Authored By: Faith Duve
University of Fort Hare
Abstract
South Africa’s patent system currently operates under a non-examining depository framework that grants patents based solely on formality requirements, without substantive evaluation of patentability criteria. This article examines the critical challenges posed by this system, particularly in the context of pharmaceutical access and the protection of innovation. Through analysis of recent legislative developments and case studies, this research argues that South Africa’s transition to substantive search and examination (SSE) is essential for creating a balanced intellectual property regime that serves both innovators and the public interest. The article evaluates the proposed Patents Amendment Bill and its potential to address systemic weaknesses while incorporating TRIPS flexibilities to enhance access to essential medicines.
Introduction
South Africa stands at a critical point in its intellectual property landscape, facing pressure to reform a patent system that has remained largely unchanged since 1978. [1] The current depository system, which grants patents without examining their substantive merit, has created significant challenges for innovation, pharmaceutical access, and economic development. This systemic issue has reached the forefront of legal and policy discourse, particularly given the proposed Patents Amendment Bill that aims to introduce substantive search and examination procedures.[2]
The urgency of patent law reform in South Africa cannot be overstated. The existing framework has enabled the growth of invalid patents, created barriers to essential medicine access, and failed to promote genuine patents.[3]This article argues that South Africa’s transition from a depository system to substantive search and examination represents not merely a technical adjustment, but a fundamental shift towards a balanced intellectual property regime that serves constitutional imperatives while fostering innovation and economic growth.
Legal Framework and Current Challenges
The Depository System: A Critical Analysis
South Africa’s patent system operates under the Patents Act 57 of 1978, which establishes a depository framework that examines only formal requirements for patent applications.[4] Under this system, as long as applicants submit the correct forms, documentation, and fees, patents are granted regardless of whether the invention meets substantive patentability criteria including novelty, inventiveness, and industrial applicability.[5]
This approach has created several systemic problems. Research indicates that over 80% of patents granted under South Africa’s depository system would likely be rejected under an examining system similar to those in Australia or Canada.[6] The lack of substantive examination has particular implications for pharmaceutical patents, where companies can obtain multiple patents on a single medicine through a practice known as “evergreening,” extending monopoly periods well beyond the standard twenty-year term.[7]
Constitutional and Public Health Implications
The deficiencies in South Africa’s patent system extend beyond technical legal concerns to constitutional issues. Section 27 of the Constitution guarantees the right to access healthcare services, including essential medicines.[8] However, the current patent regime has enabled pharmaceutical companies to maintain extended monopolies on critical medications, preventing the entry of affordable generic alternatives and undermining constitutional rights.[9]
Case studies demonstrate the severity of this problem. The drug rituximab, whose original patent expired in 2004, maintains monopoly protection in South Africa until 2030 due to secondary patents granted under the depository system representing 42 years of total protection from a single innovation.[10] Similarly, tuberculosis medications like bedaquiline and delamanid have been subject to multiple patents, maintaining prices at $900 and $1,700, respectively for six-month treatment courses, while generic versions could potentially be available for $48-$102 and $30-$96.[11]
The Path to Substantive Search and Examination
Legislative Developments and Policy Framework
The Department of Trade, Industry and Competition (DTIC) has announced plans to repeal and replace the Patents Act 57 of 1978 with new legislation that introduces substantive search and examination.[12]This reform initiative, outlined in the 2018 Intellectual Property Policy, represents a comprehensive approach to modernizing South Africa’s patent system while incorporating TRIPS flexibilities for public health protection.[13]
The proposed Patents Amendment Bill addresses three critical policy areas: introducing substantive search and examination to enhance legal certainty and encourage genuine innovation; aligning South African patent legislation with TRIPS Agreement provisions, particularly regarding access to essential medicines through compulsory licensing and parallel imports; and contributing to broader development objectives by making the patent system more accessible to South African citizens.[14]
Implementation Challenges and Capacity Building
The transition to substantive search and examination presents significant implementation challenges, particularly regarding human resources and technical capacity. The Companies and Intellectual Property Commission (CIPC) has proactively begun training 18 patent examiners with technical expertise across various technological areas to address these capacity constraints.[15]
The reform will be implemented on a phased basis, initially prioritizing certain technology sectors and focusing on local applications while continuing to build capacity.[16]This approach recognizes the practical constraints of implementing a comprehensive examination system while ensuring compliance with international treaties and obligations.
