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TRADE AND INDUSTRY PORTFOLIO COMMITTEE Mr B Martins (ANC)
2 August 2005
PATENTS AMENDMENT BILL: HEARINGS
Documents handed out:
TRADE AND INDUSTRY PORTFOLIO COMMITTEE
Mr B Martins (ANC)
Submission by the South African Institute of Intellectual Property
Submission by Spoor and Fisher
Submission Wits Aids Law Project
Submission by Mr B Erasmus
Patents Amendment Bill [B17-2005]
The Committee heard submissions from the South African Institute of Intellectual Property, Spoor and Fisher and Wits Aids Law project on the Patents Amendment Bill [B17 – 2005]. There was also a written submission by Mr BJ Erasmus. All presenters supported the principles of the Bill but proposed some amendments to strengthen and clarify it.
The definition of ‘indigenous biological resource or genetic resource’ should be slightly amended to read "indigenous biological resource or indigenous genetic resource". There could be no doubt that the Bill, when passed into law, would be confined to the Republic of South Africa and would not apply extra territorially.
Another amendment was proposed with regard to the granting of the filing date. It was submitted that paragraph (b) of the proposed Clause 30(3A) should be amended to read: "an application contemplated in subsection (1) shall not be accepted until the statement contemplated in subsection (3A)(a) has been lodged with the registrar". This would not affect the principle of the Bill. The Registrar would still be precluded from granting the application until the statement had been lodged.
It was also submitted that the Bill should be strengthened in relation to the proof of title or authority to make use of the identified indigenous biological resource, genetic resource, traditional knowledge and/or traditional use. Proof of title should accompany the application. A pre-grant opposition system by interested parties should be introduced.
Members welcomed support for the Bill, but cautioned that international patents law should not be followed slavishly without a comprehensive review of South African patents legislation.
The Chairperson welcomed Members to the meeting and invited Mr M le Roux (President: South African Institute of Intellectual Property) to make his submission. Mr Le Roux also spoke on behalf of the following law firms: Adams & Adams, Bowman Gilfillan Incorporated and DM Kisch Incorporated. The Bill originated from the Convention on Biological Diversity to which South Africa acceded in 1995 and the National Environmental Management: Biodiversity Act of 2004. The Institute supported the principles of the Bill but felt that there was a need for rectification of the wording in the Bill. There was also a need for an amendment to Clause 2 of the Bill. At the very heart of the Bill was the requirement that a person who was applying for a patent had to lodge a statement stating whether the invention was derived from an indigenous biological resource or a genetic resource and whether it was derived from traditional knowledge or traditional use. The Bill also provided that the Registrar might, upon receipt of the statement, call upon the applicant to furnish proof as to his or her title or authority to make use of the indigenous biological resource or the genetic resource or of the traditional knowledge or traditional use.
Mr Le Roux said that the definition of ‘indigenous biological resource or genetic resource’ should be slightly amended to read "indigenous biological resource or indigenous genetic resource". There could be no doubt that the Bill, when passed into law, would be confined to the Republic and would not apply extra territorially. The Registrar, upon receipt of the statement, could not be expected to investigate foreign genetic resources. It was clear that the Bill was intended to give further substance to the National Environmental Management: Biodiversity Act. The word ‘indigenous’ should be inserted before the words ‘genetic resource’ everywhere they occurred in the Bill.
The proposed Clause 30(3A)(b) was also problematic. It provided that "despite subsection (6) an application contemplated in subsection (1) shall not be given a lodging date until the statement contemplated in subsection (1) has been lodged with the registrar". It appeared that there was an erroneous reference to subsection (1) instead of section 3A(a). It should read: "despite subsection (6) an application contemplated in subsection (1) shall not be given a lodging date until the statement contemplated in subsection (3A)(a) has been lodged with the registrar".
The South African patent system rested on an applicant who had applied for a patent being allocated a filing date. This was the date on which the applicant had lodged the application with the Registrar. Any patent system could not function without a filing date being allocated. Section 30(6) of the Patents Act set out three minimum requirements for a patent application to receive a filing date. The applicant should tender the prescribed fee; submit the prescribed application form and one copy of the specification and drawings describing the invention.
