court of Appeals for the Federal Circuit ruled in their favor in a patent infringement case brought by AstraZeneca. Amneal recently announced the launch of esomeprazole strontium delayed-release capsules, developed by Hanmi. AstraZeneca sued the companies, saying the drug infringed on its patent covering the drug Nexium (esomeprazole magnesium). However, the court ruled that AstraZeneca's patent did not cover esomeprazole strontium.

"The appellate court adopted the position that Hanmi and Amneal advocated from the outset - specifically, that the Hanmi esomeprazole strontium product does not infringe the patents asserted by AstraZeneca," Amneal VP global intellectual property Kenneth Cappel said. "Moreover, Amneal's recent launch will proceed free from the legal uncertainty that may have been perceived before last week's favorable decision."