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  Biotechnology Law Report
  Volume 30, Number 1, February 2011
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  • IN MEMORIAM
  • Bertram Rowland, 1930–2010
        p.1                                                                                          +cite    

  • ARTICLES
  • US Patent Eligibility in the Wake of Bilski v Kappos: “Business as Usual” in an Age of New Technologies?
        Timo Minssen, Robert M. Schwartz
        p.3-56                                                                                    +cite        
  • A Sequel to “US Patent Eligibility in the Wake of Bilski v Kappos: ‘Business as Usual’ in an Age of New Technologies?”
        Timo Minssen, Robert M. Schwartz
        p.57-58                                                                                  +cite        
  • Expansion of the Canadian Research Exemption for Biotechnology Research Tools
        Rebecca Goulding, Matthew Voell, Emily Marden, Ed Levy
        p.59-63                                                                                  +cite        

  • REGULATORY AFFAIRS—PHARMACEUTICAL
  • Pressure Rises for Regulation of DTC Genetic Tests; Appeal of Stem Cell Ruling Succeeds; Enzyme Approved for Gout; Forest Pharmaceuticals Agrees to Guilty Plea; Company Sold Unapproved and Misbranded Drugs and Obstructed Agency Investigation; DHHS Disbanding Genetics Committee; FDA and Medicare to Join in Product Reviews; NIH, FDA Will Dispense Grants to Advance Regulatory Science; Some Progress on Biosimilars Erythropoietin Recalled Because of Concern About Tiny Glass Flakes from Vials; No Reports of Patient Injuries; Another Role for Pharmacogenomics?; EU to Release Regulations for Biosimilar Antibody Drugs; Another Blow for Patient Protection and Affordable Care Act; Judge Says 20 States Can Proceed with Suit Charging Law Is Unconstitutional
        p.65-71                                                                                  +cite    

  • CLINICAL TRIALS
  • A Close Look at Non-Inferiority Trials; FDA Issues Guidance on Safety for Clinical Trials; Geron Human Embryonic Stem Cell Trial Starts; National Academy of Sciences Discusses Postmarketing Trials; Bone Marrow Stem Cell Trial Authorized in Israel; Canadian Company Asked to Submit Proposal on Brain Injury Treatment to DoD
        p.73-76                                                                                  +cite    

  • PATENTS
  • PTO Clarifies Procedure for Review of Substantial New Questions of Patentability; Streamlined Procedure for Reviewing Inter Partes Briefs; Pay-to-Delay Ruling Stands; BIO Wants USDA to Oppose ACLU in Appeal of Myriad Genetics Decision; Bayh-Dole Is Working, But Improvements Would Be Good; Tekmira Receives Three U.S. Patents; Short Stories: News from Cook, Oncolytics
        p.77-79                                                                                  +cite    

  • PATENT LITIGATION
  • New Developments in Obviousness-Type Double Patenting; Should Sun v. Lilly Be Reheard en Banc?; Glaxo Says Genentech Is Infringing Antibody-Purification Patents; Two Generic Drug Makers Sue Each Other; Docetaxel Patents Invalid for Obviousness; CAFC Allows Suit of Teva Against Eisai to Go Forward; Japanese Patent Application Found Deficient; Rights to Human Fibroblast Interferon at Stake
        p.81-84                                                                                  +cite    

  • LITIGATION
  • Supreme Court Accepts Medicare Drug Case
        p.85                                                                                        +cite    

  • PROFESSIONAL PRACTICE
  • Restriction of Attorney–Client Privilege in Europe; Practicing Law Institute Sets Up Patent Site
        p.85                                                                                        +cite    

  • MISCONDUCT
  • Sequenom CFO Sues Company; Company Illegally Distributed Human Growth Hormone
        p.87                                                                                        +cite    

  • SCIENTIFIC AND MEDICAL DEVELOPMENTS
  • Gene Therapy Success; Nobel Prize for Synthetic Method Widely Used for Drugs; Synthetic Mitochondrial Genome Created
        p.89                                                                                        +cite    
  • On the Move
        p.91                                                                                        +cite    

  • DOCUMENTS
  • United States Government Accountability Office: Direct-to-Consumer Genetic Tests: Misleading Test Results Are Further Complicated by Deceptive Marketing and Other Questionable Practices
        p.93-103                                                                                +cite    
  • Final Report of the National Academies' Human Embryonic Stem Cell Research Advisory Committee and 2010 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research [Excerpts]
        p.105-117                                                                              +cite    
  • New Drug Approval: FDA's Consideration of Evidence from Certain Clinical Trials
        p.119-132                                                                              +cite    
  • Clarification on the Procedure for Seeking Review of a Finding of a Substantial New Question of Patentability in Ex Parte Reexamination Proceedings
        p.133-134                                                                              +cite    
  • Streamlined Procedure for Appeal Brief Review in Inter Partes Reexamination Proceedings
        p.135-136                                                                              +cite    
  • Top Eight Reasons Appeal Briefs Are Non-Compliant
        p.137                                                                                      +cite    
  • BPAI Inter Partes Reexam “Appellant's Brief Only” Review Checklist
        p.139-141                                                                              +cite    
  • Sun Pharmaceutical Industries, Ltd. v. Eli Lilly and Company (2010–1105)
        p.143-148                                                                              +cite    
  • Brief of Washington Legal Foundation and Constitutional Law Scholars as Amici Curiae in Support of Plaintiff's Motion for Summary Judgment, Commonwealth of Virginia v. Kathleen Sebelius (Civil Action No. 3:10-cv-188-HEH)
        p.149-161                                                                              +cite    
  • Brief for the United States as Amicus Curiae in Support of Neither Party: The Association for Molecular Pathology et al. v. US Patent and Trademark Office, Myriad Genetics, Inc., et al.
        p.163-181                                                                              +cite    
  • Coming Events
        p.183-184                                                                              +cite