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Furor Over Frankenfoods
Introduction
The scope of IP protection for genetically modified (GM) foods has broadened over the last few years, along with escalating public debate. The International Service for the Acquisition of Agri-biotech Applications reports that 98.6 million acres of transgenic crops were planted worldwide last year. Those crops include corn, canola, soya, flax, cottonseed and potatoes. Meanwhile, the United Nations and the World Intellectual Property Organization (WIPO) is continuing to address safety, biodiversity and food supply issues, among others. This article reports the IP and regulatory climate for GM foods around the world.
I. The pan-European regulations
Over the last decade about half a dozen directives were issued by the European Union affecting either the protection of genetically modified (GM) plants or the requirements for using and marketing GM plants and products. The EU issued a Biotech Directive 98/44/EC that is binding on its member states. The Biotech Directive assures that there is a common standard in Europe regarding the patenting of biotech inventions regardless of whether an applicant seeks protection under the EPC or the national patent law of a member state.
Some months ago, the European Patent Organisation (EPO) implemented the Biotech Directive 98/44/EC into the implementing regulation of the European Patent Convention (EPC). Under the new EPC new Rule 23(c) plants or animals may be patentable if the technical feasibility of the respective invention is not confined to a particular plant or animal variety. This has been confirmed also by a recent Decision of the Enlarged Board of Appeal of the European Patent Office where the Board stated in case G1/98 "Transgenic Plant/Novartis II" that
[a] claim wherein specific plant varieties are not individually claimed is not excluded from patentability under Article 53(b) EPC even though it may embrace plant varieties (headnote I).
Therefore, patent protection can be obtained for GM plants under the EPC as long as the claimed invention can be performed with different plant varieties which condition should generally be met in the field of GM plants. As stated, however, also in G1/98 (supra), plant varieties as such, irrespective of the way in which they were produced, are excluded from patentability under Article 53(b) EPC.
Therefore, a single plant variety, even if it contains a gene introduced into an ancestral plant by recombinant gene technology (i.e. a transgenic plant variety), is still excluded from patentability. Such plants however, may be protected as a plant variety under Directive 2100/94 which provides an EU-wide protection for new plant varieties regardless as to whether they are the outcome of a conventional breeding/selection process or the genetically modification of an ancestral plant.
Besides the protection of entire plants, GM food products containing elements derived from GM plants can be protected by patents under the EPC without facing the exclusion of plant varieties. Such GM food products are patentable, like any other chemical compositions, if they meet the requirements of novelty, inventive step and industrial application.
Any product which is covered by a patent the marketing and using of same might require the attainment of further approvals. In the case of GM plants as a constituent of GM food the novel food directive 97/258/EU is the most relevant regulation. Said Directive is directly binding to each EU member state. Said Directive inter alia requires that food products containing a GM organism (GMO) must carry a respective label.
mehrover, the Directive entitles the member states to suspend the marketing of an approved novel food product if the member state has new information that the food product in question may be detrimental to human health or the environment. The marketing and growing of GM plants has been refused by some EU member states such, as Italy and Austria, based on Article 16 of further Directive 90/220/EU concerning the release of GMOs. Said article entitles a member state to limit or prohibit the use or marketing of a GM product if one can reasonably assume that said product constitutes a danger for human health or the environment.
As regards the labeling requirement of GM food, most recent Directive 49/2000/EU requires that a novel food product needs not to be labeled as containing GM material if the product contains mehr than 1% contamination with GMOs. According to Directive 98/1139/EU the labeling of food products derived from GM corn or Soya must indicate that it is e.g. "prepared from genetically modified Soya beans".
The EU Directives also allow a seller of a food product to label the product by indicating "free of GMOs" provided that the product in question justifies this label.
II. Germany
Germany is not yet currently as far as the EPO regarding the implementation of the EU Biotechnology Directive into national law. According to a current draft the Directive shall be implemented into national law substantially unamended.
In particular Article 4 of the Directive concerning the patentability of transgenic plants shall be literally implemented into the German patent law (PatG). This forthcoming change of the German PatG should, however, not have a great impact on the German Patent Office's practice regarding the patenting of transgenic plants because the GPO always granted patents on transgenic plants as long as the patents were not limited to a certain plant variety.
