IPR protection of biological innovations
Biotechnology
IPR - Intellectual Property Rights
PBR - Plant Breeders Rights
TRIPS - Agreement on Trade-Related Aspects of Intellectual Property Rights
Background
The IPR protection of new life forms raises a number of difficult technical and ethical
issues that do not apply to other inventions. For that reason, the patentability of new
biological forms and processes is still not accepted in many countries. Consequently, no
final agreement could be reached during the TRIPS negotiations on how to tackle this
complex subject.
TRIPS has an in-built agenda for review and further consideration of issues that were not resolved during the original negotiations. At the present, biological innovations is one unresolved issue, geographical indications is the other. Review of the IPR protection of all biological innovations above the micro organism level has already commenced, but it is not clear when negotiations as such will start. New forms of micro organism should receive patent protection according to TRIPS.
Before discussing TRIPS further, a few explanations are needed on why the IPR protection of biotech innovations is so controversial. First, there are ethical issues concerning the creation of new life forms. While this is a legitimate concern, one should not lose sight of the fact that human societies have been creating new life forms through selective breeding and hybridisation of plants and animals for thousands of years. The social acceptability of new life forms is a moral issue well beyond the realm of IPR protection.
Then there is the economic issue that so far, agricultural and medical research has been conducted mainly in public research agencies and universities. One of the motives for stronger IPR protection is to shift some of this research to private enterprise. Some political and lobby groups claim that making research more profit-orientated might have adverse consequences for agricultural development and public health.
On the technical side, a frequently raised question in relation to biotechnological research is whether the new life form, or an organic substance derived from the new life form, is a scientific discovery or a technological invention. Patents are not supposed to cover scientific discoveries, only inventions. Moreover, many products of recombinant DNA are more a result of luck and patience than of original thinking. Much work in genetic engineering involves inserting and recombining genes using established techniques. It is not clear whether such recombinations should be eligible to pass the non-obviousness test, even if the result is quite novel (Barton 1993). But there are different opinions about what is obvious and what is not to technical experts in this new field of study.
Another technical question is whether the patent should be regarded as extending to the progeny of the protected life form. According to law, sellers generally exhaust their rights in the item sold, so that buyers are entitled to use it as they see fit. (The ‘exhaustion' principle is also discussed in section 3.8 in the context of parallel importing.) Thus, according to this principle, the progeny belong to the buyer. On the other hand, the unauthorised reproduction of an article containing some patented element(s) is an infringement of the patent. This clearly represents a conflict between two legal doctrines that has to be resolved.
As noted earlier, TRIPS does not provide a definite code regarding new life forms. The present version of TRIPS allows members to exclude from patent protection:
- plants and animals other than micro-organisms;
- and essentially biological processes for the production of plants or animals other than microbiological processes.
However, TRIPS stipulates that protection must be available for new plant varieties (including seeds), though this does not have to be necessarily by patents. Most countries, including Australia, offer specially designed (sui generis) protection to new plant varieties.
By virtue of requiring the protection of new micro organism by means of patents, TRIPS already covers most of the field of genetic engineering related topharmaceuticalss. The development of new proteins for pharmacological use (such as new vaccines, blood clotting agents, hormones and other therapeutic substances) depends on new strains of micro organism incorporating imported genes, rather than higher forms of life. New micro organism have been patentable in most industrialised countries (including Australia) for many years. However, there is no international consensus about what precisely should be covered by patents microorganismssms (Maskus 1997).
The Budapest TreatyThe Budapest Treaty
Developments in the field of biological IPRs led to the Budapest Treaty (1977) on the
international recognition of the deposit of micro organism for the purpose of patent
procedures. Australia is a party to this WIPO agreement. Where an invention involves a
micro organism or the use of a micro organism, disclosure is not always possible in
writing, but can be effected by the deposit with an approved institution of a sample of
the micro organism. In order to eliminate the need to deposit in each country in which
protection is sought, the Budapest Treaty provides that the deposit of a micro-organism
with any one of two dozen approved institutions around the world suffices for the purpose
of patent procedure in any member state. In Australia, this internationally approved
institution is the Australian Government Analytical Laboratories.
The Patent Act and biological innovationsThe Patent Act and biological innovations
Australian IPR protection of new life forms exceeds the current requirements of TRIPS.
Under the Patents Act 1990, patenting of biotechnology inventions is allowed. A
patent can cover the method for creating the new life form, the life form itself and the
production of substances using the new life form. The issue of whether genes and life
forms should be excluded from the patent system was considered during the parliamentary
debate of the legislation in 1989. The result of the debate was a single exclusion - human
beings and biological processes for their generation are not patentable.
