PATENTS AND BIOTECHNOLOGY Issues Around the Patenting of Life Forms

An article by Shelley A. Rowland & James W. Piper, PIPERS

Introduction
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 on our environment. A question forming part of this general discussion is whether or not it is appropriate for the government to issue patents for biotechnological inventions, and in addition, whether the current patent system is relevant to this technology. Many arguments have been raised against allowing patents for certain biotechnological inventions (genetically modified life forms in particular). In some cases, these arguments are valid and are of real concern. However, in other cases they may stem from a general misunderstanding of biotechnology and its potential applications, of the patent system and its limitations, and of other forms of legislation which control the use of this technology.

Arguments Against the Patenting of Life Forms and Genetic Material

Arguments against allowing patents for certain biotechnology inventions (specifically genetic material and life forms) include: Genetic alteration of life forms is immoral; Allowing patents for these inventions leads to the ownership and commercialisation of life, and reduces life forms to 'products of manufacture'; Human, animal and environmental safety may be compromised in the development and subsequent use of these inventions; Allowing patents for certain life forms and genetic material may lead to unauthorised exploitation of

Allowing patents for certain life forms and genetic material may be insensitive to the beliefs of indigenous populations and may exploit their knowledge; The patent system discourages disclosure of information and collaboration between researchers.

a country's natural resources;

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.

Ownership and commercialisation of life

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.

Safety may be compromised

There is little doubt that along with the advantages of innovation, there is always the potential for harm to come to humans, animals, and the environment if research protocols and the subsequent use of inventions are not sufficiently monitored. By allowing patents to be granted for certain inventions the government and the public are made aware of the practises of the patentee. In turn this allows the necessary government departments to control, monitor and contain activity where necessary. If individuals or companies were to keep their practises a secret it would make the task of monitoring their activity and its effects on the environment that much harder, if not impossible.

Unauthorised exploitation of a country's natural resources

There is widespread concern that granting patents for life forms and genetic material may encourage multinational companies to exploit the natural resources of a country without the authority and acknowledgment of, or reward to the country. However, the provisions of the Convention on Biological Diversity (the Rio Convention) of 1992, which as of 15 January 1999 175 countries have ratified, should be noted. This convention gives signatory states the right to exploit their own resources by establishing laws which prevent overseas companies from doing so.

Indigenous peoples' concerns

The concerns of indigenous populations to the patenting of genetic material and life forms are very complex in nature and as a result fall outside the scope of discussion in this article. However, it should be noted that the concerns of indigenous populations are real and need to be addressed.

Discourages disclosure of information and collaboration

It may be the case that if research has resulted in an invention which has commercial value and a patent is to be filed a researcher may delay the publication of his research until such time as a patent application has been filed. However, we must remember that patent system requires full disclosure of an invention in order to obtain protection and while publication may be delayed it will still be published. In the absence of a patent system the alternative may be that an invention is kept secret if it has commercial application.

Obtaining a patent in New Zealand

The Intellectual Property Office of New Zealand (IPONZ) is currently accepting patent applications for biotechnology inventions provided they meet the basic requirements of the patent system: that they are new, industrially applicable and are not obvious. A list of examples of biotech inventions which may fall within this category was provided in an article in NZ BioScience February 1998. IPONZ is also currently accepting patent applications directed to genetically modified plants and animals. Applications for parts (eg organs) of plants or animals obtained by means of cloning, cell lines generated from plants or animals, the isolated genetic material of plants or animals, and novel means for producing such products may also be acceptable. Applications are not accepted for plants and animals as they occur naturally. Patent applications directed to genetically, or otherwise, modified human beings are not acceptable. However, isolated genetic material, cell lines generated from humans and cloned body parts may be acceptable. Applications for methods of medical treatment of humans are not acceptable in New Zealand. This may include gene therapy procedures. However, novel constructs used in the delivery of genetic material may be acceptable.

Potential Bars to Obtaining Patent Protection

In light of the recent objections raised against the patenting of life forms applicant's 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.

Plans for the Future

IPONZ is currently reviewing concerns surrounding the patenting of life forms and genetic material. They are working closely with the Maori people in order to address their specific issues. IPONZ have published a paper which discusses relevant concerns and suggests options for reform of the current legislation. It appears that the primary aim of the suggested reform is to establish clearer provisions as to IPONZ power in refusing certain applications. Copies of the paper, entitled 'Patenting of Biotechnological Inventions', are available from IPONZ at PO Box 30687, Lower Hutt or by telephone on 04-560-1600. 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.