Detailed Table of Contents

Transcription

1 Detailed Table of Contents Foreword... vii Preface... ix vii Summary Table of Contents... xi ix I. Introduction 1. Introduction to Pharmaceutical Patents I. The Drug Patent Debate... 4 II. Overview of the Patent Law... 5 III. Overview of the Marketing Approval Process... 6 IV. A Brief History of Pharmaceutical Patent Law and Food and Drug Law A. Roche v. Bolar... 9 B. The Hatch-Waxman Act The Statutory Experimental Use Exception Abbreviated New Drug Applications Certifications for Orange Book-Listed Patents Patent Infringement Proceedings Patent Term Extension Marketing Exclusivities Generic Exclusivity The Impact of the Hatch-Waxman Act C. The Generic Animal Drug and Patent Term Restoration Act D. The Prescription Drug User Fee Act E. The Uruguay Round Agreements Act of F. The FDA Modernization Act G. The American Inventors Protection Act of H. The 2002 FTC Study xi

2 xii Pharmaceutical Patent Law 2014 Supp. I. The 2003 FDA Regulations J. The Medicare Prescription Drug, Improvement, and Modernization Act of Single 30-Month Stay Notice of Applications Counterclaim for Patent De-Listing Declaratory Judgment Actions Generic Exclusivity Notice of Agreements K. The Biologics Price Competition and Innovation Act L. The Leahy-Smith America Invents Act [New Topic]... 4 M. Additional Legislation in the 113th Congress [New Topic]... 5 II. Patent Acquisition 2. Patent Eligibility I. Basic Concepts II. Product and Process Claims A. Abstract Ideas B. Products of Nature C. Living Inventions D. Process Claims for New Uses III. Types of Pharmaceutical Patent Claims A. Drug Substances B. Formulations C. Chemical Intermediates D. Metabolites and Prodrugs E. Crystals and Polymorphs F. Isomers G. Salts H. Combination Therapies I. Methods of Using J. Methods of Making K. Methods of Diagnosis L. Kits [New Topic] IV. Methods of Medical Treatment Utility II. Moral Utility III. Practical Utility IV. Practical Utility for Pharmaceutical Patents A. Brenner v. Manson... 68

3 Detailed Table of Contents xiii B. Leading Case Law of the Court of Customs and Patent Appeals C. Early Case Law of the Federal Circuit D. The 1995 PTO Utility Examination Guidelines 73 E. The 2001 PTO Utility Examination Guidelines 75 F. In re Fisher V. Recurring Issues A. Safety and Efficacy Considerations B. Structural Similarity to Compounds With an Established Utility C. In Vitro and In Vivo Tests D. Human Clinical Data E. Chemical Intermediates F. Inoperable Species Within a Genus G. Assertions of Multiple Utilities H. The Utility Requirement in Adversarial Proceedings I. The Utility Requirement and Priority Applications Novelty I. Introduction II. Anticipation A. Genus and Species B. The Enablement Requirement III. Inherency IV. The 35 U.S.C. 102(b) Statutory Bar A. Public Use Under 35 U.S.C. 102(b) B. On Sale Under 35 U.S.C. 102(b) C. In This Country D. Experimental Use E. Patents F. Printed Publications V. Abandonment Under 35 U.S.C. 102(c) VI. Delayed U.S. Filing Under 35 U.S.C. 102(d) VII. Prior Invention Under 35 U.S.C. 102(a) VIII. Prior Invention Under 35 U.S.C. 102(g) A. Prior Art Under 35 U.S.C. 102(g) B. Priority Under 35 U.S.C. 102(g) C. Inventive Activity in Foreign Countries D. Conception E. Reduction to Practice F. Diligence G. Corroboration H. Patent Award to the Second Inventor

4 xiv Pharmaceutical Patent Law 2014 Supp. IX. Disclosure in U.S. Patent Applications Under 35 U.S.C. 102(e) X. Derivation Under 35 U.S.C. 102(f) Nonobviousness I. Introduction II. Prior Art for Nonobviousness A. Section 102 as the Source of Prior Art B. 35 U.S.C. 103(c)(1) C. The CREATE Act III. The Nonobviousness Inquiry A. The Historical Standard of Invention B. The Modern Standard of Nonobviousness C. The Person of Ordinary Skill in the Art D. The Prima Facie Case of Obviousness E. Obvious to Try IV. The Secondary Considerations A. Commercial Success B. Copying C. Licenses D. Long-Felt Need E. Praise and Skepticism F. Prior Failures of Others G. Unexpected Results V. Structural Similarities as Evidence of Obviousness A. Introduction B. Homologues Adjacent Homologues Ring Expansion and Contraction Remote Homologues C. Isomers Structural Isomerism a. Position Isomerism b. Tautomers c. Stereoisomers Bioisomerism D. Esters Prior Art Alcohols Prior Art Free Acids E. Analogs VI. Product and Process Claims The Patent Instrument I. Enablement A. Basic Concepts B. Working and Prophetic Examples

