i Table of contents 369

Life Sciences and Pharma IP Litigation 2025

Definitive global law guides offering comparative analysis from top-ranked lawyers

INTRODUCTION		5
Contributed by Nicola Dagg, Daniel Lim, Jin Ooi and Alex Magnusdottir, Kirkland & Ellis International LLP		5
AUSTRALIA		10
Trends and Developments		10
Contributed by Maddocks		10
BRAZIL		18
Law and Practice		18
Contributed by Montaury Pimenta, Machado & Vieira de Mello		18
Trends and Developments		42
Contributed by Licks Attorneys		42
CHINA		51
Law and Practice		51
Contributed by Fangda Partners		51
Trends and Developments		72
Contributed by LeanWill Law Firm		72
GERMANY		82
Law and Practice		82
Contributed by Hoffmann Eitle		82
Trends and Developments		104
Contributed by Hoffmann Eitle		104
INDIA		113
Trends and Developments		113
Contributed by Anand and Anand Advocates		113
ISRAEL		121
Law and Practice		121
Contributed by Gilat, Bareket & Co, Reinhold Cohn Group		121
ITALY		144
Law and Practice		144
Contributed by Trevisan & Cuonzo		144
JAPAN		168
Law and Practice		168
Contributed by Ohno & Partners		168
Trends and Developments		182
Contributed by Nagashima Ohno & Tsunematsu		182
MEXICO		190
Trends and Developments		190
Contributed by Calderón & De La Sierra		190
NORWAY		195
Law and Practice		195
Contributed by Wikborg Rein Advokatfirma AS		195
Trends and Developments		210
Contributed by Advokatfirmaet Thommessen AS		210
POLAND		218
Law and Practice		218
Contributed by A&O Shearman, A. Pedzich Sp. k.		218
Trends and Developments		241
Contributed by A&O Shearman, A. Pedzich Sp. k.		241
SAUDI ARABIA		248
Law and Practice		248
Contributed by Mohammed Al Dhabaan & Partners Eversheds Sutherland		248
Trends and Developments		269
Contributed by Mohammed Al Dhabaan & Partners Eversheds Sutherland		269
SINGAPORE		276
Law and Practice		276
Contributed by Drew & Napier LLC		276
SOUTH AFRICA		303
Law and Practice		303
Contributed by Adams & Adams Attorneys		303
SWITZERLAND		319
Law and Practice		319
Contributed by Wenger Plattner		319
USA		338
Law and Practice		338
Contributed by Kirkland & Ellis		338
Trends and Developments		361
Contributed by Haug Partners LLP		361
1. Life Sciences and Pharma/Biopharma Patent Litigation		21
1.1 Claimants/Plaintiffs to an Action		21
1.2 Defendants/Other Parties to an Action		22
1.3 Preliminary Injunction Proceedings		23
1.4 Structure of Main Proceedings on Infringement/Validity		24
1.5 Timing for Main Proceedings on Infringement/Validity		25
1.6 Requirements to Bring Infringement Action		26
1.7 Pre-Action Discovery/Disclosure		26
1.8 Search and Seizure Orders		26
1.9 Declaratory Relief		27
1.10 Doctrine of Equivalents		27
1.11 Clearing the Way		27
1.12 Experts		27
1.13 Use of Experiments		27
1.14 Discovery/Disclosure		28
1.15 Defences and Exceptions to Patent Infringement		28
1.16 Stays and Relevance of Parallel Proceedings		28
1.17 Patent Amendment		28
1.18 Court Arbiter		28
2. Generic Market Entry		28
2.1 Infringing Acts		28
2.2 Regulatory Data and Market Exclusivity		29
2.3 Acceptable Pre-Launch Preparations		29
2.4 Publicly Available Drug and Patent Information		30
2.5 Reimbursement and Pricing/Linkage Markets		31
3. Biosimilar Market Entry		31
3.1 Infringing Acts		31
3.2 Data and Regulatory Exclusivity		31
3.3 Acceptable Pre-Launch Preparations		31
3.4 Publicly Available Drug and Patent Information		31
3.5 Reimbursement and Pricing/Linkage Markets		31
4. Patent Term Extensions for Pharmaceutical Products		32
4.1 Supplementary Protection Certificates		32
4.2 Paediatric Extensions		33
4.3 Paediatric-Use Marketing Authorisations		33
4.4 Orphan Medicines Extensions		33
5. Relief Available for Patent Infringement		33
5.1 Preliminary Injunctive Relief		33
5.2 Final Injunctive Relief		34
5.3 Discretion to Award Injunctive Relief (Final or Preliminary)		35
5.4 Damages		35
5.5 Legal Costs		37
5.6 Relevance of Claimant/Plaintiff Conduct to Relief		37
