shutterstock_586286306Last week, the USPTO issued further guidelines for patent examiners, instructing that rejections of applications based on ineligibility require detailed explanations for the basis of the rejection.1 This new requirement is distinguished from the previous guidelines by requiring examiners … Read More...

shutterstock_553962622On April 26, 2016, the Federal Circuit denied a petition for rehearing en banc, filed by Merck and Cie. The Federal Circuit maintained that the “substantial evidence” review standard applies for an appeal from an IPR proceeding.1 Judge O’Malley, … Read More...

shutterstock_418713547In only the second decision of its kind, the U.S. Food and Drug Administration (FDA) approved Celltrion’s biosimilar Inflectra™ (infliximab-dyyb), a reproduction of Janssen Biotech’s immunosuppressant Remicade® (infliximab). Inflectra is, however, the first biosimilar monoclonal antibody to be approved in … Read More...