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 patentee 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 infringement 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 infringement or validity take place before the Patent Office.

The party that is most often sued in South Africa (SA) is the generic company manufacturing or importing the generic product (sometimes including the holding company and subsidiaries). In some cases, national pharmacy groups with wide distribution networks are also joined in the 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 ultimately succeeds in establishing his/her right;
• the balance of convenience favours the granting of interim relief; and
• the applicant has no other satisfactory remedy.

An applicant for preliminary injunction is required to bring the proceedings with some degree of urgency, which will vary depending on the circumstances. For complex matters with voluminous 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 proceedings until a hearing date could be expected. A judgment usually takes 2–3 months.

The proceedings may be based on a reasonable 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 proceedings being brought after grant but before the nine-month period has expired.

The grant of a Marketing Authorisation (MA) or activities relating to obtaining regulatory approval (other than stockpiling) are not considered to be acts of infringement. There is also no patent linkage system with the MA authority in South Africa.

Preliminary injunction proceedings are commenced by service on the respondents at their place of business and the time periods are calculated from the date of service. The application is accompanied by founding evidence in the form of one or more declarations. Urgent service usually takes one to three days. The respondent is required to file a notice of intention to oppose and, thereafter, file answering evidence. The applicants have the opportunity to file replying evidence in response to the answering evidence.

The respondents are given 15 days from the filing of the notice of intention to oppose to file their evidence and the patentee is required to reply within ten days. Often these timelines are extended by agreement between the parties.

The presiding judge considers the question of infringement and validity and the prospects of the patentee succeeding on these issues at trial. If the court is of the view that the patentee has strong prospects of succeeding at trial, then other factors, such as the balance of convenience, need not necessarily weigh heavily in favour of the applicant. However, if the court finds that the strength of the case is prima facie established but open to some doubt, factors such as the balance of convenience would need to favour the patentee more heavily.

It is common practice for the applicant to provide an undertaking that it will pay any damages to the respondent that it proves to have suffered because of the injunction being wrongly granted. This assists in arguing that the balance of convenience favours the applicant. In some cases, the respondent will provide a cross-undertaking.

Demands from respondents to provide bonds for security for legal costs (for foreign applicants who hold no fixed assets in South Africa) are not uncommon. Security for costs can be effectively provided with limited risk for applicants.

Infringement and validity proceedings are not bifurcated. A defendant is entitled to raise invalidity by way of defence or by way of a counterclaim in an infringement action.

It is possible to bring a revocation application post grant, but no opposition proceedings are available before or after grant.

A claim for damages prescribes three years from when prescription starts to run. The issuing of summons interrupts prescription. In practical terms, what this means is that, once successful in an infringement action, it is permissible to claim damages for sales that took place up to three years before a summons was instituted.

An infringement action is commenced by issuing of a summons accompanied by a particulars of claim through the court whereafter the issued summons is physically served through the Sheriff of the Court (usually at the defendant’s main place of business or registered address). All relevant time periods are calculated from the date of service.

Since the court of first instance has nationwide jurisdiction for patent infringement matters, service can be made anywhere within South Africa. It is also possible to obtain leave to serve proceedings on foreign entities in foreign jurisdictions 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 proceedings. Pleadings usually close within 3–4 months after commencing proceedings. Thereafter, discovery and any interlocutory applications (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.

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 information 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 apparent 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.

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.

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.

A declaration of non-infringement is possible. The declaration may be sought by any person and requires that the applicant furnish the full particulars of the alleged infringement to the patentee with a request for the declaration which, if refused, permits the applicant to apply to court.

South African (SA) courts adopt a purposive or contextual approach to the interpretation of claims. Within the framework of this approach, SA courts do apply a form of the doctrine of equivalents. In particular, the courts will determine whether a feature is essential or not. The considerations are broadly as follows.

• To ascertain what are and what are not the essential features or integers of a claimed invention, the specification must be read and interpreted purposively or realistically, with the understanding of persons with practical knowledge and experience of the kind of work for which the invention was intended to be used and in the light of what was generally known by such persons at the date.
• The fact that a particular feature is present in the claim does not alone suffice to make that feature an essential one, otherwise the problem would not arise.
• In general, if the feature is in fact essential to the working of the claimed invention, then it must be regarded as an essential feature. On the other hand, a patentee may indicate in his/her specification, either expressly or by implication, that he/she regards a particular integer as essential; and in that event it must be treated as essential, and it does not matter that it may not be essential to the working of the invention. However, where a feature is not essential to the working of the invention and the patentee has not indicated that he/she regards it as an essential integer, then, in general, it may be treated as unessential.

