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  Biotechnology Law Report
  Volume 25, Number 1, February 2006
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  • Foreword
  • The Long and Short of It: More on Merck and Madey
        Robert A. Bohrer
        p.1-1                                                                                      +cite        

  • Papers
  • Pharmaceutical and Biotechnology Research Revisited
        Edward T. Lentz
        p.2-5                                                                                      +cite        
  • A Brief Tabular Summary of the Decision in Merck KGaA v. Integra LifeSciences I, Ltd.
        Richard Warburg
        p.6-7                                                                                      +cite        

  • Regulatory Affairs--Pharmaceutical
  • FDA Releases Guidance on Electronic Submissions; Austria's Ban on GMOs Is Not Legal; Vaccine for Advanced Prostate Cancer Gets Fast-Track Designation; FDA Approves Trial of Immature Human Neural Cells; Short Stories: News from the FDA, EU; Press Clippings
        p.8-10                                                                                    +cite    

  • Patents
  • NAS Sees Need to Balance IP Rights, Researchers' Needs, in Genomics and Proteomics; More Bt Litigation?; No, You Won't Go to Jail; Short Story: Patent Crime?; One Fifth of Human Genome Covered by Patents; European Companies May Be Foregoing Some Protection; Press Clippings
        p.11-14                                                                                  +cite    

  • Patent Litigation
  • Who Conceived RNase H Minus RT and When?; Genentech's Method of Using Growth Factor May Be Patentable in Europe; MedImmune Cannot Challenge Validity of Cabilly II (But Patent Has Been Revoked); Infringement of a Valid Patent Causes Irreparable Harm to the Patent Holder; Elan and SkyePharma May or May Not Have Violated Sherman Act; Genetic Technologies, Applera Settle; Erythropoietin Returns to the Patent Litigation Scene
        p.15-24                                                                                  +cite    

  • Financial and Shareholder Affairs
  • FTC Sues Warner Chilcott, Barr over Agreement Not to Introduce Generic Oral Contraceptive; BLR Update: FDA Tipped Off SEC About Biopure; Two Pay Fines in ImClone Insider Trading Case; Australia Now Has Code of Best Practice for News Releases
        p.25-26                                                                                  +cite    

  • Scientific Misconduct
  • Doubts Grow About Human Cloning Report
        p.27-27                                                                                  +cite    

  • Electronic Biotechnology; Science and Society
  • Drug Information Website Can Keep Its Name; Harvard Establishes Healthcare Law Center
        p.28-28                                                                                  +cite    

  • Bibliography
  • Book Reviews
        Arthur Kyriazis
        p.29-32                                                                                  +cite        
  • On the Move
        p.33-34                                                                                  +cite    

  • Texts
  • Guidance for Industry: Providing Regulatory Submissions in Electronic Format?Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications
        p.35-45                                                                                  +cite    
  • United States Court of Appeals for the Federal Circuit: Invitrogen Corporation (formerly known as Life Technologies, Inc.) v. Clontech Laboratories, Inc. (04-1039, -1040)
        p.46-64                                                                                  +cite    
  • Decision of 29 October 2004, Boards of Appeal of the European Patent Office, Case Number T 1020/03 - 3.3.4 (Genentech)
        p.65-85                                                                                  +cite    
  • United States Court of Appeals for the Federal Circuit; MedImmune, Inc. v. Genentech, Inc. and City of Hope and Celltech R&D, Ltd. (04-1300, -1384)
        p.86-93                                                                                  +cite    
  • United States Court of Appeals for the Federal Circuit: Pfizer, Inc. and Warner-Lambert Company, LLC v. Teva Pharmaceuticals USA, Inc. and Ranbaxy Pharmaceuticals, Inc. and Ranbaxy Laboratories Limited (05-1331)
        p.94-105                                                                                +cite    
  • United States Court of Appeals for the Eleventh Circuit: Andrx Pharmaceuticals, Inc. v. Elan Corporation, PLC and SkyePharma, Inc. (03-13605)
        p.106-111                                                                              +cite    
  • In the United States District Court for the District of the District of Columbia: Federal Trade Commission v. Warner Chilcott Holdings et al.
        p.112-117                                                                              +cite    
  • Erratum
        p.118-118                                                                              +cite    
  • Coming Events
        p.119-121                                                                              +cite