TreatiseTreatise

Pharmaceutical and Biotech Patent Law

 by Arnold & Porter Kaye Scholer LLP
 
 Copyright: 2017

 Product Details >> 

Product Details

  • ISBN Number: 9781402429873
  • Page Count: 1202
  • Number of Volumes: 1
  •  

Pharmaceutical and Biotech Patent Law provides you with the legal, scientific, and technical information you need to help clients obtain, defend, and challenge patents in these important business areas. This practical guide shows you how to craft problem-free patent applications, including how to partner with the government to bring patented inventions quickly to the marketplace • invalidate competitors’ patents by proving that they fail to meet key requirements • protect against various forms of patent infringement • and successfully rebut charges of infringement.  It includes detailed checklists that help you resolve thorny patent problems in the complex pharmaceutical and biotech fields, and is regularly updated to reflect Federal Circuit rulings and other significant court decisions.
  Table of Contents
  Preface
Chapter 1: A Brief Introduction to the United States Patent System
  • § 1:1 : Constitutional Basis of the Patent System and Sources of Governing Authority1-2
    • § 1:1.1 : Constitutional Basis1-2
    • § 1:1.2 : Sources of Governing Authority1-2
    • § 1:1.3 : The America Invents Act1-4
  • § 1:2 : Patentable Subject Matter1-5
  • § 1:3 : The Patent Application1-5
    • § 1:3.1 : Examination of Patent Applications1-7
      • [A] : General1-7
      • [B] : PTO Office Actions1-8
      • [C] : Satisfaction of Requirements As of Filing Date1-9
      • [D] : One Invention per Patent1-10
      • [E] : One Patent per Invention1-10
    • § 1:3.2 : Claims to Priority1-11
    • § 1:3.3 : Publication of Patent Applications1-11
  • § 1:4 : Patent Term1-12
  • § 1:5 : Post-Grant Actions1-13
    • § 1:5.1 : Reissue (35 U.S.C. § 251)1-13
    • § 1:5.2 : Reexamination (35 U.S.C. §§ 302–307)1-14
    • § 1:5.3 : Inter Partes Review (35 U.S.C. §§ 311–318)1-15
    • § 1:5.4 : Post-Grant Review (35 U.S.C. §§ 321–329)1-17
    • § 1:5.5 : Supplemental Examinations (35 U.S.C. § 257)1-18
    • § 1:5.6 : Certificates of Correction1-19
    • § 1:5.7 : Disclaimers1-19
  • § 1:6 : Interferences and Interfering Patents; Transition from “First to Invent” to “First to File”1-19
  • § 1:7 : Derivation Proceedings and Derived Patents1-20
  • § 1:8 : Enforcement of Patents1-21
    • § 1:8.1 : Actions for Infringement1-21
    • § 1:8.2 : Remedies for Infringement1-22
      • [A] : Injunctive Relief: Permanent and Preliminary Injunctions1-22
      • [B] : Damages: Lost Profits and Reasonable Royalty1-23
      • [C] : Enhanced Damages for Willful Infringement1-27
      • [D] : Award of Attorney Fees in Exceptional Cases to the Prevailing Party1-28
    • § 1:8.3 : Defenses to a Charge of Patent Infringement1-29
  • § 1:9 : “False Marking” Actions1-30
Chapter 2: An Overview of Research & Development, Product Launch, and Patent Enforcement
  • § 2:1 : General2-2
  • § 2:2 : Research Teams2-4
    • § 2:2.1 : Patent Issues Related to Research Teams2-5
    • § 2:2.2 : Government-Funded Research: The Bayh-Dole Act2-5
    • § 2:2.3 : Joint Inventions Made by Federal Employees and Private Parties2-6
  • § 2:3 : Research2-6
    • § 2:3.1 : Early-Stage Research2-6
    • § 2:3.2 : Drug Discovery2-7
  • § 2:4 : Development2-8
    • § 2:4.1 : Preclinical Development2-8
      • [A] : Form of the Active Compound2-9
        • [A][1] : Stereoisomers2-11
        • [A][2] : Polymorphs2-11
        • [A][3] : Salt Forms2-11
        • [A][4] : Particle Size2-11
        • [A][5] : In Vivo Conversion2-12
      • [B] : Formulation2-12
      • [C] : Manufacturing Process2-12
      • [D] : Combination Therapies2-13
      • [E] : Methods of Treatment2-13
    • § 2:4.2 : Clinical Trials2-13
      • [A] : The FDA Approval Process2-14
        • [A][1] : Clinical Studies and Trials2-14
        • [A][2] : Patent Term Restoration for FDA Delay2-16
      • [B] : The Hatch-Waxman Act: Generic Competition2-16
        • [B][1] : ANDA Litigation2-16
        • [B][2] : Data Exclusivity2-17
  • § 2:5 : Patent Protection for Pharmaceutical and Biotech Inventions2-17
Chapter 3: Utility and Patentable Subject Matter Requirements
  • § 3:1 : General3-2
  • § 3:2 : Statutory Provision: Section 1013-2
  • § 3:3 : Test for Utility: Brenner v. Manson3-3
  • § 3:4 : Policy Behind Utility Requirement3-4
  • § 3:5 : Threshold for Satisfying Utility Is Not High3-5
    • § 3:5.1 : Satisfying Threshold in the PTO3-6
    • § 3:5.2 : Satisfying Threshold in Litigation3-7
  • § 3:6 : Utility for Pharmaceutical Inventions3-7
    • § 3:6.1 : Pharmacological Activity Must Be Specified3-8
    • § 3:6.2 : PTO’s Initial Burden3-10
    • § 3:6.3 : Rebutting PTO with In Vitro and In Vivo Data and Relation to FDA Approval Process3-10
    • § 3:6.4 : Examples3-13
      • [A] : Sufficient Disclosure3-13
        • [A][1] : Nelson v. Bowler3-13
        • [A][2] : Cross v. Iizuka3-14
        • [A][3] : In re Brana3-14
        • [A][4] : Fujikawa v. Wattanasin3-14
      • [B] : Insufficient Disclosure3-15
        • [B][1] : Brenner v. Manson3-15
        • [B][2] : In re Kirk3-15
        • [B][3] : Kawai v. Metlesics3-16
        • [B][4] : Rasmusson v. SmithKline Beecham3-16
  • § 3:7 : Patentable Subject Matter3-16
    • § 3:7.1 : “Processes”3-17
    • § 3:7.2 : “Manufactures” and “Compositions of Matter”3-17
  • § 3:8 : Patentable Subject Matter for Pharmaceutical Inventions3-18
    • § 3:8.1 : “Processes”3-18
      • [A] : Prometheus I3-19
      • [B] : Prometheus II3-20
      • [C] : Prometheus III and IV3-20
      • [D] : Post-Prometheus3-22
        • [D][1] : Alice v. CLS3-22
        • [D][2] : Types of Claims3-23
          • [D][2][a] : Diagnostic Claims3-23
          • [D][2][b] : Treatment Claims3-25
          • [D][2][c] : Method of Making Claims3-25
    • § 3:8.2 : “Manufactures” and “Compositions of Matter”3-25
      • [A] : Diamond v. Chakrabarty3-25
      • [B] : Association for Molecular Pathology v. Myriad Genetics3-26
        • [B][1] : Myriad I, II, and III3-26
        • [B][2] : Myriad IV3-28
      • [C] : Post-Myriad3-30
        • [C][1] : Cloned Animal Claims3-30
        • [C][2] : Primer Claims3-31
Chapter 4: Inventorship
  • § 4:1 : General Principles of Inventorship4-2
    • § 4:1.1 : Overview of Statutory Provisions4-4
      • [A] : Priority Disputes and the AIA4-4
      • [B] : Priority Disputes (Pre-AIA)4-4
      • [C] : AIA’s Elimination of Priority Disputes4-5
    • § 4:1.2 : Conception4-6
      • [A] : Requirements4-6
      • [B] : Proof of Conception Requires Corroboration4-8
      • [C] : Is There a Requirement That the Inventor Know That His Invention Will Work for Conception to Be Complete?4-10
      • [D] : Unrecognized Accidental Creation Not Invention4-14
      • [E] : Examples4-15
        • [E][1] : General Goal with No Specific Means for Implementation: Amax Fly Ash Corp. v. United States4-15
        • [E][2] : Providing Goal to Be Achieved without Direction: Morgan v. Hirsch4-15
        • [E][3] : Carrying Out Confirming Experiments: Stern v. Trustees of Columbia University4-16
    • § 4:1.3 : Reduction to Practice4-16
      • [A] : Requirements4-16
      • [B] : Proof of Reduction to Practice Requires Corroboration4-17
    • § 4:1.4 : Simultaneous Conception and Reduction to Practice4-18
    • § 4:1.5 : Priority4-19
      • [A] : Abandoned, Suppressed, or Concealed4-20
      • [B] : Diligence in Reducing Invention to Practice4-21
  • § 4:2 : Joint Inventorship: Distinguishing Inventive from Non-Inventive Contributions4-21
    • § 4:2.1 : Statutory Provision: Sections 101, 116, and 2564-22
    • § 4:2.2 : Requirements for Joint Invention4-22
      • [A] : Determining Co-Inventorship4-23
      • [B] : Assistance and Knowledge from One of Ordinary Skill Does Not Make One an Inventor4-23
  • § 4:3 : Incorrect Inventorship4-28
    • § 4:3.1 : Statutory Overview and Standard of Proof4-28
    • § 4:3.2 : Consequences of Naming the Wrong Inventors4-28
    • § 4:3.3 : Correction of Inventorship4-29
      • [A] : Statutory Basis: Section 2564-29
      • [B] : Deceptive Intent4-29
      • [C] : Comment: An Odd Policy4-30
      • [D] : Correction of Inventorship Versus Inequitable Conduct4-31
    • § 4:3.4 : Procedure for Correcting Inventorship4-31
      • [A] : Correction During Litigation4-31
      • [B] : Correcting Inventorship in the Patent Office4-32
    • § 4:3.5 : Adding Inventors Can Add Joint Owners4-32
      • [A] : Examples4-33
        • [A][1] : Ethicon, Inc. v. U.S. Surgical Corp.4-33
        • [A][2] : Burroughs Wellcome Co. v. Barr Laboratories, Inc.4-34
        • [A][3] : Ortho-McNeil Pharm., Inc. v. Mylan Labs., Inc.4-35
  • § 4:4 : Inventorship Issues for Particular Types of Inventions4-35
    • § 4:4.1 : Chemical Inventions4-35
    • § 4:4.2 : Nucleic Acid and Sequence Claims4-38
  • § 4:5 : Inventorship and Ownership4-42
    • § 4:5.1 : Inventions by Employees4-42
      • [A] : Employment Agreements4-42
      • [B] : Shop Rights4-44
      • [C] : The Rights of Joint Inventors in the Absence of Agreement or Shop Rights4-45
        • [C][1] : Joint Ownership4-45
        • [C][2] : Entire Patent—Not Claim-by-Claim4-46
  • § 4:6 : Anticipating and Resolving Joint Invention Issues4-48
    • § 4:6.1 : Putting Agreements in Place4-48
    • § 4:6.2 : Including Warranties of Freedom to Assign4-49
    • § 4:6.3 : Inventorship Checklists Before Research Begins4-49
Chapter 5: Patentability
  • § 5:1 : Introduction5-9
    • § 5:1.1 : Presumption of Validity5-10
    • § 5:1.2 : Independent and Dependent Claims5-13
    • § 5:1.3 : Claim Construction Issues Relevant to Validity5-13
    • § 5:1.4 : Grounds for Invalidity5-15
  • § 5:2 : Anticipation: An Invention Must Be Something New5-16
    • § 5:2.1 : Statutory Provisions: Sections 101 and 102 and the AIA5-16
      • [A] : Section 102 (Pre-AIA)5-17
      • [B] : Section 102 (AIA)5-18
        • [B][1] : Overview5-18
        • [B][2] : Scope of Prior Art5-18
        • [B][3] : Exceptions to Defined Scope of Prior Art5-19
      • [C] : Differences Between Pre-AIA and AIA Versions of Section 1025-20
        • [C][1] : Change from First-to-Invent to First-to-File-or-Disclose5-20
        • [C][2] : First-to-File-or-Disclose Examples5-20
        • [C][3] : New Geographic Scope for Scope of Prior Art5-22
        • [C][4] : Summary of Changes5-22
      • [D] : Determining Which Version of Section 102 Applies5-24
    • § 5:2.2 : Requirements for Anticipation5-24
      • [A] : Art Must Include All Elements of a Claim to Anticipate5-24
      • [B] : Art May Anticipate Based Only on Limited Consideration of Information Beyond the Reference5-25
      • [C] : Art Must Be Enabling to Anticipate5-26
        • [C][1] : Level of Disclosure5-26
        • [C][2] : Enablement for Section 102(b) Art5-27
      • [D] : Art May Anticipate by Inherency5-28
        • [D][1] : Examples of Inherent Anticipation5-29
        • [D][2] : Examples of No Anticipation by Inherency5-31
      • [E] : Art Disclosed Species Anticipates Genus Claim5-33
      • [F] : Art Disclosed Genus Generally Does Not Anticipate Species Claim5-33
      • [G] : Art’s Use of Equivocal Language Generally Does Not Defeat Anticipation5-35
      • [H] : Art Need Not Be in Same Field As Invention to Anticipate5-36
      • [I] : Device May Anticipate Claim to Method of Making5-37
    • § 5:2.3 : Types of Prior Art5-37
      • [A] : Printed Publications5-37
        • [A][1] : Accessibility of Publication5-37
        • [A][2] : Publication Date5-38
        • [A][3] : Examples5-39
          • [A][3][a] : Publication on FTP Site or Newsgroup5-39
          • [A][3][b] : Presentation at a Conference5-39
          • [A][3][c] : Nonconfidential but Limited Distribution5-40
          • [A][3][d] : Thesis in University Library5-41
          • [A][3][e] : Publicly Available Patent Prosecution Documents5-42
      • [B] : Known or Used by Others in This Country5-42
        • [B][1] : Known by Others5-42
        • [B][2] : Public Use5-43
          • [B][2][a] : Experimental Use Can Negate Prior Public Use5-44
          • [B][2][b] : Burden of Proof5-45
          • [B][2][c] : Evidentiary Factors5-45
          • [B][2][d] : When Do Clinical Trials Fall Within the Experimental Use Doctrine and Negate Public Use?5-46
      • [C] : On-Sale Bar5-48
        • [C][1] : “Subject of a Commercial Sale”5-48
          • [C][1][a] : General Principles5-48
            • [C][1][a][i] : Commercial Offer or Sale5-49
            • [C][1][a][ii] : Offer for the Patented Invention5-49
          • [C][1][b] : Research Agreements5-50
          • [C][1][c] : Granting Licenses5-51
          • [C][1][d] : Method Claims5-51
        • [C][2] : “Ready for Patenting”5-52
      • [D] : First Patented in a Foreign Country5-52
      • [E] : Admitted Prior Art5-53
  • § 5:3 : Obviousness5-53
    • § 5:3.1 : Statutory Provision: Section 1035-53
      • [A] : The Obviousness Standard: Section 103(a)5-53
      • [B] : Biotechnology Processes: Section 103(b)5-54
      • [C] : The Co-Ownership/Joint Venture Exception to Prior Art5-56
        • [C][1] : Pre-AIA Section 103(c)5-56
        • [C][2] : AIA Section 102(b)(2)(C)5-58
      • [D] : Incorporation of Section 102 Definition of Prior Art5-58
        • [D][1] : Pre-AIA5-58
        • [D][2] : AIA5-59
    • § 5:3.2 : Overview of the Obviousness Question5-59
      • [A] : The Graham Factors5-59
      • [B] : A Landmark Decision: KSR v. Teleflex5-60
    • § 5:3.3 : Criterion for Obviousness5-62
      • [A] : Combination of References/Prior Art Suggestion of the Invention5-64
        • [A][1] : Problem Solved by Invention5-64
        • [A][2] : Hindsight5-65
        • [A][3] : Number of References by Itself Does Not Determine Obviousness5-66
        • [A][4] : Uncorroborated Expert Testimony Not Evidence of Obviousness5-66
        • [A][5] : Art That Teaches Away from Invention5-67
        • [A][6] : Prior Art Must Be Read As a Whole5-69
        • [A][7] : Inherency5-69
      • [B] : Predictability/Reasonable Expectation of Success5-70
        • [B][1] : The Standard5-70
        • [B][2] : “Obvious to Try”5-73
      • [C] : Enablement of Obvious Teaching Required5-74
      • [D] : Unexpected Results5-75
        • [D][1] : General Rule5-75
        • [D][2] : Application to Pharmaceutical Patents5-76
    • § 5:3.4 : Questions of Law and Fact5-77
    • § 5:3.5 : Scope and Content of the Prior Art5-78
      • [A] : Analogous Art5-78
      • [B] : Defining the Problem5-79
    • § 5:3.6 : “Ordinary Skill in the Art” Under Section 1035-80
      • [A] : Six Factors5-80
      • [B] : Skill in the Pharmaceutical Arts5-81
      • [C] : Relevance of the Inventor in Determining “Ordinary Skill in the Art”5-84
    • § 5:3.7 : Practical Evidence of Nonobviousness: The Secondary Considerations5-85
      • [A] : Long-Felt Need/Failure of Others5-88
        • [A][1] : General Rule5-88
        • [A][2] : Application to Pharmaceutical Patents5-89
      • [B] : Commercial Success5-91
        • [B][1] : General Rule5-91
        • [B][2] : Application to Pharmaceutical Patents5-93
      • [C] : Licensing5-96
        • [C][1] : General Rule5-96
        • [C][2] : Application to Pharmaceutical Patents5-97
      • [D] : Copying5-98
        • [D][1] : General Rule5-98
        • [D][2] : Application to Pharmaceutical Patents5-98
      • [E] : Near-Simultaneous Invention5-99
        • [E][1] : General Rule5-99
        • [E][2] : Application to Pharmaceutical Patents5-99
    • § 5:3.8 : Prior Art Disclosure of Genus Containing Claimed Species5-100
  • § 5:4 : Written Description5-100
    • § 5:4.1 : Statutory Provision: Section 1125-100
      • [A] : Written Description Is a Separate Requirement5-100
      • [B] : Controversy over Status of Written Description Requirement5-101
      • [C] : Written Description Requirement Applies to Priority Determinations and to Adequacy of Original Disclosure5-102
        • [C][1] : Later Claims and Later Applications5-102
        • [C][2] : Unsupported Original Claims5-103
    • § 5:4.2 : The Requirement5-103
      • [A] : The Purpose of the Requirement5-103
      • [B] : The Standard Set Forth by the Federal Circuit5-104
        • [B][1] : Basic Test5-104
        • [B][2] : Predictability and Other Factors5-105
        • [B][3] : Acceptable Forms of Description5-106
        • [B][4] : Fact Determination5-108
      • [C] : Conception and Written Description5-109
    • § 5:4.3 : Genus and Species5-110
      • [A] : Claim Scope Must Correspond to Disclosure: Gentry Gallery5-110
        • [A][1] : Limiting Gentry5-111
        • [A][2] : Applying Gentry5-112
      • [B] : Species Based on a Disclosed Genus5-113
      • [C] : Genus Based on Disclosed Species or Examples5-113
      • [D] : Genus Based on Generic Description5-115
      • [E] : Range Cases5-116
      • [F] : Negative Limitations5-117
      • [G] : Unclaimed Optional Features5-118
    • § 5:4.4 : Inherency5-119
    • § 5:4.5 : Application to Particular Inventions5-120
      • [A] : Compound and Composition Claims5-120
      • [B] : DNA5-121
        • [B][1] : General Rule5-121
        • [B][2] : Deposits5-123
        • [B][3] : Genus Claims5-123
        • [B][4] : Possession of Polypeptides5-125
      • [C] : Antibodies5-125
      • [D] : Other Biological Material5-126
  • § 5:5 : Enablement5-126
    • § 5:5.1 : Statutory Provision: Section 1125-127
    • § 5:5.2 : The Policy Behind Enablement5-127
    • § 5:5.3 : Enablement: Question of Law5-128
    • § 5:5.4 : Role of the Specification5-128
      • [A] : General Principles5-128
      • [B] : Means-Plus-Function Claims5-130
    • § 5:5.5 : The Person Skilled in the Art5-131
      • [A] : Who Is the Person Skilled in the Art?5-131
      • [B] : What General Knowledge Does the Person Skilled in the Art Possess?5-131
      • [C] : Time Frame for Determining Enablement5-132
        • [C][1] : Enablement Measured As of Filing Date5-132
        • [C][2] : Using Post-Filing References to Show State of the Art at Filing5-132
        • [C][3] : Nascent Technology Must Be Disclosed5-133
        • [C][4] : Loss of Material Needed to Practice Invention5-134
    • § 5:5.6 : Requirements for Enablement5-135
      • [A] : How to Make the Claimed Invention5-135
        • [A][1] : Compound and Composition of Matter Claims5-136
        • [A][2] : Method of Use Claims5-137
      • [B] : How to Use the Claimed Invention5-138
        • [B][1] : Practical Utility5-138
        • [B][2] : Satisfying the How to Use Requirement5-139
        • [B][3] : Inoperability May Negate Enablement5-141
    • § 5:5.7 : Enabling the Full Scope of the Claim5-142
    • § 5:5.8 : No Enablement If Undue Experimentation Required5-144
      • [A] : Undue Experimentation: The Wands Factors5-144
        • [A][1] : Quantity of Experimentation Needed5-145
        • [A][2] : Direction or Guidance Provided/Working Examples and Teaching Away5-147
        • [A][3] : Nature of the Invention/State of Prior Art/Level of Skill in the Art5-149
        • [A][4] : Predictability in the Art5-149
        • [A][5] : Breadth of the Claim5-150
      • [B] : Routine Experimentation Is Allowed5-151
    • § 5:5.9 : Use of Deposits to Satisfy Enablement5-151
  • § 5:6 : Best Mode5-153
    • § 5:6.1 : Overview5-153
      • [A] : Statutory Provision: Section 1125-153
      • [B] : AIA’s Elimination of Best Mode As Grounds for Invalidity or Unenforceability5-154
    • § 5:6.2 : Purpose of the Best Mode Requirement5-155
    • § 5:6.3 : Best Mode Distinguished from Enablement5-156
    • § 5:6.4 : Best Mode: A Two-Prong Inquiry5-156
      • [A] : Subjective Inquiry: Did the Inventor Contemplate a Best Mode?5-157
        • [A][1] : Evidence of Inventor Preference5-158
        • [A][2] : Alternative Embodiments Does Not Mean There Is a Best Mode5-158
        • [A][3] : Relevance of Inventor’s Intent to Conceal5-159
        • [A][4] : Intentional Concealment—Inequitable Conduct5-160
        • [A][5] : Assignees5-160
      • [B] : Objective Inquiry: Was the Best Mode Disclosed?5-160
        • [B][1] : Scope of Claimed Invention5-161
        • [B][2] : Adequacy of Disclosure5-162
          • [B][2][a] : Enablement5-162
          • [B][2][b] : Disclosure That Mode Is Preferred5-163
        • [B][3] : Relevance of Prior Art5-163
        • [B][4] : Starting Materials5-163
        • [B][5] : Routine Features Need Not Be Disclosed5-164
        • [B][6] : Mode of Commercial Production5-164
        • [B][7] : Disclosure of Special Materials or Identity of Supplier of Material5-165
    • § 5:6.5 : Timing5-166
      • [A] : Filing an Original Application5-166
      • [B] : Continuation and Continuation-in-Part Applications5-167
        • [B][1] : Foreign Priority Applications5-167
    • § 5:6.6 : Application to Pharmaceutical Patents5-168
      • [A] : Public Deposit of Biological Materials5-168
      • [B] : Claims to Pharmaceutical Compounds5-169
        • [B][1] : Clinical Data5-169
        • [B][2] : Synthesis of Intermediates Used to Make Claimed Compounds5-169
        • [B][3] : Purification of Claimed Compound5-170
  • § 5:7 : Indefiniteness and the Requirement to Claim the Invention5-171
    • § 5:7.1 : Statutory Provision: Section 1125-171
    • § 5:7.2 : The Requirements5-171
      • [A] : Must Claim What Applicant Regards As the Invention5-171
        • [A][1] : During Prosecution5-171
        • [A][2] : Issued Patents5-171
      • [B] : Indefiniteness5-172
        • [B][1] : Evolution of the Standard for Indefiniteness5-173
        • [B][2] : Standard of Proof5-176
        • [B][3] : Role of the Jury5-177
        • [B][4] : Standard of Review5-177
        • [B][5] : Dependent Claims5-178
    • § 5:7.3 : Relationship of Indefiniteness to Other Determinations5-178
      • [A] : Indefiniteness and Claim Construction5-178
      • [B] : Indefiniteness and Infringement5-179
      • [C] : Indefiniteness Separate from Enablement5-180
      • [D] : Indefiniteness and Prior Art5-180
    • § 5:7.4 : Indefiniteness in Different Situations5-181
      • [A] : Terms of Degree5-181
      • [B] : Patent Does Not Identify Test to Measure Claimed Property5-183
        • [B][1] : Examples of Claims Found Indefinite5-183
          • [B][1][a] : Leading Example: Honeywell International v. International Trade Commission5-183
          • [B][1][b] : Other Examples5-184
        • [B][2] : Examples of Claims Found Definite5-184
          • [B][2][a] : Leading Example: PPG Industries, Inc. v. Guardian Industries Corp.5-184
          • [B][2][b] : Other Examples5-185
      • [C] : Single Claim to Both Method and Apparatus Indefinite5-185
      • [D] : Claims Requiring Knowledge or Intent5-188
      • [E] : Means-Plus-Function Claims5-188
      • [F] : Drafting Errors in Claim Language5-189
        • [F][1] : Claims Found Indefinite5-190
        • [F][2] : Claims Not Found Indefinite5-190
        • [F][3] : Lack of Antecedent Basis5-190
  • § 5:8 : Double Patenting5-191
    • § 5:8.1 : Two Forms of Double Patenting: Statutory and Non-Statutory5-191
    • § 5:8.2 : The Policy Behind Double Patenting5-192
      • [A] : Policy Prior to URAA5-193
      • [B] : Continued Applicability of Obviousness-Type Double Patenting Post-URAA5-194
    • § 5:8.3 : Double Patenting Requires Common Inventorship or Ownership5-194
    • § 5:8.4 : Situations in Which Double Patenting May Arise5-195
      • [A] : Prosecution, Reexamination, and Post-Issuance5-195
      • [B] : Later Issuing, Earlier Expiring Reference Patent5-195
      • [C] : Claims Canceled After Issuance May Still Be Reference Claims5-196
    • § 5:8.5 : Non-Statutory Double Patenting5-197
      • [A] : Anticipation and Obviousness5-197
      • [B] : Genus and Species5-198
      • [C] : The Test for Double Patenting5-199
        • [C][1] : Two-Part Test5-199
        • [C][2] : Limited Use of the Specification5-200
        • [C][3] : Use of Prior Art5-201
        • [C][4] : Use of Post-Filing-Date Art5-202
        • [C][5] : Claim-by-Claim Analysis5-203
      • [D] : Who Is the Same Person for Purposes of Double Patenting?5-203
      • [E] : Curing Double Patenting by Filing Terminal Disclaimers5-204
        • [E][1] : Effect of Filing a Terminal Disclaimer5-204
        • [E][2] : Need for Common Ownership of Patent and Its Reference Patent5-205
        • [E][3] : The Timing of a Terminal Disclaimer Filing5-206
        • [E][4] : Effect of a Terminal Disclaimer on a Patent Term Extension5-208
        • [E][5] : Effect of a Terminal Disclaimer on a Patent Term Adjustment5-210
        • [E][6] : Effect of a Disclaimer of Claims5-210
      • [F] : The Two-Way Double Patenting Test5-211
        • [F][1] : Requirements to Qualify for the Two-Way Test5-211
        • [F][2] : Satisfying the Two-Way Test5-212
      • [G] : Overlapping Claims5-212
    • § 5:8.6 : Safe Harbor Provision Involving Double Patenting5-212
      • [A] : The Safe Harbor Requires a Prior Restriction by the Examiner5-213
      • [B] : The Safe Harbor Requires Consonance Between the Restriction Requirement and the Later Claims in the Later Application5-213
      • [C] : The Safe Harbor Requires Filing of a Subsequent Application Denominated a “Divisional”5-215
    • § 5:8.7 : Double Patenting Issues in Pharmaceutical Patents5-216
      • [A] : Method Patents over Prior Compound Patents5-216
      • [B] : Examples5-217
  • § 5:9 : Inequitable Conduct5-221
    • § 5:9.1 : Introduction5-221
    • § 5:9.2 : Inequitable Conduct Requires Proof of Materiality and Intent5-222
    • § 5:9.3 : The Materiality Requirement5-223
      • [A] : Standard for Materiality Before Therasense5-223
      • [B] : The Materiality Standard Under Therasense5-225
    • § 5:9.4 : The Intent Requirement5-226
      • [A] : Actual Intent Required; Negligence Not Enough5-226
      • [B] : There Must Be a Specific Intent to Deceive5-226
      • [C] : The Intent Requirement Under Therasense5-227
        • [C][1] : Proving Intent Before Therasense5-227
          • [C][1][a] : Ferring B.V. v. Barr Laboratories, Inc.5-228
        • [C][2] : Proving Intent After Therasense5-230
        • [C][3] : Whether the Actual Intent Standard Requires That at Least One Individual Have the Requisite Culpable State of Mind5-230
    • § 5:9.5 : Categories of Inequitable Conduct5-231
      • [A] : References5-231
        • [A][1] : Non-Disclosed References5-231
        • [A][2] : References Before the Examiner5-231
        • [A][3] : Disclosure Only of Abstracts5-232
        • [A][4] : Potential Double-Patenting References5-232
        • [A][5] : Argument About a Reference5-232
      • [B] : Descriptions of Data and Experiments5-233
      • [C] : Representations Regarding Inventorship5-234
      • [D] : Related Proceedings5-235
        • [D][1] : Related Patent Office Proceedings5-235
        • [D][2] : Related Litigations5-236
      • [E] : Miscellaneous Types of Inequitable Conduct5-236
        • [E][1] : Application for Expedited Treatment5-237
        • [E][2] : Payment of Maintenance Fees5-237
        • [E][3] : Disclosure of Relationships Between Declarant and Applicant5-237
        • [E][4] : Notes About a Presentation5-238
        • [E][5] : Concealment of Best Mode5-238
        • [E][6] : Litigation Misconduct5-238
    • § 5:9.6 : Late and Corrected Disclosures5-239
      • [A] : Late Disclosures5-239
      • [B] : Correcting a Disclosure During Prosecution5-239
      • [C] : Disclosure in Reissue Proceedings5-240
    • § 5:9.7 : Practical Problems in Pharmaceutical Patent Prosecution5-241
    • § 5:9.8 : Practical Advice for Defeating Inequitable Conduct Allegations5-243
      • [A] : Disclosure of References5-243
      • [B] : Disclosure of Experimental Details5-244
      • [C] : Disclosure of Experimental Data5-244
      • [D] : Care in Patent Prosecution5-245
    • § 5:9.9 : The Legal Effect of a Finding of Inequitable Conduct5-246
      • [A] : Inequitable Conduct Renders a Patent Unenforceable5-246
      • [B] : Inequitable Conduct May Result in Assessment of Attorneys’ Fees5-246
      • [C] : Inequitable Conduct May Have Antitrust Consequences5-246
    • § 5:9.10 : Procedural Aspects5-247
      • [A] : Inequitable Conduct Is an Issue of Equity Decided by the Court, Not a Jury5-247
      • [B] : Standard of Review5-248
Chapter 6: Biological Deposits
  • § 6:1 : Introduction6-1
  • § 6:2 : The Evolution of Biological Deposits6-2
  • § 6:3 : Biological Deposits Can Satisfy Disclosure Requirements6-3
    • § 6:3.1 : Written Description6-3
    • § 6:3.2 : Enablement6-4
    • § 6:3.3 : Best Mode6-4
  • § 6:4 : Biological Deposits Not Required If Disclosure Otherwise Adequate6-5
  • § 6:5 : Making and Maintaining Biological Deposits6-5
Chapter 7: Types of Biological and Pharmaceutical Patents
  • § 7:1 : Research Tools7-8
    • § 7:1.1 : What Is a Research Tool Patent?7-8
    • § 7:1.2 : Utility Requirement for Patenting Research Tools7-10
    • § 7:1.3 : Research Tools Used to Obtain Data for FDA Submissions: Section 271(e)(1)7-11
    • § 7:1.4 : Off Shore Development Work: Section 271(f) and (g)7-13
      • [A] : Section 271(f)7-14
        • [A][1] : The Statute7-14
        • [A][2] : Legislative History7-14
        • [A][3] : Applying Section 271(f) to Research Tools7-15
      • [B] : Section 271(g)7-15
        • [B][1] : The Statute7-15
        • [B][2] : Legislative History7-16
        • [B][3] : Applying Section 271(g) to Research Tools7-16
  • § 7:2 : Patentability of Chemical Compounds7-17
    • § 7:2.1 : Novelty of a Claim to a Chemical Compound Over the Prior Art: The Requirement That an Anticipating Reference Be Enabling7-18
    • § 7:2.2 : Obviousness of a Claim to a Chemical Entity and the Impact of the Supreme Court’s Decision in KSR7-20
      • [A] : Prima Facie Obviousness7-23
        • [A][1] : An Evidentiary Mechanism7-23
        • [A][2] : Demonstrating Prima Facie Obviousness7-24
          • [A][2][a] : Properties of Claimed and Prior Art Compounds7-25
            • [A][2][a][i] : New Property Alone Does Not Defeat a Prima Facie Case7-25
            • [A][2][a][ii] : To Demonstrate Prima Facie Obviousness, a Prior Art Compound Must Suggest Some Useful Property7-26
            • [A][2][a][iii] : In re Dillon7-26
          • [A][2][b] : Prima Facie Obviousness Based on Similarity in Structure: “Structural Obviousness”7-27
            • [A][2][b][i] : Pre- KSR Federal Circuit Decisions7-27
            • [A][2][b][ii] : Post -KSR Federal Circuit Decisions7-34
            • [A][2][b][iii] : Post- KSR District Court Decisions7-46
          • [A][2][c] : Reason to Combine7-51
        • [A][3] : Nonobviousness Where Prior Art Teaches Away from Claimed Compound7-52
        • [A][4] : Examples from Pre- KSR Decisions7-53
          • [A][4][a] : Finding Structural Obviousness7-53
          • [A][4][b] : Finding No Structural Obviousness7-56
      • [B] : Rebutting a Prima Facie Case of Obviousness7-59
        • [B][1] : Unexpected Results Require a Showing of Actual Differences7-59
        • [B][2] : Compared to Closest Prior Art7-60
        • [B][3] : Differences Must Match Scope of Claim7-61
        • [B][4] : Magnitude of Difference in Properties7-61
        • [B][5] : Multiple Properties7-62
        • [B][6] : Evidence of Unexpected Properties Not Limited to Specification7-64
          • [B][6][a] : Evidence Need Not Be in Specification7-64
          • [B][6][b] : Unexpected Property Need Not Be in Specification7-65
        • [B][7] : Illustrative Cases7-66
          • [B][7][a] : Prima Facie Obviousness Rebutted7-66
          • [B][7][b] : Prima Facie Obviousness Not Rebutted7-67
    • § 7:2.3 : Genus and Species Inventions7-70
      • [A] : Anticipation of a Chemical Genus by a Prior Art Species7-71
        • [A][1] : Prior Species Anticipates Genus7-71
        • [A][2] : Conception of Species Before Prior Art Can Defeat Anticipation of Broader Genus7-72
      • [B] : Validity of a Claimed Species Over a Prior Art Genus7-73
        • [B][1] : Anticipation of Chemical Species by a Prior Art Genus7-73
          • [B][1][a] : General Rule7-73
          • [B][1][b] : Exception for Small Prior Art Genus: In re Petering7-74
        • [B][2] : Obviousness of a Chemical Species Over a Prior Art Genus7-75
          • [B][2][a] : General Rule7-75
          • [B][2][b] : Prima Facie Case Based on Prior Art Genus Can Be Rebutted7-76
          • [B][2][c] : Size of Prior Art Genus and Nature of Examples May Negate Prima Facie Case7-76
            • [B][2][c][i] : In re Jones7-77
            • [B][2][c][ii] : In re Baird7-77
      • [C] : Written Description Support for Genus and Species Composition Claims7-78
        • [C][1] : Species or Subgenus Claims7-78
        • [C][2] : Genus Claims7-78
    • § 7:2.4 : Stereoisomers, Enantiomers, and Diastereomers7-79
      • [A] : Introduction7-79
      • [B] : Patentability of Stereoisomers7-83
        • [B][1] : Anticipation7-83
        • [B][2] : Obviousness7-85
      • [C] : Claim Construction and Infringement7-90
    • § 7:2.5 : Polymorphs7-91
      • [A] : What Is a Polymorph?7-91
      • [B] : Techniques for Identifying Polymorphs7-93
        • [B][1] : X-Ray Powder Diffraction7-93
        • [B][2] : Single Crystal X-Ray Crystallographic Analysis7-93
        • [B][3] : Infrared Absorption Analysis7-93
      • [C] : Infringement7-94
        • [C][1] : Evidentiary Issues7-94
        • [C][2] : Quantity Required7-96
        • [C][3] : Conversion7-98
        • [C][4] : Claim Construction7-100
      • [D] : Validity7-100
        • [D][1] : Inherent Anticipation7-100
        • [D][2] : On-Sale Bar7-101
    • § 7:2.6 : Pharmaceutical Salts of Active Ingredients7-102
      • [A] : What Is a Salt?7-102
      • [B] : Development of Pharmaceutical Salts7-102
      • [C] : Patentability of New Salts7-103
        • [C][1] : Determinations of Obviousness/Nonobviousness of New Salt Forms of Compounds7-103
        • [C][2] : Most Common Salt Form Used for Known Active Found Obvious in Obviousness-Type Double Patenting Analysis7-108
    • § 7:2.7 : Infringement by Conversion to a Patented Form7-109
      • [A] : In Vivo Conversion7-110
        • [A][1] : Claim Construction7-110
      • [B] : Infringement and Anticipation7-112
        • [B][1] : Schering v. Geneva7-112
        • [B][2] : Pre-Schering District Court Decisions7-113
          • [B][2][a] : Marion Merrell Dow7-114
          • [B][2][b] : Omeprazole7-115
          • [B][2][c] : Buspirone7-117
      • [C] : Conversion Outside the Body: Polymorphic Form Conversion7-118
    • § 7:2.8 : Particle Size of Active Ingredient7-119
      • [A] : What Is Particle Size?7-119
      • [B] : Infringement of Particle Size Patents7-120
        • [B][1] : Measured on the API Raw Material or in the Formulation7-120
        • [B][2] : Infringement of Particle Size Patents in Hatch-Waxman Cases7-122
        • [B][3] : Method of Measurement7-123
        • [B][4] : Infringement Under the Doctrine of Equivalents7-124
      • [C] : Validity7-124
        • [C][1] : Obviousness7-124
        • [C][2] : Written Description7-125
  • § 7:3 : Pharmaceutical Formulations7-126
    • § 7:3.1 : What Is a Pharmaceutical Formulation?7-126
    • § 7:3.2 : Claim Construction Issues7-132
      • [A] : “Solubilizer” Limited to Surfactants7-132
      • [B] : “Lipophilic Component” Construed to Include More Than Surfactants7-133
      • [C] : Claim Not Limited to Particular Grade of an Excipient7-133
      • [D] : Purity Limitations7-134
      • [E] : “Hydrosol” Limited to “Medicinal Preparation”7-134
      • [F] : “Saccharides” Includes “Polysaccharides”7-135
    • § 7:3.3 : Literal Infringement and Infringement Under the Doctrine of Equivalents7-136
      • [A] : Using Different Excipients7-137
        • [A][1] : Non-Equivalence7-137
        • [A][2] : Equivalence7-138
        • [A][3] : Prosecution History Estoppel7-138
      • [B] : Controlled Release Formulations: Foreseeability of Substitution7-138
        • [B][1] : Prosecution History Estoppel Bars Equivalence7-138
        • [B][2] : No Prosecution History Estoppel7-139
      • [C] : Controlled Release Formulations: Prosecution History Estoppel7-140
      • [D] : Infringement by Equivalents: No Dedication of Equivalent Excipient7-141
    • § 7:3.4 : Patent Validity7-143
      • [A] : Obviousness7-143
        • [A][1] : Combinations of Excipients7-143
        • [A][2] : Combination Therapies7-144
          • [A][2][a] : Obvious Combination7-145
          • [A][2][b] : Nonobvious Combination7-145
        • [A][3] : Pharmacokinetic/Pharmacodynamic Limitations7-146
      • [B] : Written Description7-147
      • [C] : Enablement7-148
    • § 7:3.5 : Bibliography of Pharmaceutical Formulation Treatises and Texts7-148
  • § 7:4 : Method of Treatment7-149
    • § 7:4.1 : What Is a Method of Treatment Claim?7-149
    • § 7:4.2 : Patentability of Method of Treatment Claims7-150
    • § 7:4.3 : Conception7-152
    • § 7:4.4 : Claim Construction Issues7-152
      • [A] : Preambles7-152
        • [A][1] : Preambles Can Be Limiting7-153
        • [A][2] : Construing Preambles in Method of Treatment Claims7-153
        • [A][3] : Adding Method of Treatment Preamble Language by Amendment Can Render Preamble Limiting7-154
      • [B] : Specific Claim Terms7-155
        • [B][1] : “Treat”7-155
        • [B][2] : “Effective Amount”7-156
        • [B][3] : “Co-Administration”7-156
    • § 7:4.5 : Anticipation and Obviousness7-157
      • [A] : Inherent Anticipation7-157
        • [A][1] : Examples of Inherency7-157
        • [A][2] : Examples of No Inherency7-161
      • [B] : Prior Art Need Not Disclose Efficacy to Anticipate7-163
      • [C] : Obviousness7-164
        • [C][1] : Methods of Using New Compounds7-164
        • [C][2] : New Methods of Using Old Compounds7-165
        • [C][3] : Genus of Methods of Treatment Could Render Included Species Obvious7-165
        • [C][4] : Instructional Limitations7-166
    • § 7:4.6 : Written Description7-167
      • [A] : Examples of Method of Treatment Cases Involving Written Description7-167
      • [B] : Field of Use Claim7-167
      • [C] : Dosing7-168
    • § 7:4.7 : Enablement7-168
      • [A] : Compound Needed to Practice Claim Must Be Enabled7-168
      • [B] : Dosing7-169
    • § 7:4.8 : Best Mode7-170
    • § 7:4.9 : Infringement7-170
      • [A] : Suing the Maker of the Therapeutic: Indirect Infringement7-170
      • [B] : Suing on Method of Treatment Claims Against an ANDA Defendant7-170
  • § 7:5 : Pharmaceutical Manufacturing7-171
    • § 7:5.1 : Intermediates7-172
      • [A] : Definition and Purpose7-172
      • [B] : Utility Required7-172
    • § 7:5.2 : Product-By-Process Claims7-175
      • [A] : Definition and Purpose7-175
      • [B] : Construction of Product-By-Process Claims7-176
        • [B][1] : Patent Office Examination of Pending Product-By-Process Claims7-176
        • [B][2] : Construction of Issued Product-By-Process Claims in Patent Infringement Litigation7-177
    • § 7:5.3 : Process Claims7-180
      • [A] : Definition and Purpose7-180
      • [B] : Patentability of Process Claims7-180
      • [C] : Biotechnological Processes7-181
  • § 7:6 : Nucleic Acid Patents7-182
    • § 7:6.1 : The Promise of Genomics7-182
      • [A] : First Recombinant DNA Organism7-182
      • [B] : Cellular Factors for Making Proteins7-182
      • [C] : Genetic Basis of Disease7-183
      • [D] : Gene Therapy7-183
      • [E] : Our Expanding Knowledge of Genes7-184
      • [F] : Biotechnology Patents7-185
    • § 7:6.2 : Eligibility of Nucleic Acid Sequences for Patenting7-186
      • [A] : Product of Nature Exception to Patentability7-186
        • [A][1] : Patentability of Man-Made Living Organisms: Diamond v. Chakrabarty7-187
        • [A][2] : Purified and Isolated (prior to Myriad)7-188
          • [A][2][a] : Kuehmsted v. Farbenfabriken of Eberfield7-189
          • [A][2][b] : Merck & Co. v. Olin Mathieson7-189
      • [B] : Cases Suggesting Natural DNA Sequences Not Patentable (prior to Myriad)7-190
        • [B][1] : Funk Bros. v. Kalo7-191
        • [B][2] : General Electric v. De Forest Radio Co.7-192
    • § 7:6.3 : Utility Requirement for Nucleic Acid Patents7-193
      • [A] : PTO Board of Patent Appeals Decisions7-194
      • [B] : The PTO’s Utility Examination Guidelines and Training Materials7-196
        • [B][1] : The 1995 Utility Guidelines7-196
        • [B][2] : The 1999 Revised Utility Guidelines7-197
        • [B][3] : The 2001 Utility Guidelines7-198
        • [B][4] : The Utility Guidelines Training Materials7-198
          • [B][4][a] : “Specific” Utility7-199
          • [B][4][b] : “Substantial” Utility7-199
          • [B][4][c] : “Credible” Utility7-199
          • [B][4][d] : “Well-Established” Utility7-200
        • [B][5] : The Nucleic Acid Examples of the Training Materials7-200
          • [B][5][a] : “DNA Fragments”7-200
          • [B][5][b] : “DNA Fragment Encoding a Full Open Reading Frame (ORF)”7-201
      • [C] : Expressed Sequence Tags and Single Nucleotide Polymorphs7-202
    • § 7:6.4 : Written Description of Nucleic Acids7-203
      • [A] : Satisfying the Written Description Requirement7-204
        • [A][1] : Amgen, Inc. v. Chugai Pharmaceutical Co.7-204
        • [A][2] : Fiers v. Revel7-206
      • [B] : Heightened Written Description Requirement for Biotechnology and DNA Sequence Patents?7-206
        • [B][1] : Regents of University of California v. Eli Lilly & Co.7-206
        • [B][2] : Enzo Biochem, Inc. v. Gen-Probe, Inc. (Enzo I)7-208
        • [B][3] : Enzo Biochem, Inc. v. Gen-Probe, Inc. (Enzo II)7-209
        • [B][4] : Amgen, Inc. v. Hoechst Marion Roussel, Inc.7-211
        • [B][5] : University of Rochester v. G.D. Searle & Co.7-212
      • [C] : Practical Implications of the Federal Circuit’s Written Description Jurisprudence7-215
    • § 7:6.5 : Other Grounds for Invalidity of Nucleic Acid Inventions7-217
      • [A] : Anticipation7-217
      • [B] : Obviousness7-218
        • [B][1] : Amino Acid Sequences7-218
        • [B][2] : Nucleic Acid Sequences7-218
          • [B][2][a] : Post-KSR7-218
          • [B][2][b] : Pre-KSR7-219
      • [C] : Indefiniteness7-220
      • [D] : Enablement7-220
      • [E] : Best Mode7-221
      • [F] : Inventorship and Conception7-221
    • § 7:6.6 : Claim Construction of Nucleic Acid Claims7-222
  • § 7:7 : Antibodies7-225
    • § 7:7.1 : What Is an Antibody?7-225
      • [A] : Introduction7-225
      • [B] : Monoclonal Antibodies7-226
      • [C] : Commercial Applications for Antibodies7-228
    • § 7:7.2 : Obviousness7-229
      • [A] : Monoclonal Antibodies7-229
      • [B] : Sandwich Assay7-230
      • [C] : 35 U.S.C. § 103(b)7-230
    • § 7:7.3 : Written Description7-231
      • [A] : Describing Antibodies by Describing Their Target7-231
        • [A][1] : Overview of Written Description Requirement7-231
        • [A][2] : Antibodies and DNA7-232
        • [A][3] : Requirement for Describing the Antigen7-233
        • [A][4] : Antibodies That Bind to Particular Epitopes7-233
      • [B] : Describing Antibodies in Terms of Their Corresponding DNA or Amino Acid Sequences7-233
        • [B][1] : Describing Antibodies in Terms of Previously Known Sequences7-233
        • [B][2] : Describing Antibody Genus in Terms of Amino Acid Sequences7-234
      • [C] : Chimeric Antibodies: Chiron v. Genentech7-235
    • § 7:7.4 : Enablement7-236
      • [A] : Enablement Supported by the Prior Art7-236
        • [A][1] : Evidence of Enablement from the Prior Art7-236
        • [A][2] : Enablement Based on Level of Skill in the Art: No Undue Experimentation7-237
      • [B] : Failed Attempts Do Not Necessarily Show Lack of Enablement7-238
      • [C] : Nascent Technology7-238
    • § 7:7.5 : Claim Construction7-239
      • [A] : Chimeric and Humanized Antibodies7-239
Chapter 8: The Hatch-Waxman Act
  • § 8:1 : Patent Protection and Litigation8-6
    • § 8:1.1 : Introduction8-6
      • [A] : Background of the Hatch-Waxman Act8-6
      • [B] : Hatch-Waxman Act Overview8-7
      • [C] : Requirements for Filing an ANDA8-8
        • [C][1] : Labeling8-10
        • [C][2] : Active Ingredient8-11
        • [C][3] : Route of Administration, Dosage Form, and Strength8-11
        • [C][4] : Bioequivalence8-12
        • [C][5] : Drug Master File References8-13
      • [D] : “Suitability Petitions” for Variant Dosage Forms and Strengths8-13
      • [E] : Paper NDAs: Section 505(b)(2) Applications8-14
    • § 8:1.2 : Orange Book Listing8-16
      • [A] : What Patent Information Must Be Submitted8-16
        • [A][1] : “Drug Product” (Formulation or Composition) Patents8-17
        • [A][2] : “Drug Substance” (Active Ingredient) Patents8-18
        • [A][3] : Patents Claiming “Polymorphs”8-19
        • [A][4] : Method of Use Patents8-20
        • [A][5] : Method of Manufacture Patents8-20
      • [B] : Who Must Submit Patent Information8-21
      • [C] : Patent Certification and Duty of Care8-21
      • [D] : Consequences of False Certification8-22
      • [E] : Resolution of Orange Book Listing Disputes8-22
      • [F] : Orange Book Delisting Limitations8-23
      • [G] : Reissue Patents8-23
    • § 8:1.3 : Patent Certifications by ANDA or 505(b)(2) Applicant: Paragraphs I, II, III, and IV8-24
      • [A] : Patent Certifications by ANDA Applicant8-24
      • [B] : Patent Certifications by Section 505(b)(2) Applicant8-25
      • [C] : Notice of Paragraph IV Certification8-25
        • [C][1] : Contents of Notice8-25
        • [C][2] : When Served8-26
        • [C][3] : Who Served8-26
    • § 8:1.4 : ANDA Filing As “Artificial Act of Infringement” Under 35 U.S.C. § 271(e)(2)8-26
      • [A] : Statutory Provisions8-26
      • [B] : Elements of Section 271(e)(2) Infringement Claim8-27
        • [B][1] : “submit an application”8-27
        • [B][2] : “under Section 505(j) . . . or described in Section 505(b)(2)”8-28
        • [B][3] : “for a drug claimed in a patent or the use of which is claimed in a patent”8-29
          • [B][3][a] : “drug claimed in a patent”8-29
            • [B][3][a][i] : Patents on Different Formulations8-29
            • [B][3][a][ii] : Patents on Methods of Manufacture8-30
            • [B][3][a][iii] : Product-by-Process Patents8-30
            • [B][3][a][iv] : Patents on Different Polymorphs8-30
            • [B][3][a][v] : Patents on Metabolites8-31
            • [B][3][a][vi] : Patents on Intermediates8-31
          • [B][3][b] : “or the use of which is claimed in a patent”8-31
        • [B][4] : Enforcement of Non-Orange Book Patents8-34
      • [C] : The Section 271(e)(2) Infringement Analysis8-35
        • [C][1] : Similarities to Standard Infringement Actions8-35
        • [C][2] : Differences from Standard Infringement Actions8-36
          • [C][2][a] : Overview8-36
          • [C][2][b] : Pre-Suit Investigation8-37
          • [C][2][c] : Determining Infringement Based on ANDA8-37
          • [C][2][d] : Determining Infringement Based on Evidence Beyond the ANDA8-39
          • [C][2][e] : Determining Infringement for Method Claims8-39
    • § 8:1.5 : Procedural Considerations in ANDA Litigation8-39
      • [A] : Parties, Jurisdiction, and Venue8-39
        • [A][1] : Proper Plaintiff8-39
        • [A][2] : Proper Defendants8-40
        • [A][3] : Jurisdiction and Venue8-41
      • [B] : Pretrial Proceedings8-43
      • [C] : No Jury Trial8-43
    • § 8:1.6 : Thirty-Month Litigation Stay Preventing Launch of Generic8-43
      • [A] : Orange Book Listing Is Prerequisite to Thirty-Month Stay8-44
      • [B] : Beginning of the Thirty-Month Stay8-45
        • [B][1] : Calculated from Receipt of Notice8-45
        • [B][2] : The Forty-Five-Day Window8-45
      • [C] : Adjustment of Thirty-Month Stay8-45
      • [D] : Termination of Thirty-Month Stay8-46
        • [D][1] : Judgment of Non-Infringement, Invalidity or Unenforceability8-46
        • [D][2] : Effect of Settlement8-47
    • § 8:1.7 : Remedies8-48
      • [A] : Order Precluding FDA Approval of ANDA Until Patent Expiration8-48
      • [B] : Injunctive Relief8-48
      • [C] : Damages Only upon Commercial Sales of Infringing Product8-49
      • [D] : Attorney Fees8-49
        • [D][1] : Statutory Provisions: Sections 271(e)(4) and 2858-49
        • [D][2] : Factors for Determining Exceptional Case8-49
        • [D][3] : Hatch-Waxman Act Exceptional Case Litigation8-50
          • [D][3][a] : Baseless Certification8-50
          • [D][3][b] : Willfulness8-52
          • [D][3][c] : Opinions by Patent Counsel8-54
          • [D][3][d] : Attorney Fees Sought by ANDA Filer Based on Allegation of Baseless Suit by Patentee8-55
    • § 8:1.8 : Exemption from Infringement for Activities Related to FDA Submission8-56
      • [A] : Statutory Provision: 35 U.S.C. § 271(e)(1)8-56
      • [B] : Affirmative Defense?8-56
      • [C] : Policy Behind Enactment of the Exemption8-57
      • [D] : Situations in Which the Exemption Is Adjudicated8-59
      • [E] : Statutory Ambiguities8-60
      • [F] : Scope of the Statutory Exemption: “Under a Federal Law . . . ”8-60
        • [F][1] : Exemption Covers Class III Medical Devices8-60
        • [F][2] : Exemption Covers Class II Medical Devices8-61
      • [G] : The “Solely for Uses Reasonably Related to” Requirement8-62
        • [G][1] : “reasonably related”8-62
          • [G][1][a] : Supreme Court Weighs In: Merck v. Integra8-62
          • [G][1][b] : Post-Merck v. Integra8-63
          • [G][1][c] : Pre-Merck v. Integra8-64
        • [G][2] : “solely”8-66
        • [G][3] : Post-Product-Approval Activity8-67
        • [G][4] : Examples8-68
          • [G][4][a] : Exempt Activities8-68
          • [G][4][b] : Non-Exempt Activities8-69
      • [H] : Third-Party Support of Section 271(e)(1) Activity8-70
      • [I] : Abuse of Regulatory Review Process8-71
      • [J] : The Use of Research Tools Under Section 271(e)(1)8-72
  • § 8:2 : The First Paragraph IV Applicant’s 180-Day Exclusivity8-73
    • § 8:2.1 : Introduction8-73
    • § 8:2.2 : Basic Statutory Provision: Section 355(j)(5)(B)(iv)8-74
    • § 8:2.3 : Only the “First Applicant” Is Entitled to Exclusivity8-74
      • [A] : First ANDA with a Paragraph IV Certification for Any Patent8-74
      • [B] : “Substantially Complete” ANDA8-74
      • [C] : “Contains and Lawfully Maintains” a Paragraph IV Certification8-75
    • § 8:2.4 : Exclusivity Is Against Subsequent Paragraph IV ANDAs for Same Drug8-76
      • [A] : No Exclusivity Against Authorized Generics8-77
      • [B] : No Exclusivity Unless Subsequent ANDA Contains Paragraph IV Certification8-77
    • § 8:2.5 : Exclusivity Period Begins Only upon First Applicant’s “Commercial Marketing”8-77
    • § 8:2.6 : “Forfeiture” of 180-Day Exclusivity8-78
      • [A] : “Failure to Market”8-79
      • [B] : First Filer’s ANDA Is Withdrawn or Rejected8-80
      • [C] : First Filer’s ANDA Is Not “Tentatively Approved” Within Thirty Months8-80
      • [D] : All Challenged Patents Have Expired8-81
      • [E] : First Applicant Withdraws All Paragraph IV Certifications8-81
      • [F] : Collusive Agreement8-82
    • § 8:2.7 : 180-Day Exclusivity Under the Pre-MMA Hatch-Waxman Act8-82
      • [A] : Pre-MMA Statutory Text8-82
      • [B] : Exclusivity for Pre-MMA ANDAs8-83
        • [B][1] : “patent-by-patent” Exclusivity8-83
        • [B][2] : “shared” Exclusivity8-85
      • [C] : When Does 180-Day Period Begin?8-86
        • [C][1] : “first commercial marketing”8-86
        • [C][2] : “a decision of a court . . . holding”8-86
          • [C][2][a] : What “Holding”?8-86
          • [C][2][b] : What Parties?8-87
          • [C][2][c] : What Products?8-87
          • [C][2][d] : What Court?8-87
      • [D] : Loss of Exclusivity8-88
    • § 8:2.8 : Waiver and Transfer of Exclusivity8-88
  • § 8:3 : “Data” Exclusivity Under the FD&C Act8-89
    • § 8:3.1 : Introduction8-89
    • § 8:3.2 : New Chemical Entity Exclusivity8-89
      • [A] : Statutory Basis: Section 355(c)(3)(E)(ii) and Section 355(j)(5)(F)(ii)8-89
      • [B] : Eligibility Criteria for NCE Exclusivity8-90
        • [B][1] : “Active Ingredient” Means “Active Moiety”8-90
        • [B][2] : Novel Combinations8-91
        • [B][3] : New Forms of Previously Approved Ingredients8-93
          • [B][3][a] : Polymorphs8-93
          • [B][3][b] : Stereoisomers8-93
      • [C] : Extra Exclusivity for Certain New Antibiotics8-94
    • § 8:3.3 : “Other Significant Changes” Exclusivity8-94
      • [A] : Statutory Basis: Section 355(j)(5)(F)(iii) and (iv)8-94
      • [B] : Eligibility Criteria for OSC Exclusivity8-95
        • [B][1] : “new clinical investigations”8-95
        • [B][2] : “conducted or sponsored by the applicant”8-95
        • [B][3] : “essential to approval”8-95
      • [C] : “Carve-Out” Option for ANDAs8-96
    • § 8:3.4 : “Orphan Drug” Exclusivity8-97
      • [A] : Statutory Basis: Sections 360aa–360cc8-97
      • [B] : “Orphan Drug” Eligibility Criteria for Exclusivity8-97
      • [C] : Scope of Orphan Drug Exclusivity8-98
        • [C][1] : “same drug”8-98
