| Developments in Pharmaceutical and Biotech Patent Law 2013 TOC |
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| Chapter 1: Claim Construction Issues in Pharma and Biotech Cases |
Daniel L. Reisner ~ Kaye Scholer LLP
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| Chapter 2: Biologic and Biosimilar Drug Products |
David K. Barr ~ Kaye Scholer LLP
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| Chapter 3: Regulation of Biological Products, 42 U.S.C. § 262 (2010). (Retrieved from http://www.gpo.gov) |
David K. Barr ~ Kaye Scholer LLP
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| Chapter 4: Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product, Draft Guidance, U.S. Department of Health and Human Services, Food and Drug Administration, (February 2012, Biosimilarity) |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
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| Chapter 5: Guidance for Industry: Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product, Draft Guidance, U.S. Department of Health and Human Services, Food and Drug Administration, (February 2012, Biosimilarity) |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
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| 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Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009, Draft Guidance, US Dep't of Health and Human Services, Food and Drug Admin., (Feb. 2012, Biosimilarity) |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
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| Chapter 7: 2012 in Review: Case Law Developments in Pharmaceutical and Biotech Patents |
Stephen J. Elliott ~ Sullivan & Cromwell LLP
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| Chapter 8: An Overview of Recent Developments Regarding the America Invents Act |
Joseph M. Drayton ~ Cooley LLP
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| 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
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| 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
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| 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
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| 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
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| 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
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| Chapter 14: Technical Corrections Bill, H.R. 6621 |
Joseph M. Drayton ~ Cooley LLP
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| Chapter 15: Pharmaceutical and Biotechnology Licensing with Asia |
Daniel L. Reisner ~ Kaye Scholer LLP
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| Chapter 16: Reprinted from the PLI Legal Treatise, Pharmaceutical and Biotech Patent Law, (Order #15140) |
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| Chapter 17: Index to Developments in Pharmaceutical and Biotech Patent Law 2013 |
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