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Prelims [No Field Codes] Patent Case Management Judicial Guide Third Edition Peter S. Menell Koret Professor of Law Berkeley Center for Law & Technology University of California, Berkeley School of Law Lynn H. Pasahow James Pooley Matthew D. Powers Fenwick & West LLP Orrick, Herrington & Tensegrity Law Group LLP Sutcliffe LLP Steven C. Carlson Jeffrey G. Homrig George F. Pappas Kasowitz, Benson, Torres Latham & Watkins LLP Covington & Burling LLP & Friedman LLP Carolyn Chang Colette Reiner Mayer Marc David Peters Fenwick & West LLP Morrison & Foerster LLP Morrison & Foerster LLP in collaboration with Anita Choi John Fargo Michael Sawyer Morrison & Foerster LLP U.S. Department of Covington & Burling LLP Justice Allison A. Schmitt Michael R. Ward Patricia Young University of California, Morrison & Foerster LLP Latham & Watkins LLP Berkeley Federal Judicial Center 2016 This Federal Judicial Center publication was undertaken in furtherance of the Center’s statu- tory mission to develop educational materials for the judicial branch. While the Center re- gards the content as responsible and valuable, it does not reflect policy or recommendations of the Board of the Federal Judicial Center. Electronic copy available at: http://ssrn.com/abstract=2637605 Patent Case Management Judicial Guide, Third Edition Summary Table of Contents Table of Contents Foreword Preface Acknowledgments Chapter 1 Overview of the Patent System and General Principles for Effective Patent Case Management Chapter 2 Early Case Management Chapter 3 Preliminary Injunction Chapter 4 Discovery Chapter 5 Claim Construction Chapter 6 Summary Judgment Chapter 7 Pretrial Case Management Chapter 8 Trial Chapter 9 Posttrial Chapter 10 ANDA and Biologics Cases: Patent Infringement Actions Involving FDA-Approved Drugs Chapter 11 Design Patents Chapter 12 Plant Patents Chapter 13 Patent Suits Against the United States Chapter 14 Patent Law Primer Appendix A Glossary Appendix B Acronyms Appendix C Patent Resources Appendix D Patent Local Rules Appendix E Model Patent Jury Instructions Table of Cases Author Biographies iii Electronic copy available at: http://ssrn.com/abstract=2637605 Chapter 14 Patent Law Primer 14.1 The Patent 5 14.1.1 The Patent Document 5 14.1.1.1 The First Page—Administrative Details 7 14.1.1.2 Drawings 7 14.1.1.3 The Specification 7 14.1.1.3.1 Claims 7 14.2 Patent Prosecution and the Patent Lifecycle 9 14.2.1 Institutional Aspects 9 14.2.1.1 The Patent Office 9 14.2.1.2 The Patent Bar 10 14.2.1.3 The Patent Trial and Appeal Board (PTAB) 10 14.2.1.4 Laws Governing the USPTO and the Manual of Patent Examining Procedure (MPEP) 11 14.2.2 Filing a Patent Application 11 14.2.2.1 Overview of Patent Examination 11 14.2.2.2 The Application 12 14.2.2.2.1 Elements of a Nonprovisional Patent Application 12 14.2.2.2.2 Disclosure of Prior Art 13 14.2.2.2.2.1 Prior Art Disclosure by Applicant—Information Disclosure Statement 13 14.2.2.2.2.2 Prior Art Disclosure by Third Parties—Preissuance Submissions 13 14.2.2.2.3 Priority Date 13 14.2.2.2.4 Nonstandard Applications 13 14.2.2.3 Restriction Requirements and Divisional Applications 14 14.2.2.4 Publication 14 14.2.3 The Prosecution