Scientists and patent lawyers have long disagreed over whether DNA is a patentable invention or a mere discovery.
The Patents Act states that a patent shall not be granted "for any variety of animal or plant or any essentially biological process for the production of animals or plants, not being a micro-biological process or the product of such a process".
However, at present, there is no significant South African case law providing substantive definitions to facilitate an understanding of:
- an 'essentially biological process' for the production of animals or plants; or
- a 'microbiological process' or the product of such a process.
The EU Directive for the Legal Protection of Biotechnological Inventions (98/44/EC) provides some guidance on this matter. It states that a process for the production of plants or animals is 'essentially biological' if it consists entirely of natural phenomena such as crossing or selection. Further, a 'microbiological process' is defined as any process involving or performed on or resulting in microbiological material.
As such, a sequence or partial sequence of a gene likely cannot constitute a patentable invention. However, 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 be regarded as patentable even if the structure of the element is identical to that of a natural element.
There is also an absence of relevant South African case law that directly addresses DNA patenting. However, it is evident from foreign case law that when considering claims involving so-called 'new disruptive innovations' (ie, unimagined technologies with unimagined characteristics and implications) which do not fit into an established class of product or process, the courts will likely take public interests into account and consider international IP laws. An example of this is Myriad Genetics Inc's extensive litigation in the United States and Australia regarding the validity of its patents for two human genes associated with breast and ovarian cancer (BRCA1 and BRCA2). On June 13 2013 the US Supreme Court held that isolated genomic DNA is not patentable under the US Patents Act. The court unanimously ruled that "a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated", thus invalidating Myriad's BRCA1 and BRCA2 patents. Subsequently, on October 7 2015, the Australia High Court handed down judgment in D'Arcy v Myriad Genetics Inc, holding that the three BCRA patent claims were not patentable inventions.
As new disruptive innovations are causing ripples in patent waters and technology is developing faster than lawmakers are amending patent laws, a sensible approach should be adopted in light of the provision in the Patents Act which holds that a mere discovery is not patentable.
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