5 Detailed Table of Contents xv C. Exhibits and Biological Samples II. Best Mode III. Written Description A. New Matter B. Originally Filed Claims IV. The Claims A. Basic Claim Drafting The Preamble The Transition Phrase The Body B. Claim Formats Dependent Claims Markush Claims Product-by-Process Claims Jepson Claims Functional Claims Skuballa Claims First Medical Use and Swiss-Style Claims C. Definiteness Patent Acquisition Procedures I. Fundamentals of Patent Prosecution A. Preparation of Applications B. Provisional Applications C. Examination of Applications D. Continuing Applications E. The Restriction Requirement and Divisional Applications F. Publication of Applications G. Petition and Appeal H. Invention Secrecy Orders II. Other PTO Proceedings A. Interferences B. Protests C. Citation of Prior Art D. Public Use Proceedings III. Post-Grant Proceedings A. Certificates of Correction B. Disclaimers C. Reissue D. Reexamination Ex Parte Reexamination Inter Partes Reexamination E. Intervening Rights F. Supplemental Examination [New Topic] IV. Abuses of Patent Acquisition Procedures

6 xvi Pharmaceutical Patent Law 2014 Supp. A. Double Patenting Basic Principles Double Patenting and the Restriction Requirement Two-Way Double Patenting B. Inequitable Conduct C. Misjoinder or Nonjoinder of Inventors D. Prosecution Laches Duration of Rights I. Fundamentals of Patent Term II. Maintenance Fees III. The Patent Term Guarantee Act IV. Specialized Legislation V. The Hatch-Waxman Act A. Eligible Patents Drug Products Combination Therapies Metabolites Stereoisomers Medical Devices Patents Subject to a Terminal Disclaimer B. Application for Term Extension Time Limit for Filing Identity of the Applicant Contents Review of the Application Interim Extensions Strategic Considerations C. Period of Extension D. Limitation Upon Scope of Rights III. Marketing Approval Procedures 9. The FDA Drug Approval Process I. Marketing Approval for Innovative Drugs A. Preclinical Investigations B. Investigational New Drug Applications Phase I Investigations Phase II Investigations Phase III Investigations Treatment INDs Screening INDs C. New Drug Applications D. Postmarketing Surveillance / Phase IV Investigations

7 Detailed Table of Contents xvii II. Marketing Approval for Generic Drugs A. FDA Practices Prior to Hatch-Waxman B. Abbreviated New Drug Applications C. Section 505(b)(2) Applications D. Patent Certifications E. Section viii Statements F. Thirty-Month Stay of Marketing Approval Multiple 30-Month Stays Judicial Modification of the 30-Month Period III. Antibiotics The Orange Book I. Overview of the Orange Book II. Patents Appropriate for Orange Book Listing A. The Hatch-Waxman Act B. FDA Regulations General Rules Polymorph Patents Product-by-Process Patents C. Third-Party Patents III. The Timing of Patent Listings IV. Orange Book Listing Disputes A. The Role of the FDA B. De-listing Litigation Prior to the MMA Efforts by Generic Firms to De-list De-listing by Brand Name Firms C. De-listing Litigation Under the MMA Efforts by Generic Firms to De-list De-listing by Brand Name Firms D. FTC Enforcement Marketing Exclusivities I. Marketing Exclusivity Concepts II. New Chemical Entity Exclusivity III. New Clinical Study Exclusivity IV. Generic Marketing Exclusivity A. Basic Concepts B. Pre-MMA Standards Entitlement Timing of Notice Commencement of the 180-Day Period Separate Exclusivities for Distinct Dosages and Strengths Patent-by-Patent Approach Relationship to Pediatric Exclusivity Transferability

8 xviii Pharmaceutical Patent Law 2014 Supp. C. Standards Under the MMA Entitlement Forfeiture Timing of Notice Commencement of the 180-Day Period Product-by-Product Approach D. Unresolved Issues Authorized Generics Award of Exclusivity for Judgments of Noninfringement V. Pediatric Marketing Exclusivity VI. Orphan Drug Marketing Exclusivity VII. Infectious Disease Products [New Topic] IV. Infringement 12. Scope of Patent Rights I. Basic Concepts A. Direct Infringement B. Indirect Infringement Active Inducement Contributory Infringement Deepsouth and 35 U.S.C. 271(f) Bioconversion as Infringement C. Process Patents The Process Patent Amendments Act Screening Methods D. Government Infringers The Federal Government The Bayh-Dole Act State and Local Governments II. Infringement Under the Hatch-Waxman Act A. Patent Implications of ANDAs and Section 505(b)(2) Applications B. Notification of a Paragraph IV Certification C. Offers of Confidential Access D. Biobatch Data Versus the ANDA Specification E. Generic Submissions for Unapproved Uses III. Patent Litigation A. Subject Matter Jurisdiction B. Supplemental Jurisdiction C. Personal Jurisdiction