In addition to the protection of GM plants by patents a protection of such plants by a utility model is also currently available. This option, however, might be given up when implementing the EU Biotech Directive since according to the present draft Biotech instructions, including GM plants shall be excluded from protection by the utility model. As regards the further above EU Directives, they are directly binding to Germany as a member state of the EU.
III. The United Kingdom
By the time this article is published, the United Kingdom should have enacted legislation to give effect to the EC Directive on the legal protection of biotechnological inventions. However, at the time of writing, the United Kingdom government is still engaged in a process of consultation with interested parties, following publication of a consultation document in April of this year.
In accordance with the Directive, plant and animal varieties must continue to be excluded from patentability in the United Kingdom, subject to the requirement of Article 4(2) of the Directive that "inventions concerning plants and animals may be patentable if the technical feasibility of the invention is not confined to a particular plant or animal variety". The current proposal is that this provision will be incorporated verbatim into a new Schedule 7 to the Patents Act 1977.
GM plant varieties can also enjoy protection in the United Kingdom under the Plant Varieties Act 1997. However, as also required by the Directive, the currently proposed legislation includes a draft Regulation on compulsory cross-licensing between plant breeders' rights (whether granted under the United Kingdom Act or under the Community Regulation on plant variety rights) and plant patent rights, where the existence of one right hinders the acquisition or exploitation of the other right.
Although the proposed laws provide a good framework for protecting inventions relating to GM plants, and the consultation document strongly implies that the government is very positive in its attitude towards the potential benefits of biotechnology, the British press has recently been giving extensive (and generally unfavourable) coverage to the safety aspects of GM crops. It remains to be seen how consumers in the United Kingdom will react, and even the Royal family appears to be divided on the issue. Prince Charles is well known to be against the release of GM plants into the environment, while the Duke of Edinburgh has spoken out in favour of the new technology. According to Princess Anne, "the jury is still out".
It remains to be seen how consumers in the United Kingdom will react, and even the Royal family appears to be divided on the issue. Prince Charles is well known to be against the release of GM plants into the environment, while the Duke of Edinburgh has spoken out in favour of the new technology. According to Princess Anne, "the jury is still out".
IV. The United States
Patent protection is available in the US for GM plants and products. The Plant Variety Protection Act is also available. There are currently no labeling requirements for GM products, however several groups are strongly lobbying for such regulation, and such bills have been introduced in the legislature.
The Food and Drug Administration (FDA) has had approval authority over GM foods, and several GM foods have been approved for use. Two of the most popular GM crops in the US are herbicide-resistant soybeans (about 50% of this year's soybean crop) and insect-resistant corn (about 20% of the corn crop).
The US Dept. of Agriculture (USDA) and Environmental Protection Agency (EPA) has oversight over GM crops. The USDA and EPA maintain their approval of Bt-modified GM plants after considering lingering existence in the soil of toxins produced by pest-resistant plants.
Public attacks include shareholders urging several large food companies, including retail grocery chains, not to offer GMOs or products "until long-term safety testing has shown they are not harmful". In several cases, the shareholder resolutions were voted down, leaving safety issues to be resolved by the proper authorities such as the FDA. The Council for Biotechnology Information was instituted to inform the public of the scientific studies that have been undertaken, their results, and the meaning of those results.
V. Australia
Patent protection is available for GM plants and animals, and material derived therefrom, including foodstuffs. GM plants may also be protected under Plant Breeders Rights (PBR) legislation. Indeed, PBR for a specific GM variety may coexist with patent protection covering GM plants generally.
The Australian courts have not considered the patentability of GM plants and animals specifically, but the general principles of Australian law strongly suggest that patent protection for such inventions is likely to be upheld if tested. There have been unsuccessful attempts by a minority political party, the Australian Democrats, to restrict patent protection in this field. Thus, there is currently no legal barrier to prevent exploitation of patent or PBR rights in GMOs, and there seems little prospect of such a barrier being created in the foreseeable future.
Despite strong opposition to GM foods in some quarters and widespread scepticism among consumers, at present there is no reason to suppose that holders of patents or plant breeders rights will be unable to successfully exploit these in Australia. However, public opinion seems delicately poised on this matter and could easily swing towards a position where it becomes impractical to market products, particularly if very strict labeling requirements are ultimately enacted.