6. Other IP Rights		37
6.1 Trade Marks		37
6.2 Copyright		38
6.3 Trade Secrets		38
7. Appeal		38
7.1 Timeframe to Appeal Decision		38
7.2 Appeal Court(s) Arbiter		39
7.3 Special Provisions		39
8. Other Relevant Forums/Procedures		39
8.1 The UPC or Other Forums		39
9. Alternative Dispute Resolution		39
9.1 ADR Options		39
10. Settlement/Antitrust		40
10.1 Considerations and Scrutiny		40
11. Collective Redress		40
11.1 Group Claims		40
1. Life Sciences and Pharma/Biopharma Patent Litigation		55
1.1 Claimants/Plaintiffs to an Action		55
1.2 Defendants/Other Parties to an Action		55
1.3 Preliminary Injunction Proceedings		55
1.4 Structure of Main Proceedings on Infringement/Validity		57
1.5 Timing for Main Proceedings on Infringement/Validity		57
1.6 Requirements to Bring Infringement Action		58
1.7 Pre-Action Discovery/Disclosure		58
1.8 Search and Seizure Orders		58
1.9 Declaratory Relief		58
1.10 Doctrine of Equivalents		59
1.11 Clearing the Way		59
1.12 Experts		59
1.13 Use of Experiments		59
1.14 Discovery/Disclosure		59
1.15 Defences and Exceptions to Patent Infringement		60
1.16 Stays and Relevance of Parallel Proceedings		60
1.17 Patent Amendment		60
1.18 Court Arbiter		60
2. Generic Market Entry		60
2.1 Infringing Acts		60
2.2 Regulatory Data and Market Exclusivity		61
2.3 Acceptable Pre-Launch Preparations		61
2.4 Publicly Available Drug and Patent Information		61
2.5 Reimbursement and Pricing/Linkage Markets		62
3. Biosimilar Market Entry		63
3.1 Infringing Acts		63
3.2 Data and Regulatory Exclusivity		63
3.3 Acceptable Pre-Launch Preparations		63
3.4 Publicly Available Drug and Patent Information		63
3.5 Reimbursement and Pricing/Linkage Markets		63
4. Patent Term Extensions for Pharmaceutical Products		63
4.1 Supplementary Protection Certificates		63
4.2 Paediatric Extensions		64
4.3 Paediatric-Use Marketing Authorisations		64
4.4 Orphan Medicines Extensions		64
5. Relief Available for Patent Infringement		64
5.1 Preliminary Injunctive Relief		64
5.2 Final Injunctive Relief		65
5.3 Discretion to Award Injunctive Relief (Final or Preliminary)		65
5.4 Damages		65
5.5 Legal Costs		66
5.6 Relevance of Claimant/Plaintiff Conduct to Relief		67
6. Other IP Rights		67
6.1 Trade Marks		67
6.2 Copyright		67
6.3 Trade Secrets		68
7. Appeal		68
7.1 Timeframe to Appeal Decision		68
7.2 Appeal Court(s) Arbiter		69
7.3 Special Provisions		69
8. Other Relevant Forums/Procedures		69
8.1 The UPC or Other Forums		69
9. Alternative Dispute Resolution		70
9.1 ADR Options		70
10. Settlement/Antitrust		70
10.1 Considerations and Scrutiny		70
11. Collective Redress		71
11.1 Group Claims		71
1. Life Sciences and Pharma/Biopharma Patent Litigation		86
1.1 Claimants/Plaintiffs to an Action		86
1.2 Defendants/Other Parties to an Action		87
1.3 Preliminary Injunction Proceedings		87
1.4 Structure of Main Proceedings on Infringement/Validity		89
1.5 Timing for Main Proceedings on Infringement/Validity		90
1.6 Requirements to Bring Infringement Action		91
1.7 Pre-Action Discovery/Disclosure		92
1.8 Search and Seizure Orders		92
1.9 Declaratory Relief		92
1.10 Doctrine of Equivalents		93
1.11 Clearing the Way		93
1.12 Experts		94
1.13 Use of Experiments		94
1.14 Discovery/Disclosure		94
1.15 Defences and Exceptions to Patent Infringement		95
1.16 Stays and Relevance of Parallel Proceedings		95
1.17 Patent Amendment		96
1.18 Court Arbiter		96
2. Generic Market Entry		96
2.1 Infringing Acts		96
2.2 Regulatory Data and Market Exclusivity		97
2.3 Acceptable Pre-Launch Preparations		97
2.4 Publicly Available Drug and Patent Information		97
2.5 Reimbursement and Pricing/Linkage Markets		98
3. Biosimilar Market Entry		98
3.1 Infringing Acts		98
3.2 Data and Regulatory Exclusivity		98
3.3 Acceptable Pre-Launch Preparations		98
3.4 Publicly Available Drug and Patent Information		98
3.5 Reimbursement and Pricing/Linkage Markets		98