There is no obligation to clear the way before launching a product. However, a failure to do so is an issue that is relevant during preliminary injunction proceedings in weighing up the balance of convenience if the generic product is launched at risk.

Parties routinely rely on expert witnesses to advance their case on validity and infringement. In preliminary injunction proceedings, the evidence takes the form of declaration evidence. In trial proceedings, the party wishing to adduce expert evidence is required to indicate an intention to do so and must provide a summary of the opinion and its reasons for the opinion in an expert summary. The expert witnesses provide oral testimony and are subject to cross examination.

There is no limit to the amount of evidence that may be adduced.

Parties appoint their own expert witnesses and there is no court-appointed expert, technical or scientific adviser. However, the expert has a duty to assist the court in its findings by providing independent and objective views.

Multiple experts are often required, for example, where the notional skilled addressee is a multi-disciplinary team.

As mentioned, in preliminary injunction proceedings the evidence takes the form of declaration evidence.

Experimental evidence may be adduced and is often relied on, especially for proving infringement. The normal evidentiary rules apply. A chain of custody should be established when reliance is placed on the analysis of infringing samples.

Any party may be required to make discovery on oath of all documents and tape recordings relating to any matter in question, once pleadings have closed.

The party required to make discovery files a discovery affidavit specifying documents and tape recordings in its possession and identifies those documents and tape recordings it objects to produce.

There is no discovery by way of deposition. However, it is possible to make provision for a party to compel further or better discovery in circumstances in which the discovery is considered inadequate.

A party is required to discover and make available for inspection all documents which may either directly or indirectly enable the party requiring the affidavit of discovery either to advance its own case or damage the case of its adversary. Documents which tend to advance only the case of the party making the discovery need not be disclosed unless such party intends to rely on those documents at trial.

A party is entitled to claim privilege in certain documents, for example, communications with its legal representatives for the purpose of giving or receiving legal advice, without prejudice communications, and the like.

Documents that are confidential but do not enjoy legal privilege, are usually either redacted or disclosed to the legal advisers under suitable restrictions.

SA courts have held that the inventor story is not relevant to an objective determination of inventiveness. Therefore, discovery of inventor notebooks may be resisted as being not relevant. However, if the patentee decides to rely on aspects of the inventor story, then discovery would be required.

The following may typically be relied on by way of defence.

• Traditional grounds of invalidity.
• The patentee consented or granted a licence.
• The patentee waived its rights or is estopped from asserting them.
• Prior use and Gillette defence.
• The activities fall under the right to reasonable repair.
• Exhaustion of rights.
• The activities fall under legitimate compounding regulations.
• Experimental use.
• Bolar-type exemption.

SA courts would not ordinarily stay infringement proceedings (without an agreement between the parties) to await the outcome of foreign parallel proceedings.

Since the Court of the Commissioner of Patents has nationwide jurisdiction, and since there are no substantive proceedings before the Patent Office, parallel proceedings in different tribunals are not usually encountered. However, a stay could be ordered if there is an issue before the Court of the Commissioner of Patents or a higher court, that would be determinative of the issues and would render the proceedings moot until that issue is decided.

South Africa is a non-examining jurisdiction. The Registrar of Patents does not conduct substantive examination. Therefore, there is an onus on an applicant or patentee to make validating amendments to the claims on becoming aware of relevant prior art.

It is permissible to apply to court for amendment during infringement proceedings. The court will likely stay the infringement proceedings pending a determination of the amendment application. The amendment will be advertised for a two-month opposition period. Filing multiple auxiliary requests would be very unusual. A patentee would need to elect which amendment it wishes to make.

The court of first instance in patent matters is the Court of the Commissioner of Patents. Although the court is named as a specialist court, it is, in practice, convened by a High Court judge (without a jury) who may not have patent experience.

Since the Court of the Commissioner of Patents has nationwide jurisdiction, there is no forum shopping.

