Month: September 2008

  •     By Donald Zuhn — Last week, Teva Pharmaceutical Industries Ltd. announced that the European Commission’s Directorate General for Enterprise and Industry has granted the company a marketing authorization for its human granulocyte colony stimulating factor (G-CSF) product.  Teva had earlier received a favorable opinion for its G-CSF product from the Committee for Medicinal…

  •     By Sherri Oslick — Late last week, Magistrate Judge Mary Pat Thynge granted Amgen’s motion of summary judgment of non-infringement as to all asserted claims in Amgen Inc. v. ARIAD Pharmaceuticals Inc., Civil Action No. 06-cv-00259 (D. Del).  At issue was Amgen’s Enbrel® (etanercept, a TNF blocker) product.  (Another Amgen product, Kineret® —…

  •     By Donald Zuhn — Presidential Candidates Support Follow-on Biologics Regulatory Pathway Last week, Forbes.com reported that representatives of Senator Barack Obama's and Senator John McCain's campaigns have indicated that each candidate, if elected, would place the passage of a follow-on biologics regulatory pathway at the top of his health care agenda. The primary…

  •     By Kevin E. Noonan — After several years of having its decisions reversed by the Supreme Court — including KSR Int’l Co. v. Teleflex Inc., eBay Inc. v. MercExchange, LLC, Quanta Computer, Inc. v. LG Electronics, Inc., Merck KGAA v. Integra Lifesciences I, Ltd., Microsoft Corp. v. AT&T Corp., Festo Corp. v. Shoketsu…

  •     By Christopher P. Singer — In a Notice dated September 18, 2008, the U.S. Patent and Trademark Office announced that the postal interruptions cause by Hurricane Gustav in regions of Louisiana and Texas (beginning on August 30, 2008) and by Hurricane Ike in regions of Florida, Louisiana, and Texas (beginning on September 7,…

  •     By Sherri Oslick — About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. National Genetics Institute et al. v. Talecris Biotherapeutics, Inc.5:08-cv-00464; filed September 15, 2008 in the Eastern District of North Carolina Infringement of…

  • September 22-23, 2008 – FDA Boot Camp*** (American Conference Institute) September 22-23, 2008 – Patent Litigation 2008 (Practising Law Institute) – San Francisco, CA September 22-23, 2008 – 2008 World Stem Cell Summit (Genetics Policy Institute) – Madison, WI September 23-24, 2008 – Biotech Patenting (C5) – London, England October 6-7, 2008 – Patent Litigation…

  • Visiongain will be holding its 4th Biosimilars conference on November 11-13, 2008 in Philadelphia, PA.  The conference is intended to help attendees: • Identify the trends that will shape future market development of follow-on biologics;• Explore the current market and regulatory environment for biosimilars in Europe and the relevance to U.S. legislation;• Examine the emerging…

  •     By Donald Zuhn — On Wednesday, Dr. Laurence J. Kotlikoff, a professor of economics at Boston University, released the results of his analysis of the impact of varying lengths of market exclusivity on innovation in the biotechnology sector.  The 20-page report, entitled "Stimulating Innovation in the Biologics Industry:  A Balanced Approach to Marketing…

  •     By Donald Zuhn — Earlier this month, eGenomics, Inc. announced that the U.S. Patent and Trademark Office has issued U.S. Patent No. 7,349,808, which is directed to a method for performing real-time infection control by determining the phylogenetic relatedness between sequence data obtained from a microorganism sample isolated in a health care facility…