Month: March 2012

  • The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "The FDA's Guidance on Biosimilars: Understanding the Impact on Patent Prosecution and Litigation" on March 22, 2012 beginning at 2:00 pm (ET).  A panel consisting of Henry Hadad of Bristol-Myers Squibb Co., Erika Lietzan of Covington & Burling LLP, and Suzanne Munck of…

  • By Kevin E. Noonan — In response to an earlier post on Novartis' challenge to the Indian Patent Office's decision not to grant a patent on its anticancer drug Gleevec® (see "Indian Supreme Court to Rule on Gleevec Patent"), a reader opined that we should appreciate the erudition and wisdom of the patent official in…

  • By Kevin E. Noonan — In what was an object of great controversy, the Leahy-Smith America Invents Act grants the Director of the U.S. Patent and Trademark Office the authority to "set or adjust by rule any fee established, authorized, or charged under title 35, United States Code, or the Trademark Act of 1946 (15…

  • By Kevin E. Noonan — A broad coalition of 111 public interest groups announced today a manifesto for containing "synthetic biology," a term with a loose definition (including "extreme genetic engineering") that includes efforts such as Craig Venter's to produce novel microorganisms to more traditional biotechnology efforts in transgenic plants and animals and other genetically…

  • By Kevin E. Noonan — One of the signal achievements of late 20th Century trade diplomacy was the ratification of the Uruguay Round of the General Agreement on Tariffs and Trade (GATT), and specifically the Trade-related Aspects on Intellectual Property Rights (TRIPS).  These international agreements created the World Trade Organization and changed national practices regarding…

  • By Kevin E. Noonan — The promise of an era of "personalized medicine" has been pursued for a generation, being one of the rationales for and purported benefits of the Human Genome Project.  It has become such a sought-for goal that it has been used to drive policy:  it is something that health care reform…

  • March 14-15, 2012 – Biotech Patenting (C5) – Munich, Germany March 20-21, 2012 – FDA Boot Camp*** (American Conference Institute) – New York, NY March 26-27, 2012 – PTO Procedures under the America Invents Act*** (American Conference Institute) – New York, NY March 27, 2012 – The Biosimilar Drug Approval Pathway: Draft FDA Guidance and…

  • American Conference Institute (ACI) will be holding a conference on Biosimilars on May 22-23, 2012 in New York, NY.  ACI faculty will help attendees: • Understand and comply with the FDA's current position on defining biosimilarity and demonstrating interchangeability under the abbreviated pathway;• Determine the financial viability of biosimilars and explore new strategic alliances and…

  • Strafford will be offering a webinar entitled "Patent Term Adjustments and Extensions: Recent Developments" on April 18, 2012 from 1:00 – 2:30 pm (EDT).  Thomas L. Irving of Finnegan Henderson Farabow Garrett & Dunner and Margaret J. Sampson of Vinson & Elkins will provide guidance to IP counsel for calculating patent term adjustments and extensions,…

  • Strafford will be offering a webinar entitled "Contested Proceedings Before the New Patent Trial and Appeal Board" on April 3, 2012 from 1:00 – 2:30 pm (EDT).  Scott A. McKeown and Greg H. Cardella of Oblon Spivak McClelland Maier & Neustadt will examine the new Patent Trial and Appeal Board (PTAB) and procedures for contested…