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Washington & Lee Law School
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  Biotechnology Law Report
  Volume 28, Number 4, August 2009
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  • Japanese Biotech Patenting Strategies in the Era of Follow-On Biologics
        John A. Tessensohn, Shusaku Yamamoto
        p.483-496                                                                              +cite        

  • COMMENT ON A RECENT ARTICLE
  • Comment on Getting Written Description Right in the Biotechnology Arts: A Realist Approach to Patent Scope
        Bert Rowland, Karen G. Potter
        p.497-499                                                                              +cite        

  • CONFERENCE REPORT
  • Personalized Medicine: Planning for the Future Colloquium I: Diagnostics and Diagnoses, Paths to Personalized Medicine
        M.P. Moon
        p.500-502                                                                              +cite        

  • REGULATORY AFFAIRS—PHARMACEUTICAL
  • Guidance on Placement of Integrated Effectiveness and Safety Summaries; Advice from FDA on Presenting Risk Information; More Warnings for Erlotinib; Sanofi-Aventis Said to Overstate Efficacy of Docetaxel; Possible Dosage Alterations for Rituximab; FDA Establishes Transparency Task Force; Unauthorized Clinical Trials Alleged; FDA Should Release Information on Unapproved Uses; Pegylated Anti-TNF Product Closer to European Approval; Viral Contaminant Reducing Supplies of Replacement Enzymes; First Follow-On Biologic Approved in Japan; More Human Embryonic Stem Cell Lines May Be Approved for Research; All Genetic Tests and Performance Data Should Be Registered; Early Development of Biologics to Gain New Regulatory Body in India; Rapid Test for C. diff. Approved; Label Changes for Immunosuppressives Reflect Concern About Kidney Virus
        p.503-507                                                                              +cite    

  • CLINICAL TRIALS
  • Cardiac Stem Cell Trial to Proceed; Earlier Use of Drugs That Have Completed Clinical Trials; Harmonization of European Clinical Trial Rules Demanded
        p.508-508                                                                              +cite    

  • REGULATORY AFFAIRS—AGRICULTURAL AND ENVIRONMENTAL
  • FDA Cannot Write Definitions on Its Own; APHIS Releases Biotechnology Quality Management System; Environmental Impact Statement Needed for Alfalfa; EU Finds Monsanto Corn Safe; High-Oleic Soybeans Okayed; Farmer Irritated with Biotechnology Opponents; Canada Drops Canola Complaint Against WTO; Cambridge to Ban Level 4 Laboratories; Restriction on Use of Antibiotics in Animal Field; Eight-Feature Corn Gets U.S., Canadian Approval
        p.509-511                                                                              +cite    

  • LITIGATION
  • Steps Taken to Prevent Federal Preemption; CAFC Finds Vaccine Did Cause Child's Injury
        p.512-513                                                                              +cite    

  • PATENTS
  • ACLU, Others Attack Patents on Breast Cancer Genes; PTO Upholds Patents on Uses of Stem Cells; Venture Capital Group Says 12 Years of Exclusivity Required for Biologics; DoJ Objects to Pay-to-Delay Agreements; EU Acts on Pay-to-Delay Issue; U.K. Minister Asks for Surrender of Patent Rights to Anti-HIV Drugs
        p.514-516                                                                              +cite    

  • PATENT LITIGATION
  • Double Patenting and Process Patents; Apparently, Oxford, U.K., Is Not in California; When Does the Two-Way Test for Obviousness Apply?; Illumina Sues for Infringement of Analytical Technology Patent; Ruling in Favor of Affymetrix Overturned; Abbott Ordered to Pay $1.67 Billion; BASF Sues Pioneer Hi-Bred for Unlawful Use of Technology; DuPont Countersues Monsanto; Beckman, Orchid, and Sequenom Suit Dropped
        p.517-523                                                                              +cite    

  • FINANCIAL AND SHAREHOLDER AFFAIRS
  • Vermont Requires Full Disclosure of Payments to Healthcare Providers; Medicare Panel Wants Pathway for Follow-On Biologics; Sequenom Being Investigated by SEC over Down's Syndrome Test Problems; Amgen Pays Fine for Allegedly Overcharging
        p.524-524                                                                              +cite    

  • MISCONDUCT
  • Two Researchers Barred from Involvement in Clinical Trials; Enough, Already! The Scientist Says Some Who Are Guilty of Misconduct; Deserve a Second Chance; The Non-Expert Expert?; More Questions About Payments to Surgeon Researcher; Fake Paper Creates Questions About “Open Access” Journals; Elsevier Said to Have Published Eight Additional Journals with Undisclosed Drug Company Sponsorship; Transplantation Researchers Have 8-Year History of Fraud, ORI Says
        p.525-528                                                                              +cite    
  • Bibliography
        p.529-530                                                                              +cite    
  • On the Move
        p.531-531                                                                              +cite    

  • DOCUMENTS
  • Guidance for Industry: Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document
        p.532-536                                                                              +cite    
  • Guidance for Industry: Presenting Risk Information in Prescription Drug and Medical Device Promotion
        p.537-554                                                                              +cite    
  • Takeda Pharmaceutical Co., Ltd. v. John J. Doll, Acting Under Secretary of Commerce for Intellectual Property
        p.555-561                                                                              +cite    
  • Autogenomics, Inc. v. Oxford Gene Technology Limited
        p.562-572                                                                              +cite    
  • In re Frits Jacobus Fallaux, Robert Cornelius Hoeben, Alex Jan van der Eb, Abraham Bout, and Domenico Valerio
        p.573-576                                                                              +cite