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  Biotechnology Law Report
  Volume 28, Number 3, June 2009
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  • ARTICLES
  • Is the Gene Patenting Party Over? Biotechnology Patents After In re Kubin
        Michael J. Stimson
        p.329-331                                                                              +cite        
  • The EPO's Decision G 2/06 on the Patentability of Human Embryonic Stem Cells: Sounding the Bell for the Next Round?
        Rainer Plaggenborg, Franz-Josef Zimmer
        p.332-337                                                                              +cite        

  • COMMENT ON A RECENT CASE
  • In re Gleave: Anticipation of Genus by Prior Art Species in Long List
        Harold C. Wegner
        p.338-338                                                                              +cite        

  • REGULATORY AFFAIRS—PHARMACEUTICAL
  • Recombinant Drug May Be Rationed; Ranbaxy Still in Trouble with FDA; FDA Joins Nanotechnology Review Body; New HPV Tests Approved; FDA Official Reminds Staff to Protect Information; Anti-IL-6 Drug Linked to Deaths; Genentech Withdraws Raptiva Monoclonal Antibody; FDA Finds Problems with Internet Drug Advertisements
        p.339-341                                                                              +cite    

  • CLINICAL TRIALS
  • GAO Finds Serious Problems with Oversight of Clinical Trials; Draft Guidance on Cell Therapy for Heart Disease; Texas May Require Insurance Coverage of Routine Medical Care for Patients; in Clinical Trials; Hsp90 Inhibitor to Begin Phase I Study; Phase I Trial of Lung Cancer Drug Expanded
        p.342-343                                                                              +cite    

  • REGULATORY AFFAIRS—AGRICULTURAL AND ENVIRONMENTAL
  • Revisions to Regulations on Importation, Movement, and Release of Genetically Engineered Organisms
        p.344                                                                                      +cite    

  • LITIGATION
  • Failure-to-Warn Prempro Case to Proceed; Class Action Status Denied in Vioxx Case
        p.345                                                                                      +cite    

  • PATENTS
  • CAFC Agrees Kubin Claims Are Obvious; Mixed Decision from CAFC on Changes Desired by PTO; Options for Patenting Genetic Tests; Roche Sues Mylan over Capecitabine Plans; Human Gene Patents Not as Toxic as Predicted; Pacific Biosciences Named Senior Party in Dispute with Life Technologies; Novocell Receives U.S. Endoderm Patent; Helicos to Appeal EPO Maintenance of Illumina Patent; Alnylam to Receive RNA Interference Patent; Mixed Decision in Compact Disk Dispute at ITC; Patent Misuse Defense Is One Issue
        p.346-358                                                                              +cite    

  • PATENT LITIGATION
  • Lilly Entitled to Longer Protection of Raloxifene; Netherlands Removes Partial Patent Validity Law; Sanctionable Conduct Does Not Always Justify Award of Attorney Fees; Invitrogen–GE Healthcare Suit Sent to Texas; CAFC Rejects Appeal in HPV Case; Ariad, MIT Patent on Transcription Factor Fails Written Description Test; Motion for Summary Judgment of Non-Infringement Denied
        p.359-365                                                                              +cite    

  • FINANCIAL AND SHAREHOLDER AFFAIRS
  • Medicare Considering Whether to Pay for Genetic Tests; Gifts and Consulting Fees Being Curtailed
        p.366-367                                                                              +cite    

  • SCIENCE AND SOCIETY
  • Research on Human Embryonic Stem Cells Now Eligible for NIH Funding; Tort Reform Legislation Proposed in Georgia; Free Access Policy Made Permanent; Worries About Synthetic Bioweapons; Two Animal Rights Extremists Indicted; Two Genetic Tests Not Endorsed by CDC Group; What Regulation Is Needed for Genetic Testing?; Possible Criminalization of Stem Cell Research
        p.368-371                                                                              +cite    

  • MISCONDUCT
  • Obama Lays Out Procedures for Improving Scientific Integrity; Weill Medical College Fined over Inadequate Reporting of Scientist Workload; Former Bristol-Myers Executive Admits Attempting to Block Introduction of Generic Clopidogrel; Quest Diagnostics Settles over Diagnostic Kits; “Fake” Orthopedics Journal Revealed; Study Reporting Value of Bone Growth Protein Retracted
        p.372-373                                                                              +cite    
  • Bibliography
        p.374-376                                                                              +cite    
  • On the Move
        p.377                                                                                      +cite    

  • DOCUMENTS
  • 2009 Draft Guidelines on Human Stem Cell Research
        p.378-381                                                                              +cite    
  • Importation, Interstate Movement, and Release into the Environment of Certain Genetically Engineered Organisms [excerpts]
        p.382-408                                                                              +cite    
  • In re Marek Z. Kubin and Raymond G. Goodwin (2008-1184) (Serial no. 09/667,859)
        p.409-416                                                                              +cite    
  • Secretary's Advisory Committee on Genetics, Health, and Society—Public Consultation Draft Report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests (Draft Report for Public Comment) [excerpts]
        p.417-442                                                                              +cite    
  • Triantafyllos Tafas and SmithKline Beecham Corporation (doing business as GlaxoSmithKline), SmithKline Beecham PLC, and Glaxo Group Limited (doing business as GlaxoSmithKline) v. John J. Doll (2008-1352)
        p.443-461                                                                              +cite    
  • Eli Lilly and Company v. Teva Pharmaceuticals USA, Inc. (2009-1071)
        p.462-467                                                                              +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.468-477                                                                              +cite    
  • Coming Events
        p.478-481                                                                              +cite