South Africa has extensive laws governing the collection and use of human genetic material (see Table 1 below)3. However, we do not have case law to assist with the interpretation of these statutes. We have a few examples from international law, and we will look at the case of Association for Molecular Pathology v. Myriad Genetics, Inc.1 In the early 1990s, there was very significant research into the genetic causes of breast cancer1. Ultimately, a research group from the University of California at Berkeley, located the gene on chromosome 17 that appeared to play a big role in breast cancer1. The gene was named BRCA1. A biotechnology company, Myriad Genetics, created by the University of Utah’s Centre of Genetic Epidemiology (with funding from Eli Lilly), sequenced the BRCA1 gene1. They proceeded to file patents for the BRCA1 gene sequence as well as more than 40 mutations and variations of the gene1. Myriad also patented a synthetic version of BRCA1 that contained only the essential “working parts” of the gene1.
Source : https://www.nature.com/scitable/topicpage/discovery-of-dna-structure-and-function-watson-397/
Myriad was actively enforcing their rights to exclusivity granted by their numerous patents and sent cease and desist letters to any researchers working on isolating the BRCA1 gene and testing thereof1. Finally, health care organisations, doctors, patient advocacy groups and more, filed a lawsuit against Myriad in 2010, contesting the patents related to BRCA1 and BRCA2 (which they also isolated and filed patents for its sequence)1. After countless court proceedings, the US Supreme court ruled that “[w]hoever invents or discovers any new and useful…composition of matter, or any new and useful improvements thereof”, the court has “long held that this provision contains an important implicit exception[:] Laws of nature, natural phenomena, and abstract ideas” are basic tools and building blocks and, hence, “lie beyond the domain of patent protection”1. Patents exist to promote creation and to protect ideas, while the elements of nature are “free to all men and reserved exclusively to none”1. Consequently, it was agreed that Myriad did not create the genes or alter any information found therein but rather discovered the location of the genes within the chromosomes.
The US Supreme court looked at the Diamond v. Chakrabarty case wherein a patent was granted for the addition of four plasmids to a bacterium which enabled the bacterium to break down some elements of crude oil1. This patent was deemed valid because the addition of the plasmids to the bacterium rendered it new and with different characteristics from those of a naturally occurring organisms1. In Funk Brothers Seed Co. v. Kalo Inoculant Co. some farmers obtained a patent for a mix of bacteria which helped plants to extract nitrogen from the air and fix it to the soil1. This mixture was not found to be patentable as there were no changes made to the bacteria, they were in their natural state1. The court acknowledged the hard work that Myriad put in to locate and sequence the BRCA1 and BRCA2 genes however stated that isolated a gene from a chromosome does not constitute an invention, “discovery, by itself, does not render the BRCA genes” patentable1. The synthetic version of the BRCA1 gene was however deemed patentable because the lab technician created something new even if it had the same sequence as the naturally occurring gene1.
Source : https://www.canva.com/
From the European perspective, Article 3 of the Directive 98/44/EC of The European Parliament and of The Council, states that:
“1. For the purposes of this Directive, inventions which are new, which involve an inventive step, and which are susceptible of industrial application shall be patentable even if they concern a product consisting of or containing biological material or a process by means of which biological material is produced, processed or used.
2. Biological material which is isolated from its natural environment or produced by means of a technical process may be the subject of an invention even if it previously occurred in nature.”2
Unlike the US findings wherein an isolated gene constitutes a discovery and therefore not considered patentable, the EU directive considers such an isolated gene patentable even if it is no different to the naturally occurring gene in its natural environment. This is supported by Article 5 which states that “An element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element.”2 However, the directive requires that the industrial application of said sequence or partial sequence of a gene must be disclosed. So, an isolated sequence may be patentable, but it must have industrial application. Otherwise, it is just a discovery which in many territories, is not patentable.
We are excited to see all the technological developments in the health sector and look forward to practical applications of our statutes. At Tshaya Mashabela Attorneys, we are able to assist you with the protection and commercialisation of your biological inventions, ensuring that it complies with national laws and regulations.
Table 1: Legal instruments affecting collection and use of human genetic materials.
| Title | Description | Date |
| Constitution of the Republic of South Africa | This Constitution is the supreme law of the Republic; law or conduct inconsistent with it is invalid, and its obligations must be fulfilled. | August 23, 2013 (17th amendment) |
| Medicines and Related Substances Act, 1965 (Act No. 101 of 1965) | Establishes the South African Health Products Regulatory Authority. Provides for the regulation of medicines (MRS Act) | June 1, 2017 |
| General Regulations to the Medicines and Related Substances Act of 1965 | Regulations to the Medicines and Related Substances Act, 1965. (MRS Regulations) | August 25, 2017 |
| Genetically Modified Organisms Act, 2007 (Act 15 of 1997) | Provide for measures to promote the responsible development, production, use and application of genetically modified organisms (GMO Act) | April 17, 2007 |
| National Health Act, 2003 (Act No 61of 2003) | Provides a framework for a structured health system in South Africa and takes into account the obligations imposed by the Constitution (NH Act) | September 2, 2013 |
| Government Notice R. 175 | Regulations relating to Artificial Fertilisation of Persons (R. 175) | March 2, 2012 |
| Government Notice R. 177 | Regulations regarding Human Biological Materials (R. 177) | March 2, 2012 |
| Government Notice R. 179 | Regulations relating to Blood and Blood Products (R. 179) | March 2, 2012 |
| Government Notice R. 180 | Regulations regarding the General Control of Human Bodies, Tissue, Blood, Blood Products and Gametes (March 2, 2012) and amended by Government Notice 392 in Government Gazette 40816 (R. 180) | April 26, 2017 |
| Government Notice R. 181 | Regulations relating to the Import and Export of Human Tissue, Blood, Blood Products, Cultured Cells, Stem Cells, Embryos, Foetal Tissue, Zygotes and Gametes (R. 181) | March 2, 2012 |
| Government Notice R. 182 | Regulations on Tissue Banks (R. 182) | March 2, 2012 |
| Government Notice R. 183 | Regulations on Stem Cell Banks (R. 183) | March 2, 2012 |
Source : https://www.sciencedirect.com/science/article/pii/S0300908422000505
Written by: Tumelo Mashabela, Managing Director and Registered Patent Attorney
For all your IP, commercial and corporate law services, please contact us on 012 942 8710 / tumelom@tm-attorneys.africa. You can also find us on social media platforms with the handle @TshayaMashabelaAttorneys (@TshayaMashabela on Twitter).
References:
- https://journalofethics.ama-assn.org/article/supreme-court-myriad-genetics-synthetic-dna-patentable-isolated-genes-are-not/2015-09
- https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX%3A31998L0044%3AEN%3AHTML
https://www.sciencedirect.com/science/article/pii/S0300908422000505