History or “File Wrapper” 15 14.2.3.1 Office Actions 15 14.2.3.1.1 Affidavits 15 14.2.3.1.2 Interview Report 15 14.2.3.2 Request for Continued Examination (RCE) 16 14.2.3.3 Continuation Applications 16 14.2.3.4 Continuation-in-Part (CIP) Applications 16 14.2.3.5 PTO Petition and Appeals 17 14.2.4 Patent Duration 17 14.2.4.1 Patent-Term Adjustments 18 14.2.4.2 Patent-Term Restoration 18 14.2.5 Postissuance Corrections and Administrative Proceedings 18 14.2.5.1 Disclaimers 18 14.2.5.2 Certificate of Correction 19 14.2.5.3 Supplemental Examination 19 14.2.5.4 Reissue 20 14.2.5.4.1 Narrowing Reissues 21 14.2.5.4.2 Broadening Reissues 21 14.2.5.4.2.1 The Recapture Rule 21 14.2.5.4.2.2 Intervening Rights 22 14.2.5.5 Reexamination 23 14.2.5.5.1 The Reexamination Process 23 14.2.5.5.2 Ex Parte Reexamination 24 14.2.5.5.3 Inter Partes Reexamination 24 14.2.5.5.4 Reexamination and Concurrent Litigation 24 14.2.5.6 Inter Partes Review (IPR) 25 14.2.5.7 Postgrant Review (PGR) 26 14-1 Patent Case Management Judicial Guide, Third Edition 14.2.5.7.1 Covered Business-Method Review (CBMR) 26 14.2.5.7.2 Postgrant, Inter Partes, and Covered Business-Method Review and Concurrent Litigation 27 14.2.6 The Presumption of Validity 28 14.3 Validity 29 14.3.1 Patentable Subject Matter (§ 101) 29 14.3.1.1 Modern Core Principles: Ineligible Subject Matter and Inventive Application 30 14.3.1.2 The Evolution of Patentable Subject-Matter Limitations 31 14.3.1.2.1 Early Development of Patent-Eligibility Limitations 32 14.3.1.2.2 Funk Brothers (1948): The Emergence of Inventive Application 34 14.3.1.2.3 The New Technological Age 36 14.3.1.2.4 The Rise of the Federal Circuit and Dismantling of Patentable Subject- Matter Limitations 40 14.3.1.2.5 The Supreme Court’s Revival of Subject-Matter Limitations 41 14.3.1.3 Patent-Eligibility Conundrums 44 14.3.1.4 Subject Matter Expressly Excluded by Statute 45 14.3.1.4.1 Tax Strategies 45 14.3.1.4.2 Human Organisms 45 14.3.2 Utility (§ 101) 45 14.3.3 Disclosure (§ 112) 46 14.3.3.1 Written Description 47 14.3.3.1.1 Policing Continuation Practice 47 14.3.3.1.2 Biotechnology Patents 48 14.3.3.2 Enablement 48 14.3.3.3 Best Mode 50 14.3.3.4 Claim Definiteness 50 14.3.4 Novelty and Statutory Bars (§ 102) 51 14.3.4.1 The First-to-Invent Regime 51 14.3.4.1.1 First to Invent—§ 102(a) 52 14.3.4.1.1.1 “Known or Used” 53 14.3.4.1.1.2 Printed Publication 53 14.3.4.1.2 Novelty—First to Invent—§ 102(g) 54 14.3.4.1.2.1 Conception 55 14.3.4.1.2.2 Reduction to Practice 55 14.3.4.1.2.3 Reasonable Diligence 56 14.3.4.1.2.4 Abandoned, Suppressed, or Concealed 56 14.3.4.1.2.5 Section 102(g)—Summary 56 14.3.4.1.3 Novelty—“Secret Prior Art”—§ 102(e) 57 14.3.4.1.4 Novelty—Derivation—§ 102(f) 57 14.3.4.1.5 Statutory Bars—Timely Filing—§ 102(b) 57 14.3.4.1.5.1 Experimental Use 58 14.3.4.1.5.2 On Sale Bar 58 14.3.4.1.6 Statutory Bars—Abandonment—§ 102(c) 60 14.3.4.1.7 Statutory Bars—International Filing—§ 102(d) 60 14.3.4.2 The First-to-File Regime 60 14.3.4.2.1 Novelty and Prior Art—§ 102(a) 60 14.3.4.2.2 Novelty—Grace Period and Exceptions to Prior Art—§ 102(b) 61 14.3.4.2.3 Novelty—Joint Research—§ 102(c) 62 14.3.4.2.4 Effective Date of Patent Prior Art—§ 102(d) 63 14.3.4.2.5 Derivation Proceedings 