Ortho-McNeil to appeal Razadyne patent ruling

Ortho-McNeil Neurologics, a division of Johnson & Johnson's Ortho-McNeil-Janssen Pharmaceuticals, says that it will appeal a decision by the US District Court of Delaware, which ruled the patent for Razadyne (galantamine hydrobromide) is invalid.

The decision allows FDA-approved generic versions of immediate-release galantamine hydrobromide to enter the US marketplace "at risk" pending an appeal. A favorable ruling would have provided patent protection for Razadyne IR until the patent expires on December 14, this year.

"We are disappointed by the court's decision and will appeal this ruling," said Janet Vergis, president of Janssen and Ortho-McNeil Neurologics. "We believe the patent protecting Razadyne is valid and would be infringed by the introduction of a generic galantamine hydrobromide product," she added.