Patenting DNA – discovery or invention?
In grappling with the question as to whether DNA is a patentable invention or a mere discovery, scientists and patent lawyers have been at loggerheads for years. The South African 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.
There is, to date, no significant South African case law providing substantive definitions to facilitate an understanding as to what an “essentially biological process” for the production of animal or plants and “microbiological process” or the products of such processes means. Guidance is therefore sought from the European Directive for the Legal Protection of Biotechnological Inventions (Directive 98/44/EC).
The Directive defines “biotechnological inventions” as inventions concerning a product consisting of, or containing, biological material or a process by means of which biological matter is produced, processed or used. “Biological material” is defined as any material containing genetic information and capable of reproducing itself or being reproduced in a biological system. A process for the production of plants or animals is “essentially biological” if it consists entirely of natural phenomena such as crossing or selection. “Microbiological process” is defined as any process involving or performed upon or resulting in microbiological material and “plant variety” means, in summary, any plant grouping within a single botanical tax on of the lowest known rank.
The Directive furthermore provides that biotechnological inventions are patentable if they concern biological material which is isolated from its natural environment or produced by means of a technical process, plants or animals if the technical feasibility of the invention is not confined to a particular plant or animal variety, and a microbiological or other technical process, or a product obtained by means of such a process other than a plant or animal variety.
It is stipulated that patents shall not be granted in respect of biotechnological inventions which, in particular, concerns a process for cloning human beings, processes for modifying germ line genetic identity of a human, uses of human embryos for industrial or commercial purposes, processes for modifying the genetic identity of animals that are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes. It is thus evident that a sequence or partial sequence of a gene 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 that element is identical to that of a natural element.
In the absence of relevant South African case law directly dealing with the patenting of DNA, further guidance is sought from foreign case law. In particular, Myriad Genetics Inc litigated extensively in the USA and Australia, regarding the validity of patents on two human genes associated with breast and ovarian cancer (BRCA1 and BRCA2).
On 13 June 2013, USA’s Supreme Court held that isolated genomic DNA (“gDNA”) is not patentable under their Patents Act. However, complementary DNA (“cDNA”) was found to be patentable. cDNA is defined as synthetically created DNA which contains the same protein-coding information found in DNA but excludes the DNA-portions which do not code for proteins (non-coding regions). 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 patents on the BRCA1 and BRCA2 genes. However, the Court further held that manipulation of a gene to create something not found in nature, such as a strand of synthetically-produced cDNA, could still be eligible for patent protection. The impact of the case was of fairly straightforward significance in that it struck down patent claims on gDNA that has been merely ‘isolated’ from the body without any further manipulation and more specifically held that gDNA was not patentable subject matter as provided for in the US Patents Act. Thus a patent claiming for isolated DNA sequence which codes for a specified protein is invalid.
On 7 October 2015, the High Court of Australia, handed down judgment in the D’Arcy v Myriad Genetics Inc and Anor matter, and held that three BCRA patent claims was not a ‘patentable invention’. The patentability requirement which was at issue was the concept of a “manner of manufacture” – it was held that it cannot be patentable as the invention as claimed would involve an extension of the concept of a manner of manufacture which was not appropriate for judicial determination. It is thus evident for claims involving so-called ‘new disruptive innovations’ (i.e. those “unimagined technologies with unimagined characteristics and implications”) and which don’t fit into an established class of products or processes, the courts are likely to take public interests into account and consider international intellectual property laws.
New disruptive innovations are causing ripples in patent waters and technology develops faster than lawmakers amend patent laws. Ultimately a sensible approach is to be adopted in light of the provision in the South African Patents Act that a mere discovery is not patentable.