Overview of the South African Patent System
South Africa's patent system is a critical component of the country's intellectual property framework, but it has been criticized for its impact on public health and access to affordable medicines. The system is characterized by a non-examining patent process, which lacks substantive search and examination of patent applications[5].
Patentability Requirements
For a biopharmaceutical invention to be patentable in South Africa, it must meet specific criteria:
- Novelty: The invention must be new and not have been disclosed to the public before the patent application.
- Inventive Step: The invention must involve an inventive step, meaning it must be non-obvious to a person skilled in the field.
- Utility in Trade, Industry, or Agriculture: The invention must be capable of being used in trade, industry, or agriculture[3].
Challenges in Patent Examination
South Africa currently operates under a patent registration system rather than a patent examination system. This means that the South African Patent Office does not conduct substantive examinations to determine if the claimed inventions meet patentability requirements. Instead, the examination is often conducted by courts during infringement or revocation proceedings[3][5].
Impact of Weak Patent Standards
The lack of substantive examination and weak patent standards in South Africa lead to several issues:
- Frivolous and Abusive Patenting Practices: Pharmaceutical companies can obtain multiple patents on minor modifications to existing drugs, a practice known as "evergreening." This extends patent protection beyond the standard 20 years and keeps medicine prices artificially high[2].
- Excessive Patenting: South Africa grants more patents on pharmaceuticals than other emerging economies, such as India, Brazil, and Argentina. This excessive patenting prevents cheaper generics from entering the market, making lifesaving drugs unaffordable[2].
Evergreening and Its Consequences
Evergreening is a significant problem in South Africa's patent system. Pharmaceutical companies exploit this by making trivial changes to existing molecules to secure new patents. To prevent evergreening, South Africa should adopt stricter national criteria similar to those in Argentina or India, excluding new uses, new forms, new formulations, or other trivial changes from patentability[2].
Compulsory Licenses
Compulsory licenses are a critical flexibility under the TRIPS Agreement that countries can use to access affordable medicines. However, in South Africa, the process for issuing a compulsory license is burdensome and requires a court application, which is time-consuming and costly. There has been no compulsory license issued for a medicine in South Africa to date. Reforming the process to include an administrative route could expedite access to affordable medicines[1][2].
Parallel Importation
South Africa does not utilize parallel importation, which allows countries to import patented medicines from countries where they are sold at lower prices. Adopting parallel importation, as seen in countries like Kenya and the Philippines, could help reduce the cost of medicines in South Africa[2].
Patent Eligibility in Life Sciences
Genetic Sequences and cDNA
The patentability of genetic sequences and cDNA is a contentious issue. While the European Court has recognized the patentability of isolated genetic sequences, the Australian Court has ruled that cDNA genetically identical to a naturally occurring gene sequence is not patentable. South African courts have not yet adjudicated on this matter but may follow European precedents[3].
Antibodies and Diagnostic Tools
Antibodies play a crucial role in life sciences as therapeutic drugs and diagnostic tools. Their patent eligibility is evaluated similarly to other inventions, requiring novelty, an inventive step, and utility in trade or industry[3].
Methods of Treatment
Methods of treatment by surgery or therapy, as well as diagnostic methods performed on humans or animals, are generally not eligible for patent protection in South Africa and Europe. However, substances and compositions intended for use in these methods are eligible for patent protection. In contrast, the US allows medical methods of treatment to be patented[3].
Enforceability of Patents
Preliminary Injunctions
Preliminary injunctions are a common tool in patent litigation in South Africa. The courts consider the validity of the patent claims when deciding on preliminary injunctions. If a patent claim is found to be invalid, the entire patent can be rendered invalid and unenforceable until the invalidity is cured by amendment[5].
Divisional Patents
South African law allows for parent and divisional patents with overlapping claims of varying scope, but coterminous claims (claims of identical scope) are not permitted. Patentees often manage their patent applications to ensure commercially important embodiments are claimed in divisional applications[5].
Retailers and Preliminary Injunctions
Retailers must be cautious of preliminary injunctions, especially when generic companies launch products "at risk" before clearing patent issues. The courts in South Africa have favored the grant of preliminary injunctions in such cases, which can significantly impact the market availability of generic medicines[5].
Role of Public Interest
The public interest plays a crucial role in patent litigation, particularly in the life sciences sector. Courts must balance the need to incentivize innovation with ensuring public access to healthcare. The South African Constitution guarantees the right to healthcare, and the state has a positive obligation to progressively realize this right. Therefore, patent laws and their enforcement must align with public health objectives[2].
Key Takeaways
- Substantive Examination: South Africa needs to transition from a registration system to a substantive examination system to ensure patents meet national criteria.
- Compulsory Licenses: Simplifying the process for issuing compulsory licenses could expedite access to affordable medicines.
- Parallel Importation: Adopting parallel importation could reduce medicine costs.
- Evergreening: Stricter national criteria are needed to prevent evergreening practices.
- Public Interest: Patent laws and enforcement must balance innovation with public health needs.
FAQs
What are the main challenges with South Africa's current patent system?
The main challenges include weak patent standards, lack of substantive examination, and the prevalence of evergreening practices, which keep medicine prices high and prevent generics from entering the market.
How does the lack of substantive examination affect patent quality in South Africa?
The lack of substantive examination leads to the granting of patents that do not meet national patentability criteria, resulting in excessive and frivolous patenting that keeps prices artificially high.
What is evergreening, and how does it impact access to medicines?
Evergreening involves making minor modifications to existing drugs to secure new patents, extending patent protection and keeping medicine prices high. This practice prevents cheaper generics from entering the market.
Why are compulsory licenses important, and how can the process be improved in South Africa?
Compulsory licenses are crucial for accessing affordable medicines. The process in South Africa is currently burdensome and requires a court application. Improving this by introducing an administrative process could expedite access to affordable medicines.
How does the South African patent system compare to other emerging economies?
South Africa grants more patents on pharmaceuticals than other emerging economies like India, Brazil, and Argentina, and is more willing to grant patent monopolies than even the U.S. or European Patent Offices.
Sources
- South Africa's patent system encourages profits over lives | MSF
- Why we need to Fix the Patent Laws in South Africa:
- Patentability of Life Sciences Invention - Spoor & Fisher
- Coterminous Meaning for Divisional Patents - Spoor & Fisher
- Life Sciences & Pharma IP Litigation 2024 - South Africa