4. Patent Term Extensions for Pharmaceutical Products		98
4.1 Supplementary Protection Certificates		98
4.2 Paediatric Extensions		99
4.3 Paediatric-Use Marketing Authorisations		100
4.4 Orphan Medicines Extensions		100
5. Relief Available for Patent Infringement		100
5.1 Preliminary Injunctive Relief		100
5.2 Final Injunctive Relief		100
5.3 Discretion to Award Injunctive Relief (Final or Preliminary)		100
5.4 Damages		101
5.5 Legal Costs		101
5.6 Relevance of Claimant/Plaintiff Conduct to Relief		102
6. Other IP Rights		102
6.1 Trade Marks		102
6.2 Copyright		102
6.3 Trade Secrets		102
7. Appeal		102
7.1 Timeframe to Appeal Decision		102
7.2 Appeal Court(s) Arbiter		102
7.3 Special Provisions		102
8. Other Relevant Forums/Procedures		102
8.1 The UPC or Other Forums		102
9. Alternative Dispute Resolution		102
9.1 ADR Options		102
10. Settlement/Antitrust		103
10.1 Considerations and Scrutiny		103
11. Collective Redress		103
11.1 Group Claims		103
1. Life Sciences and Pharma/Biopharma Patent Litigation		124
1.1 Claimants/Plaintiffs to an Action		124
1.2 Defendants/Other Parties to an Action		124
1.3 Preliminary Injunction Proceedings		124
1.4 Structure of Main Proceedings on Infringement/Validity		126
1.5 Timing for Main Proceedings on Infringement/Validity		126
1.6 Requirements to Bring Infringement Action		128
1.7 Pre-Action Discovery/Disclosure		128
1.8 Search and Seizure Orders		128
1.9 Declaratory Relief		128
1.10 Doctrine of Equivalents		129
1.11 Clearing the Way		129
1.12 Experts		129
1.13 Use of Experiments		130
1.14 Discovery/Disclosure		130
1.15 Defences and Exceptions to Patent Infringement		130
1.16 Stays and Relevance of Parallel Proceedings		132
1.17 Patent Amendment		133
1.18 Court Arbiter		133
2. Generic Market Entry		133
2.1 Infringing Acts		133
2.2 Regulatory Data and Market Exclusivity		133
2.3 Acceptable Pre-Launch Preparations		134
2.4 Publicly Available Drug and Patent Information		134
2.5 Reimbursement and Pricing/Linkage Markets		135
3. Biosimilar Market Entry		135
3.1 Infringing Acts		135
3.2 Data and Regulatory Exclusivity		135
3.3 Acceptable Pre-Launch Preparations		135
3.4 Publicly Available Drug and Patent Information		135
3.5 Reimbursement and Pricing/Linkage Markets		135
4. Patent Term Extensions for Pharmaceutical Products		135
4.1 Supplementary Protection Certificates		135
4.2 Paediatric Extensions		136
4.3 Paediatric-Use Marketing Authorisations		136
4.4 Orphan Medicines Extensions		136
5. Relief Available for Patent Infringement		136
5.1 Preliminary Injunctive Relief		136
5.2 Final Injunctive Relief		137
5.3 Discretion to Award Injunctive Relief (Final or Preliminary)		138
5.4 Damages		138
5.5 Legal Costs		139
5.6 Relevance of Claimant/Plaintiff Conduct to Relief		140
6. Other IP Rights		140
6.1 Trade Marks		140
6.2 Copyright		141
6.3 Trade Secrets		141
7. Appeal		141
7.1 Timeframe to Appeal Decision		141
7.2 Appeal Court(s) Arbiter		141
7.3 Special Provisions		141
8. Other Relevant Forums/Procedures		141
8.1 The UPC or Other Forums		141
9. Alternative Dispute Resolution		142
9.1 ADR Options		142
10. Settlement/Antitrust		142
10.1 Considerations and Scrutiny		142
11. Collective Redress		142
11.1 Group Claims		142
1. Life Sciences and Pharma/Biopharma Patent Litigation		147
1.1 Claimants/Plaintiffs to an Action		147
1.2 Defendants/Other Parties to an Action		147
1.3 Preliminary Injunction Proceedings		148
1.4 Structure of Main Proceedings on Infringement/Validity		149
1.5 Timing for Main Proceedings on Infringement/Validity		150
1.6 Requirements to Bring Infringement Action		151
1.7 Pre-Action Discovery/Disclosure		152
1.8 Search and Seizure Orders		152
1.9 Declaratory Relief		153
1.10 Doctrine of Equivalents		153
1.11 Clearing the Way		154
1.12 Experts		154
1.13 Use of Experiments		155
1.14 Discovery/Disclosure		155
1.15 Defences and Exceptions to Patent Infringement		156
1.16 Stays and Relevance of Parallel Proceedings		156
