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  Biotechnology Law Report
  Volume 27, Number 4, August 2008
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  • Paper
  • Chemical Selection Inventions in the EPO and Germany: Continued Divergence in Legal Interpretation
        Steven M. Zeman, Franz-Josef Zimmer
        p.293-303                                                                              +cite        

  • Regulatory Affairs—Pharmaceutical
  • Third Circuit Accepts Preemption Arguments; More Cautions About Follow-On Biologics; Health Canada Issues Approval Guidance; FDA Takes First Steps in Expanding Drug Safety; Congress Proposes Requiring “Country of Origin” Statement; Congress Wants Direct Treatment Comparisons; Further Congressional Questions About Drug Advertising; Promised Studies Not Done; Warning over Avandia; Inspections of Foreign Facilities Will Not Be Easy; FDA Guidance on Genomics Term Definitions; European Scientists Want More Nanotechnology Regulation; Geron Stem Cell Trial on Hold; South Korea Clarifies Cloning Regulations; Decisions Needed on Antivirals in Advance of Flu Epidemic; Efforts to Control Genetic Testing; Bush Signs Genetic Information Nondiscrimination Act; Drug Companies Petition for Looser Restrictions on Literature on Off-Label Uses; Merck Said to Have Violated Publishing Ethics; Trade in Biotechnology Requires Closer Control; U.N. Alleges Chinese Dissidents Being Used as Organ Sources; Recent Approvals; Approval Delays?; NIH's Open Access Policy Still Has Publishers Roiled; Tilting at the FDA
        p.304-319                                                                              +cite    

  • Clinical Trials
  • When You Don't Need a Form 3674; FDA Is Asked for Guidance on Design of Pneumonia Trials; IRB Blocked from Granting Expedited Approvals; PhRMA Objects to Characterization of All Industry-Sponsored Clinical Trials as Biased; Protections for Subjects in Overseas Trials; Questionable Cell Therapy Trial Under Investigation in Austria; FDA to Increase Control of Clinical Trials; FDA, EMEA to Accept Biomarker Data on Renal Damage
        p.320-322                                                                              +cite    

  • Patents
  • Human Genetics Society Has Advice on Gene Patents; New Patents and Applications
        p.323-323                                                                              +cite    

  • Patent Litigation
  • MedImmune Suit Ends; Syngenta, Monsanto Cross-License Genetic Engineering Technology; More Litigation Between StemCells and Neuralstem; Mixed Decision in Dako Case; Writ of Mandamus Denied in PCR Case; How Far Does Safe Harbor Reach?; Anticoagulant Patent Found Unenforceable
        p.324-330                                                                              +cite    
  • Bibliography
        p.331-333                                                                              +cite    
  • On the Move
        p.334-335                                                                              +cite    

  • Texts
  • Draft Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration Staff: Certifications to Accompany Drug, Biological Product, and Device Applications/Submissions
        p.336-337                                                                              +cite    
  • Joseph C. Colacicco, Individually and as Executor of the Estate of Lois Ann Colacicco, Deceased, v. Apotex Inc.; SmithKline Beecham, d/b/a GlaxoSmithKline; Beth Ann McNellis, on Behalf of the Estate of Theodore DeAngelis, Deceased and in Her Own Right, v. Pfizer Inc.; John Does 1-5; ABC Doe Corp.; DEF Doe Corp.; GHI Doe Corp. Pfizer Inc. (No. 06-3107; No. 06-5148; No. 06-3107)
        p.338-358                                                                              +cite    
  • Guidance for Industry E15 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data, and Sample Coding Categories
        p.359-363                                                                              +cite    
  • Prescription Drug User Fee Act (PDUFA) IV Drug Safety Five-Year Plan
        p.364-375                                                                              +cite    
  • Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Commitment Studies; Availability
        p.376-378                                                                              +cite    
  • The Regents of the University of California, Abbott Molecular, Inc., and Abbott Laboratories, Inc. v. Dakocytomation California, Inc., Dako A/S, and Dako North America, Inc. (2006-1334, -1452, -1202)
        p.379-390                                                                              +cite    
  • In re Roche Molecular Systems, Inc., Roche Diagnostics Corporation, and Roche Diagnostics Operations, Inc.(Miscellaneous Docket No. 854)
        p.391-395                                                                              +cite    
  • Amgen, Inc. v. International Trade Commission and Roche Holding Ltd., F. Hoffmann-La Roche Ltd., Roche Diagnostics GmbH, and Hoffman-La Roche Inc. (2007-1014)
        p.396-403                                                                              +cite    
  • Aventis Pharma S.A. and Aventis Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc. and Teva Pharmaceuticals USA, Inc. (2007-1280)
        p.404-415                                                                              +cite    
  • Coming Events
        p.416-420                                                                              +cite