"#41957"--Spine ; "G1131"--Spine. Prepared for distribution at the program of the same name held April, 2013. Includes bibliographical references and index.
Contents:
Guidance for Industry: Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product, Draft Guidance, U.S. Department of Health and Human Services, Food and Drug Administration, (February 2012, Biosimilarity) / David K. Barr Kaye Scholer LLP -- Biologic and Biosimilar Drug Products / David K. Barr Kaye Scholer LLP -- Regulation of Biological Products, 42 U.S.C. 262 (2010). (Retrieved from http://www.gpo.gov) / David K. Barr Kaye Scholer LLP -- Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product, Draft Guidance, U.S. Department of Health and Human Services, Food and Drug Administration, (February 2012, Biosimilarity) / David K. Barr Kaye Scholer LLP -- Guidance for Industry: Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product, Draft Guidance, U.S. Department of Health and Human Services, Food and Drug Administration, (February 2012, Biosimilarity) / David K. Barr Kaye Scholer LLP -- Preissuance Submissions Final Rules Excerpt From: Changes to Implement the Preissuance Submissions by Third Parties Provision of the Leahy Smith America Invents Act; Final Rule, 77 Fed. Reg. 42150 (July 17, 2012) / Joseph M. Drayton Cooley LLP -- 2012 in Review: Case Law Developments in Pharmaceutical and Biotech Patents / Stephen J. Elliott Sullivan & Cromwell LLP -- An Overview of Recent Developments Regarding the America Invents Act / Joseph M. Drayton Cooley LLP -- Preissuance Submissions Final Rules Excerpt From: Changes to Implement the Preissuance Submissions by Third Parties Provision of the Leahy Smith America Invents Act; Final Rule, 77 Fed. Reg. 42150 (July 17, 2012) / Joseph M. Drayton Cooley LLP -- Post Grant Review Final Rules Excerpt From: Changes to Implement Inter Partes Review Proceedings, Post Grant Review Proceedings, and Transitional Program for Covered Business Method Patents; Final Rule, 77 Fed. Reg. 48680 (August 14, 2012) / Joseph M. Drayton Cooley LLP -- Inter Partes Review Final Forms Excerpt From: Changes to Implement Inter Partes Review Proceedings, Post Grant Review Proceedings, and Transitional Program for Covered Business Method Patents; Final Rule, 77 Fed. Reg. 48680 (August 14, 2012) / Joseph M. Drayton Cooley LLP -- Post Grant Review Final Rules Excerpt From: Changes to Implement Inter Partes Review Proceedings, Post Grant Review Proceedings, and Transitional Program for Covered Business Method Patents; Final Rule, 77 Fed. Reg. 48680 (August 14, 2012) / Joseph M. Drayton Cooley LLP -- Reprinted from the PLI Legal Treatise, Pharmaceutical and Biotech Patent Law, (Order #15140) Daniel L. Reisner Kaye Scholer LLP -- Technical Corrections Bill, H.R. 6621 / Joseph M. Drayton Cooley LLP -- Pharmaceutical and Biotechnology Licensing with Asia / Daniel L. Reisner Kaye Scholer LLP -- Reprinted from the PLI Legal Treatise, Pharmaceutical and Biotech Patent Law, (Order #15140)
Series:
Intellectual property course handbook series ; no. G-1131
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