Biotech / Biotechnology
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.
Background to Biotechnological Patents
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 can I obtain patent protection for my life sciences invention?
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.
Genetic Engineering Patents
Isolated DNA sequences, proteins to which functions have been ascribed, and other metabolites are usually viewed in patent terms as chemical compounds, much like a new organic drug molecule. The unique sequence of the nucleotides or amino acids that you have uncovered constitutes a novel biological molecule (much like a novel chemical molecule) and may thus be patentable. In addition, vectors containing your nucleotide sequence and cells containing the vector / DNA may also be patented, provided they are new.
Microbiological Sciences Patents
South African patent law provides specifically for the patenting of microbiological processes (such as fermentation or brewing) and the products derived therefrom. This would obviously include genetically modified organisms used in such processes, which may also be eligible for patent protection. In addition, new microbes that you have isolated, purified and cultured are generally considered patentable, provided they can fulfill the usefulness patent requirement described above. There are, however, certain preconditions for patent applications regarding the depositing of sample materials that have to be met - this is discussed below.
Plant and Animal Sciences Patents
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. However, as there has been no South African case law addressing this aspect of patent law, one has to look further afield to European and UK patent court decisions. It appears from the European Biotech Directive and the UK Patent Office practice manual that patent claims to a genetically modified plant per se (and not to a plant variety) are allowable in a biotechnological patent application.
While this difference may seem pedantic, it represents the difference between a patent application that may be considered valid and one that is invalid. The term "essentially biological processes" for plant or animal production refer generally to the process of obtaining new varieties by traditional breeding methods - plants or animals obtained in this way are not considered patentable. Should you have originated a new plant variety by conventional breeding, however, this may be protected by way of a Plant Breeders' Rights application in South Africa, and not a patent.
The USA is the exception to this and issues so-called Plant Patents. Please let us know should you require patent assistance in this regard. Similarly, biotech patent claims to animals obtained by traditional breeding methods are not allowable at most Patent Offices, but a genetically modified animal is considered patentable in the UK, Europe and USA. There is currently no equivalent in the animal sciences field to the protection offered by Plant Breeders' Rights.
Primers used for diagnostic purposes may be protected by way of patents, as well as kits containing such primers. Single nucleotide polymorphisms and expressed sequence tags may under certain strict conditions be considered patentable and of use in diagnostics, but they may fall foul of the utility patent requirement discussed above. In addition, novel antigens and receptors that you have located may also be protected by way of a patent, provided you have ascribed a function to them. Novel monoclonal antibodies and immunological tests (such as ELISA tests) using novel antibodies are also worthy of biotechnological patent protection. In addition, other novel diagnostic tests may also be patentable.
Pharmaceutical and chemical sciences patents
Novel purified chemical or pharmaceutical compounds are patentable, as well as their pharmaceutically acceptable isomers and salts. Crude extracts in which a compound is enriched may also be patentable, depending on the level of enrichment relative to the natural, unfractionated state. Importantly, novel pharmaceutical carriers may also be patented. Patent protection may also be obtained for pharmaceutical compositions containing your novel pharmaceutical compound.
Method of Treatment Patents
South African, British and European patent laws specifically exclude from patentability methods of treatment by surgery, diagnosis, or therapy, if practised on the human or animal body. However, the following may under certain circumstances be included in a patent application and may be used to address the restriction on therapeutic treatments in patents:
- 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.
Medical sciences patents
Due to the medical patent restriction on methods of treatment, diagnosis or surgery mentioned above, surgical techniques are specifically excluded from patent protection in these regions. However, instruments for use in surgery, diagnosis or therapy may be patented. In addition, diagnosis based upon a sample obtained from the body is allowable and should, accordingly, be limited to in vitro applications in a patent application.
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.