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...

shutterstock_558540649Another layer of complexity has been added to patent prosecution under the District Court of Michigan’s expanded interpretation of the obviousness type double patenting (“ODP”) doctrine.1 The district court held that a continuation application can, in certain circumstances, invalidate … Read More...