Intellectual property protection for new plants

Modern agriculture requires improvements in the technology of plant breeding to produce new varieties of plant which yield crops having improved resistance to diseases, pests, and other stresses.

What is a plant variety?

A plant variety is a biological classification, below that of genus and species. Members of the same species can breed with one another, though they may look quite different. Thus, in the animal kingdom, dogs all form a single species and all interbreed: but different breeds of dog are nevertheless clearly recognisable by their appearance and characteristics (Labradors, spaniels, sheepdogs and the like). These breeds have been evolved by selection of their parents. Each has its own characteristic appearance, determined by the genes it has inherited. Plant varieties are similar to animal breeds. Many particular plant varieties are well-known: examples are the rose Peace, and the eating apple Cox’s Orange Pippin. Peace has a specific colour and scent; Cox apples have a recognisable appearance and acid, orange-flavoured taste. Legally, a plant variety must be distinct (have a different combination of traits from all other known varieties), uniform (all plants have the same traits when grown under the same conditions) and stable (plants can be grown over a number of generations without change in traits). Thus a plant variety is characterised by its specific combination of traits. Changing a single trait (colour, leaf shape, growth habit) will give a new variety.

Plant variety rights

Earlier methods of developing new varieties (so-called traditional breeding methods) were largely restricted to exploiting processes such as crossing selected individual plants to enhance or combine desired characteristics. These breeding methods take up time and resources - to breed a new variety of wheat may take ten years. To make such an investment in a product that is easily reproduced requires robust market protection. In the late 1950s, a special system of ‘Plant Variety Rights’ (PVR) for the legal protection of new varieties was established in a number of countries and regulated internationally under the umbrella of the ‘International Union for the Protection of New Varieties of Plants’ (the UPOV Convention of 1961).

The main motivation for devising the special PVR system was that the long-established patent system, intended for the protection of technical inventions, was in several countries and for various reasons not considered suitable for protecting new plant varieties obtained by traditional methods. The criteria for the grant of plant variety rights are quite different from those required for patent protection and the protection available under the two systems is also very different. Plant variety rights are available for specific new plant varieties - unlike the patent system there is no requirement for the variety to be inventive. Plant variety protection grants the owner exclusive rights with regard to the propagating material (seed) of the specific new variety. However, the plant variety system also contains exemptions which in general (a) render breeders free to use protected varieties as a starting point for breeding further varieties (the ‘breeder’s privilege’) and (b) allow farmers to save seed from a crop sown from a purchased protected variety for subsequent sowing on their own farms (the ‘farmer’s privilege’).

The original UPOV Convention also prevented signatory States from offering ‘double protection’ i.e. both patent protection and plant variety rights within the same genus or species. This provision accommodated opinion in the agricultural industry prevalent at that time. Since then, the advent of modern biotechnology, especially recombinant DNA technology, has made it possible to manipulate the genetic structure of a plant in a directed way at the molecular level and free from the constraints inherent in sexual reproduction, so that genes from an unrelated species or even synthetic genes may be introduced. Genetic engineering has allowed the development of plants with new traits that could never have been obtained by the traditional methods.  The impact of genetic engineering on plant breeding stimulated a reappraisal of the UPOV Convention and as a result an extensively modified Convention was adopted early in 1991, and entered into force in April 1998. One of the changes was to allow ‘double protection’.

Apart from individual States (over 60 countries are now members), the UPOV Convention is now open to intergovernmental organisations provided that they have their own legislation for the grant of plant variety rights.

The European Union has adopted Regulation 2100/94 on Community Plant Variety Rights. This Regulation establishes a Community Plant Variety Right granted by a European Plant Variety Office which supplements national offices. Following introduction of the Regulation and the revision of UPOV, the British Government has appropriately revised the Plant Varieties and Seeds Act 1964. Most provisions of the new Plant Varieties Act 1997 came into force on 8 May 1998.

Patent protection

Although the UPOV convention now allows ‘double protection’, in Europe Article 53(b) of the European Patent Convention (EPC) continues to exclude from patent protection plant varieties or essentially biological processes for the production of plants, subject to the proviso that this exclusion does not apply to microbiological processes or the products thereof.  Similar provisions are incorporated into the national laws of the EPC Member States. Restrictions on patentability of plant varieties are not, however, present in the patent laws of some other countries, e.g. the United States, Japan and Australia.

In July 1998, the European Parliament and Council of the European Union approved Directive 98/44/EC on the Legal Protection of Biotechnological Inventions, which obliges EU States to amend their national patent laws as regards biotechnology inventions. Like the EPC, the Directive prohibits patenting of plant varieties or essentially biological processes for the production thereof, subject to a similar proviso regarding microbiological ‘or other technical’ processes. However, the Directive further clarifies this prohibition by specifying that inventions which concern plants shall be patentable if the technical feasibility of the invention is not confined to a particular plant variety, and that a process is to be considered essentially biological only if it consists entirely of natural phenomena such as crossing or selection.

Directive 98/44/EC, being an EU instrument, is not directly applicable to the EPC, although the European Patent Office (EPO) has adopted its main provisions as regards plant patenting. In 2000, a case was brought to the EPO Enlarged Board of Appeal, in which the crucial claim in the patent application was directed to transgenic plants (from a range of species) having specific foreign genes which conferred resistance to certain pathogens. The Board, clarifying and correcting previous conflicting EPC case law on Article 53(b), confirmed that a patent may be granted for a transgenic plant provided the claim is not directed (limited) to a specific variety or varieties: i.e. if the claim is generic in scope as opposed to being directed to an individual plant variety. The fact that such a claim is broad enough to ‘embrace’ unspecified varieties is no bar to its patentability.

However, the Board declined at that time to provide further guidance as to when, under the EPC, a process for preparing a plant is to be considered ‘an essentially biological process’ and thus barred from patent protection. The Boards of Appeal have held that processes of preparing transgenic plants by transformation and regeneration are likewise acceptable under Article 53(b) EPC; but questions remain as to what other type of process constitute technical, as opposed to natural, phenomena, and to what extent a process comprising both ‘technical’ and ‘natural’ steps can be allowed. To try and resolve these questions, two further cases have now been referred to the Enlarged Board of Appeal (in 2007/2008). The first case relates to methods of genetic marker assisted selection of Brassica species exhibiting enhanced levels of anticarcinogenic glucosinolates, and the second case concerns a method for breeding tomatoes having reduced water content. The further decisions of the Enlarged Board are awaited.

April 2009

This paper on Intellectual property protection for new plants can be downloaded as a PDF.