1.17 Patent Amendment		157
1.18 Court Arbiter		157
2. Generic Market Entry		157
2.1 Infringing Acts		157
2.2 Regulatory Data and Market Exclusivity		158
2.3 Acceptable Pre-Launch Preparations		158
2.4 Publicly Available Drug and Patent Information		159
2.5 Reimbursement and Pricing/Linkage Markets		159
3. Biosimilar Market Entry		159
3.1 Infringing Acts		159
3.2 Data and Regulatory Exclusivity		159
3.3 Acceptable Pre-Launch Preparations		159
3.4 Publicly Available Drug and Patent Information		159
3.5 Reimbursement and Pricing/Linkage Markets		160
4. Patent Term Extensions for Pharmaceutical Products		160
4.1 Supplementary Protection Certificates		160
4.2 Paediatric Extensions		160
4.3 Paediatric-Use Marketing Authorisations		161
4.4 Orphan Medicines Extensions		161
5. Relief Available for Patent Infringement		162
5.1 Preliminary Injunctive Relief		162
5.2 Final Injunctive Relief		162
5.3 Discretion to Award Injunctive Relief (Final or Preliminary)		163
5.4 Damages		163
5.5 Legal Costs		163
5.6 Relevance of Claimant/Plaintiff Conduct to Relief		164
6. Other IP Rights		164
6.1 Trade Marks		164
6.2 Copyright		164
6.3 Trade Secrets		164
7. Appeal		164
7.1 Timeframe to Appeal Decision		164
7.2 Appeal Court(s) Arbiter		165
7.3 Special Provisions		166
8. Other Relevant Forums/Procedures		166
8.1 The UPC or Other Forums		166
9. Alternative Dispute Resolution		166
9.1 ADR Options		166
10. Settlement/Antitrust		166
10.1 Considerations and Scrutiny		166
11. Collective Redress		166
11.1 Group Claims		166
1. Life Sciences and Pharma/Biopharma Patent Litigation		171
1.1 Claimants/Plaintiffs to an Action		171
1.2 Defendants/Other Parties to an Action		171
1.3 Preliminary Injunction Proceedings		171
1.4 Structure of Main Proceedings on Infringement/Validity		172
1.5 Timing for Main Proceedings on Infringement/Validity		172
1.6 Requirements to Bring Infringement Action		173
1.7 Pre-Action Discovery/Disclosure		173
1.8 Search and Seizure Orders		173
1.9 Declaratory Relief		173
1.10 Doctrine of Equivalents		174
1.11 Clearing the Way		174
1.12 Experts		175
1.13 Use of Experiments		175
1.14 Discovery/Disclosure		175
1.15 Defences and Exceptions to Patent Infringement		175
1.16 Stays and Relevance of Parallel Proceedings		175
1.17 Patent Amendment		175
1.18 Court Arbiter		175
2. Generic Market Entry		176
2.1 Infringing Acts		176
2.2 Regulatory Data and Market Exclusivity		176
2.3 Acceptable Pre-Launch Preparations		176
2.4 Publicly Available Drug and Patent Information		176
2.5 Reimbursement and Pricing/Linkage Markets		177
3. Biosimilar Market Entry		177
3.1 Infringing Acts		177
3.2 Data and Regulatory Exclusivity		177
3.3 Acceptable Pre-Launch Preparations		177
3.4 Publicly Available Drug and Patent Information		177
3.5 Reimbursement and Pricing/Linkage Markets		177
4. Patent Term Extensions for Pharmaceutical Products		178
4.1 Supplementary Protection Certificates		178
4.2 Paediatric Extensions		178
4.3 Paediatric-Use Marketing Authorisations		178
4.4 Orphan Medicines Extensions		178
5. Relief Available for Patent Infringement		178
5.1 Preliminary Injunctive Relief		178
5.2 Final Injunctive Relief		179
5.3 Discretion to Award Injunctive Relief (Final or Preliminary)		179
5.4 Damages		179
5.5 Legal Costs		180
5.6 Relevance of Claimant/Plaintiff Conduct to Relief		180
6. Other IP Rights		180
6.1 Trade Marks		180
6.2 Copyright		180
6.3 Trade Secrets		180
7. Appeal		180
7.1 Timeframe to Appeal Decision		180
7.2 Appeal Court(s) Arbiter		181
7.3 Special Provisions		181
8. Other Relevant Forums/Procedures		181
8.1 The UPC or Other Forums		181
9. Alternative Dispute Resolution		181
9.1 ADR Options		181
10. Settlement/Antitrust		181
10.1 Considerations and Scrutiny		181
11. Collective Redress		181
11.1 Group Claims		181
1. Life Sciences and Pharma/Biopharma Patent Litigation		198
1.1 Claimants/Plaintiffs to an Action		198
