Planting a factory
Patent protection encourages significant advancement in biotechnology
BIOTECHNOLOGY HAS BECOME a significant field in the area of intellectual property over the past few decades, with a number of South African developments – ranging from the trial of HIV-vaccines to new yeast fermentation techniques for the beer and wine industries.
A typical example that has significant positive ramifications is the mapping of the human genome, which has already had numerous medical spin-offs. An online encyclopaedia reports that the human genome comprises 24 distinct chromosomes with approximately 3bn DNA base pairs containing an estimated 20 000 to 25 000 genes. The Human Genome Project produced a reference sequence of the human genome, now used worldwide in biomedical sciences.
Sandra Clelland, a partner at intellectual property law firm Spoor & Fisher, paraphrases US author Bill Bryson in his book A Short History of Nearly Everything that due to the genome-mapping project “science now has a list of parts but still needs an operating manual to know how the genes all work.” In other words, much research still needs to be done.
“The SA Government is very supportive of research in the field of biotechnology and accordingly has provided significant funding and support for research and development.”
As a result of the increasing amount of biotechnological research being conducted in SA, Spoor & Fisher established a division to advise a wide spectrum of companies and institutions on biotechnology IP. Most of the R&D into biotechnology, Clelland says, is being conducted at universities, Government-funded research organisations, such as the Medical Research Council and the Council for Scientific and Industrial Research (CSIR), and a number of smalland medium-sized private sector companies, many being Cape-based.
While Clelland says there are no predominant trends or themes in biotechnology, a significant amount of money is being allocated to different HIV/Aids research projects. “That’s such an important area of research for Africa and we have a number of world-renowned scientists in SA working in different areas of Aids research, from diagnosing and monitoring HIV infection to developing possible HIV vaccines.”
In addition, some institutions and organisations are conducting research into indigenous plants to establish the active ingredients used in traditional medicine so that commercial products can be developed. A typical example is the appetite suppressant property qualities of the hoodia plant, used for thousands of years by the indigenous San people of the Kalahari. “The CSIR isolated the active ingredient in hoodia a few years ago and filed patent applications for this compound in a number of countries worldwide. This invention has now been licensed to a large multinational company and the San community will be receiving royalty payments. So there’s been a positive outcome for them too.”
Clelland points to a number of developments where companies are now trying to develop genetically modified plants that will produce the active ingredients in certain pharmaceuticals. “For example, in the future a field of sunflowers could be cultivated to produce the active ingredients of pharmaceuticals rather than manufacturing the active ingredients in a traditional factory. However, there’s been a lot of opposition to these developments by anti-GMO (genetically modified organisms) groups.”
But GMO research has produced many positive spin-offs. For example, the University of Cape Town is developing drought tolerant maize and Stellenbosch University is producing a strain of yeast that will give white wine the same health benefits as red wine.
Patent protection is essential for both funders and researchers, as it provides a mechanism preventing others from duplicating the invention without a licence. “It also gives the patent owner bargaining power, as they can then license their own patent to another patent holder in exchange for a licence from the other patent holder.”
Clelland acknowledges that some parties take a philanthropic approach to scientific invention and advancement, advocating against patents and rather believing that inventions should be made available to everybody.
However, she points out that this approach can backfire. “If an invention isn’t patented it may be difficult to interest a company in developing it to a point where it can be placed on the market. Take the development of a new pharmaceutical. It’s an extremely expensive process to develop and formulate a new pharmaceutical composition, to conduct the necessary trials and to then obtain regulatory approval. Consequently, most companies with the necessary resources are unlikely to undertake the development of a new pharmaceutical product unless it’s patented.”
The patent process can be lengthy and expensive, she says, especially if the inventor or developer wants to protect his product worldwide. A worldwide patent application can cost between R1m and R4m, so most inventors generally only identify a few countries where they seek patent protection. It’s very rare to file worldwide.”
Patent protection normally lasts 20 years from the filing date of the patent application to provide sufficient time for owners of patents to recoup their investment and filing costs – and, hopefully, make a profit.
Much research still needed. Sandra Clelland