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  Biotechnology Law Report
  Volume 24, Number 6, December 2005
  homepage                   other issues
 

  • Paper
  • Between a Rock and a Hard Place: University Research After Merck 1 and Madey 2 and the University of Rochester
        Robert A. Bohrer
        p.713-720                                                                              +cite        

  • Regulatory Affairs--Pharmaceutical
  • Sandoz Sues FDA over Omnitrope; FDA Releases Drafts of Guidances on Follow-Up of Gene Therapy Trials, Design of Pediatric Trials; Short Stories: News from Centocor, Genzyme, FDA
        p.721-723                                                                              +cite    

  • Clinical Trials
  • IFPMA Launches Clinical Trial Website; Genentech Halts Trial of Avastin in Advanced Ovarian Cancer for Safety Reasons
        p.724-724                                                                              +cite    

  • Regulatory Affairs--Agricultural and Environmental
  • Insect-Resistant Cotton Receives Nonregulated Status; Double-Feature Corn Now Unregulated
        p.725-725                                                                              +cite    

  • Patents
  • Diversion of Patent Fees Is Constitutional; PTO Makes Changes in Requirements for Claiming Benefit of a Provisional Application Not Written in English; Two Companies Settle with Columbia over Royalties; CAFC Upholds Denial of Patent on Maize ESTs; Rader Dissents; Sequence Data Are Not Necessarily Required; Cabilly Patent May Represent Double Patenting; Personalized Medicine Expected to Have Profound Effects on Intellectual Property Strategies; Press Clippings
        p.726-733                                                                              +cite    

  • Patent Litigation
  • Enzo's Gonorrhea Diagnosis Patent Falls; Novo Nordisk Loses Its hGH Patent; Internal Use Is Not Public Use; One Patent Is Unenforceable; the Other Is Infringed; Ventana Is Infringing, But Some Claims May Be Obvious; Short Stories
        p.734-742                                                                              +cite    

  • Financial and Shareholder Affairs
  • SEC Investigating Reports of Leaks of Clinical Trial Data; SEC Brings Civil Fraud Charges Against Biopure
        p.743-743                                                                              +cite    
  • On the Move
        p.744-745                                                                              +cite    

  • Texts
  • Draft Guidance for Industry: Gene Therapy Clinical Trials--Observing Participants for Delayed Adverse Events
        p.746-758                                                                              +cite    
  • Guidance for Industry: How to Comply with the Pediatric Research Equity Act
        p.759-770                                                                              +cite    
  • Miguel Figueroa v. the United States
        p.771-782                                                                              +cite    
  • Provisions for Claiming the Benefit of a Provisional Application with a Non-English Specification and Other Miscellaneous Matters
        p.783-799                                                                              +cite    
  • In re Dane K. Fisher and Raghunath V. Lalgudi (Serial No. 09/619,643) (04-1465)
        p.800-812                                                                              +cite    
  • Daniel J. Capon, Arthur Weiss, Brian A. Irving, Margo R. Roberts, and Krisztina Zsebo v. Zelig Eshhar, Daniel Schindler, Tova Waks, and Gideon Gross v. Jon Dudas (Interference No. 103,887) (03-1480, -1481)
        p.813-821                                                                              +cite    
  • Enzo Biochem, Inc. v. Gen-Probe Incorporated and Becton Dickinson and Company (04-1570)
        p.822-828                                                                              +cite    
  • Novo Nordisk Pharmaceuticals, Inc., and Novo Nordisk A/S v. Bio-Technology General Corp. and Teva Pharmaceuticals USA, Inc. (04-1581)
        p.829-840                                                                              +cite    
  • Invitrogen Corporation v. Biocrest Manufacturing, L.P., Stratagene Holding Corp., 841 and Stratagene, Inc. (04-1273, -1274)
        p.841-846                                                                              +cite    
  • Pharmacia Corporation, Pharmacia AB, Pharmacia Enterprises S.A., and Pharmacia 847 & Upjohn Company and The Trustees of Columbia University in the City of New York v. Par Pharmaceutical, Inc. (04-1478, -1496)
        p.847-849                                                                              +cite    
  • CytoLogix Corporation v. Ventana Medical Systems, Inc. (04-1446)
        p.852-859                                                                              +cite    
  • Purdue Pharma L.P., The Purdue Frederick Company, The P.F. Laboratories, Inc., and The Purdue Pharma Company and EuroCeltique S.A. v. Endo Pharmaceuticals Inc. and Endo Pharmaceuticals Holdings Inc. (04-1189, -1347, -1357)
        p.860-866                                                                              +cite    
  • Coming Events
        p.867-869                                                                              +cite