1.2 Defendants/Other Parties to an Action		198
1.3 Preliminary Injunction Proceedings		198
1.4 Structure of Main Proceedings on Infringement/Validity		199
1.5 Timing for Main Proceedings on Infringement/Validity		199
1.6 Requirements to Bring Infringement Action		200
1.7 Pre-Action Discovery/Disclosure		200
1.8 Search and Seizure Orders		200
1.9 Declaratory Relief		201
1.10 Doctrine of Equivalents		201
1.11 Clearing the Way		201
1.12 Experts		201
1.13 Use of Experiments		201
1.14 Discovery/Disclosure		202
1.15 Defences and Exceptions to Patent Infringement		202
1.16 Stays and Relevance of Parallel Proceedings		202
1.17 Patent Amendment		202
1.18 Court Arbiter		202
2. Generic Market Entry		203
2.1 Infringing Acts		203
2.2 Regulatory Data and Market Exclusivity		203
2.3 Acceptable Pre-Launch Preparations		204
2.4 Publicly Available Drug and Patent Information		204
2.5 Reimbursement and Pricing/Linkage Markets		205
3. Biosimilar Market Entry		205
3.1 Infringing Acts		205
3.2 Data and Regulatory Exclusivity		205
3.3 Acceptable Pre-Launch Preparations		205
3.4 Publicly Available Drug and Patent Information		205
3.5 Reimbursement and Pricing/Linkage Markets		205
4. Patent Term Extensions for Pharmaceutical Products		206
4.1 Supplementary Protection Certificates		206
4.2 Paediatric Extensions		206
4.3 Paediatric-Use Marketing Authorisations		206
4.4 Orphan Medicines Extensions		206
5. Relief Available for Patent Infringement		206
5.1 Preliminary Injunctive Relief		206
5.2 Final Injunctive Relief		206
5.3 Discretion to Award Injunctive Relief (Final or Preliminary)		207
5.4 Damages		207
5.5 Legal Costs		207
5.6 Relevance of Claimant/Plaintiff Conduct to Relief		207
6. Other IP Rights		208
6.1 Trade Marks		208
6.2 Copyright		208
6.3 Trade Secrets		208
7. Appeal		208
7.1 Timeframe to Appeal Decision		208
7.2 Appeal Court(s) Arbiter		208
7.3 Special Provisions		208
8. Other Relevant Forums/Procedures		209
8.1 The UPC or Other Forums		209
9. Alternative Dispute Resolution		209
9.1 ADR Options		209
10. Settlement/Antitrust		209
10.1 Considerations and Scrutiny		209
11. Collective Redress		209
11.1 Group Claims		209
1. Life Sciences and Pharma/Biopharma Patent Litigation		222
1.1 Claimants/Plaintiffs to an Action		222
1.2 Defendants/Other Parties to an Action		222
1.3 Preliminary Injunction Proceedings		222
1.4 Structure of Main Proceedings on Infringement/Validity		223
1.5 Timing for Main Proceedings on Infringement/Validity		223
1.6 Requirements to Bring Infringement Action		224
1.7 Pre-Action Discovery/Disclosure		224
1.8 Search and Seizure Orders		225
1.9 Declaratory Relief		226
1.10 Doctrine of Equivalents		226
1.11 Clearing the Way		226
1.12 Experts		226
1.13 Use of Experiments		227
1.14 Discovery/Disclosure		227
1.15 Defences and Exceptions to Patent Infringement		227
1.16 Stays and Relevance of Parallel Proceedings		228
1.17 Patent Amendment		228
1.18 Court Arbiter		228
2. Generic Market Entry		228
2.1 Infringing Acts		228
2.2 Regulatory Data and Market Exclusivity		229
2.3 Acceptable Pre-Launch Preparations		229
2.4 Publicly Available Drug and Patent Information		230
2.5 Reimbursement and Pricing/Linkage Markets		230
3. Biosimilar Market Entry		231
3.1 Infringing Acts		231
3.2 Data and Regulatory Exclusivity		231
3.3 Acceptable Pre-Launch Preparations		231
3.4 Publicly Available Drug and Patent Information		231
3.5 Reimbursement and Pricing/Linkage Markets		231
4. Patent Term Extensions for Pharmaceutical Products		231
4.1 Supplementary Protection Certificates		231
4.2 Paediatric Extensions		232
4.3 Paediatric-Use Marketing Authorisations		232
4.4 Orphan Medicines Extensions		233
5. Relief Available for Patent Infringement		233
5.1 Preliminary Injunctive Relief		233
5.2 Final Injunctive Relief		233
5.3 Discretion to Award Injunctive Relief (Final or Preliminary)		233
5.4 Damages		234
5.5 Legal Costs		235
5.6 Relevance of Claimant/Plaintiff Conduct to Relief		235
