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IO T E C H N O L O G Y Is su es Ar o u n d th e P at e nt in g of Lif e
Forms
Introduc tion An article by Shelley A. Rowland & James W. Piper,
PIPERS
The field of biotechnology is rapidly advancing, and with every advance comes increased media attention. Since the report of the first successful cloning of a sheep named Dolly in early 1997, advances in genetic engineering have gained attention on a global scale. It seems everyone, from scientists to the lay public, is voicing an opinion on the subject, and discussion ranges from the advantages this kind of research may provide to the moral/ethical dilemmas which it raises, from concerns regarding individual and public safety to the effects this kind of research may have
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It is probably fair to say that opponents of patents for inventions relating to biotechnology and life forms are probably more concerned with the ethical, moral and safety issues surrounding the research, development and use of such inventions rather than the issue of allowing patents for them.
Morality
The genetic alteration of life is an emotional subject and there is no doubt that the debate on whether it is appropriate or not will continue and evolve with the developments in biotechnology. This will be the case whether such inventions are patented or not as further experimentation and advances in this area will not be prevented merely by prohibiting patents for life forms and genetic material. However, by allowing patents for such inventions it may be considered that the Government is encouraging and perhaps facilitating further research, development and use in these areas.
O w n e r s h i p a n d c o m m e r c i a l i s a t i o n o f l i f e
The concern that allowing patents for genetic information and life forms reduces life to a commodity seems somewhat misguided. The human race has claimed ownership of and has been exploiting nature, including life forms, to a commercial end for centuries. Further, we have been involved in genetic selection and manipulation to obtain genetically superior species of plants and animals; albeit via breeding programmes. The only difference between these past practises and the use of the current technology is that biotechnology makes it easier, and potentially more economical, for us to select for desirable genetic traits (whatever the application). It only seems logical that the same legal framework that acknowledges and protects a mechanical or electrical invention should offer the same advantages to a biological one so long as it meets the criteria for patentability.
should be aware that there are provisions within the Patents Act which allow IPONZ and other parties interested to attempt to prevent a patent being granted or to revoke a granted patent. Of these provisions, those of particular relevance to patents on genetic material and life forms are discussed below.
Morality
IPONZ has the right to refuse registration of a patent application on the grounds that it is contrary to morality. This objection is of limited use in practice and questions arise as to the suitability of IPONZ in judging matters of morality. However, there is the potential for it to be relied upon.
Contrary to Law
The definition of an invention within the Patents Act loosely refers to the fact that the use of an invention should not be contrary to law or generally inconvenient. Thus, IPONZ may refuse to accept the application if the use of the invention would be in breach of any other legislation; for example, the Hazardous Substances and New Organisms Act 1996 may prevent the use of a particular genetically modified plant. In addition, there is potential for this provision to be used by a third party wishing to oppose a patent or patent application.
Judicial Review
It is possible that a third party could apply for Judicial Review of any decision of IPONZ relating to the acceptance of patents for life forms and genetic material where they feel the decision is wrong in law. This happened recently where the Commissioner of Patents decided that patents directed to a new therapeutic use for a known compound should be allowable; Pharmac, the government agency responsible for determining which pharmaceuticals in New Zealand qualify for government subsidy applied for the Judicial Review.
Use
It is worth noting that the grant of a patent does not necessarily permit the use of an invention; it merely excludes others from doing so. The use of an invention is subject to any legislation provided to prohibit or monitor such use. For example, the Hazardous Substances and New Organisms Act 1996 governs whether or not a new organism (including one which is genetically modified) may be introduced into the environment.
It is worth noting that the government is also addressing the advances in biotechnology in relation to other legislation. New or amended legislation addressing these advances has been proposed in areas including assisted human reproduction, human health, hazardous substances and new organisms, resource management, environmental risk management, animal welfare and food safety. This article was published in NZ BioScience.
Please forward any queries to: Patents and Biotechnology Pipers, PO Box 5298, Auckland Email: ebody@piperpat. com
Jim Piper is the principal of Pipers and has 35 years experience as a patent attorney both in New Zealand and Australia. Jim currently specialises in pharmaceutical and biotechnology patents.