Amgen Sues Sandoz Over 'Patent Dance' In Case Involving First Biosimilar Application

Amgen has sued Sandoz, the first domestic biosimilar applicant that seeks to copy an Amgen product, charging the biosimilar applicant violated the law's patent exchange process by not sharing its manufacturing information -- a move closely watched by stakeholders because the outcome may drive key patent policies as FDA begins implementing the health law's new biosimilar pathway. Sandoz was required to share with Amgen its filgrastim application and manufacturing processes, but did not, Amgen asserts in asking a federal court...