6. Other IP Rights		235
6.1 Trade Marks		235
6.2 Copyright		235
6.3 Trade Secrets		236
7. Appeal		236
7.1 Timeframe to Appeal Decision		236
7.2 Appeal Court(s) Arbiter		238
7.3 Special Provisions		238
8. Other Relevant Forums/Procedures		238
8.1 The UPC or Other Forums		238
9. Alternative Dispute Resolution		238
9.1 ADR Options		238
10. Settlement/Antitrust		239
10.1 Considerations and Scrutiny		239
11. Collective Redress		240
11.1 Group Claims		240
1. Life Sciences and Pharma/Biopharma Patent Litigation		252
1.1 Claimants/Plaintiffs to an Action		252
1.2 Defendants/Other Parties to an Action		252
1.3 Preliminary Injunction Proceedings		253
1.4 Structure of Main Proceedings on Infringement/Validity		253
1.5 Timing for Main Proceedings on Infringement/Validity		253
1.6 Requirements to Bring Infringement Action		254
1.7 Pre-Action Discovery/Disclosure		255
1.8 Search and Seizure Orders		255
1.9 Declaratory Relief		255
1.10 Doctrine of Equivalents		255
1.11 Clearing the Way		256
1.12 Experts		256
1.13 Use of Experiments		257
1.14 Discovery/Disclosure		257
1.15 Defences and Exceptions to Patent Infringement		257
1.16 Stays and Relevance of Parallel Proceedings		258
1.17 Patent Amendment		258
1.18 Court Arbiter		259
2. Generic Market Entry		259
2.1 Infringing Acts		259
2.2 Regulatory Data and Market Exclusivity		259
2.3 Acceptable Pre-Launch Preparations		259
2.4 Publicly Available Drug and Patent Information		260
2.5 Reimbursement and Pricing/Linkage Markets		260
3. Biosimilar Market Entry		260
3.1 Infringing Acts		260
3.2 Data and Regulatory Exclusivity		261
3.3 Acceptable Pre-Launch Preparations		261
3.4 Publicly Available Drug and Patent Information		261
3.5 Reimbursement and Pricing/Linkage Markets		261
4. Patent Term Extensions for Pharmaceutical Products		261
4.1 Supplementary Protection Certificates		261
4.2 Paediatric Extensions		262
4.3 Paediatric-Use Marketing Authorisations		263
4.4 Orphan Medicines Extensions		263
5. Relief Available for Patent Infringement		264
5.1 Preliminary Injunctive Relief		264
5.2 Final Injunctive Relief		264
5.3 Discretion to Award Injunctive Relief (Final or Preliminary)		264
5.4 Damages		264
5.5 Legal Costs		265
5.6 Relevance of Claimant/Plaintiff Conduct to Relief		265
6. Other IP Rights		265
6.1 Trade Marks		265
6.2 Copyright		266
6.3 Trade Secrets		266
7. Appeal		267
7.1 Timeframe to Appeal Decision		267
7.2 Appeal Court(s) Arbiter		267
7.3 Special Provisions		267
8. Other Relevant Forums/Procedures		268
8.1 The UPC or Other Forums		268
9. Alternative Dispute Resolution		268
9.1 ADR Options		268
10. Settlement/Antitrust		268
10.1 Considerations and Scrutiny		268
11. Collective Redress		268
11.1 Group Claims		268
1. Life Sciences and Pharma/Biopharma Patent Litigation		280
1.1 Claimants/Plaintiffs to an Action		280
1.2 Defendants/Other Parties to an Action		281
1.3 Preliminary Injunction Proceedings		282
1.4 Structure of Main Proceedings on Infringement/Validity		283
1.5 Timing for Main Proceedings on Infringement/Validity		283
1.6 Requirements to Bring Infringement Action		286
1.7 Pre-Action Discovery/Disclosure		286
1.8 Search and Seizure Orders		287
1.9 Declaratory Relief		287
1.10 Doctrine of Equivalents		288
1.11 Clearing the Way		288
1.12 Experts		288
1.13 Use of Experiments		289
1.14 Discovery/Disclosure		289
1.15 Defences and Exceptions to Patent Infringement		291
1.16 Stays and Relevance of Parallel Proceedings		291
1.17 Patent Amendment		292
1.18 Court Arbiter		293
2. Generic Market Entry		293
2.1 Infringing Acts		293
2.2 Regulatory Data and Market Exclusivity		294
2.3 Acceptable Pre-Launch Preparations		294
2.4 Publicly Available Drug and Patent Information		294
2.5 Reimbursement and Pricing/Linkage Markets		294
3. Biosimilar Market Entry		295
3.1 Infringing Acts		295
3.2 Data and Regulatory Exclusivity		295
3.3 Acceptable Pre-Launch Preparations		295
