USA
Canada
United States of America
Washington DC
Law and Practice Contributed by: Rob Cerwinski, Michael Johnson, Heather M Schneider and Michael B Cottler Gemini Law LLP
Mexico
Contents 1. Life Sciences and Pharma/Biopharma Patent Litigation p.255 1.1 Claimants/Plaintiffs to an Action p.255 1.2 Defendants/Other Parties to an Action p.255 1.3 Preliminary Injunction Proceedings p.256 1.4 Structure of Main Proceedings on Infringement/ Validity p.257 1.5 Timing for Main Proceedings on Infringement/Validity p.257 1.6 Requirements to Bring Infringement Action p.258 1.7 Pre-Action Discovery/Disclosure p.258 1.8 Search and Seizure Orders p.259 1.9 Declaratory Relief p.259 1.10 Doctrine of Equivalents p.260 1.11 Clearing the Way p.260 1.12 Experts p.260
4. Patent Term Extensions for Pharmaceutical Products p.265 4.1 Supplementary Protection Certificates p.265 4.2 Paediatric Extensions p.265 4.3 Paediatric-Use Marketing Authorisations p.266 4.4 Orphan Medicines Extensions p.266 5. Relief Available for Patent Infringement p.266 5.1 Preliminary Injunctive Relief p.266 5.2 Final Injunctive Relief p.266 5.3 Discretion to Award Injunctive Relief (Final or Preliminary) p.266 5.4 Damages p.266 5.5 Legal Costs p.267 5.6 Relevance of Claimant/Plaintiff Conduct to Relief p.267 6. Other IP Rights p.268 6.1 Trade Marks p.268 6.2 Copyright p.268 6.3 Trade Secrets p.268 7. Appeal p.268 7.1 Timeframe to Appeal Decision p.268 7.2 Appeal Court(s) Arbiter p.268 7.3 Special Provisions p.268 8. Other Relevant Forums/Procedures p.268 8.1 The UPC or Other Forums p.268 9. Alternative Dispute Resolution p.269 9.1 ADR Options p.269 10. Settlement/Antitrust p.269 10.1 Considerations and Scrutiny p.269 11. Collective Redress p.269 11.1 Group Claims p.269
1.13 Use of Experiments p.260 1.14 Discovery/Disclosure p.260
1.15 Defences and Exceptions to Patent Infringement p.261 1.16 Stays and Relevance of Parallel Proceedings p.261 1.17 Patent Amendment p.261 1.18 Court Arbiter p.262 2. Generic Market Entry p.262 2.1 Infringing Acts p.262 2.2 Regulatory Data and Market Exclusivity p.263 2.3 Acceptable Pre-Launch Preparations p.263 2.4 Publicly Available Drug and Patent Information p.263 2.5 Reimbursement and Pricing/Linkage Markets p.264 3. Biosimilar Market Entry p.264 3.1 Infringing Acts p.264 3.2 Data and Regulatory Exclusivity p.264 3.3 Acceptable Pre-Launch Preparations p.265 3.4 Publicly Available Drug and Patent Information p.265 3.5 Reimbursement and Pricing/Linkage Markets p.265
253 CHAMBERS.COM
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