BIOPIRACY: A Biopsy of the administrative dilemma involved in ensuring sound patent practice
The term “biopiracy” was coined to refer to the appropriation of plants and traditional knowledge by corporations and other entities for their own financial gain.
With recent legislation coming to the fore to safeguard traditional knowledge around the world and especially in South Africa, the role of patents has become more important than ever before.
Sufficient disclosure of an invention is a principal requirement for a patent application. This means that a person skilled in the art should be able to perform the invention as detailed in the description of the invention in the patent application without undue burden. More so, the description must be written in a manner which enables the skilled person to carry out the invention.
It is sometimes difficult, if not impractical, to describe inventions in a way which allow them to be repeated from written instructions alone. This particularly applies to inventions based on biological materials, such as microorganisms. For instance, where a microorganism is publicly available, the skilled person can carry out the invention by following the written description and by obtaining the microorganism from a public source. If this microorganism is not readily available, a patent using it could be rendered invalid because its disclosure was not repeatable.
This difficulty has been partially overcome by the practice of depositing biological materials and is regulated by the Budapest Treaty. This Treaty provides the possibility to deposit samples of biological material with an International Depositary Authority (IDA) in order to enable the sample to become available to persons wishing to repeat the disclosure of the patent application.
Noteworthy is that no IDA exists in South Africa and thus applicants wishing to deposit samples of biological material in order to comply with the disclosure requirements pertaining to their patent application will need to contact an IDA in other country.
This challenge is further compounded by the onerous requirements set forth by South Africa’s Bioprospecting Regulations stipulating that a bioprospecting permit must be applied for and granted in respect of all indigenous resources, including microorganisms, indigenous to South Africa.
Unfortunately, the administrative burden does not end there. A bioprospecting export permit must also be applied for and granted in all instances where indigenous resources are sought to be exported from South Africa.
In view of the above, and in order to comply with the Budapest Treaty requirement for depositing biological material, applicants in South Africa are obliged to first apply for a dual bioprospecting and export permit in order to enable use of the microorganism and exportation of the microorganism to the IDA of another country.
It is not guaranteed that, after obtaining the abovementioned bioprospecting and export permit in order to allow the microorganism to be exported from South Africa, that a country of interest having an IDA where the microorganism is sought to be deposited, will, in fact, allow that microorganism to be imported into that country with a view to be deposited with that country’s IDA.
One well established IDA known to the writer requires specific import permits from various regulatory agencies of that country, such as the Department of Agriculture and the Public Health Service, which are to be duly applied for and granted prior to acceptance and deposit of the microorganism. In addition, hereto, safety testing is required in respect of certain cell lines, hybridomas and microorganisms before importation will be granted, adding further administrative burden and timing implications which, in turn, has an effect on the patent application process.
In particular, there is no clarity regarding when the microorganism must be deposited in so far as this relates to the patent application process.
In certain jurisdictions, the priority document plays a fundamental role towards the validity of the eventual granted patent (for instance, in Europe) and thus it would be essential to deposit the microorganism with an IDA and to obtain the depository number which is to be included in the patent application as early as in the first priority document.
In other jurisdictions, Patent Offices allow the sample to be deposited any time prior to the grant of the patent application, allowing for ample time (in fact, several years) to effect deposit of the microorganism with an IDA. This is especially true for the US.
In South Africa, it would be advisable to err on the side of caution and to deposit the microorganism prior to the filing of the priority document (also known as a South African provisional patent application) in order to avoid invalidity objections on a future granted patent.
The administrative dilemma regrettably does not end there. In South Africa, the requirements for completing the bioprospecting permit includes almost full disclosure of the invention in the form of a detailed project proposal which is to be attached to the bioprospecting permit application.
Should this information end up in the wrong hands, this would have dire consequences, jeopardizing the novelty of the invention for which the patent application is sought. More so, no directive has been given by South Africa’s Department of Environmental Affairs (DEA) on whether this information will remain confidential.
It would thus be wise to caution applicants to insist on a Non-Disclosure Agreement being signed by the recipient of the bioprospecting permit application at the DEA to preserve confidentiality.
Our team of specialised patent attorneys are at your disposal to discuss any aspects of the process in further detail.
1 - The "person skilled in the art" is presumed to be a skilled practitioner in the relevant field of technology, who is possessed of average knowledge and ability and is aware of what was common general knowledge in the art at the relevant date. He/she should also be presumed to have had access to everything in the "state of the art" and to have had at his disposal the means and capacity for routine work and experimentation which are normal for the field of technology in question.
2 - Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure, 1977
3 - Bioprospecting, Access and Benefit Sharing (BABS) Regulations, 2008
4 - Provided by the Department of Environmental Affairs, Republic of South Africa