3.4 Publicly Available Drug and Patent Information		295
3.5 Reimbursement and Pricing/Linkage Markets		295
4. Patent Term Extensions for Pharmaceutical Products		295
4.1 Supplementary Protection Certificates		295
4.2 Paediatric Extensions		295
4.3 Paediatric-Use Marketing Authorisations		295
4.4 Orphan Medicines Extensions		295
5. Relief Available for Patent Infringement		296
5.1 Preliminary Injunctive Relief		296
5.2 Final Injunctive Relief		296
5.3 Discretion to Award Injunctive Relief (Final or Preliminary)		297
5.4 Damages		297
5.5 Legal Costs		297
5.6 Relevance of Claimant/Plaintiff Conduct to Relief		299
6. Other IP Rights		299
6.1 Trade Marks		299
6.2 Copyright		299
6.3 Trade Secrets		299
7. Appeal		299
7.1 Timeframe to Appeal Decision		299
7.2 Appeal Court(s) Arbiter		300
7.3 Special Provisions		300
8. Other Relevant Forums/Procedures		301
8.1 The UPC or Other Forums		301
9. Alternative Dispute Resolution		301
9.1 ADR Options		301
10. Settlement/Antitrust		301
10.1 Considerations and Scrutiny		301
11. Collective Redress		301
11.1 Group Claims		301
1. Life Sciences and Pharma/Biopharma Patent Litigation		307
1.1 Claimants/Plaintiffs to an Action		307
1.2 Defendants/Other Parties to an Action		307
1.3 Preliminary Injunction Proceedings		307
1.4 Structure of Main Proceedings on Infringement/Validity		308
1.5 Timing for Main Proceedings on Infringement/Validity		308
1.6 Requirements to Bring Infringement Action		309
1.7 Pre-Action Discovery/Disclosure		309
1.8 Search and Seizure Orders		309
1.9 Declaratory Relief		310
1.10 Doctrine of Equivalents		310
1.11 Clearing the Way		310
1.12 Experts		310
1.13 Use of Experiments		311
1.14 Discovery/Disclosure		311
1.15 Defences and Exceptions to Patent Infringement		311
1.16 Stays and Relevance of Parallel Proceedings		311
1.17 Patent Amendment		312
1.18 Court Arbiter		312
2. Generic Market Entry		312
2.1 Infringing Acts		312
2.2 Regulatory Data and Market Exclusivity		313
2.3 Acceptable Pre-Launch Preparations		313
2.4 Publicly Available Drug and Patent Information		313
2.5 Reimbursement and Pricing/Linkage Markets		313
3. Biosimilar Market Entry		313
3.1 Infringing Acts		313
3.2 Data and Regulatory Exclusivity		314
3.3 Acceptable Pre-Launch Preparations		314
3.4 Publicly Available Drug and Patent Information		314
3.5 Reimbursement and Pricing/Linkage Markets		314
4. Patent Term Extensions for Pharmaceutical Products		314
4.1 Supplementary Protection Certificates		314
4.2 Paediatric Extensions		314
4.3 Paediatric-Use Marketing Authorisations		314
4.4 Orphan Medicines Extensions		314
5. Relief Available for Patent Infringement		314
5.1 Preliminary Injunctive Relief		314
5.2 Final Injunctive Relief		315
5.3 Discretion to Award Injunctive Relief (Final or Preliminary)		315
5.4 Damages		315
5.5 Legal Costs		316
5.6 Relevance of Claimant/Plaintiff Conduct to Relief		317
6. Other IP Rights		317
6.1 Trade Marks		317
6.2 Copyright		317
6.3 Trade Secrets		317
7. Appeal		317
7.1 Timeframe to Appeal Decision		317
7.2 Appeal Court(s) Arbiter		318
7.3 Special Provisions		318
8. Other Relevant Forums/Procedures		318
8.1 The UPC or Other Forums		318
9. Alternative Dispute Resolution		318
9.1 ADR Options		318
10. Settlement/Antitrust		318
10.1 Considerations and Scrutiny		318
11. Collective Redress		318
11.1 Group Claims		318
1. Life Sciences and Pharma/Biopharma Patent Litigation		323
1.1 Claimants/Plaintiffs to an Action		323
1.2 Defendants/Other Parties to an Action		323
1.3 Preliminary Injunction Proceedings		323
1.4 Structure of Main Proceedings on Infringement/Validity		325
1.5 Timing for Main Proceedings on Infringement/Validity		325
1.6 Requirements to Bring Infringement Action		326
1.7 Pre-Action Discovery/Disclosure		326
1.8 Search and Seizure Orders		326
1.9 Declaratory Relief		326
1.10 Doctrine of Equivalents		327
1.11 Clearing the Way		327
1.12 Experts		327
1.13 Use of Experiments		327
1.14 Discovery/Disclosure		328
