Partner MaryAnne Armstrong, Ph.D. Quoted in Life Sciences IP Review on CAFC Amgen v. Sandoz Decision
BSKB partner MaryAnne Armstrong, Ph.D., was quoted in the July 23, 2015 Life Sciences IP Review article entitled “‘Patent Dance’ Ruling Leaves Lawyers in a Spin.” Discussing the recent U.S. Court of Appeals for the Federal Circuit’s (CAFC) decision in Amgen v. Sandoz, Dr. Armstrong said that although she believed the court’s ruling was the “interpretation that the biosimilar industry was hoping for”, there is a lack of clarity over the 180-day rule. Furthermore, “what is the penalty if the applicant does not provide the reference product sponsor with the required 180-day notice? This question was not answered in the dispute because Sandoz provided notice after they received approval. But what would be Amgen’s recourse if Sandoz did not provide notice and simply launched their product?”