Life Sciences and Pharma IP Litigation 2025

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

Since the court of first instance has nationwide jurisdiction for patent infringement matters, ser - vice can be made anywhere within South Africa. It is also possible to obtain leave to serve pro - ceedings on foreign entities in foreign jurisdic - tions through a process of edictal citation to confirm jurisdiction. This is less common in life sciences matters where the generic company is situated in South Africa and is directly involved in the act(s) of infringement. An infringement action is usually concluded within 18 to 24 months after commencing pro - ceedings. Pleadings usually close within 3–4 months after commencing proceedings. There - after, discovery and any interlocutory applica - tions (for example, to compel further or better discovery) take place. This usually takes about 3–6 months to conclude. Once discovery has been concluded, expert summaries are filed. In practice, the parties usually exchange expert summaries 2–3 months before trial. 1.6 Requirements to Bring Infringement Action An infringement trial action can be instituted nine months after grant of the patent, or after grant and before the expiry of nine months with leave of the court if special circumstances exist. There are no translation or validation formalities that need to be completed. There are no pre-trial discovery-/seizure-type orders available in SA (apart from Anton Piller- type orders which are very specific ex-parte orders that are rarely invoked because they only apply where there is a reasonable likelihood that evidence will be spirited away). A trial action is instituted based on a reasonable apprehension of infringement. Relevant infor - mation to prove infringement must be obtained

through the normal discovery procedures which would be applicable once the trial action has been instituted (at the close of pleadings). Potential challenges arise when the details of the infringement (for example, a process or specific amounts of an excipient) are not readily appar - ent from public documents and are not in the possession of the defendant who, as importers, allege no knowledge thereof. Expert evidence may be required to examine impurity markers, excipient amounts, or the like to reverse the onus, or documents from foreign proceedings may be relied on if permissible in terms of the law of the foreign jurisdiction. A claim in respect of a process for making a new product shall be assumed to be made by the patented process unless the contrary is proved. 1.7 Pre-Action Discovery/Disclosure As indicated previously, there are no pre-trial discovery-/seizure-type orders available in SA (apart from Anton Piller-type orders which are very specific ex-parte orders that are rarely invoked because they only apply where there is a reasonable likelihood that evidence will be spirited away). Information obtained from foreign jurisdictions may be used if permissible under the laws of the foreign jurisdiction. 1.8 Search and Seizure Orders No seizure orders are available. However, inspections in loco may be ordered during the discovery process. Information obtained from foreign jurisdictions may be used if permissible under the laws of the foreign jurisdiction.

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