Having been the subject matter of patent applications worldwide from as early as 1873, micro-organisms are fast becoming a focus area in South African patent practice. The reason for this is not based on a resurgence of the amount of biological inventions relating to the use of micro-organisms, but rather the complex legislative framework that must be negotiated in order to ensure the validity of a South African patent based on micro-organisms indigenous to the country.
In understanding the legislative framework, applicants must consider:
- the United Nations Convention on Biological Diversity (CBD);
- the Budapest Treaty on the International Recognition of the Deposit of Micro-organisms for the Purposes of Patent Procedure, signed on April 28 1977;
- the South African Patents Act (57/1978); and
- the policy and legislative environment for biodiversity in South Africa.
In this context, concerns extend beyond the scope of patent validity and include the risk of applicants receiving a fine that far exceeds the monetary value of the commercialisation of the patent subject matter.
The impetus for this discussion is Section 61(1)(e) of the Patents Act, which sets out that a patent revocation application can be made on the basis that:
"the complete specification concerned does not sufficiently describe, ascertain and, where necessary, illustrate or exemplify the invention and the manner in which is to be performed in order to enable the invention to be carried out by a person skilled in the art of such invention."
Further, under Section 32(6) of the Patents Act and Patent Regulation 28A, if a patent application involves an invention pertaining to a micro-biological process or a product thereof – and therefore requires for the performance of the invention the use of a micro-organism which is unavailable to the public on the date of application – and which cannot be made or obtained on the basis of the description in the specification, a culture of the micro-organism must be deposited with an international depositary authority (IDA) under the Budapest treaty.
To date, South African case law has failed to clarify when a micro-organism cannot be sufficiently made or obtained on the basis of the description in the specification. Further, there is no provision, such as in the United Kingdom, stating that mere failure to make such a deposit is in itself a ground for revocation. As such, it is necessary to look elsewhere to determine when a deposit is required in order to establish sufficiency of disclosure.
The World Intellectual Property Organisation, in its publication on IP theory and practice, states that it is difficult to disclose the micro-organism sufficiently in the description of a specification. In its Manual of Patent Examining Procedure Section 2402, the US Patent and Trademark Office – setting out a similar requirement as seen in Section 32(6) above – recognises the US Court of Appeals Federal Circuit judgment in Ajinomoto Co Inc v Archer Daniels Midland Co,(1) which reiterates that when an invention concerns a new biological material, the material cannot be reproducible even when detailed procedures and a complete taxonomic description are included in the specification. Under these circumstances, the court stated that "it is then a condition of the patent grant that physical samples of such materials be deposited and made available to the public".
In light of the above, it would be safe practice to deposit a micro-organism with an IDA before lodging the patent application in order to avoid possible revocation under Section 61(1)(e) of the Patents Act. As South Africa does not have a recognised IDA, the matter is complicated by the commercialisation and export requirements set out in the National Environmental Management: Biodiversity Act (57/2004), acting within the framework set out in the National Environmental Management Act (107/1998).
The National Environmental Management: Biodiversity Act and the National Environmental Management Act were enacted to ratify the CBD and aim to promote its objectives of conserving biological diversity, ensuring the suitable use of its components and the fair and equitable sharing of the benefits arising out of the utilisation of genetic resources. In enforcing this objective, the National Environmental Management: Biodiversity Act sets out stringent material transfer and benefit-sharing agreement requirements between the applicant and the access provider to the resource when applying to export and commercialise the subject matter of the intended patent application.
Once the applicant has satisfied the requirements set out in the National Environmental Management: Biodiversity Act and obtained the relevant permits, important consideration must be given to the intended recipient IDA country. Unforeseen administrative issues can arise when the applicant intends to import the micro-organism to a state that is not party to the CBD, such as the United States, and therefore does not recognise the permits as issued under the act.
Should an applicant choose to circumvent the onerous requirements of the National Environmental Management: Biodiversity Act when commercialising or exporting the micro-organism as used in the intended invention, Regulations 42(1) and 424(2) of the Regulations on Bio-Prospecting, Access and Benefit-Sharing state that the applicant can be fined an amount not exceeding R10 million or an amount equal to three times the commercial value of the activity, whichever is greater.
For further information on this topic please contact Dawid Prozesky at KISCH IP by telephone (+27 11 324 3000) or email ([email protected]). The KISCH IP website can be accessed at www.kisch-ip.com.
(1) 228 F3d 1338, 1345-46, 56 USPQ2d 1332, 1337-38 (Federal Circuit 2000).