Mylan is feisty:
06:36 ET Mylan Labs sues FDA after Duragesic patch patent protected through Jan 2005 (MYL) 22.42: Reuters reports that the FDA plans to extend patent protection for the pain-relief patch Duragesic by six months, Janssen Pharma said on Tuesday, delaying the launch of a generic version. Separately, MYL announced that it is filing suit against the FDA in the U.S. District Court for the District of Columbia, seeking to restore final approval for its fentanyl transdermal system. "In siding with Janssen and withdrawing Mylan's final approval, the FDA has acted contrary to multiple sections of the Federal Food, Drug, and Cosmetic Act and the Administrative Procedures Act, its published regulations and the legal precedent on point. We view this decision as yet another assault on the generic pharmaceutical industry. Among other problems created by the FDA's decision, this opinion encourages branded pharmaceutical companies to ignore the 45-day timeline to sue and effectively eliminates a generic company's ability to challenge patents that are nearing expiration." Local procedural rules require a hearing in the suit to be held prior to July 23, 2004, and as a result, MYL suspended annual earnings guidance. |