1.15 Defences and Exceptions to Patent Infringement		328
1.16 Stays and Relevance of Parallel Proceedings		328
1.17 Patent Amendment		329
1.18 Court Arbiter		329
2. Generic Market Entry		329
2.1 Infringing Acts		329
2.2 Regulatory Data and Market Exclusivity		330
2.3 Acceptable Pre-Launch Preparations		330
2.4 Publicly Available Drug and Patent Information		330
2.5 Reimbursement and Pricing/Linkage Markets		330
3. Biosimilar Market Entry		331
3.1 Infringing Acts		331
3.2 Data and Regulatory Exclusivity		331
3.3 Acceptable Pre-Launch Preparations		331
3.4 Publicly Available Drug and Patent Information		331
3.5 Reimbursement and Pricing/Linkage Markets		331
4. Patent Term Extensions for Pharmaceutical Products		331
4.1 Supplementary Protection Certificates		331
4.2 Paediatric Extensions		332
4.3 Paediatric-Use Marketing Authorisations		332
4.4 Orphan Medicines Extensions		332
5. Relief Available for Patent Infringement		332
5.1 Preliminary Injunctive Relief		332
5.2 Final Injunctive Relief		333
5.3 Discretion to Award Injunctive Relief (Final or Preliminary)		333
5.4 Damages		334
5.5 Legal Costs		334
5.6 Relevance of Claimant/Plaintiff Conduct to Relief		335
6. Other IP Rights		335
6.1 Trade Marks		335
6.2 Copyright		335
6.3 Trade Secrets		335
7. Appeal		335
7.1 Timeframe to Appeal Decision		335
7.2 Appeal Court(s) Arbiter		336
7.3 Special Provisions		336
8. Other Relevant Forums/Procedures		336
8.1 The UPC or Other Forums		336
9. Alternative Dispute Resolution		336
9.1 ADR Options		336
10. Settlement/Antitrust		337
10.1 Considerations and Scrutiny		337
11. Collective Redress		337
11.1 Group Claims		337
1. Life Sciences and Pharma/Biopharma Patent Litigation		342
1.1 Claimants/Plaintiffs to an Action		342
1.2 Defendants/Other Parties to an Action		343
1.3 Preliminary Injunction Proceedings		343
1.4 Structure of Main Proceedings on Infringement/Validity		344
1.5 Timing for Main Proceedings on Infringement/Validity		344
1.6 Requirements to Bring Infringement Action		345
1.7 Pre-Action Discovery/Disclosure		345
1.8 Search and Seizure Orders		345
1.9 Declaratory Relief		346
1.10 Doctrine of Equivalents		346
1.11 Clearing the Way		346
1.12 Experts		346
1.13 Use of Experiments		347
1.14 Discovery/Disclosure		347
1.15 Defences and Exceptions to Patent Infringement		348
1.16 Stays and Relevance of Parallel Proceedings		349
1.17 Patent Amendment		349
1.18 Court Arbiter		350
2. Generic Market Entry		350
2.1 Infringing Acts		350
2.2 Regulatory Data and Market Exclusivity		351
2.3 Acceptable Pre-Launch Preparations		352
2.4 Publicly Available Drug and Patent Information		352
2.5 Reimbursement and Pricing/Linkage Markets		352
3. Biosimilar Market Entry		353
3.1 Infringing Acts		353
3.2 Data and Regulatory Exclusivity		353
3.3 Acceptable Pre-Launch Preparations		354
3.4 Publicly Available Drug and Patent Information		354
3.5 Reimbursement and Pricing/Linkage Markets		354
4. Patent Term Extensions for Pharmaceutical Products		354
4.1 Supplementary Protection Certificates		354
4.2 Paediatric Extensions		355
4.3 Paediatric-Use Marketing Authorisations		355
4.4 Orphan Medicines Extensions		355
5. Relief Available for Patent Infringement		355
5.1 Preliminary Injunctive Relief		355
5.2 Final Injunctive Relief		355
5.3 Discretion to Award Injunctive Relief (Final or Preliminary)		356
5.4 Damages		356
5.5 Legal Costs		357
5.6 Relevance of Claimant/Plaintiff Conduct to Relief		358
6. Other IP Rights		358
6.1 Trade Marks		358
6.2 Copyright		358
6.3 Trade Secrets		358
7. Appeal		358
7.1 Timeframe to Appeal Decision		358
7.2 Appeal Court(s) Arbiter		359
7.3 Special Provisions		359
8. Other Relevant Forums/Procedures		359
8.1 The UPC or Other Forums		359
9. Alternative Dispute Resolution		359
9.1 ADR Options		359
10. Settlement/Antitrust		360
10.1 Considerations and Scrutiny		360
11. Collective Redress		360
11.1 Group Claims		360

Powered by