By Ghati Nyehita
I did my research placement at BioCiTi as part of my Open AIR/ QES experience. BioCiTi is a biotech incubator that provides shared laboratory equipment and co-working space for biotech companies. Access to their labs, co working spaces and biotech entrepreneurs, gave me practical experience in the field of biotech innovation and has aided my research on leveraging on Intellectual Property (IP) for inclusion of women into the innovation paradigm.
The maker movement for biotech entrepreneurs
Shared spaces in the form of innovation hubs have become a commonplace for entrepreneurial individuals. The phenomenon of using shared spaces (makerspaces) to enhance innovation through hands on (Do It Yourself (DIY)) creation is referred to as the maker movement. Working with BioCiTi has made me appreciate how biotech entrepreneurs benefit from the infrastructure of the maker movement. For biotech entrepreneurs, makerspaces provide a space for testing biotech ideas outside the conventional academic venues and business incubation. They also provide networking options for biotech startups to build personal and professional connections. I attended demo days where BioCiTi entrepreneurs pitched their companies to local investors and consumers. This goes to show that makerspaces give biotech start-ups visibility to investors and consumers. Most importantly, through business and innovation management, makerspaces expose biotech entrepreneurs to government policies and programs aimed at enhancing science, innovation and empowering women, marginalized groups and start-ups. Consequently, biotech makerspaces contribute to increasing innovation and commercialization of bio fabrication, food security, improved health care and providing solutions to everyday problems.
IP and biotech
While working at BioCiTi, I realized that the main IP challenge for biotech innovators is applying the different IP regimes, in South Africa, to their innovations. The three main IP regimes for protection of biotech innovation are patents, trade secrets and protection of plant varieties. These provisions exclude discoveries, any variety of animals and plants, “any essentially derived biological processes, not being a microbiological process or products of such processes”. Copyrights and trademarks provide protection, albeit to a smaller extent, while the protection of traditional knowledge ensures that biotech innovation is ethical. Open source biotech is appreciated for its crucial role in enhancing biotech innovation.
For most biotech innovators, patents are the go to system for protecting and commercializing their innovations. However, biotech innovations do not fit neatly into the patents system. The EPO opinion states that “essentially derived biological process, not being a microbiological process or products of such processes”. Most biotech innovations are not patentable by virtue of sections 25(2) (a) and 25 (4) (b) of the Patents Act. These provisions exclude discoveries, any variety of animals and plants, “any essentially derived biological processes” and “microbiological process or products of such processes”. There is no case law or guidelines on what constitutes “any essentially derived biological processes” or a “microbiological process or products of such processes”. This coupled with South Africa’s depository patent registration system create a possibility for granting patents for excluded biotech innovations. In this system, patent applications do not undergo substantive examinations. They are only examined against substantive criteria of patentability: novelty (does not form part of the state of the art immediately before the priority date of any claim to that invention), inventive step it (not obvious to a person skilled in the art) and industrial applicability. It should however be noted that the grant of patent is not the final hurdle as the validity can still be challenged in the Court of Commissioner of Patents.
To establish whether biotech innovations that are patentable, we can seek guidance from the European Patent Office (EPO) opinion on plant patents. The EPO opinion states that “essentially derived biological process” and “microbiological process or products of such processes” may escape the exclusion if they contain additional features of a technical nature. Consequently, the following biotech inventions are patentable if they fulfil the patentability criteria:
- Biological material which is isolated from its natural environment or produced by means of a technical process even if it previously occurred in nature
- Plants or animals if the technical feasibility of the invention is not confined to a particular plant or animal variety and if said plants or animals are not exclusively obtained by means of an essentially biological process
- A microbiological or other technical process, or a product obtained by means of such a process other than a plant or animal variety.
Once the patent is granted, it could last for 20 years or three years from the date of filing if it is not renewed. Since all IP rights are territorial, the innovator is required to seek protection in other jurisdictions. This is made easier through utilization of the Patent Cooperation Treaty (PCT) procedures.
Trade secrets are an easy way to go around the subject matter restrictions and costs associated with patent applications. Trade secrets can be used to protect any aspect of the innovation that provides a competitive advantage. The protection can last forever provided the secrecy is closely guarded. Most researchers are against this since the trade secrets allow innovators to recoup the costs of development but hinders the disclosure of technology to facilitate further innovation. On the other hand, the Plant Breeders’ Rights Act can protect innovations relating to varieties of certain kinds of plants that meet the protection criteria: new, distinct, uniform and stable. The term for protection of vines and trees is 25 years from the date of registration and 20 years for the other plant varieties.
Copyright could afford some form of protection of copyrightable works that are part of innovation like literary works, artistic works; sound recordings; published editions and computer programs. These copyrightable works should be original, reduced into material form and created by a qualified person. If the works satisfy these criteria they assume protection immediately and there is no need for registration. The duration for the different types of works varies and is provided in section 3(2) of the Copyright Act. The copyright term for literary and artistic works is the life of the author plus 50 years from the end of the year which the author dies, for example. Additionally, copyright gives protection in South Africa and other countries that are signatories to the Berne Convention.
Trademarks come in handy when marketing the biotech innovations. Any marks that are capable of distinguishing a product or service such as brand names, logos and slogans can be trademark protected. Trademarks last for 10 years from the date of application and are renewable before the expiration. The protection could therefore last in perpetuity if renewed every 10 years. A South African registration does not give protection overseas. You are required to apply for registration in countries you think your product would be used unless the mark is so well known that it attracts protection in foreign jurisdictions by virtue of the Paris Convention.
Bioprospecting relies on traditional or indigenous knowledge associated with biological resources. Adherence to the Protection, Promotion, Development and Management of Indigenous Knowledge Act 6 of 2019 (the Act), is therefore important in ensuring that biotech innovations are ethical. The Act requires biotech innovators to seek consent, acknowledge and/or compensate the relevant communities when commercializing their knowledge.
Following my interactions with the BioCiTi community, I also learnt that some of the biotech entrepreneurs were in support of open source biotech. Their support for open source biotech is grounded on the need to mitigate the effects of strong IP regimes which limit access to research tools and make the biotech innovation expensive. They also appreciate the fact that they are beneficiaries of openly available research and research tools. The greatest challenge for these open source biotech proponents and start-ups, thus far is how to recoup their investment in development beyond the public interest purpose.
Overall, working with BioCiTi has aided my research by helping me to contrast the role of IP and makerspaces in bridging the gender divide in innovation, between women with Science Technology Engineering & Mathematics (STEM) backgrounds and those without. My upcoming research on harnessing the maker movement for inclusion of women into the innovation paradigm will provide a detailed analysis on ways of promoting gender main streaming for policies, programs and projects that can be applied in the biotech industry.