Firstly, we would like to state that we are in support of the principle that an applicant for a patent should be required to state whether or not the invention is directly derived from an indigenous biological resource or is based on or derived from traditional knowledge or traditional use.

However, we are concerned that some of the provisions of the Bill are unclear, too broad and/or have unduly harsh consequences.

In terms of the Bill, these two terms are defined together.

► It is submitted that as these two terms have distinct and separate meanings under the National Environment Management: Biodiversity Act, 2004 ("the Biodiversity Act"), they should be defined separately in the Bill.

Section 2 of the Patents Act, 1978 ("the Act") is being amended by the insertion of definitions of "traditional knowledge" and "traditional use". Traditional knowledge is defined as meaning "the knowledge that an indigenous community has regarding the use of an indigenous biological resource or genetic resource." Traditional use is defined as "the way in which or the purpose for which an indigenous community has used an indigenous biological or genetic resource." No definition, however, is provided for an indigenous community, either in the Bill or in the Biodiversity Act. In the absence of such a definition, it is submitted that this term is uncertain. For example, is the term "indigenous community" wide enough to cover communities outside of South Africa or is it intended to be limited to communities within South Africa only?

► We therefore submit that a further definition be inserted in section 2 of the Act, as follows:

1. The prescribed form

Proposed subsection 30(3A)(a) refers to "a statement in the prescribed form…". No proposed forms or regulations have been published or made available, and as such we cannot provide any comment thereon.

3.2. The invention

In sections 3A and 3B, it should be made clear that the "invention" is the invention for which protection is claimed – i.e. the invention which is set out in the claims. The body of a patent specification may describe more than one invention, and in some cases describes many inventions, while in general only one invention is claimed. Patent protection is only granted for the invention that is claimed, and thus the statements that are contemplated in the Bill should relate to only the invention that is claimed.

We thus submit that the words "for which protection is claimed" should be inserted after the word "invention" in these sections.

3. Inventions derived from a genetic resource

New subsection 3A(a)(i) requires that an applicant should state whether or not the invention is directly derived from an indigenous biological resource (as defined in the Biodiversity Act) or a genetic resource (as defined in the Biodiversity Act). The definition of a genetic resource is much wider in scope than an indigenous biological resource, in that firstly, a genetic resource is not limited to an indigenous genetic resource and secondly, when it comes to bioprospecting and benefit-sharing, section 80(2) of the Biodiversity Act further limits the definition of an indigenous biological resource. For example, genetic material from humans is excluded, as are exotic plants and animals which have not been modified to include indigenous genetic material.

By including the term "genetic resource" in this provision, any applicant for a patent for an invention derived from a genetic resource, whether human or non-human, and from anywhere in the world, will be required to state that the invention is derived from "an indigenous biological resource or a genetic resource".

Thus, an invention which relates to a new drug discovery made in Europe using one of thousands of commercially available immortal cell lines would fall within the provisions of this section. Applications for inventions relating to the cloning of an animal, such as Dolly the Sheep, would also fall within this section, as would all applications for inventions relating to genetically modified organisms, the fermenting of grains or fruits (e.g. to produce beer or wine), the production of proteins, and so forth. In short, virtually every application for a biologically-based or biotechnology-based invention will be based on some sort of genetic resource. Of these many thousands of applications, only a few will be directly derived from an indigenous biological resource to which the Biodiversity Act relates, and only these few should require proof of title or authority of the applicant to use the biological or genetic resource.

It is therefore submitted that references to a genetic resource in subsection 3A and 3B should be deleted. The definition of an indigenous biological resource as provided by the Biodiversity Act is in any event broad enough to encompass a genetic resource (except where specifically excluded by the provisions of section 80(2), and it is submitted that these exclusions should also apply to this Bill).

There is a minor clerical error in proposed section 30(3A)(b). The phrase "the statement contemplated in subsection (1)…" should instead refer to subsection (3A)(a). Thus, after correction, the phrase should read: "the statement contemplated in subsection (3A)(a)…".

Subsection 3A(b) will have the effect that many patent applications are not afforded the priority date to which they are entitled, and are therefore not valid in South Africa, merely because the signed statement to which this section relates could not be lodged at the time of filing of the patent application. This subsection relates to all patent applications, as a statement is required to be filed for even those applications which don’t relate to the use of an indigenous biological resource, genetic resource, traditional knowledge or traditional use.

In most countries, it is not necessary to lodge the prescribed forms requiring a signature by the applicant or inventor at the time of filing the patent application, and these forms can usually be lodged within a set time after the filing date, or in any event, before the application is accepted.

The provision in section 3A(b) that an application for a patent will be denied a filing date until such time as the declaration has been lodged will make it much more onerous for an applicant to file a South African patent application. The effect hereof will be that it will be impossible for many applicants to file the necessary statement in time to obtain a filing date within the priority period or within the PCT national phase filing period, and the number of patent applications filed in South Africa will decrease.

We instead propose that a patent application should not be accepted unless the required statement has been lodged. This could be handled in the same way as the declaration in terms of regulation 22(c) is handled. Regulation 33 provides a time limit for filing the declaration, and a similar time limit may be prescribed by the regulations.

► We therefore submit that subsection 3A be reworded as follows:

In terms of this subsection, the registrar may require the applicant to provide proof of his or her title or authority to make use of the traditional biological resource or traditional knowledge. The wording "in the prescribed manner" is used, and we presume that this will be set out in new regulations. As previously mentioned, no regulations have been published for comment. We would like to submit, however, that when such regulations are drafted, then the required proof should not be limited to the terms of the Biodiversity Act. There may be other types of agreement which would satisfy the requirement to compensate an indigenous community for its knowledge or use of resources. For example, it is possible that the applicant may have entered into an agreement with an indigenous community before the Act came into force (and indeed, some of the chapters of the Biodiversity Act have not yet come into operation).

► The regulations should therefore include an option along the lines of:

"Any other proof to the satisfaction of the registrar."

In order that the wording of section 61(g) is consistent with the wording of other sections and regulations in the act, the word "declaration" should not be deleted from section 61(g), as this section refers to both the declaration required in terms of regulation 22(c) and the statement required in terms of section 30(3A). Similarly, no "representation" is lodged with the registrar, and this word should therefore not be inserted into the section.

► We thus submit that section 61(g) be amended as follows:

Spoor & Fisher

July 2005