There is a growing public backlash against GM foods orchestrated by lobby groups such as the Australian Gene Ethics Network. A Government body, Biotechnology Australia, has been set up to increase public awareness, with a particular emphasis on safety issues, apparently in an effort to counter this trend. Nevertheless, despite assurances by the government body charged with food safety issues, the Australia New Zealand Food Authority, scepticism in the marketplace remains.
Surveys suggest that the public shows a clear preference to have genetically-altered foods labeled as such. Even so, there have been (somewhat controversial) attempts to water down the applicable regulations to require labeling only when a predetermined amount of GM material is present. It is likely that some consumers will choose to avoid products labeled as containing GM materials, but there does not seem to be sufficient opposition among consumers at large to suggest widespread adherence to any organised boycott.
VI. Canada
Plants, seeds and animals are not patentable, regardless of whether they have been genetically modified. However, patent protection is available for genetically modified cells for ex-vivo use, and for novel genetic material (e.g. an isolated and sequenced gene), and for known genetic material in a novel combination (e.g. compositions of matter comprising a gene encoding a desired trait in combination with vectors, promoters, or the genome of a transformed cell). This, in effect, confers some patent protection for genetically modified higher life forms.
Novel products including foods derived from genetically modified organisms are patentable. Foods produced from novel genetically modified organisms but which are not novel in themselves, for example, oil extracted from disease resistant canola, may be patentable as a product of a novel process (see below).
Also patentable are processes used to produce plants, seeds or animals which are not essentially natural biological processes, and which require significant technical intervention by man. Accordingly, traditional plant cross-breeding processes are not patentable, while laboratory gene manipulation processes are, provided the gene is novel or unexpected results are obtained. Processes used to produce foods from genetically modified organisms are patentable, provided the process or the organism is novel.
Limited sui generis protection is available for new plant varieties that are distinct, uniform and stable, regardless of whether genetic modification is involved. Plant breeders' rights are granted for the production and sale of reproductive material only, and afford no protection for foods derived from the new variety. .
All food crops must meet the stringent safety requirements enforced by government regulators (Food Inspection Agency, Health Canada and Environment Canada). The emphasis in assessing safety is on the product and not on the process used to obtain it. Assessment of genetically modified foods is made on a case-by-case basis and only those foods judged to be as safe as their conventional counterparts are approved for human consumption. The fewer uncertainties exist regarding the nature of a novel food product or its method of manufacture, the mehr easily any safety concerns can be addressed.
Under current law, labeling is required if there is a health or safety concern from allergens or a significant nutrient or compositional change. Labeling must be understandable, truthful and not misleading. Voluntary labeling standards for genetically modified foods are currently being developed to provide manufacturers with guidelines.
Further information can be obtained from Food Institute of Canada at http://foodnet.fic.ca
VII. Mexico
Mexico is not an exception to the countries concerned with the protection of technological innovation in matters related to food. Genetically-engineered food, transgenic plants, plant genes, plant varieties were protected through patent registration until October, 1994, when the Mexican Industrial Property Law changed.
As a result of this change, the plant varieties were excluded from patentability and a new kind of protection instituted: BREEDER'S CERTIFICATE OF PLANT VARIETIES. The Breeder's Certificate is regulated by the Mexican Plant Variety Law, in force since October 26, 1996 and based on the Principles of 1978 UPOV Agreement.
A Breeder's Certificate protects a Plant Variety and the its propagation material (seed, plant or part of a plant). The duration is 18 years for perennial varieties and 15 for the remaining varieties. The technical requirements to obtain a Breeder's Certificate are Novelty, Distinctness, Stability and Uniformity.
The authority in charge of the prosecution and allowance of a Breeder's Certificate is the Ministry of Agriculture, Cattle and Rural Development (SAGAR).
However, plant genes and transgenic plants can be protected through a Patent Registration as long as the gene is handled "in vitro" (methods essentially biological are not considered patentable subject matter). In order to obtain this protection, the application should comply with all the patentability requirements of Novelty, Inventive Step and Industrial Application.