9 Detailed Table of Contents xix 1. General Principles Implications of the Hatch-Waxman Act D. Venue E. Declaratory Judgment General Principles Declaratory Judgment Actions in the Hatch-Waxman Framework F. The Availability of Jury Trials Under the Hatch-Waxman Act IV. Infringement Defenses A. Invalidity and Unenforceability B. Issue Preclusion C. Laches and Estoppel D. Licenses Basic Concepts Licensee and Assignor Estoppel Implied Licenses Shop Rights E. Prior User Rights V. Remedies A. General Principles Injunctions Compensatory Damages a. Reasonable Royalties b. Lost Profits i. But For Causation ii. Proximate Causation iii. The Entire Market Value Rule Marking Provisional Rights Enhanced Damages B. Remedies Under the Hatch-Waxman Act Remedies Available for Infringing Generic Applications Generic Filings as Willful Infringements C. Implications of Generic Market Entry During Patent Litigation Claim Interpretation and the Doctrine of Equivalents I. Claim Interpretation A. Basic Concepts B. Markman v. Westview Instruments C. Canons of Claim Construction D. Dictionaries, the Specification, and the Phillips Case E. Representative Claim Construction Cases

10 xx Pharmaceutical Patent Law 2014 Supp. II. The Doctrine of Equivalents A. Basic Concepts Graver Tank and the Function-Way-Result Standard Warner-Jenkinson and the Insubstantial Differences Standard Functional Equivalents B. Limitations on the Doctrine of Equivalents The All Elements Rule Prior Art Limitations Prosecution History Estoppel The Public Dedication Doctrine C. The Reverse Doctrine of Equivalents Parallel Importation I. Introduction II. FDA Practices With Respect to Importing Prescription Drugs A. The Prescription Drug Marketing Act of B. The MEDS Act of C. The MMA of D. Reform Proposals III. Patent Implications of Parallel Importation A. The Exhaustion Doctrine B. International Exhaustion C. Reform Proposals D. Potential Legal Issues The Takings Clause State and Local Governments The TRIPS Agreement Free Trade Agreements Label Licenses The Experimental Use Privilege I. The Common Law Experimental Use Privilege A. Origins of the Experimental Use Privilege B. Cases Upholding the Privilege C. Experimental Use as a Matter of Remedies D. Cases Rejecting the Experimental Use Privilege E. The Common Law Experimental Use Privilege in Pharmaceutical Cases F. The Common Law Experimental Use Privilege in Academic Settings G. Experimental Use Policy

11 Detailed Table of Contents xxi II. The Statutory Experimental Use Privilege A. Introduction to 35 U.S.C. 271(e)(1) Roche v. Bolar The Hatch-Waxman Act Basic Analytical Framework B. Application of 35 U.S.C. 271(e)(1) Manufacture Preclinical Trials Clinical Trials Other Product Testing Sales Displays and Demonstrations Publications and Promotions Foreign Patenting and Regulatory Approval Medical Devices Research Tools Importation Post-Marketing Activity [New Section] Antitrust Considerations I. Introduction II. Notice of Patent Settlements III. Judicial Treatment of Reverse Payment Settlements A. Sixth Circuit B. Eleventh Circuit C. Second Circuit D. Federal Circuit E. Concluding Observations V. International and Comparative Aspects 17. International and Comparative Patent Law I. The Paris Convention A. National Treatment B. Independence of Patents C. International Priority D. Benefits of Paris Convention Priority E. Limitations of the Paris Convention II. The Patent Cooperation Treaty III. Foreign Filing Licenses IV. Regional Agreements A. NAFTA B. Other Regional Agreements

12 xxii Pharmaceutical Patent Law 2014 Supp. V. The TRIPS Agreement A. National Treatment and Most-Favored-Nation Status B. Minimum Standards of Protection C. Compulsory Licenses TRIPS Agreement Article The Doha Declaration D. Other Provisions E. Effective Dates Pipeline Protection Exclusive Marketing Rights F. Dispute Settlement India Pharmaceutical Products Canada Pharmaceutical Products G. Debate on the TRIPS Agreement VI. Free Trade Agreements A. Patent Term Restoration B. Data Exclusivity C. Confidential Status of Experimental Data D. Accelerated Generic Marketing Approval E. Experimental Use Privilege F. Parallel Importation G. Implications VII. Comparative Patent Law A. Deferred Examination B. Experimental Use Privilege C. Grace Period D. Methods of Medical Treatment E. Oppositions F. Patent Validity as an Infringement Defense G. Priority Principle H. Publication of Pending Applications I. Patentable Subject Matter J. The Promise of the Patent Doctrine [New Topic] International and Comparative Data Protection Law I. International Data Protection Standards A. The TRIPS Agreement Basic Principles Eligible Data Protection Against Unfair Commercial Use Protection Against Disclosure B. Free Trade Agreements

13 Detailed Table of Contents xxiii II. Comparative Law A. European Union Data Protection Law Introduction The Pre /10 Formula and Beyond: The Formula Orphan Drugs The Pediatric Testing Incentive B. European Supplementary Protection Certificates C. Japan VI. Biologics 19. Follow-On Biologics I. Introduction II. The Regulatory Pathway A. Biosimilars B. Interchangeable Biologics C. The Role of the FDA III. Marketing Exclusivities and Data Protection A. Brand-Name Products B. First Interchangeable Products IV. Patent Dispute Resolution V. Observations and Potential Issues Appendices List of Documents Included on CD-ROM The Leahy-Smith America Invents Act Table of Cases Index About the Author