Examining the role of intellectual property law, policy and management in open innovation models that facilitiate innovation in and access to genomic medicine.

Abstract

The traditional closed innovation model is largely supported by a regime where intellectual property rights (IPRs) are used to secure monopolies over inventions, with one justification being that this maximises profits for future innovation. In the pharmaceutical and related healthcare technology industries, such a regime has been criticised as impeding access to healthcare technologies and hampering cumulative innovation. One response to this criticism has been a shift towards a more open innovation model, where more permeable boundaries between organisations facilitates the flow of knowledge for innovation. In such a model, IPRs may be used to facilitate such knowledge flows rather than solely as a means of securing a monopoly, satisfying the interests of private actors to profits, public interest to access advanced technology, and private-public interest to further innovation. In this dissertation, it is explored how IPRs, particularly as patents, may be used to facilitate open collaborative innovation in the genomic medicine field. This relatively nascent field of medicine endeavours to personalise medical decisions based on an individual's genome, but in order to develop the necessary technologies, requires vast amounts of knowledge on the human genome. Many initiatives have adopted intellectual property (IP) policies that facilitate open innovation so as to accelerate knowledge flows and resulting innovation in genomic medicine. Herein, these policies are consolidated to provide a tentative IP policy framework that supports open collaborative innovation in genomic medicine, against which South Africa's Draft IP policy and the IP policy of South Africa's leading research body, the Medical Research Council, is compared. It is found that whilst other countries are directly addressing the issues of patenting in genomic medicine through legislature and case law, South Africa is yet to take comparable actions. This is reflected in its vague patent laws and IP policies regarding IP in genomic medicine. Though there may be common elements that support open innovation between the policies of international initiatives and those of South Africa, the lack of clarity in the South African instruments does not provide a strong foundation for open innovation in genomic medicine. However, as the national IP policy is still in its draft phase, and this policy recognises the value of protecting public health, there may be opportunity to amend provisions to provide the necessary direction towards open innovation in genomic medicine, especially for bodies such as the Medical Research Council.