Utility Model Patents and Innovation Accessibility
A significant component of the proposed reforms involves introducing utility model patents, sometimes called “second-tier patents,” to protect incremental innovations that may not meet the higher standards required for traditional patents.[17] Utility models require only novelty and industrial applicability, without the inventive step requirement, making patent protection more accessible to small and medium enterprises, historically disadvantaged individuals, and informal sector operators.[18]
This innovation is particularly relevant given that approximately 150 million patents or applications exist globally, of which 85% are not patented in African countries and can therefore be freely used, further developed by local industry, and protected through utility models.[19]This presents significant opportunities for technology transfer and local innovation development, particularly in green technologies and other priority sectors.
Critical Analysis and Comparative Perspectives
TRIPS Flexibilities and Compulsory Licensing
The proposed patent reforms specifically incorporate TRIPS flexibilities to address public health concerns while maintaining intellectual property protection.[20] Compulsory licensing provisions in the draft legislation aim to create a more accessible system for overriding patent rights during national emergencies, including health crises and pandemics.[21]
However, South Africa’s historical record on compulsory licensing raises concerns about implementation effectiveness. Despite existing provisions in Sections 55 and 56 of the current Patents Act, the Commissioner of Patents has never issued a single compulsory license.[22] This implementation gap suggests that legislative reform alone may be insufficient without accompanying procedural improvements and political commitment to utilize available flexibilities.
International Best Practices and Benchmarking
South Africa’s proposed reforms align with international trends toward more rigorous patent examination while maintaining accessibility for developing country innovators. The introduction of utility models follows successful models implemented in Germany, South Korea, and China, where these mechanisms have fostered local innovation and technology development.[23]
The phased implementation approach also reflects best practices observed in other jurisdictions that have transitioned from depository to examining systems. However, the success of these reforms will depend on sustained investment in human capital, technological infrastructure, and institutional capacity building.
Economic and Innovation Implications
Impact on Pharmaceutical Industry and Access to Medicines
The transition to substantive search and examination has significant implications for pharmaceutical innovation and access to medicines in South Africa. Proponents argue that rigorous patent examination will prevent the granting of invalid patents that create artificial barriers to generic competition, potentially reducing medicine prices and improving access.[24]
Critics within the pharmaceutical industry express concerns that increased examination requirements may delay patent grants and create uncertainty for research and development investments. [25] However, evidence suggests that most countries with examining systems maintain robust pharmaceutical innovation while providing better protection against invalid patents.
Technology Transfer and Local Innovation
The proposed reforms, particularly the introduction of utility models, have the potential to stimulate local innovation and technology transfer. By providing more accessible intellectual property protection for incremental innovations, the system could encourage domestic research and development activities while facilitating adaptation of foreign technologies to local conditions.[26]
The emphasis on making the patent system more inclusive for small businesses and previously disadvantaged citizens through expanded agent services and preliminary advice programs represents an important democratization of intellectual property access.[27]
Recommendations and Way Forward
Institutional Capacity and Human Resources
Successful implementation of patent reform requires sustained investment in institutional capacity building. The CIPC must continue expanding its examiner training programs while developing partnerships with international patent offices to leverage expertise and best practices. Establishing clear career development pathways for patent examiners will be essential for retaining qualified personnel.[28]
Stakeholder Engagement and Public Participation
The reform process must include meaningful engagement with all stakeholders, including civil society organizations, healthcare advocates, legal practitioners, and industry representatives. Public participation in policy development will help ensure that the reformed system balances intellectual property protection with broader public interest considerations.[29]
Monitoring and Evaluation Framework
Implementing a comprehensive monitoring and evaluation framework will be crucial for assessing the effectiveness of patent reforms. Key performance indicators should include examination quality metrics, processing times, patent grant rates, and impact on medicine access and innovation outcomes.[30]
Conclusion
South Africa’s patent law reform represents a critical opportunity to address longstanding systemic deficiencies while creating a modern intellectual property framework suited to the country’s development needs. The transition from a depository system to substantive search and examination, combined with the introduction of utility models and enhanced TRIPS flexibilities, offers potential to balance innovation incentives with public health imperatives.
However, the success of these reforms depends on effective implementation, sustained institutional investment, and continued political commitment to utilizing available policy tools. The proposed changes represent not merely technical adjustments to patent law, but fundamental shifts toward a more equitable and effective intellectual property system that serves both innovators and the broader public interest.
The urgency of this reform cannot be understated, particularly given the ongoing challenges in pharmaceutical access and the need to foster local innovation capacity. South Africa has the opportunity to become a model for developing countries seeking to implement balanced patent systems that promote both innovation and access to essential technologies. The time for comprehensive patent law reform is now.
Reference(S):
Statutes and Legislation
- Constitution of the Republic of South Africa, 1996.
- Patents Act 57 of 1978 .