The patentee must show a reasonable apprehension of infringement. South Africa has a bolar-type provision. Therefore, any acts associated with obtaining an MA or the possession of an MA are not considered acts of infringement. To show a reasonable apprehension of infringement, post MA registration reliance is often placed on number of surrounding circumstances, including pre-launch activities, a pricing approval request and/or obtaining a reimbursement code for medical insurance. The private market sector is often the most relevant market where tender supply does not apply. However, a submission of a tender would be relevant to the public sector and would amount to “offering to dispose of” which is an act of infringement. Tender submissions would typically not be accessible but could be obtained by way of SA access to information legislation (subject to a trade secret defence) or could be obtained by way of discovery in trial proceedings.

There has been no skinny labelling litigation in South Africa. However, it is well settled law that contributory infringement is actionable (for example, by way of inducement).

An originator product that has been put on the market by the patentee or with the consent of the patentee in another jurisdiction (free of restrictions) is subject to the exhaustion of rights defence in South Africa. Therefore, if a licensee supplies a product in another country under a territorially limited agreement, the importation of that product into South Africa may result in an infringement. Importation is a specified act of infringement in South Africa. The Minister of Health is empowered by Section 15C of the Medicines and Related Substances Control Act to prescribe the conditions on which any patented medicine may be parallel imported into South Africa regardless of the provisions of the Patents Act. This is seldom invoked.

There is no data package exclusivity of any kind available in South Africa.

In terms of the South African Bolar provision, it shall not be an act of infringement to make, use, exercise, offer to dispose of, or dispose of, or import a patented invention on a non-commercial scale and solely for the purposes reasonably related to obtaining, development and submission required under any law that regulates the manufacture, production distribution, use or sale of any product. However, stockpiling with a commercial intent is not permissible.

No Orange Book or patent linkage system is used in South Africa.

The fact of the registration, including the holder and basic product details, becomes available on grant of the MA. However, no notification is provided.

Underlying documents are not freely available and must be obtained through access to information legislation (which is subject to certain defences including trade secrets defences) or through the discovery proceedings in trial proceedings.

As noted in 2.4 Publicly Available Drug and Patent Information, no Orange Book or patent linkage system is used in South Africa.

There has been no skinny labelling litigation in South Africa. However, it is well settled law that contributory infringement is actionable (for example, by way of inducement).

Tender supply is limited to the public sector. The most relevant sector in patent disputes is usually the private sector. Best practice in the private sector is to put in an indication code on the script, but that rarely takes place. In practice, the pharmacy will look to fill the script for the drug (even under a general reimbursement code). So, the drug gets prescribed for off-label use and there is no practical prevention measure based on an indication specific code at prescription level. Generic substitution takes place at pharmacy level unless the clinician indicates no generic substitution. If the drug is being prescribed for an approved chronic condition, the clinician will need to submit the prescribed chronic application to the scheme where the indication and justification is set out. However, if chronic approval is denied (because it does not fit within the chronic diseases) then the drug can still be dispensed against the patient’s savings portion on the scheme (depending on the level the patient is on).

There is generally no notification made of any listing or reimbursement application, although the MA holder becomes aware when the reimbursement price is lowered to the generic price.

Generally, administration suits to force delisting or listing of products are not filed.

There are no differences for infringing acts in biosimilar market entry when compared with the same in 2.1 Infringing Acts.

See 2.2 Regulatory Data and Market Exclusivity.

There are no differences for acceptable pre-launch preparations in biosimilar market entry when compared with the same in 2.3 Acceptable Pre-Launch Preparations.

There are no differences for publicly available drug and patent information in biosimilar market entry when compared with the same in 2.4 Publicly Available Drug and Patent Information.

There are no differences for reimbursement and pricing/linkage markets in biosimilar market entry when compared with the same in 2.5 Reimbursement and Pricing/Linkage Markets.

No patent term extensions including Supplementary Protection Certificates (SPCs) are available.

No paediatric patent term extensions including SPCs are available.

No patent term extensions including SPCs are available for paediatric-use marketing authorisations.

No patent term extensions including SPCs are available for orphan medicines.

There is no requirement for a patentee or licensee 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 position 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.

There is no requirement for a patentee to pay a bond before the preliminary injunction is enforceable. Proceedings for a final order of infringement should be brought simultaneously or shortly after the institution of an application for a preliminary injunction.