The authority responsible for patent protection is the Mexican Industrial Property Institute and the duration of a patent in Mexico is 20 years from the filing date.
Regarding the defense of the rights obtained either by a Breeder's Certificate or a Patent, Mexico has Administrative and Judicial (Civil and Penal) procedures with which it is possible to stop infringer action and obtain the payment of damages.
VIII. China
Food is one of the patentable subject matters in China, no matter what kind of food it is or how it has been made. The patent protection is available to both the product and the process relating to food. Some GM foods are available on the market in China. However, there is no specific rule or regulation in effect or pending regarding the control or administer the sale of such kind of food. According to an informal source, some regulation may come out soon. The competent authority for such work is the Quality Control Division, Market Information Department, Ministry of Agriculture.
According to Article 25 of the Chinese Patent Law, the patents are also available for processes used in producing a new variety of the animal or plant. The processes refer mainly to those produced by non-biological methods. Whether or not a process belongs to "mainly through biological method" depends on the degree of the involvement of the technologies of the human. If the involvement of the technologies of the human is the controlling and decisive factor for achieving the result or effect of that process, then patent protection is available.
However, no patent right may be granted to the plant varieties per se. To encourage cultivation of new varieties of plants and to protect the rights of new plant varieties, the Chinese Government promulgated officially the "Regulations for the Protection of New varieties of Plants of the People’s Republic of China" on March 20, 1997. A new plant variety for which the variety right is granted shall possess novelty, speciality, homogeneity and stability. The authorities for examination and approval of the right of new plant varieties are the Ministry of Agriculture and the State Forestry Administration.
Conclusion
The IP protection that is available for GMOs has expanded and is starting to reach a relatively even level of availability around the world. However, even for GM foods and crops whose safety and impact has been meticulously evaluated and approved by authorities who understand the science, statistics and issues, public backlash is affecting the value of that IP through regulation and boycotts.
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Authors
1. Europe and Germany
Franz Josef Zimmer (German and EPO practice)
Grunecker, Kinkeldey, Stockmair &Schwanhausser
Maximilianstrasse 58
D-80538 Munchen, GERMANY
Phone: 089/21 23 50 (country code: 49)
Fax: 089/22 02 87
e-mail: Zimmer@Grunecker.de
website: www.grunecker.com
2. United Kingdom
Adrian J. Fisher (United Kingdom and EPO practice)
Carpmaels & Ransford
43 Bloomsbury Square
London WC1A 2RA, ENGLAND
Phone: 71-242-8692 (country code: 44)
Fax: 71-405-4166 or 831-8501
website: www.carpmaels.com/partners/fisher.html
3. United States
Shannon L. Nebolsky
Welsh & Katz, Ltd.
120 S. Riverside Plaza, 22nd Floor
Chicago, IL 60606, USA
Phone: (312) 655-1500
Fax: (312) 655-1501
e-mail: SLNebolsky@WelshKatz.com
website: www.WelshKatz.com
4. Canada
Joy D. Morrow and Thuy Nguyen
Smart & Biggar/Fetherstonhaugh & Co.
P.O. Box 2999 Station D
Ottawa, Ontario K1P5Y6 CANADA
Phone: (613) 235-4373
Fax: (613) 232-8440
website: www.fetherstonhaugh.ca
5. Australia
Brendan Nugent
Griffith Hack
GPO Box 3125, Brisbane Queensland 4001, AUSTRALIA
Phone: (61 7) 3221 7200
Fax: (61 7) 3221 1245
e-mail: Brendan.Nugent@griffithhack.com.au
website: www.griffithhack.com.au
6. Mexico
Angelica Pardavell
Clarke, Modet y Cia. de Mexico, S.A.
San Francisco No. 310
Col Del Valle 03100 Mexico D.F.
P.O. Box 27-416 Admon. 27 06760 Mexico D.F.
Phone: (52-5) 536-0011 or 523-9857
Fax: (52-5) 523-6418 or 682-2023
e-mail: info@ClarkeModet.com.mx
website: www.ClarkeModet.com.mx
7. China
Helen Han
Lung Tin International Patent & Trademark Agent Ltd.
1220 N. State PKWY
Chicago, IL 60610 USA
Phone: (312) 321-6488
Fax: (312) 321-6489
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