Biotechnology and the Law

Preface xxxi About the Editors xxxv About the Contributors xxxix Introduction to Biotechnology and the Law 1(24) Robert F. Copple The Biotech Primer 4(1) Biotech Defined 4(1) Three-Branch Approach 5(1) The Biotech Company Life Cycle 5(7) Phase I: Start-up 6(1) Intellectual Property 6(1) Company Formation 7(1) Investment Capital 7(1) Phase II: Early Development 8(1) Additional Investment 8(1) The Regulatory Track 9(1) Business Growth and Complexity 9(1) Phase III: Later-Stage Development and Product Approval 10(1) Phase IV: Challenges Facing the Now Mature Company 10(1) Commercialization 11(1) Regulatory Oversight 11(1) Litigation 11(1) Conclusion 12(13) Glossary 13(12) Managing Innovation: Patent Basics for Biotechnology Counsel 25(44) Dr. Michael H. Brodowski Thomas A. Turano Dr. Christine C. Vito Introduction 25(1) U.S. Patent Portfolios 26(19) Patent Rights---The Claims 26(2) Types of Patents 28(1) Provisional Patent Applications 29(1) Continuing Patent Application Practice 30(1) Requirements for Patentability 31(3) Preparation of a Patent Application 34(1) Patent Application Formalities 35(3) Publication of Patent Applications 38(1) Patent Prosecution 39(2) Appeal of Patent Office Final Rejections 41(1) Notice of Allowance 42(1) Post-Issue Patent Considerations 43(2) Foreign Patent Portfolios 45(13) Protection Strategy 46(3) Patentability Differences 49(2) Other Considerations 51(1) Prerequisites to Filing 52(1) Options for Filing in Other Jurisdictions 53(4) Additional Considerations 57(1) Managing the Company's Patent Estate 58(11) A Family Portrait 58(2) Keeping It in the Family 60(2) Skeletons in the Closet 62(1) Rights of Ownership 63(1) Correspondence to Products or Business Strategies 64(2) Freedom to Operate 66(3) Company Formation 69(70) Andrew T. Hoyne Steven E. Pozaric Mark L. Stoneman Introduction 69(4) ``But will it help us get money?'' 69(1) The Importance of the Board of Directors 70(2) Speed 72(1) Simplicity 73(1) The Role of the Company's Attorneys 73(1) Biotechnology Company Models 73(6) Company Formed Before In-Licensing While R&D Continues at University 74(1) Technology Flip 75(1) Revenue-Funded Company 75(1) Corporate Deal-Funded Company 75(1) Venture Fund--Launched Company 76(1) Angel Investor--Funded Company 76(1)