Examining the role of intellectual property law, policy and management in open innovation models that facilitiate innovation in and access to genomic medicine.
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Date
2017
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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.
Description
Master of Laws in Medical Law. University of KwaZulu-Natal, Pietermaritzburg 2017.
Keywords
Theses - Law.