Mr L Labuschagne (DA) asked if the lodging and filing dates where one and the same thing. Mr Le Roux agreed.
Mr Le Roux said that there were many other requirements that an applicant had to comply with before the application could be accepted and granted. There was no reason why the statement contemplated in the Bill should become a basic filing requirement so that a date could be allocated. The statement, along with all the other requirements, must be filed with the Registrar and the Registrar should not issue acceptance of the application until the statement had been filed. There were usually time limits within which some of the requirements had to be filed. For instance, the declaration had to be filed within six months of the application. The Registrar could also call for the outstanding requirements before processing the application. The international position with regard to the issuing of the filing date was that the requirements were kept down to as few as possible. He gave Kenya, Botswana, the Philippines and Argentina as examples.
Like other systems across the world, the South African patent system was a first-to-file system. Should person A file an application for a patent before person B, A would enjoy protection over B. The denial of a filing date would lead to a large-scale loss of rights. An invention could not be patented if it was already known. It was must be new as at the date of the filing of the application. It was often the case that an applicant might have to file the application in a hurry because the invention was about to be disclosed or exhibited. The filing of the statement requirement could frustrate attempts to preserve the novelty of the invention. The statement could not be taken lightly because the applicant might have to do considerable research and background work to ensure that the statement was accurate and correct.
The applicant might have to involve inventors in investigating whether the invention was one that involved an indigenous biological resource or an indigenous genetic resource or was based on traditional knowledge or use. In terms of Clause 3 of the Bill a false representation or statement might lead to the revocation of the patent. It was submitted that subparagraph (b) of the proposed Clause 30(3A) should be amended to read "an application contemplated in subsection (1) shall not be accepted until the statement contemplated in subsection (3A)(a) has been lodged with the registrar". This would not affect the principle of the Bill. The Registrar would still be precluded from granting the application until the statement had been lodged.
Mr Labuschagne said that it seemed that the proposed amendments were technical and did not affect the principles of the Bill. The Institute’s argument was not against the submission of the statement but the time in which it had to be lodged. The Bill provided that the statement should be lodged upfront.
Mr Le Roux confirmed that Mr Labuschagne’s understanding was correct. The grant of the patent was the final step in the procedure. The Registrar would issue acceptance once all the documents had been submitted. The application would then be published in a patent journal and then granted.
Spoor and Fisher submission
Ms S Clelland made the submission. (See document attached). This firm of attorneys supported the principle that an applicant for a patent should be required to state whether or not the invention was directly derived from an indigenous biological resource or was based on or derived from traditional knowledge or traditional use. However, some of the provisions of the Bill were unclear, too broad and/or had unduly harsh consequences. She supported the submission by Mr Le Roux with regard to the granting of the filing date.
The definition of traditional knowledge and traditional use referred to the indigenous community. However, no definition was provided for an indigenous community in either the Bill or the Biodiversity Act. A further definition should be inserted in Section 2 of the Act. An indigenous community should mean "a community of people which occurs, or has previously occurred, within the borders of the Republic".
The requirement that an applicant for a patent should state whether or not the invention was directly derived from an indigenous biological resource or a genetic resource was problematic. The definition of a genetic resource was much wider in scope than an indigenous biological resource. The definition of an indigenous biological resource as provided by the Biodiversity Act was in any event broad enough to encompass a genetic resource (except where specifically excluded by the provisions of Section 80(2)). The exclusions included genetic materials of human origin, exotic plants and animals that had not been modified to include indigenous genetic materials.
The definition of an indigenous biological resource was problematic, in that firstly, a genetic resource was not limited to an indigenous genetic resource and secondly, when it came to bioprospecting and benefit-sharing, Section 80(2) of the Biodiversity Act further limited the definition of an indigenous biological resource. For example, genetic material from humans was excluded, as were exotic plants and animals that 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, would be required to state that the invention was derived from "an indigenous biological resource or a genetic resource".