The biological patent application in Australia must meet all the usual requirements for patentability, that is novelty, inventiveness and appropriate description. In addition, a biological invention must be repeatable, a criterion that need not be considered for non-biological inventions. The requirement for repeatability rules out traditional methods for creating new life forms through selective breeding or hybridisation. It also excludes some modern techniques such as mutation by means of radioactive irradiation. In all these cases, it is not possible to obtain the same outcome time and again. However, with techniques based on genetic manipulations, it is possible to obtain repeatable outcomes, at least for a fraction of the population being bred. Hence the patentability of new life forms is restricted almost exclusively to the field of genetic engineering.
Plant breeders' rightsPlant breeders' rights
Apart from providing patents for bio-engineering inventions, Australia also offers
protection for new plant varieties through aspecifically designedd ‘sui generis'
protection regime. This protection is generally weaker than for patents. The protection of
new plant varieties was first introduced in the United States in 1930. It was adopted
later in Western Europe and was harmonised following the establishment of the
International Union for the Protection of New Varieties of Plants (UPOV) in 1961. UPOV is
an organisation largely independent of WIPO. The UPOV Convention has been revised several
times since 1961.
The Australian plant breeders' rights legislation for the protection of new plant varieties is modelled on the UPOV Convention. Protection of plant breeders' rights is obtained from the Plant Breeders' Rights Office, an agency of the Department of Agriculture, Fisheries and Forestry. In order to gain protection, the new plant variety must be distinct, uniform and stable. Unlike biotechnological patents, there is no requirement for repeatability, therefore plant varieties developed through selective breeding; hybridisation, budding, grafting and tissue cultures are all acceptable.
The plant breeder obtains the right for the sale and the distribution of the new variety. Based on the principle of ‘exhaustion' of the IPR rights of sellers, the breeder's rights do not extend to the use of a grower's crop (that is, the grower does not have to pay royalty on the crop produced directly from the seeds or grafts sold by the right-holder). However, the breeder's rights extend to the use of the progeny from the plant variety sold. While buyers can use the progeny from the seed for the production of another crop on their land, the breeders of the new plant variety can exercise their IP rights (including the right for royalties) when the harvested material is disposed of commercially. The time limit for protection is 25 years for trees and vines and 20 years for other species.
The Australian plant breeders' rights legislation satisfies TRIPS requirement for at least some IPR protection for new plant varieties. Furthermore, in Australia patent protection can be taken out for a new plant variety created by genetic engineering, an option that is not available in many countries. In many cases plant breeders' rights offer a weaker protection than biological patents, because the protection does not extend to new genes or to the process of creating the new plant variety.
TRIPS negotiations on biotechnologyTRIPS negotiations on biotechnology
In the current TRIPS review of biological innovations (including new plant varieties), the
broad contours of the negotiating camps are already discernible. According to the sketchy
details presented by Hoinkes (1997), Farquhar (1998) and DFAT (1998) there appear to be
three distinct groups.
The United States sees biotechnology patent protection as a key intellectual property and trade priority and would like to see mandatory IPR protection in this area around the world. On the opposite side of the fence are a number of developing countries, led by India, who are arguing for further strengthening of TRIPS provisions excluding plants and animals from the scope of mandatory protection. Some of these countries would like to see some new form of sui generis protection for example, one recognising farmers' rights.
The third group is dominated by Europeans, who seem to be still struggling with the issue of patenting biotechnology. The European Union directive (Directive 98/44/EC of the European Parliament and of the Council of6 July 1998 on the legal protection of biotechnological inventions) is a bit opaque, but essentially establishes plant and animal inventions as patentable, provided the technical feasibility of the invention is not confined to a particular plant or animal variety. This implies a patent on the process of creating the new life form, rather than patenting the new animal or plant variety itself. This could be characterised as a mid-range approach between full and no patentability of transgenic innovations involving plants and animals above the microorganism level. Currently the position of most European countries seems to be to maintain the status quo in the TRIPS agreement, which allows every member to decide for itself on how to protect biotech innovations, apart from micro organism and new plant varieties.
The patent protection afforded in Australia to new life forms is much closer to the US model than to practices in most other countries. Biotechnology, both in TRIPS and more widely, is emerging as a key trade policy issue with major implications for the development of Australia's agrifood and pharmaceutical industries. Given our relatively strong expertise in biotechnology, it seems likely that this is an area where Australian industry will want access to IPR protection in as many markets as possible (Farquhar 1998). Consequently, it might be in Australia's interest to support the United States position in favour of mandatory IPR protection for biotech innovations around the world.
Source:
Trade Related Aspects of Intellectual Property Rights. Staff Research Paper.
Productivity Commission. John Revesz ISBN 0-646-33592-8
