Patenting micro-organisms: To deposit or not to deposit
Micro-organisms, although the subject matter of patent applications from as early as 1873 internationally, are fast becoming a focus area in South African local patent practice. The reason for this is not based in a resurgence of the amount of biological inventions relating to the use of micro-organisms, but rather the complex legislative framework that needs to be negotiated in order to ensure the validity of a South African patent based on micro-organisms indigenous to the Republic.
In understanding the legislative framework, the applicant has to consider the United Nations Convention on Biological Diversity (CBD), the Budapest Treaty, the South African Patents Act 57 of 1978 (the Patents Act) and the policy and legislative environment for biodiversity in South Africa. Recognition must be given to the fact that the concern extends beyond the scope of patent validity, but to where an applicant is issued a fine far exceeding the monetary value of the commercialisation of the patent subject matter.
Providing the impetus for the discussion is Section 61(1)(e) of the Patents Act which sets out a ground for application for revocation of a patent as follows:
“…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 to this, in terms of 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 not available 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.
Given that there is as of yet no clarity in South African case law as to when a micro-organism cannot be sufficiently made or obtained on the basis of the description in the specification and 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, one must look elsewhere to try and understand when a deposit is required in order to establish sufficiency of disclosure.
The World Intellectual Property Organization, in their publication on the theory and practice of Intellectual Property, states that it is difficult, if not impossible, to disclose the micro-organism sufficiently in the description of a specification. The United States Patent and Trademark Office, in their Manual of Patent Examining Procedure Section 2402 setting out a similar requirement as seen in section 32(6) above, recognises the judgment in Ajinomoto Co. Inc. v Archer Daniels Midland Co. in the United States Court of Appeals, Federal Circuit. The judgment reiterates that when an invention relates to a new biological material, the material may not be reproducible even when detailed procedures and a complete taxonomic description are included in the specification. Under these circumstances the court stated:
“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 at an IDA prior to lodging the patent application in order to avoid possible revocation under Section 61(1)(e). Seeing as South Africa does not have a recognised IDA, the matter is complicated by the commercialisation and export requirements as set out in the National Environmental Management: Biodiversity Act 57 of 2004 (NEMBA), acting within the framework as set out in the National Environmental Management Act 107 of 1998 (NEMA).
NEMBA and NEMA were enacted to ratify the CBD and intend to promote its objective as conserving biological diversity, ensuring the suitable use of its components and the fair and equitable sharing of the benefits arising out of the utilization of genetic resources. In enforcing this objective NEMBA sets our 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 NEMBA and has been issued the relevant permits, important consideration must then 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, such as the United States of America, not party to the CBD, therefore not recognising the permits as issued under NEMBA.
Should an applicant choose to circumvent the onerous requirements of NEMBA when commercialising or exporting the micro-organism as used in the intended invention, Regulations 42(1) and 424(2) in terms of the Regulations on Bio-Prospecting, Access and Benefit-Sharing states that the applicant can be fined an amount not exceeding ten million rand, or an amount equal to three times the commercial value of the activity, whichever is the greater.
In this regard it is as true as ever that ignorance of the law excuses no man, and when protecting biotechnology, take due regard of the above going forward. At KISCH IP we pride ourselves in being experts in this field and are available to assist you with your enquiry.
1. Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure, signed on 28 April 1977
2. 228 F.3d 1338, 1345-46, 56 USPQ2d 1332, 1337-38 (Federal Circuit 2000)