The grant of a preliminary injunction is usually not appealable unless the decision has final effect. In that case, if leave to appeal is granted, the order may be suspended pending a determination of the appeal. It would be possible to approach court to have the order kept in place pending the outcome of the appeal. An order which is final in effect in a preliminary injunction application is very unusual in patent cases. Therefore, it is common for the preliminary injunction to remain in place pending the appeal process being completed. A bond will not lift a preliminary injunction.

Final injunctions are enforceable from when the Court of the Commissioner of Patents hands down judgment in final proceedings for infringement. Judgments are typically handed down electronically by email or on the electronic case management platform. There is no formal service process, and no bond is payable to have the order enforced. The filing of an application for leave to appeal against the judgment and order automatically suspends the judgment and order pending a determination of the application for leave to appeal. Should leave to appeal be granted, the judgment and order are stayed pending a determination of the appeal. As noted, an existing preliminary injunction will remain in place during this period. If no preliminary injunction is in place, it is in principle possible to have the final order remain in place pending the appeal, for example, if irreparable harm is in issue. However, such applications are not often granted.

One of the issues that contributes to a consideration of the balance of convenience in preliminary injunction applications is the public interest. The principle of public interest has not been applied to the grant of a final injunction to date. The provisions of the Patents Act provide that a patentee shall be entitled to an injunction. It is not clear to what extent a court will refuse a final interdict if a valid patent is infringed on the ground of public interest and, in lieu of an injunction, award an amount of damages.

The Patents Act makes provision for the grant of a compulsory licence in limited circumstances. Furthermore, the Minister of Health is empowered by Section 15C of the Medicines and Related Substances Control Act to prescribe the conditions on which any patented medicine may be parallel imported into South Africa regardless of the provisions of the Patents Act. This is interpreted to be limited to the patent owners’ “branded” product.

The Patents Act further provides that a Minister of State may use an invention for public purposes on such conditions as may be agreed upon with the patentee, or in default of agreement on such conditions as are determined by the commissioner on application by or on behalf of such Minister and after hearing the patentee. This is rarely invoked.

The purpose of a damages order in South Africa is to, as far as possible, restore the plaintiff to a position that it would have been in but for the infringement. The patentee is required to show that, had it not been for the infringing sales, on a balance of probabilities, it would have made those sales. Only lost profits may be claimed as damages. There are no punitive damages for wilful infringement nor is the concept of account of profits applied. The question of transfer pricing would become relevant to the damages calculation if used between affiliate and parent company.

Infringement and damages are separated in South Africa. If a court finds that a patent has been infringed, it may order an enquiry into damages suffered by the plaintiff. A plaintiff may then institute an action for damages. Damages are rarely litigated in South Africa and experience has shown that parties usually settle on the quantum.

A patentee or licensee may, at its election, claim a reasonable royalty in lieu of damages. If the patentee has entered into exclusive or non-exclusive licence agreements, the commercial terms of those agreements may be relevant in assisting a court in determining what damages or royalty would be payable.

It is well settled law in South Africa that, in circumstances in which damages are difficult to calculate, a court is required to take a robust approach based on the relevant market and the loss suffered by the patentee to arrive at an appropriate or reasonable estimate.

Damages accrue from when the infringement first took place. However, the prescription period for damages in South Africa is three years, subject to being interrupted by proceedings for infringement. Thus, a party can claim damages for acts of infringement that took place up to three years before proceedings for infringement were instituted. Interim awards are not made in South Africa. Interest is payable from when the damages amount is determined. The Prescribed Rate of Interest Act applies, and the interest rate prescribed is amended from time to time.

There are no reported cases in South Africa where a respondent in a preliminary injunction application has been awarded damages, either on the strength of an undertaking made by a patentee, or otherwise, in circumstances in which the preliminary injunction was wrongly granted. Neither are there any reported cases in South Africa where a third party has claimed damages for the wrongful grant of a preliminary injunction. However, parties have settled damages claims in circumstances in which the preliminary injunction was found to have been wrongfully granted.

A successful party in patent litigation proceedings in South Africa is usually entitled to recover from the unsuccessful party what is termed the “taxed party and party costs” through an award of costs made by the court. Legal costs are recoverable only after proceedings have been instituted but may include costs for pre-litigation work. There are no court fees payable in South Africa. If the court is of the opinion that the party to whom costs have been awarded has been put to unnecessary expense, or if the opposing party and/or their legal representatives have not acted with bona fides, alternative costs scales with higher tariffs may be ordered.

