Intellectual Property protection for New Plants

Introduction

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) 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.

Earlier methods of developing new varieties (so-called traditional breeding methods) were largely restricted to exploiting naturally-occurring processes, such as by 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 10 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 varieties produced in this way 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 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 protection was narrower than was offered under the patent system, being essentially confined to the propagating material (seed) of the specific new variety itself (and not to the methodology). The system also contained exemptions which (a) rendered breeders free to use protected varieties as a starting point for breeding further varieties (the "breeder’s privilege") and (b) allowed farmers to save seed from a crop sown from a purchased protected variety for subsequent sowing on their own farms (the "farmer’s privilege"). These provisions accommodated opinion in the agricultural industry prevalent at that time

The original UPOV Convention prevented signatory States from offering "double protection" i.e both patent protection and plant variety rights within the same genus or species. The European Patent Convention of 1973 (EPC) went even further by specifically excluding plant varieties from patent protection, by EPC Article 53(b), and similar provisions were incorporated into the national laws of the EPC Member States. Such 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.

But the advent of modern biotechnology, especially recombinant DNA technology, 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. This puts in question the restrictions on plant patenting under EPC Article 53 (b). Such new traits need individual protection: not just in combination with a specific set of known traits, which is all that PVR can offer. Following a series of heavily-contested decisions under case law, the current conditions for the grant of patents for genetically manipulated plants can now be summarised (see later).

PVR Developments

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 most important changes was to allow "double protection". Certain modifications of the breeder’s and farmer’s privileges mentioned above were also introduced.

The Chartered Institute welcomed the revision of the UPOV Convention because it strengthened the protection available to breeders of valuable new plant varieties, whether or not they would meet the criteria for protection under the patent system. Apart from individual States (over 50 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.

The Chartered Institute of Patent Attorneys fully supports the intention behind the Regulation, which is to promote the development of new plant varieties, and agrees that a Community Plant Variety Right has become a most useful tool to that end.

Patent Law Developments

In July 1998, the European Parliament and Council of the European Union approved Directive 98/44/EC on the Legal Protection of Biotechnological Inventions. This obliges EU States to amend their national patent laws to improve protection for biotechnology inventions. This Directive, being an EU instrument, was not directly applicable to the EPC, although the European Patent Office has adopted its main provisions as regards plant patenting. The Directive does not alter the EPC ban on patenting plant varieties.

Directive 98/44/EC allows the patenting of transgenic plants. The Enlarged Board of Appeal (in 2000), clarifying and correcting previous conflicting EPC case law on EPC Article 53 (b), concluded that this was a restatement of, rather than a change in, the law. In the case brought to the Enlarged Board 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’s decision allows a patent 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.

The Chartered Institute welcomes the above ruling of the Enlarged Board as a most helpful contribution to patent practice in this field, so long as the present law is retained. However, the Institute remains of the view that any technological advance, including a new plant variety, which can meet the normal patentability requirements should be patentable. In addition, the possibility of protection under Plant Variety Laws must be retained, as many new plant varieties may not qualify for patent protection. In the longer term, therefore, a removal of the ban on patenting plant varieties at present contained both in the EPC and in the national Patent Laws of EPC Member States would be welcome.

May 2005