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  Biotechnology Law Report
  Volume 29, Number 2, April 2010
  homepage                   other issues
 

  • ARTICLE
  • Pharmacogenomics and the FDA: The Challenges of Incorporating Research into Practice—Is the FDA Hindering Progress?
        Evan J. Topol
        p.147-163                                                                              +cite        

  • COMMENTS ON RECENT CASES
  • Thoughts on Abbott, Intervet, and Ariad
        Harold C. Wegner
        p.165                                                                                      +cite        
  • What Subject Matter Is Patentable? Reading Myriad Genetics While Waiting for the Bilski Decision: Why Is This Molecule Different from All Other Molecules?
        Gerry J. Elman
        p.167-169                                                                              +cite        

  • REGULATORY AFFAIRS—PHARMACEUTICAL
  • Risk Management Plan Issued for Erythropoietin; U.S.–European Agreement to Reduce Burden of Orphan Drug Documentation; New Product Approvals from FDA; FDA, NIH Form Partnership to Improve Regulation
        p.171-172                                                                              +cite    

  • CLINICAL TRIALS
  • FDA Issues Guidance on Adaptive Clinical Trial Design
        p.173                                                                                      +cite    

  • REGULATORY AFFAIRS—AGRICULTURAL AND ENVIRONMENTAL
  • Monsanto's Sugarbeets Can Be Planted
        p.175                                                                                      +cite    

  • PATENTS
  • CAFC Finds a Separate Written Description Requirement; Criticism of Bars to Patentability in Indian Law; Patent on Lysine-Synthesizing Bacteria Dies for Lack of Best Mode Description
        p.177-182                                                                              +cite    

  • PATENT AND TRADE SECRET LITIGATION
  • Ablynx Succeeds in Opposition to GlaxoSmithKline Patent; Obviousness Question Requires Review; Nucleic Acid Detection Claims Are Invalid; Genetic Technologies Sues Several Companies for Infringement; State Courts Do Not Have Jurisdiction in Trade Secret Cases; Bayer, Novartis Settle Hemophilia Treatment Litigation
        p.183-186                                                                              +cite    
  • Bibliography
        p.187-193                                                                              +cite    
  • On the Move
        p.195                                                                                      +cite    

  • TEXTS
  • Guidance for Industry: Adaptive Design Clinical Trials for Drugs and Biologics [excerpts]
        p.197-215                                                                              +cite    
  • Ariad Pharmaceuticals, Inc., Massachusetts Institute of Technology, The Whitehead Institute for Biomedical Research, and the President and Fellows of Harvard College v. Eli Lilly and Company (2008-1248)
        p.217-241                                                                              +cite    
  • In re Andrew P. Chapman and David J. King (Serial No. 09/719,045)(2009-1270)
        p.243-249                                                                              +cite    
  • Enzo Biochem, Inc., Enzo Life Sciences, Inc., and Yale University v. Applera Corp. and Tropix, Inc. (2009-1281)
        p.251-262                                                                              +cite    
  • Ajinomoto Co., Inc. and Ajinomoto Heartland LLC v. International Trade Commission and Global Bio-Chem Technology Group Company Ltd., et al. (2009-1081)
        p.263-270                                                                              +cite    
  • HIF Bio, Inc. and BizBiotech Co., Ltd. v. Yung Shin Pharmaceuticals Industrial Co., Ltd., et al., Carlsbad Technology, Inc., and Fish and Richardson P.C. and Y. Rocky Tsao (2006-1522)
        p.271-277                                                                              +cite    
  • Coming Events
        p.279-281                                                                              +cite