63 14.3.5 Nonobviousness—§ 103 63 14.3.5.1 Historical Development 63 14.3.5.2 Nonobviousness Standard 64 14.3.5.2.1 Nonobviousness Under the First-to-Invent Regime 64 14-2 Chapter 14: Patent Law Primer 14.3.5.2.2 Nonobviousness Under the First-to-File Regime 65 14.3.5.3 Applying § 103 65 14.3.5.3.1 Determining the Level of Ordinary Skill in the Art 65 14.3.5.3.2 Scope and Content of the Prior Art 67 14.3.5.3.3 Differences Between Invention and Prior Art 68 14.3.5.3.4 Secondary Considerations 68 14.3.5.3.4.1 Long-Felt Need and Failure by Others 69 14.3.5.3.4.2 Awards and Praise 69 14.3.5.3.4.3 Skepticism, “Teaching Away,” and Unexpected Results 69 14.3.5.3.4.4 Licensing Activity 70 14.3.5.3.4.5 Copying 70 14.3.5.3.4.6 Commercial Success 70 14.3.5.3.5 The Ultimate Conclusion and Combining References 70 14.3.6 Inventorship 75 14.3.6.1 Inventive Entities 76 14.3.6.2 Default Rights of Owners 76 14.3.6.3 Correction of Inventorship 76 14.4 Enforcement: Infringement, Defenses, and Remedies 77 14.4.1 Infringement 77 14.4.1.1 Section 271 77 14.4.1.2 Direct Infringement 77 14.4.1.3 Indirect Infringement 77 14.4.1.3.1 Inducement 78 14.4.1.3.2 Contributory Infringement 79 14.4.1.3.3 Joint Infringement 79 14.4.1.4 Infringement Analysis 80 14.4.1.4.1 Literal Infringement 80 14.4.1.4.1.1 Interpreting the Literal Scope of Means-Plus-Function Claims (§ 112(f)) 80 14.4.1.4.1.1.1 Determining Whether a Claim Limitation Is Governed by § 112(f) 81 14.4.1.4.2 Nonliteral Infringement—The Doctrine of Equivalents 82 14.4.1.4.2.1 Limiting Principles 82 14.4.1.4.2.1.1 The All-Elements (All-Limitations) Rule 83 14.4.1.4.2.1.1.1 Claim Vitiation 83 14.4.1.4.2.1.2 Prosecution History Estoppel 83 14.4.1.4.2.1.2.1 Specific Exclusion 85 14.4.1.4.2.1.3 Prior Art Rule 85 14.4.1.4.2.1.4 The Public Dedication Rule 86 14.4.1.4.2.2 Interpreting the Nonliteral Scope of Means-Plus-Function Claims 86 14.4.1.4.3 The Reverse Doctrine of Equivalents 87 14.4.1.5 Extraterritorial Infringement 88 14.4.1.5.1 Manufacturing Components Within the United States for Assembly Abroad—§ 271(f) 88 14.4.1.5.2 Importing Products Made Using Patented Processes—§ 271(g) 89 14.4.2 Defenses 89 14.4.2.1 Noninfringement 89 14.4.2.2 Absence of Liability 89 14.4.2.2.1 Consent or License 89 14.4.2.2.1.1 First Sale Doctrine/Exhaustion Principle 90 14.4.2.2.1.2 Shop Right 91 14.4.2.2.2 Experimental Use Defense 91 14.4.2.2.3 Prior-Use Right 92 14.4.2.2.4 Bar Against Remedies for Infringement of Medical Procedure Patents by Doctors and Hospitals 92 14.4.2.2.5 Sovereign Immunity 93 14-3 Patent Case Management Judicial Guide, Third Edition 14.4.2.3 Unenforceability 93 14.4.2.3.1 Inequitable Conduct 93 14.4.2.3.2 Patent Misuse 94 14.4.2.3.2.1 Postexpiration Royalties 95 14.4.2.3.3 Equitable Estoppel 95 14.4.2.3.4 Laches 96 14.4.2.3.4.1 Prosecution Laches 96 14.4.2.4 Invalidity 97 14.4.2.4.1 Double Patenting 97 14.4.2.4.1.1 Statutory, or Same-Invention 97 14.4.2.4.1.2 Nonstatutory, or Obviousness-Type 98 14.4.2.4.2 Estoppel by Transfer of Ownership 98 14.4.2.4.2.1 Assignor Estoppel 98 14.4.2.4.2.2 No Licensee Estoppel 99 14.4.2.4.2.3 Assignee Estoppel 100 14.4.2.5 Antitrust Counterclaims 100 14.4.3 Remedies 101
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