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  Biotechnology Law Report
  Volume 28, Number 1, February 2009
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  • Paper
  • Getting Written Description Right in the Biotechnology Arts: A Realist Approach to Patent Scope
        Karen G. Potter
        p.1-17                                                                                    +cite        

  • Regulatory Affairs—Pharmaceutical
  • FDA Issues Guidance on Cooperative Manufacturing; Another Hold-Up for Rheumatoid Arthritis Drug; FDA, WebMD Launch Website; Grassley Wants More Information on Ghostwritten Articles on Hormone Replacement Product; Genentech Petitions for Tighter Regulation of Laboratory Tests; FDA Delays Decision on Myozyme; Recent Approvals
        p.18-20                                                                                  +cite    

  • Clinical Trials
  • Data Must Be Retained When Subjects Withdraw from a Trial; When Should Antineoplastic Drug Use Be Restricted by Genetics?; FibroGen Drug for Pancreatic Cancer Begins Trials; Stem Cell Trial in Ischemic Stroke Begins
        p.21-22                                                                                  +cite    

  • Regulatory Affairs—Agricultural and Environmental
  • Cotton Oil and Seed Contaminated with Unapproved Variety; Second-Generation Genetically Modified Soybean Approved for Use (But Not Planting) in Europe; NAS Committee Finds Inadequacies in Federal Nanotechnology Research and Regulation; Universal Waste Rules Now Cover Drugs
        p.23-25                                                                                  +cite    

  • Patents
  • Thomson Patent Fails in Europe; CAFC Considers Grouping of Claims; University Petitions for Addition of Inventors; Myriad Gets Its European BRCA Patent Back, But with Modifications; One Antibody Does Not Characterize a Class; FDA Has Advice on Patents for “Old” Antibiotics; Nutraceutical Juice Is Obvious
        p.26-32                                                                                  +cite    

  • Patent Litigation
  • CAFC Split on Abbott-Sandoz Litigation; A Patent on a Racemate Does Not Preclude One on an Enantiomer; CAFC Upholds Attorney, Expert Witness Fees; eBioscience Says It Is Not Infringing Invitrogen Patents; One Boniva Patent Found Invalid
        p.33-38                                                                                  +cite    

  • Science and Society
  • Vatican Issues Authoritative Statement on Reproductive Science; Concern About Web Ads for Stem Cell Therapy; U.K. Government Authorizes Hybrid Embryos for Stem Cell Research
        p.39-40                                                                                  +cite    
  • On the Move
        p.41-42                                                                                  +cite    

  • Texts
  • Guidance for Sponsors, Clinical Investigators, and IRBs: Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials
        p.43-46                                                                                  +cite    
  • Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics
        p.47-55                                                                                  +cite    
  • Amendment to the Universal Waste Rule: Addition of Pharmaceuticals [excerpts]
        p.56-75                                                                                  +cite    
  • Guidance for Industry: Submission of Patent Information for Certain Old Antibiotics
        p.76-78                                                                                  +cite    
  • University of Kansas Center for Research, Inc. v. The United States of America, Represented by the Department of Health and Human Services, by and Through Its Agents the National Institutes of Health and the National Cancer Institute
        p.79-82                                                                                  +cite    
  • In re Kenneth Alonso
        p.83-87                                                                                  +cite    
  • In re DBC
        p.88-95                                                                                  +cite    
  • Gilbert P. Hyatt v. Jon W. Dudas
        p.96-100                                                                                +cite    
  • Abbott Laboratories v. Sandoz, Inc.
        p.101-128                                                                              +cite    
  • Sanofi-Synthelabo, Sanofi-Synthelabo, Inc., and Bristol-Myers Squibb Sanofi Pharmaceuticals Holding Partnership v. Apotex, Inc. and Apotex Corp.
        p.129-138                                                                              +cite    
  • Takeda Chemical Industries, Ltd. and Takeda Pharmaceuticals North America, Inc. v. Mylan Laboratories, Inc., Mylan Pharmaceuticals, Inc., and UDL Laboratories, Inc., and Alphapharm Pty., Ltd. and Genpharm, Inc.
        p.139-146                                                                              +cite    
  • Coming Events
        p.147-150                                                                              +cite