SOUTH AFRICA Law and Practice Contributed by: Russell Bagnall, Danie Dohmen, Sophia Smallbones and Ramon Pereira, Adams & Adams Attorneys
3.2 Data and Regulatory Exclusivity See 2.2 Regulatory Data and Market Exclusiv- ity . 3.3 Acceptable Pre-Launch Preparations There are no differences for acceptable pre- launch preparations in biosimilar market entry when compared with the same in 2.3 Accept- able Pre-Launch Preparations . 3.4 Publicly Available Drug and Patent Information There are no differences for publicly available drug and patent information in biosimilar mar - ket entry when compared with the same in 2.4 Publicly Available Drug and Patent Information . 3.5 Reimbursement and Pricing/Linkage Markets There are no differences for reimbursement and pricing/linkage markets in biosimilar mar - ket entry when compared with the same in 2.5 Reimbursement and Pricing/Linkage Markets . 4. Patent Term Extensions for Pharmaceutical Products 4.1 Supplementary Protection Certificates No patent term extensions including Supple - mentary Protection Certificates (SPCs) are avail - able. 4.2 Paediatric Extensions No paediatric patent term extensions including SPCs are available.
4.3 Paediatric-Use Marketing Authorisations
No patent term extensions including SPCs are available for paediatric-use marketing authorisa - tions. 4.4 Orphan Medicines Extensions No patent term extensions including SPCs are available for orphan medicines.
5. Relief Available for Patent Infringement 5.1 Preliminary Injunctive Relief
There is no requirement for a patentee or licen - see to give an undertaking to pay damages in exchange for a preliminary injunction. However, if a patentee volunteers an undertaking that it will pay damages caused by the wrongful grant of preliminary injunction, it strengthens their posi - tion in showing that the balance of convenience favours the grant of the preliminary injunction. Typically, such undertakings are in force for so long as trial proceedings, or any appeals, remain pending. Thereafter, the undertaking will either lapse or become enforceable, depending on the outcome. The undertaking is made in such a way as to be personal to the opposing parties to the preliminary injunction application. Third parties not party to the preliminary injunction application would not be beneficiaries of the undertaking. Preliminary injunctions are enforceable from when the Court of the Commissioner of Patents grants the injunction. A party against whom a preliminary injunction has been granted will be in contempt of court if it continues its conduct after the order has been handed down. Proceedings for contempt of court may be brought against that party.
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