Life Sciences and Pharma IP Litigation 2025

SOUTH AFRICA

Botswana

Mozambique

Namibia

Pretoria

Eswatini

Lesotho

Republic of South Africa

Law and Practice Contributed by: Russell Bagnall, Danie Dohmen, Sophia Smallbones and Ramon Pereira Adams & Adams Attorneys

Contents 1. Life Sciences and Pharma/Biopharma Patent Litigation p.306 1.1 Claimants/Plaintiffs to an Action p.306

1.2 Defendants/Other Parties to an Action p.306 1.3 Preliminary Injunction Proceedings p.306

1.4 Structure of Main Proceedings on Infringement/Validity p.307 1.5 Timing for Main Proceedings on Infringement/Validity p.307 1.6 Requirements to Bring Infringement Action p.308 1.7 Pre-Action Discovery/Disclosure p.308 1.8 Search and Seizure Orders p.308 1.9 Declaratory Relief p.309 1.10 Doctrine of Equivalents p.309 1.11 Clearing the Way p.309 1.12 Experts p.309

1.13 Use of Experiments p.310 1.14 Discovery/Disclosure p.310

1.15 Defences and Exceptions to Patent Infringement p.310 1.16 Stays and Relevance of Parallel Proceedings p.310 1.17 Patent Amendment p.311 1.18 Court Arbiter p.311 2. Generic Market Entry p.311 2.1 Infringing Acts p.311 2.2 Regulatory Data and Market Exclusivity p.312 2.3 Acceptable Pre-Launch Preparations p.312 2.4 Publicly Available Drug and Patent Information p.312 2.5 Reimbursement and Pricing/Linkage Markets p.312 3. Biosimilar Market Entry p.312 3.1 Infringing Acts p.312 3.2 Data and Regulatory Exclusivity p.313 3.3 Acceptable Pre-Launch Preparations p.313 3.4 Publicly Available Drug and Patent Information p.313 3.5 Reimbursement and Pricing/Linkage Markets p.313

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