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Intellectual property protection for plants

Summary
Intellectual property rights in plants may be of several kinds: patents, plant variety rights, trade marks, trade secrets, genetic resource rights. Rights vary from country to country: here we give the position in the European Union. 

Patents
Plants generally may be patented if new, not obvious and useful, and one can describe how to produce them repeatably. These are the universal requirements to patent anything. Many patents have been granted on GM plants. 'Essentially biological processes' are not patentable, in particular crossing and selection. Most new plants are at least in part the result of crossing and selection. It is currently being argued that plants so produced are not patentable: the EPO1  (Enlarged Board) will decide shortly. 

Plant variety rights (PVR)
Plants that are new but obvious cannot be protected by patents. But they may still be very useful. Breeding new plants is expensive and time-consuming (may take up to a decade). Plant variety rights reward investment in plant breeding. A plant variety is defined by the combination of all its characteristics (present or absent). Protected plant varieties may not be multiplied by others, but anyone may use them as starting material for breeding new varieties (the 'breeder's privilege'). 

Trade Marks
Trade marks certify trade origin only. A trader may sell many different types of seed under a single trade mark. Purchasers may sell the seeds on, even under the same mark: or (if they are not otherwise protected) multiply the seeds and sell the progeny under a different trade mark or none.

Trade Secrets
Commercially traded seeds are of two main kinds: 'pure lines' and F1 hybrids. 'Pure lines' are the progeny of identical pure line parents: F1 hybrids are the progeny of two different pure line male and female parents. In each case, the seeds are uniform, and give uniform progeny. But hybrids differ from pure lines in the second generation. The latter still breed true, but the former do not. So replanting seeds harvested from an F1 hybrid produces a non-uniform crop, of lower quality than the parent. The original parents of F1 hybrids are often not sold, but retained by breeders in-house as trade secrets. Without access to both parent lines, customers and competitors cannot reproduce the F1 hybrid.

Genetic resource rights
Under the Convention on Biological Diversity (CBD), 'countries of origin' have rights to control access to their genetic resources. The Nagoya Protocol to the CBD gives countries control over research on their genetic resources. When the Protocol is in force (probably in 2014) research on genetic resources (to develop new varieties) may require a benefit-sharing agreement with the 'country of origin'. Many crops are likely to be excluded, however.

This paper deals in more detail with patents, plant variety rights and genetic resource rights.

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’s apples have a recognisable appearance and an 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 properties 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 repeated crossing of selected individual plants to enhance or combine desired characteristics. These breeding methods take up much time and resources - to breed a new variety of wheat may take ten years. The resultant seed can easily be multiplied simply by replanting. To justify such an investment in a product that is so 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 by 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 rights available under the two systems is also very different. Plant variety rights are available for new plant varieties that are distinct, uniform and stable. Unlike the patent system there is no requirement for the variety to be inventive. Plant variety protection grants the owner exclusive rights in the reproductive material (seed, bulbs, cuttings, etc.) of the specific new variety. Protected seed which has been acquired for planting may be planted, but the product of the harvest is for consumption; replanting it breaches the breeder's right. However, the plant variety system also contains exemptions which in general
 (a) allow breeders to use protected varieties as a starting point for breeding further varieties (the “breeder’s privilege”) and
 (b) allow farmers, under certain conditions, 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 accorded with the views of the agricultural industry 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, free from the constraints inherent in sexual reproduction. In this way, 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 traditional methods. The impact of genetic engineering on plant breeding led to a review of the UPOV Convention. 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 70 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 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 - though this exclusion does not apply to microbiological processes or their products. Similar provisions are found in 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 obliged EU States to amend their national patent laws on biotechnology inventions. Like the EPC, the Directive prohibits patenting of plant varieties or essentially biological processes for their production, 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 EPO adopted its main provisions on 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 varieties. The fact that such a claim is broad enough to "embrace" unspecified varieties is no bar to patentability.

However, the Board failed 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 remained 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 resolve these questions, two further cases were referred to the Enlarged Board of Appeal (in 2007/2008). The first case relates to genetic-marker-assisted selection of Brassica species having high levels of anticarcinogenic glucosinolates, and the second case to a method for breeding tomatoes having reduced water content: and the products so obtained. The Enlarged Board decided that breeding processes including a step of "crossing and selection" are (in most cases) inherently unpatentable. The other steps in the process may be patentable separately. The patentees responded by deleting their process claims, and relying only on product claims. The Technical Board doubted whether this response was adequate: if a process was unpatentable, could the product of the process be protected? That question is now before the Enlarged Board, who are expected to decide it shortly.


Rights in Genetic Resources
The Convention on Biological Diversity (CBD) came into force in December 1993. Nearly all countries in the world are members, with the significant exception of USA. Its objects are:
 to conserve biodiversity
 to encourage its sustainable use
 to promote equitable sharing of benefits between those who provide biodiversity and those who use it. Biodiversity is a synonym for genetic resources.

It is a principle of the CBD that national sovereignty gives "countries of origin" of biodiversity the right to control access to it. This is not difficult or contentious, as long as the genetic resources remain within the country of origin. But once they are removed from the country of origin, problems arise. Was this done legally? How do you tell? Many countries do not plan to enforce their "genetic resource" rights2. It is often difficult to tell which the original "country of origin" was3. