Source: https://legacy.pli.edu/content/Treatise/Pharmaceutical_and_Biotech_Patent_Law_2018/_/N-4lZ1z140b4?ID=346966
Timestamp: 2019-05-22 09:31:40
Document Index: 144376139

Matched Legal Cases: ['Art5', '§ 5', '§ 5', '§ 5', '§ 5', '§ 5', '§ 5', '§ 5', '§ 5', '§ 5', '§ 5', '§ 5', 'Art5', 'Art?5', '§ 5', '§ 5', '§ 5', 'Art5', 'Art5', '§ 5', '§ 5', '§ 5', '§ 5', '§ 5', '§ 5', 'Art5', '§ 5', '§ 5', '§ 5', '§ 5', '§ 5', '§ 5', 'Art5', '§ 5', '§ 5', '§ 5', '§ 5', '§ 5', '§ 5', '§ 5', 'Art5', 'Art5', '§ 5', '§ 5', '§ 5', '§ 5', '§ 5', '§ 5', '§ 5', '§ 5', '§ 5', '§ 5', '§ 5', '§ 5', '§ 5', '§ 7', '§ 7', '§ 7', '§ 7', '§ 7', '§ 7', '§ 7', '§ 7', '§ 7', '§ 7', '§ 7', '§ 7', '§ 7', '§ 7', '§ 7', '§ 7', '§ 7', '§ 7', '§ 7', '§ 7', '§ 7', '§ 7', '§ 7', '§ 7', '§ 7', '§ 7', '§ 7', '§ 7', 'arty7', '§ 7', '§ 7', '§ 7', '§ 7', '§ 7', '§ 7', '§ 7', '§ 103', '§ 7', '§ 7', 'Art7', 'Art7', '§ 7', '§ 8', '§ 8', '§ 8', '§ 8', '§ 271', '§ 8', '§ 8', '§ 8', '§ 8', '§ 8', '§ 8', '§ 8', '§ 8', '§ 8', '§ 8', '§ 8', '§ 8', '§ 8', '§ 8', '§ 8', '§ 355', '§ 8', '§ 8', '§ 8', '§ 8', '§ 8']

PLI: Treatises - Pharmaceutical and Biotech Patent Law (2019 Edition)
Pharmaceutical and Biotech Patent Law (2019 Edition)
ISBN Number: 9781402431388
[C] : PrometheusIII and IV3-20
[C] : Enablement of Obvious Teaching Required5-75
[A] : Analogous Art5-79
[B] : Defining the Problem5-80
[B] : Commercial Success5-92
[B][1] : General Rule5-92
[B][2] : Application to Pharmaceutical Patents5-94
[C] : Licensing5-97
[C][1] : General Rule5-97
[D][2] : Application to Pharmaceutical Patents5-99
[E][2] : Application to Pharmaceutical Patents5-100
§ 5:4 : Written Description5-101
§ 5:4.1 : Statutory Provision: Section 1125-101
[A] : Written Description Is a Separate Requirement5-101
[C] : Written Description Requirement Applies to Priority Determinations and to Adequacy of Original Disclosure5-103
[C][1] : Later Claims and Later Applications5-103
[C][2] : Unsupported Original Claims5-104
§ 5:4.2 : The Requirement5-104
[A] : The Purpose of the Requirement5-104
[B] : The Standard Set Forth by the Federal Circuit5-105
[B][1] : Basic Test5-105
[B][2] : Predictability and Other Factors5-106
[B][3] : Acceptable Forms of Description5-107
[B][4] : Fact Determination5-109
[C] : Conception and Written Description5-110
§ 5:4.3 : Genus and Species5-111
[A] : Claim Scope Must Correspond to Disclosure: Gentry Gallery5-111
[A][1] : Limiting Gentry5-112
[A][2] : Applying Gentry5-113
[C] : Genus Based on Disclosed Species or Examples5-114
[D] : Genus Based on Generic Description5-116
[E] : Range Cases5-117
[F] : Negative Limitations5-118
[G] : Unclaimed Optional Features5-119
§ 5:4.5 : Application to Particular Inventions5-121
[A] : Compound and Composition Claims5-121
[B] : DNA5-122
[B][1] : General Rule5-122
[B][2] : Deposits5-124
[B][3] : Genus Claims5-124
[B][4] : Possession of Polypeptides5-126
[C] : Antibodies5-127
[D] : Other Biological Material5-128
§ 5:5 : Enablement5-128
§ 5:5.1 : Statutory Provision: Section 1125-128
§ 5:5.2 : The Policy Behind Enablement5-129
§ 5:5.3 : Enablement: Question of Law5-129
§ 5:5.4 : Role of the Specification5-130
[A] : General Principles5-130
[B] : Means-Plus-Function Claims5-132
§ 5:5.5 : The Person Skilled in the Art5-132
[A] : Who Is the Person Skilled in the Art?5-132
[B] : What General Knowledge Does the Person Skilled in the Art Possess?5-133
[C] : Time Frame for Determining Enablement5-134
[C][1] : Enablement Measured As of Filing Date5-134
[C][2] : Using Post-Filing References to Show State of the Art at Filing5-134
[C][3] : Nascent Technology Must Be Disclosed5-135
[C][4] : Loss of Material Needed to Practice Invention5-136
§ 5:5.6 : Requirements for Enablement5-137
[A] : How to Make the Claimed Invention5-137
[A][1] : Compound and Composition of Matter Claims5-138
[A][2] : Method of Use Claims5-138
[B] : How to Use the Claimed Invention5-140
[B][1] : Practical Utility5-140
[B][2] : Satisfying the How to Use Requirement5-141
[B][3] : Inoperability May Negate Enablement5-142
§ 5:5.7 : Enabling the Full Scope of the Claim5-143
§ 5:5.8 : No Enablement If Undue Experimentation Required5-146
[A] : Undue Experimentation: The Wands Factors5-146
[A][1] : Quantity of Experimentation Needed5-147
[A][2] : Direction or Guidance Provided/Working Examples and Teaching Away5-149
[A][3] : Nature of the Invention/State of Prior Art/Level of Skill in the Art5-151
[A][4] : Predictability in the Art5-151
[A][5] : Breadth of the Claim5-152
[B] : Routine Experimentation Is Allowed5-153
§ 5:5.9 : Use of Deposits to Satisfy Enablement5-153
§ 5:6 : Best Mode5-155
§ 5:6.1 : Overview5-155
[A] : Statutory Provision: Section 1125-155
[B] : AIA’s Elimination of Best Mode As Grounds for Invalidity or Unenforceability5-156
§ 5:6.2 : Purpose of the Best Mode Requirement5-157
§ 5:6.3 : Best Mode Distinguished from Enablement5-158
§ 5:6.4 : Best Mode: A Two-Prong Inquiry5-158
[A] : Subjective Inquiry: Did the Inventor Contemplate a Best Mode?5-159
[A][1] : Evidence of Inventor Preference5-159
[A][2] : Alternative Embodiments Does Not Mean There Is a Best Mode5-160
[A][3] : Relevance of Inventor’s Intent to Conceal5-161
[A][4] : Intentional Concealment—Inequitable Conduct5-161
[A][5] : Assignees5-162
[B] : Objective Inquiry: Was the Best Mode Disclosed?5-162
[B][1] : Scope of Claimed Invention5-162
[B][2] : Adequacy of Disclosure5-164
[B][2][a] : Enablement5-164
[B][2][b] : Disclosure That Mode Is Preferred5-164
[B][3] : Relevance of Prior Art5-165
[B][4] : Starting Materials5-165
[B][5] : Routine Features Need Not Be Disclosed5-166
[B][6] : Mode of Commercial Production5-166
[B][7] : Disclosure of Special Materials or Identity of Supplier of Material5-167
§ 5:6.5 : Timing5-168
[A] : Filing an Original Application5-168
[B] : Continuation and Continuation-in-Part Applications5-169
[B][1] : Foreign Priority Applications5-169
§ 5:6.6 : Application to Pharmaceutical Patents5-170
[A] : Public Deposit of Biological Materials5-170
[B] : Claims to Pharmaceutical Compounds5-171
[B][1] : Clinical Data5-171
[B][2] : Synthesis of Intermediates Used to Make Claimed Compounds5-171
[B][3] : Purification of Claimed Compound5-172
§ 5:7 : Indefiniteness and the Requirement to Claim the Invention5-173
§ 5:7.1 : Statutory Provision: Section 1125-173
§ 5:7.2 : The Requirements5-173
[A] : Must Claim What Applicant Regards As the Invention5-173
[A][1] : During Prosecution5-173
[A][2] : Issued Patents5-173
[B] : Indefiniteness5-174
[B][1] : Evolution of the Standard for Indefiniteness5-175
[B][2] : Standard of Proof5-178
[B][3] : Role of the Jury5-179
[B][4] : Standard of Review5-179
[B][5] : Dependent Claims5-180
§ 5:7.3 : Relationship of Indefiniteness to Other Determinations5-180
[A] : Indefiniteness and Claim Construction5-180
[B] : Indefiniteness and Infringement5-181
[C] : Indefiniteness Separate from Enablement5-182
[D] : Indefiniteness and Prior Art5-182
§ 5:7.4 : Indefiniteness in Different Situations5-183
[A] : Terms of Degree5-183
[B] : Patent Does Not Identify Test to Measure Claimed Property5-185
[B][1] : Examples of Claims Found Indefinite5-185
[B][1][a] : Leading Example: Honeywell International v. International Trade Commission5-185
[B][1][b] : Other Examples5-186
[B][2] : Examples of Claims Found Definite5-186
[B][2][a] : Leading Example: PPG Industries, Inc. v. Guardian Industries Corp.5-186
[B][2][b] : Other Examples5-187
[C] : Single Claim to Both Method and Apparatus Indefinite5-187
[D] : Claims Requiring Knowledge or Intent5-190
[E] : Means-Plus-Function Claims5-190
[F] : Drafting Errors in Claim Language5-191
[F][1] : Claims Found Indefinite5-192
[F][2] : Claims Not Found Indefinite5-192
[F][3] : Lack of Antecedent Basis5-192
§ 5:8 : Double Patenting5-193
§ 5:8.1 : Two Forms of Double Patenting: Statutory and Non-Statutory5-193
§ 5:8.2 : The Policy Behind Double Patenting5-194
[A] : Policy Prior to URAA5-195
[B] : Continued Applicability of Obviousness-Type Double Patenting Post-URAA5-196
§ 5:8.3 : Double Patenting Requires Common Inventorship or Ownership5-196
§ 5:8.4 : Situations in Which Double Patenting May Arise5-197
[A] : Prosecution, Reexamination, and Post-Issuance5-197
[B] : Later Issuing, Earlier Expiring Reference Patent5-197
[C] : Claims Canceled After Issuance May Still Be Reference Claims5-198
§ 5:8.5 : Non-Statutory Double Patenting5-199
[A] : Anticipation and Obviousness5-199
[B] : Genus and Species5-200
[C] : The Test for Double Patenting5-201
[C][1] : Two-Part Test5-201
[C][2] : Limited Use of the Specification5-202
[C][3] : Use of Prior Art5-203
[C][4] : Use of Post-Filing-Date Art5-204
[C][5] : Claim-by-Claim Analysis5-205
[D] : Who Is the Same Person for Purposes of Double Patenting?5-205
[E] : Curing Double Patenting by Filing Terminal Disclaimers5-206
[E][1] : Effect of Filing a Terminal Disclaimer5-206
[E][2] : Need for Common Ownership of Patent and Its Reference Patent5-207
[E][3] : The Timing of a Terminal Disclaimer Filing5-208
[E][4] : Effect of a Terminal Disclaimer on a Patent Term Extension5-210
[E][5] : Effect of a Terminal Disclaimer on a Patent Term Adjustment5-212
[E][6] : Effect of a Disclaimer of Claims5-212
[F] : The Two-Way Double Patenting Test5-213
[F][1] : Requirements to Qualify for the Two-Way Test5-213
[F][2] : Satisfying the Two-Way Test5-214
[G] : Overlapping Claims5-214
§ 5:8.6 : Safe Harbor Provision Involving Double Patenting5-214
[A] : The Safe Harbor Requires a Prior Restriction by the Examiner5-215
[B] : The Safe Harbor Requires Consonance Between the Restriction Requirement and the Later Claims in the Later Application5-215
[C] : The Safe Harbor Requires Filing of a Subsequent Application Denominated a “Divisional”5-217
§ 5:8.7 : Double Patenting Issues in Pharmaceutical Patents5-219
[A] : Method Patents over Prior Compound Patents5-219
[B] : Examples5-219
§ 5:9 : Inequitable Conduct5-223
§ 5:9.1 : Introduction5-223
§ 5:9.2 : Inequitable Conduct Requires Proof of Materiality and Intent5-225
§ 5:9.3 : The Materiality Requirement5-225
[A] : Standard for Materiality Before Therasense5-225
[B] : The Materiality Standard Under Therasense5-227
§ 5:9.4 : The Intent Requirement5-228
[A] : Actual Intent Required; Negligence Not Enough5-228
[B] : There Must Be a Specific Intent to Deceive5-229
[C] : The Intent Requirement Under Therasense5-229
[C][1] : Proving Intent Before Therasense5-230
[C][1][a] : Ferring B.V. v. Barr Laboratories, Inc.5-230
[C][2] : Proving Intent After Therasense5-232
[C][3] : Whether the Actual Intent Standard Requires That at Least One Individual Have the Requisite Culpable State of Mind5-233
§ 5:9.5 : Categories of Inequitable Conduct5-233
[A] : References5-233
[A][1] : Non-Disclosed References5-233
[A][2] : References Before the Examiner5-233
[A][3] : Disclosure Only of Abstracts5-234
[A][4] : Potential Double-Patenting References5-235
[A][5] : Argument About a Reference5-235
[B] : Descriptions of Data and Experiments5-235
[C] : Representations Regarding Inventorship5-237
[D] : Related Proceedings5-237
[D][1] : Related Patent Office Proceedings5-237
[D][2] : Related Litigations5-238
[E] : Miscellaneous Types of Inequitable Conduct5-239
[E][1] : Application for Expedited Treatment5-239
[E][2] : Payment of Maintenance Fees5-239
[E][3] : Disclosure of Relationships Between Declarant and Applicant5-240
[E][4] : Notes About a Presentation5-240
[E][5] : Concealment of Best Mode5-241
[E][6] : Litigation Misconduct5-241
§ 5:9.6 : Late and Corrected Disclosures5-241
[A] : Late Disclosures5-241
[B] : Correcting a Disclosure During Prosecution5-241
[C] : Disclosure in Reissue Proceedings5-243
§ 5:9.7 : Practical Problems in Pharmaceutical Patent Prosecution5-243
§ 5:9.8 : Practical Advice for Defeating Inequitable Conduct Allegations5-245
[A] : Disclosure of References5-245
[B] : Disclosure of Experimental Details5-246
[C] : Disclosure of Experimental Data5-247
[D] : Care in Patent Prosecution5-247
§ 5:9.9 : The Legal Effect of a Finding of Inequitable Conduct5-248
[A] : Inequitable Conduct Renders a Patent Unenforceable5-248
[B] : Inequitable Conduct May Result in Assessment of Attorneys’ Fees5-248
[C] : Inequitable Conduct May Have Antitrust Consequences5-249
§ 5:9.10 : Procedural Aspects5-249
[A] : Inequitable Conduct Is an Issue of Equity Decided by the Court, Not a Jury5-249
[B] : Standard of Review5-250
[A][2][b][i] : Pre-KSR Federal Circuit Decisions7-27
[A][2][b][ii] : Post-KSR Federal Circuit Decisions7-34
§ 7:2.4 : Stereoisomers, Enantiomers, and Diastereomers7-80
[A] : Introduction7-80
§ 7:2.5 : Polymorphs7-92
[A] : What Is a Polymorph?7-92
[B] : Techniques for Identifying Polymorphs7-94
[B][1] : X-Ray Powder Diffraction7-94
[B][2] : Single Crystal X-Ray Crystallographic Analysis7-94
[B][3] : Infrared Absorption Analysis7-94
[C] : Infringement7-95
[C][1] : Evidentiary Issues7-95
[C][2] : Quantity Required7-97
[C][3] : Conversion7-99
[C][4] : Claim Construction7-101
[D] : Validity7-101
[D][1] : Inherent Anticipation7-101
[D][2] : On-Sale Bar7-102
§ 7:2.6 : Pharmaceutical Salts of Active Ingredients7-103
[A] : What Is a Salt?7-103
[B] : Development of Pharmaceutical Salts7-103
[C] : Patentability of New Salts7-104
[C][1] : Determinations of Obviousness/Nonobviousness of New Salt Forms of Compounds7-104
[C][2] : Most Common Salt Form Used for Known Active Found Obvious in Obviousness-Type Double Patenting Analysis7-109
§ 7:2.7 : Infringement by Conversion to a Patented Form7-110
[A] : In Vivo Conversion7-111
[A][1] : Claim Construction7-111
[B] : Infringement and Anticipation7-113
[B][1] : Schering v. Geneva7-113
[B][2] : Pre-Schering District Court Decisions7-114
[B][2][a] : Marion Merrell Dow7-115
[B][2][b] : Omeprazole7-116
[B][2][c] : Buspirone7-118
[C] : Conversion Outside the Body: Polymorphic Form Conversion7-119
§ 7:2.8 : Particle Size of Active Ingredient7-120
[A] : What Is Particle Size?7-120
[B] : Infringement of Particle Size Patents7-121
[B][1] : Measured on the API Raw Material or in the Formulation7-121
[B][2] : Infringement of Particle Size Patents in Hatch-Waxman Cases7-123
[B][3] : Method of Measurement7-124
[B][4] : Infringement Under the Doctrine of Equivalents7-125
[C] : Validity7-125
[C][1] : Obviousness7-125
[C][2] : Written Description7-126
§ 7:3 : Pharmaceutical Formulations7-127
§ 7:3.1 : What Is a Pharmaceutical Formulation?7-127
§ 7:3.2 : Claim Construction Issues7-133
[A] : “Solubilizer” Limited to Surfactants7-133
[B] : “Lipophilic Component” Construed to Include More Than Surfactants7-134
[C] : Claim Not Limited to Particular Grade of an Excipient7-134
[D] : Purity Limitations7-135
[E] : “Hydrosol” Limited to “Medicinal Preparation”7-135
[F] : “Saccharides” Includes “Polysaccharides”7-136
§ 7:3.3 : Literal Infringement and Infringement Under the Doctrine of Equivalents7-137
[A] : Using Different Excipients7-138
[A][1] : Non-Equivalence7-138
[A][2] : Equivalence7-139
[A][3] : Prosecution History Estoppel7-139
[B] : Controlled Release Formulations: Foreseeability of Substitution7-139
[B][1] : Prosecution History Estoppel Bars Equivalence7-139
[B][2] : No Prosecution History Estoppel7-140
[C] : Controlled Release Formulations: Prosecution History Estoppel7-141
[D] : Infringement by Equivalents: No Dedication of Equivalent Excipient7-142
§ 7:3.4 : Patent Validity7-144
[A] : Obviousness7-144
[A][1] : Combinations of Excipients7-144
[A][2] : Combination Therapies7-145
[A][2][a] : Obvious Combination7-146
[A][2][b] : Nonobvious Combination7-146
[A][3] : Pharmacokinetic/Pharmacodynamic Limitations7-147
[B] : Written Description7-148
[C] : Enablement7-149
§ 7:3.5 : Bibliography of Pharmaceutical Formulation Treatises and Texts7-149
§ 7:4 : Method of Treatment7-150
§ 7:4.1 : What Is a Method of Treatment Claim?7-150
§ 7:4.2 : Patentability of Method of Treatment Claims7-151
§ 7:4.3 : Conception7-153
§ 7:4.4 : Claim Construction Issues7-153
[A] : Preambles7-153
[A][1] : Preambles Can Be Limiting7-154
[A][2] : Construing Preambles in Method of Treatment Claims7-154
[A][3] : Adding Method of Treatment Preamble Language by Amendment Can Render Preamble Limiting7-155
[B] : Specific Claim Terms7-156
[B][1] : “Treat”7-156
[B][2] : “Effective Amount”7-157
[B][3] : “Co-Administration”7-157
§ 7:4.5 : Anticipation and Obviousness7-158
[A] : Inherent Anticipation7-158
[A][1] : Examples of Inherency7-158
[A][2] : Examples of No Inherency7-162
[B] : Prior Art Need Not Disclose Efficacy to Anticipate7-164
[C] : Obviousness7-165
[C][1] : Methods of Using New Compounds7-165
[C][2] : New Methods of Using Old Compounds7-166
[C][3] : Genus of Methods of Treatment Could Render Included Species Obvious7-166
[C][4] : Instructional Limitations7-167
§ 7:4.6 : Written Description7-168
[A] : Examples of Method of Treatment Cases Involving Written Description7-168
[B] : Field of Use Claim7-168
[C] : Dosing7-169
§ 7:4.7 : Enablement7-169
[A] : Compound Needed to Practice Claim Must Be Enabled7-169
[B] : Dosing7-170
§ 7:4.8 : Best Mode7-171
§ 7:4.9 : Infringement7-171
[A] : Suing the Maker of the Therapeutic: Indirect Infringement7-171
[B] : Suing on Method of Treatment Claims Against an ANDA Defendant7-171
§ 7:5 : Pharmaceutical Manufacturing7-172
§ 7:5.1 : Intermediates7-173
[A] : Definition and Purpose7-173
[B] : Utility Required7-173
§ 7:5.2 : Product-By-Process Claims7-176
[A] : Definition and Purpose7-176
[B] : Construction of Product-By-Process Claims7-177
[B][1] : Patent Office Examination of Pending Product-By-Process Claims7-177
[B][2] : Construction of Issued Product-By-Process Claims in Patent Infringement Litigation7-178
§ 7:5.3 : Process Claims7-181
[A] : Definition and Purpose7-181
[B] : Patentability of Process Claims7-181
[C] : Biotechnological Processes7-182
§ 7:6 : Nucleic Acid Patents7-183
§ 7:6.1 : The Promise of Genomics7-183
[A] : First Recombinant DNA Organism7-183
[B] : Cellular Factors for Making Proteins7-183
[C] : Genetic Basis of Disease7-184
[D] : Gene Therapy7-184
[E] : Our Expanding Knowledge of Genes7-185
[F] : Biotechnology Patents7-186
§ 7:6.2 : Eligibility of Nucleic Acid Sequences for Patenting7-187
[A] : Product of Nature Exception to Patentability7-187
[A][1] : Patentability of Man-Made Living Organisms: Diamond v. Chakrabarty7-188
[A][2] : Purified and Isolated (prior to Myriad)7-189
[A][2][a] : Kuehmsted v. Farbenfabriken of Eberfield7-190
[A][2][b] : Merck & Co. v. Olin Mathieson7-190
[B] : Cases Suggesting Natural DNA Sequences Not Patentable (prior to Myriad)7-191
[B][1] : Funk Bros. v. Kalo7-192
[B][2] : General Electric v. De Forest Radio Co.7-193
§ 7:6.3 : Utility Requirement for Nucleic Acid Patents7-194
[A] : PTO Board of Patent Appeals Decisions7-195
[B] : The PTO’s Utility Examination Guidelines and Training Materials7-197
[B][1] : The 1995 Utility Guidelines7-197
[B][2] : The 1999 Revised Utility Guidelines7-198
[B][3] : The 2001 Utility Guidelines7-199
[B][4] : The Utility Guidelines Training Materials7-199
[B][4][a] : “Specific” Utility7-200
[B][4][b] : “Substantial” Utility7-200
[B][4][c] : “Credible” Utility7-200
[B][4][d] : “Well-Established” Utility7-201
[B][5] : The Nucleic Acid Examples of the Training Materials7-201
[B][5][a] : “DNA Fragments”7-201
[B][5][b] : “DNA Fragment Encoding a Full Open Reading Frame (ORF)”7-202
[C] : Expressed Sequence Tags and Single Nucleotide Polymorphs7-203
§ 7:6.4 : Written Description of Nucleic Acids7-204
[A] : Satisfying the Written Description Requirement7-205
[A][1] : Amgen, Inc. v. Chugai Pharmaceutical Co.7-205
[A][2] : Fiers v. Revel7-207
[B] : Heightened Written Description Requirement for Biotechnology and DNA Sequence Patents?7-207
[B][1] : Regents of University of California v. Eli Lilly & Co.7-207
[B][2] : Enzo Biochem, Inc. v. Gen-Probe, Inc. (Enzo I)7-209
[B][3] : Enzo Biochem, Inc. v. Gen-Probe, Inc. (Enzo II)7-210
[B][4] : Amgen, Inc. v. Hoechst Marion Roussel, Inc.7-212
[B][5] : University of Rochester v. G.D. Searle & Co.7-213
[C] : Practical Implications of the Federal Circuit’s Written Description Jurisprudence7-216
§ 7:6.5 : Other Grounds for Invalidity of Nucleic Acid Inventions7-218
[A] : Anticipation7-218
[B] : Obviousness7-219
[B][1] : Amino Acid Sequences7-219
[B][2] : Nucleic Acid Sequences7-219
[B][2][a] : Post-KSR7-219
[B][2][b] : Pre-KSR7-220
[C] : Indefiniteness7-221
[D] : Enablement7-221
[E] : Best Mode7-222
[F] : Inventorship and Conception7-222
§ 7:6.6 : Claim Construction of Nucleic Acid Claims7-223
§ 7:7 : Antibodies7-226
§ 7:7.1 : What Is an Antibody?7-226
[A] : Introduction7-226
[B] : Monoclonal Antibodies7-227
[C] : Commercial Applications for Antibodies7-229
§ 7:7.2 : Obviousness7-230
[A] : Monoclonal Antibodies7-230
[B] : Sandwich Assay7-231
[C] : 35 U.S.C. § 103(b)7-231
§ 7:7.3 : Written Description7-232
[A] : Describing Antibodies by Describing Their Target7-232
[A][1] : Overview of Written Description Requirement7-232
[A][2] : Antibodies and DNA7-233
[A][3] : Requirement for Describing the Antigen7-234
[B] : Describing Antibodies in Terms of Their Corresponding DNA or Amino Acid Sequences7-235
[B][1] : Describing Antibodies in Terms of Previously Known Sequences7-235
[B][2] : Describing Antibody Genus in Terms of Amino Acid Sequences7-236
[C] : Chimeric Antibodies: Chiron v. Genentech7-237
§ 7:7.4 : Enablement7-238
[A] : Enablement Supported by the Prior Art7-238
[A][1] : Evidence of Enablement from the Prior Art7-238
[A][2] : Enablement Based on Level of Skill in the Art: No Undue Experimentation7-238
[B] : Failed Attempts Do Not Necessarily Show Lack of Enablement7-239
[C] : Nascent Technology7-239
§ 7:7.5 : Claim Construction7-241
[A] : Chimeric and Humanized Antibodies7-241
[B][2] : “under Section 505(j) . . . or described in Section 505(b)(2)”8-29
[B][3] : “for a drug claimed in a patent or the use of which is claimed in a patent”8-30
[B][3][a] : “drug claimed in a patent”8-30
[B][3][a][i] : Patents on Different Formulations8-30
[B][3][a][iv] : Patents on Different Polymorphs8-31
[B][3][b] : “or the use of which is claimed in a patent”8-32
[C] : The Section 271(e)(2) Infringement Analysis8-36
[C][1] : Similarities to Standard Infringement Actions8-36
[C][2][c] : Determining Infringement Based on ANDA8-38
[C][2][e] : Determining Infringement for Method Claims8-40
§ 8:1.5 : Procedural Considerations in ANDA Litigation8-40
[A] : Parties, Jurisdiction, and Venue8-40
[A][1] : Proper Plaintiff8-40
[B] : Pretrial Proceedings8-44
[C] : No Jury Trial8-44
§ 8:1.6 : Thirty-Month Litigation Stay Preventing Launch of Generic8-44
[A] : Orange Book Listing Is Prerequisite to Thirty-Month Stay8-45
[B] : Beginning of the Thirty-Month Stay8-46
[B][1] : Calculated from Receipt of Notice8-46
[B][2] : The Forty-Five-Day Window8-46
[C] : Adjustment of Thirty-Month Stay8-46
[D] : Termination of Thirty-Month Stay8-47
[D][1] : Judgment of Non-Infringement, Invalidity or Unenforceability8-47
[D][2] : Effect of Settlement8-48
§ 8:1.7 : Remedies8-49
[A] : Order Precluding FDA Approval of ANDA Until Patent Expiration8-49
[B] : Injunctive Relief8-49
[C] : Damages Only upon Commercial Sales of Infringing Product8-50
[D] : Attorney Fees8-50
[D][1] : Statutory Provisions: Sections 271(e)(4) and 2858-50
[D][2] : Factors for Determining Exceptional Case8-51
[D][3] : Hatch-Waxman Act Exceptional Case Litigation8-51
[D][3][a] : Baseless Certification8-51
[D][3][b] : Willfulness8-53
[D][3][c] : Opinions by Patent Counsel8-55
[D][3][d] : Attorney Fees Sought by ANDA Filer Based on Allegation of Baseless Suit by Patentee8-56
§ 8:1.8 : Exemption from Infringement for Activities Related to FDA Submission8-57
[A] : Statutory Provision: 35 U.S.C. § 271(e)(1)8-57
[B] : Affirmative Defense?8-57
[C] : Policy Behind Enactment of the Exemption8-58
[D] : Situations in Which the Exemption Is Adjudicated8-60
[E] : Statutory Ambiguities8-61
[F] : Scope of the Statutory Exemption: “Under a Federal Law . . . ”8-61
[F][1] : Exemption Covers Class III Medical Devices8-61
[F][2] : Exemption Covers Class II Medical Devices8-62
[G] : The “Solely for Uses Reasonably Related to” Requirement8-63
[G][1] : “reasonably related”8-63
[G][1][a] : Supreme Court Weighs In: Merck v. Integra8-63
[G][1][b] : Post-Merck v. Integra8-64
[G][1][c] : Pre-Merck v. Integra8-65
[G][2] : “solely”8-67
[G][3] : Post-Product-Approval Activity8-68
[G][4] : Examples8-69
[G][4][a] : Exempt Activities8-69
[G][4][b] : Non-Exempt Activities8-70
[H] : Third-Party Support of Section 271(e)(1) Activity8-71
[I] : Abuse of Regulatory Review Process8-72
[J] : The Use of Research Tools Under Section 271(e)(1)8-73
§ 8:2 : The First Paragraph IV Applicant’s 180-Day Exclusivity8-74
§ 8:2.1 : Introduction8-74
§ 8:2.2 : Basic Statutory Provision: Section 355(j)(5)(B)(iv)8-75
§ 8:2.3 : Only the “First Applicant” Is Entitled to Exclusivity8-75
[A] : First ANDA with a Paragraph IV Certification for Any Patent8-75
[B] : “Substantially Complete” ANDA8-75
[C] : “Contains and Lawfully Maintains” a Paragraph IV Certification8-76
§ 8:2.4 : Exclusivity Is Against Subsequent Paragraph IV ANDAs for Same Drug8-77
[A] : No Exclusivity Against Authorized Generics8-78
[B] : No Exclusivity Unless Subsequent ANDA Contains Paragraph IV Certification8-78
§ 8:2.5 : Exclusivity Period Begins Only upon First Applicant’s “Commercial Marketing”8-78
§ 8:2.6 : “Forfeiture” of 180-Day Exclusivity8-79
[A] : “Failure to Market”8-80
[B] : First Filer’s ANDA Is Withdrawn or Rejected8-81
[C] : First Filer’s ANDA Is Not “Tentatively Approved” Within Thirty Months8-81
[D] : All Challenged Patents Have Expired8-82
[E] : First Applicant Withdraws All Paragraph IV Certifications8-82
[F] : Collusive Agreement8-83
§ 8:2.7 : 180-Day Exclusivity Under the Pre-MMA Hatch-Waxman Act8-83
[A] : Pre-MMA Statutory Text8-83
[B] : Exclusivity for Pre-MMA ANDAs8-84
[B][1] : “patent-by-patent” Exclusivity8-84
[B][2] : “shared” Exclusivity8-86
[C] : When Does 180-Day Period Begin?8-87
[C][1] : “first commercial marketing”8-87
[C][2] : “a decision of a court . . . holding”8-87
[C][2][a] : What “Holding”?8-87
[C][2][b] : What Parties?8-88
[C][2][c] : What Products?8-88
[C][2][d] : What Court?8-88
[D] : Loss of Exclusivity8-89
§ 8:2.8 : Waiver and Transfer of Exclusivity8-89
§ 8:3 : “Data” Exclusivity Under the FD&C Act8-90
§ 8:3.1 : Introduction8-90
§ 8:3.2 : New Chemical Entity Exclusivity8-90
[A] : Statutory Basis: Section 355(c)(3)(E)(ii) and Section 355(j)(5)(F)(ii)8-90
[B] : Eligibility Criteria for NCE Exclusivity8-91
[B][1] : “Active Ingredient” Means “Active Moiety”8-91
[B][2] : Novel Combinations8-92
[B][3] : New Forms of Previously Approved Ingredients8-94
[B][3][a] : Polymorphs8-94
[B][3][b] : Stereoisomers8-94
[C] : Extra Exclusivity for Certain New Antibiotics8-95
§ 8:3.3 : “Other Significant Changes” Exclusivity8-95
[A] : Statutory Basis: Section 355(j)(5)(F)(iii) and(iv)8-95
[B] : Eligibility Criteria for OSC Exclusivity8-96
[B][1] : “new clinical investigations”8-96
[B][2] : “conducted or sponsored by the applicant”8-96
[B][3] : “essential to approval”8-96
[C] : “Carve-Out” Option for ANDAs8-97
§ 8:3.4 : “Orphan Drug” Exclusivity8-98
[A] : Statutory Basis: Sections 360aa–360cc8-98
[B] : “Orphan Drug” Eligibility Criteria for Exclusivity8-98
[C] : Scope of Orphan Drug Exclusivity8-99
[C][1] : “same drug”8-99
[C][1][a] : “same” Structure8-99
[C][1][b] : “same” Clinical Performance8-100
§ 8:3.5 : Pediatric “Exclusivity”8-100
[A] : Statutory Basis: 21 U.S.C. § 355a8-100
[B] : Eligibility for Pediatric Exclusivity8-101
[C] : Interim Extension8-102
[D] : Label Revision Not Required8-102
[E] : Scope of Pediatric Extension8-103
[E][1] : Extension of Data-Based Exclusivity8-103
[E][2] : Extension of Patent Protection8-103
§ 8:4 : Patent Term Restoration8-105
§ 8:4.1 : Introduction8-105
§ 8:4.2 : Eligibility for Patent Term Restoration8-107
[A] : Threshold Requirement8-107
[B] : Five Conditions for Extension Eligibility8-108
[C] : The “First Permitted Commercial Marketing or Use of the Product”8-109
[C][1] : Need Not Be the First Product Covered by the Patent to Receive Regulatory Approval8-109
[C][2] : Patent Cannot Merely Claim a New Formulation of a Previously Approved Active Ingredient8-110
[C][3] : Patent Cannot Claim an Active Ingredient if Any Salt or Ester of That Active Ingredient Has Been Previously Approved8-110
[C][4] : Patent Cannot Claim Combination of Two Previously Approved Drugs8-111
[D] : Section 156 and the Uruguay Round Agreements Act8-112
§ 8:4.3 : Scope of Protection During Restoration Period8-113
[A] : The Scope of Protection During the Extension Period8-113
§ 8:4.4 : Mechanics of Patent Term Restoration8-116
[A] : Application for a Patent Term Restoration8-116
[B] : Roles of PTO and FDA in Handling Patent Term Restoration Applications8-117
[C] : Interim Extensions8-118
[B][4][b][i] : Applying the Rule of Reason Under Actavis13-16
[B][4][b][ii] : Defining a Large and Unexplained Payment13-16
[B][4][b][iii] : Lawful Agreements13-18
[B][4][b][iv] : The Relevance of Patent Validity13-19