Government Documents and Policy
- Department of Trade, Industry and Competition, Intellectual Property Policy of the Republic of South Africa Phase I (2018).
- Section27, The Patent Amendments Bill: The Negative Impact of Half a Decade of Delays (2024).
- B. Zulu, M. Phosiwa & M. Ncube, CIPC to Introduce Substantive Search and Examination, De Rebus.
Case Law
- Ascendis Animal Health (Pty) Ltd v Merck Sharpe Dohme Corporation and Others, 2020 (1) SA 327 (CC).
Books and Journal Articles
- A. Pouris, Patents and Economic Development in South Africa, 20 S. Afr. J. Sci. 6 (2011).
- C. Tomlinson et al., How Patent Law Reform Can Improve Affordability and Accessibility of Medicines in South Africa: Four Medicine Case Studies, 109 S. Afr. Med. J. 388 (2019).
- C. Tomlinson, Reforming South Africa’s Procedures for Granting Patents to Improve Medicine Access, 105 S. Afr. Med. J. 741 (2015).
- N. Lesofe, Anti-Competitive Behaviour as a Ground for Compulsory Licensing (2021) (Univ. of Witwatersrand Research Report).
- Intellectual Property Association of South Africa (IPASA), Substantive Search and Examination of Patent Applications (2015).
Internet Sources
- Kisch IP, Exciting Reforms Ahead for South African Patent and Design Law (2024), https://www.golegal.co.za/patent-design-law/(last accessed Sept. 24, 2025).
- MSF Access Campaign, Patent Barriers to Medicine Access in South Africa (2016), https://msfaccess.org/(last accessed Sept. 24, 2025).
- Cancer Alliance, Exploring Patent Barriers to Cancer Treatment Access in SA (2017), https://canceralliance.org.za/(last accessed Sept. 24, 2025.)
- MSF Access Campaign, South Africa’s New IP Policy Welcomed by MSF and Fix the Patent Laws (2019), https://msfaccess.org/(last accessed Sept. 24, 2025).
[1] Patents Act 57 of 1978.
[2] Kisch IP, “Exciting Reforms Ahead for South African Patent and Design Law” (2024) available at https://www.golegal.co.za/patent-design-law/.
[3] A Pouris, “Patents and economic development in South Africa” (2011) 20 South African Journal of Science 6.
[4] Patents Act 57 of 1978, s 34 read with Regulations 40 and 41.
[5] Ibid s 25(1).
[6] A Pouris, “Patents and economic development in South Africa” (2011) 20 South African Journal of Science 6.
[7] C Tomlinson et al, “How patent law reform can improve affordability and accessibility of medicines in South Africa: Four medicine case studies” (2019) 109 SAMJ 388.
[8] Constitution of the Republic of South Africa, 1996, s 27.
[9] MSF Access Campaign, “Patent barriers to medicine access in South Africa” (2016).
[10] Cancer Alliance, “Exploring Patent Barriers to Cancer Treatment Access in SA” (2017).
[11] MSF Access Campaign, “South Africa’s New IP policy welcomed by MSF and Fix the Patent Laws” (2019).
[12] Department of Trade, Industry and Competition, “Intellectual Property Policy of the Republic of South Africa Phase I” (2018).
[13] Ibid.
[14] Ibid.
[15] B Zulu, M Phosiwa & M Ncube, “CIPC to introduce Substantive Search and Examination” De Rebus.
[16] Ibid.
[17] Department of Trade, Industry and Competition, “Intellectual Property Policy of the Republic of South Africa Phase I” (2018).
[18] Ibid.
[19] Ibid.
[20] Ibid.
[21] Section27, “The Patent Amendments Bill: The negative impact of half a decade of delays” (2024).
[22] N Lesofe, “Anti-competitive behaviour as a ground for compulsory licensing” (2021) University of the Witwatersrand Research Report
[23] Department of Trade, Industry and Competition, “Intellectual Property Policy of the Republic of South Africa Phase I” (2018).
[24] C Tomlinson, “Reforming South Africa’s procedures for granting patents to improve medicine access” (2015) 105 SAMJ 741.
[25] IPASA, “Substantive search and examination of patent applications” (2015).
[26] IPASA, “Substantive search and examination of patent applications” (2015).
[27] Ibid.
[28] Department of Trade, Industry and Competition, Intellectual Property Policy of the Republic of South Africa Phase I (2018).
[29] B Zulu, M Phosiwa & M Ncube, “CIPC to introduce Substantive Search and Examination,” De Rebus.
[30] C Tomlinson, “Reforming South Africa’s procedures for granting patents to improve medicine access,” (2015) 105 South African Medical Journal 741.
