Course Handbook   Course Handbook

Developments in Pharmaceutical and Biotech Patent Law 2013

Publication Date: April 2013 Number of Volumes: 1
ISBN Number: 9781402419713 Page Count: 406 pages

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Developments in Pharmaceutical and Biotech Patent Law 2013 TOC
Chapter 1: Claim Construction Issues in Pharma and Biotech Cases Daniel L. Reisner ~ Kaye Scholer LLP
Chapter 2: Biologic and Biosimilar Drug Products David K. Barr ~ Kaye Scholer LLP
Chapter 3: Regulation of Biological Products, 42 U.S.C. § 262 (2010). (Retrieved from http://www.gpo.gov) David K. Barr ~ Kaye Scholer LLP
Chapter 4: Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product, Draft Guidance, U.S. Department of Health and Human Services, Food and Drug Administration, (February 2012, Biosimilarity) David K. Barr ~ Kaye Scholer LLP
Chapter 5: Guidance for Industry: Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product, Draft Guidance, U.S. Department of Health and Human Services, Food and Drug Administration, (February 2012, Biosimilarity) David K. Barr ~ Kaye Scholer LLP
Chapter 6: Guidance for Industry: Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009, Draft Guidance, US Dep't of Health and Human Services, Food and Drug Admin., (Feb. 2012, Biosimilarity) David K. Barr ~ Kaye Scholer LLP
Chapter 7: 2012 in Review: Case Law Developments in Pharmaceutical and Biotech Patents Stephen J. Elliott ~ Sullivan & Cromwell LLP
Chapter 8: An Overview of Recent Developments Regarding the America Invents Act Joseph M. Drayton ~ Cooley LLP
Chapter 9: 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
Chapter 10: Supplemental Examination Final Rules Excerpt From: Changes to Implement the Supplemental Examination Provisions of the Leahy-Smith America Invents Act and to Revise Reexamination Fees; Final Rule, 77 Fed. Reg. 48828 (August 14, 2010) Joseph M. Drayton ~ Cooley LLP
Chapter 11: 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
Chapter 12: 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
Chapter 13: PTAB Practice Final Rules Excerpt From: Rules of Practice for Trials Before the Patent Trial and Appeal Board and Judicial Review of Patent Trial and Appeal Board Decisions; Final Rule, 77 Fed. Reg. 48612 (August 14, 2012) Joseph M. Drayton ~ Cooley LLP
Chapter 14: Technical Corrections Bill, H.R. 6621 Joseph M. Drayton ~ Cooley LLP
Chapter 15: Pharmaceutical and Biotechnology Licensing with Asia Daniel L. Reisner ~ Kaye Scholer LLP
Chapter 16: Reprinted from the PLI Legal Treatise, Pharmaceutical and Biotech Patent Law, (Order #15140)
Chapter 17: Index to Developments in Pharmaceutical and Biotech Patent Law 2013
Course Handbook from the program Developments in Pharmaceutical and Biotech Patent Law 2013, held April, 2013.
Co-Chair(s)
David K. Barr, Kaye Scholer LLP
Daniel L. Reisner, Kaye Scholer LLP
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