The proposed subsections 3A and 3B should clearly state that the invention in question should be the invention for which protection was claimed. The words "for which protection is claimed" should be inserted after the word "invention" in these subsections. Patent protection could only be granted for the invention that was claimed. The body of a patent specification might describe more than one invention, and in some cases described many inventions, while in general only one invention was claimed.
In terms of Clause 30(3B) 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" was used, and one presumed that this would be set out in new regulations. No regulations had been published for comment. It was submitted that when such regulations were drafted, the required proof should not be limited to the terms of the Biodiversity Act. There might be other types of agreements that would satisfy the requirement to compensate an indigenous community for its knowledge or use of resources. For example, the applicant might have entered into an agreement with an indigenous community before the Act came into force.
Ms Clelland also submitted that the word "declaration" should not be deleted from Section 61(g) of the Act as this section referred both to the declaration required in terms of regulation 22(c) and the statement required in terms of the proposed Clause 30(3A). The word "representation" should be deleted from the clause.
Mr Labuschagne asked if the presenter felt that the definition of indigenous biological resource in terms of the Biodiversity Act was sufficient and the words ‘genetic resource’ could therefore excluded. Ms Clelland agreed.
Mr J Maake (ANC) asked what would be contained in the statement contemplated in the Bill.
Mr Clelland replied that the Department of Trade and Industry had not yet published the statement. It might require an applicant to say if the invention related to an indigenous biological resource or genetic resource or traditional knowledge or use. The applicant might be required to state how he had obtained permission to use the traditional knowledge or use.
Wits Aids Law Project and Treatment Action Campaign submission
Mr J Berger (Head of Law and Treatment Access Unit) made the submission. (See document attached). He supported the Bill and the manner in which it sought to achieve its objectives. However, some amendments were necessary to strengthen the Bill.
The Bill should be strengthened in relation to the proof of title or authority to make use of the identified indigenous biological resource, genetic resource, traditional knowledge and/or traditional use. One should not have to wait for the Registrar to request such information. Proof of title should accompany the application. Without the obligation on the applicant to submit proof, a patent could be granted in the absence of title or authority, amounting to classic biopiracy. A pre-grant opposition system by interested parties should be introduced. The South African patent system operated in the absence of any detailed patent examination. This opened the way for granting patents that should not have been granted. The grounds of patent revocation should be expanded to include revocation on the basis of a lack of valid legal title or authority.
He submitted that South Africa required a comprehensive review of its patent legislation to enable the development of an appropriate patent regime within the bounds of both what was permitted in terms of international trade law and what was required by international human rights law and the Constitution. In many respects, the level of protection afforded to patentees in the Patents Act remained inappropriate for a country with our level of development, burden of disease and industrial strategy regarding the domestic generic pharmaceutical industry.
Mr Labuschagne asked for clarification on the opposition procedure under the current law. He was of the view that there was no pre-grant opposition. He asked if opposition was only possible once the patent had been granted and published.
Mr Berger replied that one could apply for a revocation of a patent in terms of Section 61 of the Patents Act. Opposition to the patent was possible only once it had been granted.
Mr Le Roux replied that the 1978 Patents Act had done away with the opposition procedure. One could still apply for a revocation. This was based on the principle that patent applications in South Africa were not examined on their merits. South Africa had a deposit system similar to the one in the Netherlands. The Act contained a provision that precluded a patentee from instituting any proceedings for the infringement of a patent for a period of nine months after the granting of the patent. This period was there to allow people to apply for revocation.
Mr M Netshitenzhe replied that people should not place too much reliance on international experience when dealing with the minimum requirements for an application for a patent. Such experiences should be carefully considered because some countries were not yet signatories to certain international conventions and treaties on biological diversity. Some of them were even vehemently opposed to what the Bill intended to achieve. He agreed that South Africa could not legislate beyond its borders. However, it could have some influence across its borders. He also agreed with the need for a holistic review of patent legislation. However, it was important to confine the discussion to the contents of the Bill. It was encouraging that all presenters had supported the Bill. The Department would carefully study the submissions and respond in due course. The Department would effect some amendments around the granting of the date of filing.
The meeting was adjourned.