Inevitable Does Not Equal Obvious Earlier this week, the Unites States Court of Appeals for the Federal Circuit (“CAFC”) held that the United States District Court for the District of Delaware clearly erred in its obviousness analysis in Millennium Pharmaceuticals, Inc. v. Sandoz, Inc, reversing the lower court’s decision and entering judgment in favor of Millennium. Millennium Pharmaceuticals, Inc. (“Millennium”) […] Continue Reading →
White House Calls for Modernization of Biotechnology Regulations Biotechnological innovation is potentially subject to a variety of governmental regulations. For example, therapeutics for disease treatment or prevention in humans are subject to review and approval by the Food and Drug Administration (FDA). Innovations relating to crops or livestock may be subject to the Department of Agriculture (USDA). However, the regulations promulgated by these governmental agencies are […] Continue Reading →
FDA Releases First “Purple Book” for Biosimilar Products The Biosimilars Act (BSA) was passed into law on March 23, 2010 with the goal of encouraging the market entry of generic products, similar to the system that exists for generic drugs under the Hatch-Waxman Act. The BSA sets forth an abbreviated approval pathway for biologics through a regulatory demonstration of biosimilarity (i.e. interchangeability). More […] Continue Reading →
Federal Judicial Center – Hot Topics in Patent Litigation The Federal Judicial Center recently released a Webinar entitled “Hot Topics in Patent Litigation: Actavis, Hatch-Waxman and the Biosimilars Act.” The Webinar focused on recent developments in areas regarding enforcement of patents in the life science area, generic drugs, and generic biologics. The entire webinar is available here; the following are brief highlights: Hatch-Waxman Patent […] Continue Reading →