Biotechnology, research and intellectual property law andrew j allen

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IV. Biotechnology: A Scientific Discipline and a Rapidly Growing Industry

Biotechnology involves the harnessing of the productive capacities of living organisms. It is defined as the industrial use of living organisms or biological techniques developed through basic research.12 The term 'basic research' is used to describe pure research as distinct from applied research. The power to exploit these capacities lies in the genetic information locked up in the genome of every living cell. Biotechnological innovations can carry this information with them. Fragments of DNA can be extremely useful and valuable both as research tools and as building blocks for further innovations. DNA sequences are both useful chemical molecules and carriers of information.

The traditional system of publicly funded research, conducted in universities and public research centres, created a pool of knowledge which was free for all to use. Basic or upstream research was paid for by the government and the results were disseminated widely. The role of the private sector was to take this knowledge and develop downstream commodities. Two trends in the conduct of biotechnological research in the USA over the past two decades have been noted.13 First, private sector involvement in research has increased. Commercial biotechnology firms have engaged in basic research because the distance between a new discovery and a vendible product can be very short. Secondly, public funding of research has declined.

There is evidence that similar trends are occurring in New Zealand. Crown Research Institutes are encouraged to seek commercial clients for their research services. Universities now encourage the securing of intellectual property rights for industrial applications arising from research conducted in campus laboratories. As a result of these changes, the sorts of research results that, in an earlier era, would have been made freely available in the public domain are being claimed as intellectual property. As knowledge becomes more central to industry, private property rights in knowledge assume a prominent role. The most profitable companies are those with property rights in some form of knowledge.14 It has been asserted that patent claims to information locked up in genetic material may restrict the availability of that information to the public.15 A particular concern is whether patent rights over genetic information carriers inhibit future innovation based upon that genetic information.16 However, the traditional patent bargain has always called for a free disclosure of information to the public.17

Basic research today is likely to be funded by private money and patents sought for the results. It has been suggested that the capture of upstream research as intellectual property can inhibit downstream product development.18 An example is the patenting of gene fragments. Early gene patents were granted for specific genes that had a known function such as encoding therapeutic proteins. Patent applications for newly identified DNA sequences such as expressed sequence tags (ESTs) — for which no physiological function is yet known — extend private ownership of research to a position further upstream in the process of product development.19 The privatisation of research brings the prospect of substantial investment of private funds into basic research to supplement dwindling public funding, but it also brings challenges to the traditional approaches to the conduct of research. Intellectual property rights will be a necessary enticement to the private sector to make the investment. But the scope of these rights must be carefully defined to ensure that they do not hinder research.

V. Scientific Tradition and Research Norms

It has long been held that scientific advancement is a result of building on what has gone before. This belief is epitomised in the famous quote attributed to Sir Isaac Newton: 'If I have seen farther it is by standing on the shoulders of giants'.20 It is believed the public interest is served by making new knowledge as widely available as possible in order to promote advancement.21 The accepted tradition has been that additions to the stock of human knowledge belong to all members of the research community in consideration for the contributor's use of all previous knowledge. The idealised picture of information available to all as the model for the successful transmission and growth of knowledge is not entirely accurate.22 Early empiricists such as Newton and Boyle were keen to share their discoveries with each other, but strove to keep the new knowledge out of the public domain. Secret codes used in patent applications perhaps point to a patent rationale that had more to do with promoting commercial activity than with the dissemination of new ideas.

Traditionally, basic scientific discoveries have been distinguished from inventions: 'Research is a mechanism for converting money into knowledge. Innovation is a mechanism for converting knowledge into money'.23 The latter qualifies for patent protection while the former does not. Patent law does not protect mere discoveries of how the world works, but as soon as someone applies a natural product or process to a commercial use they can get a patent for the end product or process: 'The giant's reward should be the satisfaction of discovery and fame while the mechanical pygmy is an inventor who contributes a practical benefit to society and is rewarded with a patent' .24 The inventor does not have to pay the discoverer for the use of the discovery.

The publication of research findings serves two purposes. First, it enables other researchers to verify the claims through reproducing the experiments. This acts as a check on fraudulent claims. Secondly, new knowledge is able to be generated through the putting together of the clues provided by prior work. One of the classic examples of this approach is the discovery of the structure of DNA by Watson and Crick.25 This work pulled together a mosaic of clues from the work of many others, including the work of New Zealander Maurice Wilkins, to identify the double helix structure of DNA.

These purposes are encouraged by a reward system that accords recognition and esteem to the first person to publish new information. A strong publication record is still regarded as a measure of status in the research community. However, the rights of the discoverer are limited to a right to have his or her authorship recognised.

There are significant parallels between the patent system and the norms of scientific research. Both aim to encourage innovation by offering incentives. The addition of new knowledge to the public domain is also common to both systems. It has been questioned whether the increased involvement of the private sector, and private property rights in the products of research, will alter the traditional ways in which research has been conducted.26 These concerns are clearly illustrated in the field of biotechnology where the raw material of research, genetic information, may be vulnerable to being locked up as the subject of private property rights. Some scientists have raised concerns over how the change in funding source — from the public purse to the private sector — will impact upon the scientific traditions of open communication and free flow of information.27 A concern raised by the Royal Commission on Genetic Modification was the potential for intellectual property rights in biotechnological inventions to lock up in private ownership information carried by genetic material. It was argued that the scientific tradition of free communication and exchange of information and ideas was undermined by gene patents.28 There are two ways in which gene patents may impact adversely on the progress of biotechnological research. Firstly, a researcher may delay the publication of research findings while patent applications are being processed. This delay is to ensure that publication does not jeopardise the grant, by constituting a prior publication of the invention, and to prevent

other researchers from using the published information to overtake him or her in the race to arrive at the patentable innovation. It is common for many research teams to be simultaneously working towards the same goal, yet the patent system only rewards the first inventor. This means that there is an incentive to secure patent protection before disclosing the results of research to other scientists. Secondly, the right conferred upon the patentee allows him or her to control the use of the invention by others. Where others may wish to use the invention in further research, such use may require a licence from the patent holder. This is subject to the scope of an experimental use exclusion from patent infringement, which is discussed below.29

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