SOUTH AFRICA Law and Practice Contributed by: Russell Bagnall, Danie Dohmen, Sophia Smallbones and Ramon Pereira, Adams & Adams Attorneys
1. Life Sciences and Pharma/ Biopharma Patent Litigation 1.1 Claimants/Plaintiffs to an Action Only the patentee and a very specific type of licensee (a party endorsed as a licensee of right) are entitled to bring proceedings for infringement. To have standing, a licensee’s interest must be recorded in the Patent Office Register. The pat - entee is required to notify licensees recorded in the register (which would include exclusive and non-exclusive licensees) of the intention to bring proceedings and such licensees are entitled to join in the proceedings as co-plaintiffs. A co-patentee is not entitled to institute infringe - ment proceedings unless there is an agreement to that effect or consent given by the other co- patentee(s). There are no specific standing requirements to bring a nullity action. The relevant provision of the Patents Act provides that “any person” may do so. No substantive proceedings relating to infringe - ment or validity take place before the Patent Office. 1.2 Defendants/Other Parties to an Action The party that is most often sued in South Afri - ca (SA) is the generic company manufacturing or importing the generic product (sometimes including the holding company and subsidiar - ies). In some cases, national pharmacy groups with wide distribution networks are also joined in the proceedings.
1.3 Preliminary Injunction Proceedings Inter partes preliminary injunctions are possible, but not ex-parte injunctions. The applicant must show that: • the right sought to be protected by means of interim relief is clear or, if not clear, is prima facie established, though open to some doubt; • if the right is only prima facie established, there is a well-grounded apprehension of irreparable harm to the applicant if the interim relief is not granted and the applicant ulti - mately succeeds in establishing his/her right; • the balance of convenience favours the grant - ing of interim relief; and • the applicant has no other satisfactory rem - edy. An applicant for preliminary injunction is required to bring the proceedings with some degree of urgency, which will vary depending on the cir - cumstances. For complex matters with volumi - nous evidence, 4–6 weeks is not unusual to bring proceedings if there is some degree of urgency. SA courts have commented that approximately 3–4 weeks may constitute utmost expedition for patent matters. The time to a hearing varies, depending on several factors, including the number of days required which impacts the availability of a court. Typically, 3–4 months from instituting proceed - ings until a hearing date could be expected. A judgment usually takes 2–3 months. The proceedings may be based on a reason - able apprehension of infringement rather than an actual infringement. However, proceedings may only be brought nine months after grant unless special circumstances are shown to warrant pro -
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