On 14 May 2020 the European Patent Office (EPO) Enlarged Board of Appeal issued opinion G 3/19 (Pepper), in which it may have finally ended the debate on the patentability of plants and animals which are exclusively obtained by essentially biological processes by ruling that these are not patentable.
Article 53(b) of the European Patent Convention (EPC) provides that patents cannot be granted in respect of plant or animal varieties or essentially biological processes for the production of plants or animals. The above debate arose in 2015 when two Enlarged Board of Appeal decisions concluded that under Article 53(b) of the EPC, European patents could not be granted for essentially biological processes for the production of plants or animals, but that this did not extend to products that are exclusively obtained by means of an essentially biological process.
In July 2017 the EPO Administrative Council sought to clarify the situation by introducing Rule 28(2) to the EPC, which provides that under Article 53(b), European patents will not be granted in respect of plants or animals which are exclusively obtained by means of an essentially biological process.
Unfortunately, the waters were muddied in 2018 when a technical board of appeal held that Rule 28(2) of the EPC had no impact on the interpretation of Article 53(b) and instead followed the enlarged board's 2015 decisions.
In 2019 the president of the EPO referred the matter to the Enlarged Board of Appeal, requesting the interpretation of Article 53(b) of the EPC in view of legal and other developments which occurred after its 2015 decisions, particularly in view of Rule 28(2) of the EPC.
On 14 May 2020 the Enlarged Board of Appeal returned its finding on this point of law, ruling that the non-patentability of essentially biological processes for the production of plants or animals also extends to plant or animal products that are exclusively obtained by means of an essentially biological process.
Section 25(4)(b) of the South African Patents Act provides that no patent will be granted for any variety of animal or plant or any essentially biological process for the production of animals or plants which is not a microbiological process or the product of such a process. South Africa has a depositary system for patent filing, under which there is no substantive examination of applications. Any patent application, including one with claims to an essentially biological process or an animal or plant produced from such a process, will be granted, provided that it complies with the formal filing requirements. Any challenge to an allegedly invalid patent must occur after grant in the Court of the Commissioner of Patents.
No South African court precedent interprets this section. However, when considering legislation, the Constitution requires that in addition to local precedent, international court decisions may be taken into account. As the wording of Section 25(4)(b) is similar to Article 53(b) of the EPC, the South African courts will likely take the decisions of the Enlarged Board of Appeal into account when interpreting this section.
This means that in light of the new Enlarged Board of Appeal decision, the South African courts are likely to interpret Section 25(4)(b) to mean that the following are not patenatable:
- essentially biological processes for the production of plants or animals; and
- plant or animal products that are exclusively obtained by means of an essentially biological process.
As regards the meaning of 'essentially biological', the Enlarged Board of Appeal has already provided that unless there is an additional step of a technical nature which introduces a trait into the genome or modifies a trait in the genome of the plant produced which is not the result of mixing the genes chosen for sexual crossing, such a process for production of a plant is excluded from patentability as being essentially biological. Additional steps of a technical nature which merely serve to enable or assist the performance of the steps of sexual crossing of the whole genome of plants or of subsequently selecting plants do not allow a claim to escape the exclusion of patentability.
Although it is possible to obtain a plant breeders' right for such a new variety of plant, the South African Plant Breeders' Rights Act allows for farmers' privilege, under which farmers can use harvested material from the land that they occupy to propagate new plants. This forms part of an ancient agricultural practice in South Africa. Further, many smallholder and subsistence farmers rely on saved seed or the vegetative propagation of crops (eg, maize, sorghum, soya beans, wheat, vegetables and fruit) for their future crops.
No such similar provision relating to farmers' privilege is found in the Patents Act. This means that if the enlarged board's 2015 interpretation were to hold precedent:
- plants that are exclusively obtained by means of an essentially biological process would be patentable; and
- a patent would preclude a smallholder or subsistence farmer from exercising their farmers' privilege.
However, if South Africa follows the board's latest interpretation, where essentially biological processes such as natural breeding techniques have been used to produce a plant or animal product, such a plant or animal product (and the process for producing the plant or animal) will not be patentable.
Another social impact may be the removal of patent restrictions on processed or yielded products from plants and animals which are produced by essentially biological processes that do not themselves meet the patentability requirements.
Ultimately, the impact of the latest European developments on local patent practice remains to be seen.
