Biotechnology Patents in South Africa
Research and Developmen
Research and development in the life sciences is extremely costly and time-consuming. The pharmaceutical industry provides a good example of the time-scales and funding one needs in order to bring a drug or biological product to market, and most academic or other research programmes do not have these resources available. However, in order to leverage funding or to recoup your investment in biotech research, there is usually one prerequisite required by private and, increasingly, public funders – a clearly defined biotech patent right to the invention. Consequently, without patent protection for usable inventions, investments in science diminish.
The biotech patent system has evolved over the past four centuries to afford patent monopolies to certain individuals who have invested effort and ingenuity in devising new or better solutions to existing problems. Patent monopolies are granted to such individuals as an incentive for them to exploit their patented inventions without having to fend off unfair competition. As a consequence of this, the patent system stimulates further innovation, as competitors advance the field while attempting to find alternative ways of solving the same or similar problems. Far from stifling innovation, biotech patents have been instrumental in fostering advances in technology.
How to obtain patent protection for life sciences inventions:
As you will see from our enclosed patent brochure, all inventions must be novel, inventive and useful in order to be eligible for biotech patent protection. Biotechnological or life sciences inventions are no exception, but it is the manner in which these requirements are addressed that can curb or extend the biotech patent protection you acquire. Certain sections of local and foreign patent legislation deal specifically with inventions relating to biological processes or products and these requirements must be adhered to. Furthermore, only inventions and not mere discoveries are eligible for biotech patent protection – an invention goes further than a mere discovery, as it provides a practical application of the discovery in order to provide a solution to a problem.
Examples of life science inventions which may be eligible for patent protection:
Listed below are examples of life sciences inventions that may be eligible for biotech patent protection. These patent examples should not be considered exhaustive or complete, but serve merely as a guide as to what may possibly be patented in your discipline. Your invention may, of course, encompass several of these artificial classifications and you eventual patent application will most likely be a mosaic covering several aspects of each of these patent classes.
Further notes pertaining to biotechnological inventions and Patents
With the great increase in biotechnological patent filings based upon new and advanced sequencing and fractionation technologies, foreign examining Patent Offices have introduced more onerous requirements on patent applicants filing patent applications for technologies relating to this field, in order to counter the granting of overbroad patents. The patent examiners’ objections relate particularly to the patent requirements for inventiveness, utility and sufficiency of disclosure. We require a full disclosure of your invention in order to fully and clearly describe the invention in sufficient detail in the patent application. Although South Africa no longer requires patent applicants to disclose the best method of performing an invention in the patent specification, this patent requirement is still required by the Patent Offices of numerous foreign jurisdictions and it is a requirement that persons skilled in the field of your technology be able to replicate your results by following the instructions in the patent specification without undue experimentation. Similarly, one cannot obtain general patent protection for DNA sequences of a novel gene in a number of species if one has only sequenced a single vertebrate or invertebrate example. Description of the species usually does not allow protection for the genus in patents in the biosciences. We can only protect what you have invented at the time of filing the patent application and cannot artificially extend your patent rights to protect aspects that you have not shown experimentally in the biotech patent application. Also, DNA sequences for which no function has been demonstrated are generally not considered patentable any longer. On-line motif shopping is not enough and experimental results confirming the predicted function(s) are increasingly being called for by foreign examining patent offices.
Micro-organisms and sufficiency of description in patent applications
As stated above, it is a requirement of patent law that the invention be sufficiently described in the patent application. In the complex field of biotechnology, it is not always possible to fully describe a microorganism in terms of physical, chemical and genetic characteristics in a patent specification. South Africa is a signatory to the Budapest Treaty which provides a solution to this patent problem – patent applicants may deposit a sample of the organism (as claimed in the patent specification) at a recognised patent depository and in doing so may overcome patent examiners’ arguments as regards insufficiency of description of the microorganism in the biotech patent application. The deposit number of the sample must be reflected in the patent specification and the deposit must have been made before or at the time of filing the patent application. Please feel free to contact us regarding the depositing of microbiological samples for your patent applications.
Does obtaining patent protection preclude me from publishing my results?
No – however, you must always first file a provisional patent application before publishing your results, should you wish to protect your patent rights. You may publish your results immediately following the filing of your provisional patent application – you need not wait two or three years until your patent is granted. However, if you publish your results following the filing of your provisional patent application then you are committed to obtaining final patent protection in South Africa and any other foreign countries where you require protection. If your patent application lapses or is not completed timeously then you will lose all patent rights to your invention. As you have by then most likely published the results (and subsequently lost your patent rights), competitors may be free to copy your research without fear of prosecution. Your patent strategy and timelines should thus be seen as integral to your research planning.
Pharmaceutical / Chemical Sciences
Method of Treatment
- A substance or composition for use in a method of treatment; and
- The use of a substance in the manufacture of a medicament to treat a disease.
Plant and Animal Sciences
More information regarding Patents
Patents – In simple terms, a South African patent may be granted for an invention that is: New, Inventive and Useful. If your invention meets these three requirements, generally, subject to certain exclusions detailed below…
Biotech Patents – Research and development in the life sciences is extremely costly and time-consuming. The pharmaceutical industry provides a good example of the time-scales and funding one needs in order to bring…
International Patent Protection – It is important to note that patents are territorial rights – a patent granted in South Africa can be enforced in South Africa only. However, you may, within 12 months…
Software Patents – Historically, software has been protected primarily through the provisions in the South African Copyright Act. Examples of subject matter for copyright protection of computer programs and mobile apps are…
Requirements for Patent Application – We need a full, detailed technical description of the invention in order to draft a patent specification. If you have a prototype or drawings of your invention…
Plant and Animal Sciences – According to the patent laws of several countries, one cannot obtain biotechnological patent protection for plant or animal varieties, or essentially biological processes for the production of plants or animals…
Patent Search – It is very important for applicants to do a patent search for similar inventions before applying for protection. A Patent Search will indicate whether your idea or inventions has been patented before. Although novelty can never be determined…
Patent Requirements – Although novelty can never be determined conclusively, an indication of the novelty of your invention may be found by conducting patent and literature searches. South Africa has a so-called…
Patent Costs – A novelty search is conducted prior to filing a Provisional Patent Application to identify potentially novel and/or inventive aspects of an invention in light of what already exists (i.e. the prior art)…
Patent Exclusions – Anything which consists of a discovery; a scientific theory; a mathematical method; a literary; dramatic, musical or artistic work; or any aesthetic creation; a scheme, rule, or method for performing a mental act…