Parties can expect bills of costs to be taxed within 3 to 6 months of being submitted to the Registrar. A party can typically expect to recover 30 to 40% of their legal costs.

In some cases, the court may choose to order only a portion of the costs in favour of the successful party. Factors that influence this decision can be whether the successful party succeeded on all grounds and the amount of court time spent on dealing with issues in respect of which it was unsuccessful.

In preliminary injunction proceedings, conduct-related issues, such as delay in bringing the application or the main action, could impact on the grant of an injunction. The issues of delay are less relevant to the outcome of the merits of a trial action, but the court could take into consideration the conduct of the parties in making a costs order. It would be very unusual in patent matters for a plaintiff to be penalised in a costs order for starting an action without engaging in pre-action correspondence or a delay in bringing the matter. A licensee not recorded in the register does not have standing to join proceedings for infringement.

Brand name applications for medicines form part of the application for marketing approval made to the South African Health Regulatory Authority. There have been occasions where a generic medicine alleged to infringe a patent was also alleged to infringe the patentee’s registered trade mark, resulting in parallel patent and trade mark infringement proceedings. More generally, trade mark disputes certainly do take place in the life sciences and pharma sector in South Africa and patentees have successfully enforced trade mark rights.

Copyright issues are uncommon in the life sciences and pharma sector in South Africa. There may be a claim by a patentee against a generic medicine holder relating to the copyright in the package insert and/or the trade dress. However, such actions are usually of limited value.

Trade secret disputes rarely arise in the life sciences and pharma sector that relate to the sale of the allegedly infringing product. However, trade secret issues may arise in access to information or discovery disputes.

A party against whom the Court of the Commissioner of Patents has made an order, may apply to the Court of the Commissioner of Patents for leave to appeal within 15 days from when the order is handed down. Usually, the same judge that heard the main matter hears the application for leave to appeal.

In patent matters, parties typically ask for the appeal, if granted, to be to the Supreme Court of Appeal, instead of the full bench of the High Court. If leave to appeal is granted, the appellant has one month to file their notice of appeal. If leave to appeal is refused, the party seeking leave to appeal may make a further application for leave to appeal directly to the Supreme Court of Appeal.

Leave to appeal may only be given where the judge or judges concerned are of the opinion that the appeal would have a reasonable prospect of success, or there is some other compelling reason why the appeal should be heard, including conflicting judgments on the matter under consideration.

As noted, a preliminary injunction is not appealable unless the order is final in effect.

If an injunction decision is overturned on appeal or the patent is revoked, the preliminary injunction would most likely be extinguished.

Patent appeals are most frequently heard in the Supreme Court of Appeal, the highest court on non-constitutional matters. The quorum is five non-specialist judges.

There are certain specific procedures prescribed in the Patents Act. For example, patent revocation proceedings are brought on a specific form, with prescribed timelines for the exchange of pleadings and declaration evidence. Specific procedures also apply to oppositions to applications for post-grant amendments of patents and to oppositions to applications to restore lapsed patents. Where specific provision is not made for procedure in the Patents Act or Regulations, the Superior Courts Act and Uniform Rules of Court govern proceedings in the Court of the Commissioner of Patents. Therefore, proceedings for infringement follow the ordinary high court procedural rules.

Procedures are available for custom searching and seizing of counterfeit goods and suspected trade mark infringement. However, there are no customs-related procedures especially applicable to patent infringement.

Arbitration proceedings may be used but they are not relied on in South Africa.

The pharma/biopharma industry has come under recent scrutiny by the Competition Commission where issues such as anti-competitive pricing, abuse of dominance and denying access to an essential facility, and the like, have been considered. The disputes are often settled with the Commission (on pricing-related issues) before a referral to the Competition Tribunal takes place. Settlement agreements are usually made confidential between the parties.

South Africa has a well-developed class actions regime that is framed by common law principles and recent case law. Class action litigation in principle can be brought in relation to allegedly defective medicines or medical devices. The common law of negligence would usually apply. In addition, the Consumer Protection Act (2008) makes provision for potential liability of any supplier involved in product supply chain and, in specific instances, provides for strict liability (Section 61). Both class actions and strict liability statutory claims are fast developing areas of the law and whilst claims in the life sciences/pharma sector are possible, they are not yet common.