          • [C][1][a] : “same” Structure8-98
          • [C][1][b] : “same” Clinical Performance8-99
    • § 8:3.5 : Pediatric “Exclusivity”8-99
      • [A] : Statutory Basis: 21 U.S.C. § 355a8-99
      • [B] : Eligibility for Pediatric Exclusivity8-100
      • [C] : Interim Extension8-101
      • [D] : Label Revision Not Required8-101
      • [E] : Scope of Pediatric Extension8-102
        • [E][1] : Extension of Data-Based Exclusivity8-102
        • [E][2] : Extension of Patent Protection8-102
  • § 8:4 : Patent Term Restoration8-104
    • § 8:4.1 : Introduction8-104
    • § 8:4.2 : Eligibility for Patent Term Restoration8-106
      • [A] : Threshold Requirement8-106
      • [B] : Five Conditions for Extension Eligibility8-107
      • [C] : The “First Permitted Commercial Marketing or Use of the Product”8-108
        • [C][1] : Need Not Be the First Product Covered by the Patent to Receive Regulatory Approval8-108
        • [C][2] : Patent Cannot Merely Claim a New Formulation of a Previously Approved Active Ingredient8-109
        • [C][3] : Patent Cannot Claim an Active Ingredient if Any Salt or Ester of That Active Ingredient Has Been Previously Approved8-109
        • [C][4] : Patent Cannot Claim Combination of Two Previously Approved Drugs8-110
      • [D] : Section 156 and the Uruguay Round Agreements Act8-111
    • § 8:4.3 : Scope of Protection During Restoration Period8-112
      • [A] : The Scope of Protection During the Extension Period8-112
    • § 8:4.4 : Mechanics of Patent Term Restoration8-115
      • [A] : Application for a Patent Term Restoration8-115
      • [B] : Roles of PTO and FDA in Handling Patent Term Restoration Applications8-116
      • [C] : Interim Extensions8-117
Chapter 9: Claim Construction
  • § 9:1 : General9-2
    • § 9:1.1 : The Purpose of Claims9-2
    • § 9:1.2 : Role of Jury, District Court and Appellate Courts9-3
      • [A] : Claim Construction Is a Matter of Law9-3
      • [B] : Standards of Review for Claim Constructions9-3
    • § 9:1.3 : Claim Construction Is a Predicate for Infringement and Invalidity9-4
    • § 9:1.4 : Procedure for Claim Construction9-5
  • § 9:2 : Sources for Interpreting Claims9-8
    • § 9:2.1 : Precedent Prior to Phillips v. AWH9-8
      • [A] : Hierarchy of Evidence9-8
        • [A][1] : Intrinsic Evidence9-9
        • [A][2] : Extrinsic Evidence9-9
      • [B] : Superseded Focus on Ordinary Meaning9-10
    • § 9:2.2 : Phillips v. AWH9-11
      • [A] : Rejecting “Dictionary First” Approach9-11
      • [B] : Method for Construing Claims9-11
    • § 9:2.3 : Post-Phillips Rules of Claim Construction9-13
      • [A] : Patentee Acting As a Lexicographer9-13
      • [B] : Extrinsic Evidence9-14
      • [C] : Disclosed Embodiments9-15
      • [D] : Construction Preferably Does Not Render Terms Superfluous or Differences in Terminology Meaningless9-15
      • [E] : Order of Method Steps9-16
      • [F] : Range Claims9-16
      • [G] : Disavowal or Disclaimer9-16
  • § 9:3 : Interpretation of Common Claim Terms9-17
    • § 9:3.1 : Preambles9-17
      • [A] : Preamble Recites Essential Structure9-18
      • [B] : Preamble Recites Important Steps9-18
      • [C] : Preamble Provides Antecedent Basis9-18
      • [D] : Reliance on Preamble During Prosecution9-19
    • § 9:3.2 : Transition Phrases9-19
      • [A] : “Comprising”9-19
      • [B] : “Consisting of”9-20
      • [C] : “Consisting essentially of”9-20
      • [D] : “Group of,” “Group consisting of,” Markush Group9-21
      • [E] : “Whereby”9-22
    • § 9:3.3 : Articles and Conjunctions9-22
      • [A] : “a” or “an”9-22
      • [B] : “the”9-23
      • [C] : “and”/“or”9-23
  • § 9:4 : Construction of Means-Plus-Function Claims9-24
  • § 9:5 : Disclaimer of Subject Matter That Literally Falls Within Claim Language9-24
  • § 9:6 : Pharmaceutical Patents9-25
    • § 9:6.1 : Planning for Claim Construction During Prosecution9-25
    • § 9:6.2 : Common Construction Issues in Pharmaceutical Patents9-26
Chapter 10: Patent Infringement
  • § 10:1 : Introduction10-2
  • § 10:2 : Acts Constituting Infringement10-3
    • § 10:2.1 : Direct Infringement10-3
    • § 10:2.2 : Inducing Infringement10-4
      • [A] : Elements of Inducing Infringement10-4
      • [B] : Inducement Under Section 271(e)(2)10-6
    • § 10:2.3 : Contributory Infringement10-6
    • § 10:2.4 : Section 271(f): Infringement by Shipment from the United States of Component of a Patented Invention to Be Assembled Abroad10-7
    • § 10:2.5 : Section 271(g): Infringement of a U.S. Process Patent by Importing into the United States or Offering to Sell, Selling, or Using a Product Made by the Patented Process10-8
    • § 10:2.6 : “Divided” Infringement of Method Claim10-10
  • § 10:3 : Infringement Under the Doctrine of Equivalents10-12
    • § 10:3.1 : The “All Elements” Rule10-13
    • § 10:3.2 : Tests for Equivalence10-13
    • § 10:3.3 : Limitations on the Doctrine of Equivalents10-14
      • [A] : Prosecution History Estoppel10-15
        • [A][1] : Estoppel by a Claim Amendment Made for Substantial Reason Related to Patentability10-15
          • [A][1][a] : Presumption of General Disclaimer of Equivalents; Rebutting the Presumption10-15
            • [A][1][a][i] : Unforeseeability of Equivalent10-16
            • [A][1][a][ii] : Amendment Bears “No More than a Tangential Relation” to Equivalent10-18
            • [A][1][a][iii] : Some Other Reason10-18
        • [A][2] : Estopped by Argument Made During Prosecution10-19
      • [B] : Dedication of Described, but Unclaimed Subject Matter: Johnson & Johnston10-19
      • [C] : Specific Exclusion: Dolly v. Spalding10-21
      • [D] : Vitiation of a Claim Element10-21
      • [E] : The Prior Art: Wilson Sporting Goods10-22
  • § 10:4 : The “Reverse Doctrine of Equivalents”10-22
  • § 10:5 : Infringement Defenses10-23
    • § 10:5.1 : Patent Invalidity10-23
    • § 10:5.2 : Express License10-23
    • § 10:5.3 : Implied License10-24
    • § 10:5.4 : Exhaustion10-25
    • § 10:5.5 : Laches10-27
      • [A] : Unreasonable and Inexcusable Delay10-27
      • [B] : Prejudice10-28
      • [C] : The Federal Circuit’s En Banc Decision on Laches in SCA Hygiene Products10-30
    • § 10:5.6 : Equitable Estoppel10-32
      • [A] : Misleading Statement or Conduct by the Patentee10-32
      • [B] : Reasonable Reliance10-33
    • § 10:5.7 : Inequitable Conduct10-33
    • § 10:5.8 : Prosecution Laches10-33
    • § 10:5.9 : Patent Misuse10-34
    • § 10:5.10 : 35 U.S.C. § 271(e)(1)10-35
    • § 10:5.11 : Experimental Use10-35
    • § 10:5.12 : Defense of Prior Commercial Use10-36
Chapter 11: Experimental Use Defense to Patent Infringement
  • § 11:1 : Introduction11-1
  • § 11:2 : Historical Development11-2
  • § 11:3 : Cases11-3
    • § 11:3.1 : Roche Products, Inc. v. Bolar Pharmaceutical Co.11-3
    • § 11:3.2 : Deuterium Corp. v. United States11-4
    • § 11:3.3 : Embrex, Inc. v. Service Engineering Corp.11-7
    • § 11:3.4 : Madey v. Duke University11-8
  • § 11:4 : Other Views11-10
Chapter 12: Government Funded Research: Bayh-Dole and Other Acts
  • § 12:1 : Policy Behind Enactment of Bayh-Dole12-2
    • § 12:1.1 : Ownership of Government Funded Inventions Prior to Bayh-Dole12-3
    • § 12:1.2 : The Motive for Change12-3
    • § 12:1.3 : Reagan Policy Extension of Bayh-Dole to All Contracting Parties12-4
  • § 12:2 : Overview of the Bayh-Dole Act12-4
    • § 12:2.1 : “Funding Agreements”12-4
    • § 12:2.2 : Potential Requirement for Written Agreement12-5
    • § 12:2.3 : Private Party Right to Acquire Inventions Made Under Funding Agreement12-6
    • § 12:2.4 : Requirements for Acquiring Private Ownership of an Invention Pursuant to Funding Agreement12-7
      • [A] : Notice of the Invention12-7
        • [A][1] : Timing12-7
        • [A][2] : Scope of Disclosure12-8
        • [A][3] : Good Practices12-9
      • [B] : Election to Retain Rights to the Invention12-9
      • [C] : Consequences of Failure to Provide Timely or Sufficient Notice or Election12-10
        • [C][1] : Insufficient Disclosure: Campbell Plastics12-10
        • [C][2] : Failure to Comply with Bayh-Dole Act As a Defense: T.M. Patents12-11
        • [C][3] : Good Practices12-12
      • [D] : Filing Patent Applications12-12
    • § 12:2.5 : Special Funding Agreement Requirements for Non-Profit Corporations12-13
  • § 12:3 : Retained Government Rights in Inventions Funded Under a Bayh-Dole Agreement12-13
    • § 12:3.1 : Non-Exclusive Government License12-14
      • [A] : Statutory Provision12-14
      • [B] : Potential Impact on Patented Drugs12-14
    • § 12:3.2 : March-In Rights: Federal Power to Use Privately Owned Bayh-Dole Act Patents to Make Inventions Publicly Available12-15
      • [A] : Statutory Provision12-15
      • [B] : Failure to Satisfy U.S. Manufacturing Requirements Could Trigger Use of March-In Rights12-16
