Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
In a formulation claim, if elements are listed separately, does this necessarily entail that those elements are “separate and distinct components”? This was the question before the district court in Regeneron...more
The US Court of Appeals for the Federal Circuit invalidated yet another set of antibody genus claims, finding the case “materially indistinguishable” from those in the 2023 Supreme Court of the United States case, Amgen v....more
The Situation: The Biologics Price Competition and Innovation Act was considered in a November 2017 decision by the United States Court of Appeals for the Federal Circuit. The Result: The court found that the commercial...more
WBIP, LLC v. Kohler Co. (No. 2015-1038, -1044, 7/19/16) (Moore, O'Malley, Chen) - Moore, J. Affirming denial of JMOL that patent was invalid as obvious and lacked an adequate written description, affirming finding of...more