      • [C] : Petitions to Exercise March-In Rights12-17
        • [C][1] : Product Still in Trials: In re CellPro12-17
        • [C][2] : High Prices: In re Norvir® and In re Xalatan®12-18
      • [D] : Failure of Prior Government Efforts to Support Research As a Means to Regulate Drug Prices12-19
      • [E] : Federal Abuse of March-in Rights Would Defeat Policy Behind Act12-19
    • § 12:3.3 : Additional Contractually Imposed Restrictions12-20
  • § 12:4 : Federal Employee Inventions12-20
  • § 12:5 : Ownership of Private Party-Government Employee Co-Inventions12-20
  • § 12:6 : Bayh-Dole Act Does Not Change the Substance of the Patent or Antitrust Laws12-21
  • § 12:7 : Licensing Federally Owned Inventions12-22
  • § 12:8 : Government Sale of Patent Rights12-24
  • § 12:9 : The Federal Technology Transfer Act12-24
Chapter 13: Antitrust, FTC, and State Competition Law
  • § 13:1 : Introduction13-3
  • § 13:2 : Sherman Act Claims13-4
    • § 13:2.1 : Elements of a Section 1 Claim13-4
      • [A] : Concerted Conduct13-4
      • [B] : Unreasonable Restraint of Trade13-5
      • [C] : Patent License Agreements13-7
        • [C][1] : Analysis of Specific Agreement Terms13-8
          • [C][1][a] : Royalty Rates13-8
          • [C][1][b] : Extending License Beyond Patent Term13-9
          • [C][1][c] : Resale Price Maintenance13-9
          • [C][1][d] : Extending License Beyond Patent Subject Matter13-10
          • [C][1][e] : Field of Use and Territory Restrictions13-10
          • [C][1][f] : No-Challenge Provisions13-10
      • [D] : Patent Litigation Settlement Agreements13-11
        • [D][1] : Importance of Settlement Agreements13-11
        • [D][2] : Importance of Patent Monopoly13-12
        • [D][3] : FTC/DOJ Reporting Requirement13-12
        • [D][4] : Analysis of Pharmaceutical Patent Litigation Settlements13-13
          • [D][4][a] : Federal Trade Commission v. Actavis, Inc.13-14
          • [D][4][b] : Post-Actavis Reverse Payment Cases13-15
            • [D][4][b][i] : Applying the Rule of Reason Under Actavis13-16
            • [D][4][b][ii] : Defining a Large and Unexplained Payment13-16
            • [D][4][b][iii] : Lawful Agreements13-18
            • [D][4][b][iv] : The Relevance of Patent Validity13-19
    • § 13:2.2 : Elements of a Section 2 Claim13-20
      • [A] : Relevant Market Definition13-21
      • [B] : Predatory Conduct Involving Patents13-23
        • [B][1] : Walker Process13-24
          • [B][1][a] : More Is Required to Prove a Walker-Process Claim than to Prove Inequitable Conduct13-24
          • [B][1][b] : Case Upholding Finding of Walker-Process Violation13-25
          • [B][1][c] : Case Reversing Finding of Walker-Process Violation13-26
        • [B][2] : Sham Patent Litigation13-26
          • [B][2][a] : The Noerr-Pennington Doctrine13-26
          • [B][2][b] : The Professional Real Estate Exception for Sham Litigation13-27
            • [B][2][b][i] : Grounds for Rejecting Sham Litigation Claims13-28
            • [B][2][b][ii] : Cases Addressing Sham Litigation Claims Based on Pharmaceutical Patent Litigation13-29
          • [B][2][c] : Application of Professional Real Estate to a Series of Related Cases13-31
        • [B][3] : Orange Book Listings13-32
          • [B][3][a] : Application of Noerr-Pennington13-32
          • [B][3][b] : Standard for Listing13-34
        • [B][4] : “Product Hopping”13-35
    • § 13:2.3 : Antitrust Injury Requirement13-38
      • [A] : Elements of Antitrust Injury13-39
      • [B] : Orange Book Listings13-40
    • § 13:2.4 : Antitrust Standing Requirement13-40
      • [A] : Factors Relevant to Standing13-41
      • [B] : Overcharges13-42
      • [C] : Suppliers13-42
      • [D] : Associations and Advocacy Organizations13-43
      • [E] : Standing in Walker-Process Cases13-43
  • § 13:3 : Related State-Law Causes of Action13-44
    • § 13:3.1 : State-Law Antitrust and Unfair Competition Claims13-44
      • [A] : Indirect Purchaser Claims13-44
      • [B] : Removal of Actions Asserting Claims Under State Law13-45
        • [B][1] : Misrepresentation of Patent Rights13-46
        • [B][2] : Agreement to Drop Invalidity Challenge13-47
        • [B][3] : Claims Based on Settlement Agreements13-47
      • [C] : Statutory Requirements13-48
        • [C][1] : Choice of Law13-48
        • [C][2] : Noerr-Pennington Applies to State Law Claims13-49
        • [C][3] : Application of Federal Precedents to Construe State Antitrust Laws13-49
    • § 13:3.2 : Unjust Enrichment13-50
      • [A] : Elements of State Law Unjust Enrichment Claim13-50
  • § 13:4 : Damages13-52
    • § 13:4.1 : Antitrust Damages13-52
      • [A] : Overcharges to Purchasers13-53
      • [B] : Indirect Purchasers13-53
      • [C] : Claims by Competitors13-54
      • [D] : Period for Calculating Damages13-54
    • § 13:4.2 : Disgorgement Remedy for Unjust Enrichment13-55
  • § 13:5 : Class Actions13-55
    • § 13:5.1 : Rule 23(a)13-55
      • [A] : Numerosity13-55
      • [B] : Commonality13-56
      • [C] : Typicality13-56
      • [D] : Adequacy13-57
        • [D][1] : Conflict of Interest13-57
        • [D][2] : Vigor13-59
    • § 13:5.2 : Rule 23(b)13-59
      • [A] : Inconsistency13-59
      • [B] : Type of Relief13-59
      • [C] : Predominance and Superiority13-59
        • [C][1] : Predominance13-59
        • [C][2] : Superiority13-61
    • § 13:5.3 : The Class Action Fairness Act of 200513-61
Chapter 14: Biologic and Biosimilar Drug Products
  • § 14:1 : Introduction14-2
  • § 14:2 : Biological Drug Product Defined14-3
  • § 14:3 : FDA Approval of “Follow-On Biologics” Before the BPCIA14-4
  • § 14:4 : The BPCIA14-5
    • § 14:4.1 : “Biosimilar” Drug Products14-5
    • § 14:4.2 : “Interchangeable” Biosimilar Drug Products14-6
    • § 14:4.3 : FDA Guidances on Biosimilar Drugs14-7
    • § 14:4.4 : BPCIA Exclusivity Provisions14-8
      • [A] : Reference Product Exclusivity14-8
        • [A][1] : Pediatric Exclusivity14-8
        • [A][2] : Orphan Drug Exclusivity14-9
      • [B] : Exclusivity for the First Interchangeable Biological Product14-9
    • § 14:4.5 : The “Purple Book”14-10
    • § 14:4.6 : BPCIA’s Patent Dispute Resolution Provisions14-11
      • [A] : Confidential Access to the Biosimilar Application and Manufacturing Information14-11
      • [B] : Patent Lists Relating to the Reference Product14-13
      • [C] : Patent Resolution Negotiations14-14
      • [D] : Patent Infringement Actions Based on Filing of a Biosimilar Application14-14
      • [E] : Remedies for Infringement14-16
      • [F] : Later Issued or Exclusively Licensed Patents14-18
      • [G] : Notice of Commercial Marketing and Preliminary Injunction Motions14-18
      • [H] : Limitation on Declaratory Judgment Actions14-19
  • § 14:5 : Litigation Under the BPCIA14-20
    • § 14:5.1 : Sandoz v. Amgen (Enbrel®)14-20
    • § 14:5.2 : Celltrion v. Kennedy Trust and Hospira v. Janssen (Remicade®)14-22
    • § 14:5.3 : Amgen v. Sandoz (Neupogen®)14-23
      • [A] : The District Court Decision14-24
      • [B] : The Federal Circuit Decision14-26
      • [C] : The Supreme Court Decision14-31
    • § 14:5.4 : Amgen v. Sandoz (Neulasta®)14-34
    • § 14:5.5 : Amgen v. Hospira (Epogen®)14-34
  • § 14:6 : Conclusion14-35
Appendix A: Glossary of Biotechnology Terminology from Case Law
Appendix B: Primer on Basic Biotechnology Concepts
Appendix C: The Science of Biosimilars
  Table of Authorities
  Index

  Please click here to view the latest update information for this title: Last Update Information  
 

Share
Email
UPKEEP SERVICE
Your purchase will also sign you up for “Upkeep Service,” whereby you will receive future automatic shipments of updates, new editions and supplements to this edition, as they become available, for a 30-day preview. Updates, new editions and supplements published within 90 days of your purchase will be issued free of charge; all other updates will be subject to an additional charge if kept beyond the preview period, invoiced at the time of delivery. This service will continue until canceled by you at any time. See here.
”With over 25 years’ experience, it’s no surprise [Kaye Scholer] hit such a home run. The book is clear, easy to read, thorough, thoughtful, and practical … In the final analysis, the book is a great addition to the library of any legal or business practitioner in the field, as well as for any government office. And it would make a great course book for any law school or continuing education class on the topic.”
F. Scott Kieff, Professor of Law, Washington University in St. Louis, in the New York Law Journal


  • FOLLOW PLI:
  • twitter
  • LinkedIn
  • GooglePlus
  • RSS

All Contents Copyright © 1996-2017 Practising Law Institute. Continuing Legal Education since 1933.

© 2017 PLI PRACTISING LAW INSTITUTE. All rights reserved. The PLI logo is a service mark of PLI.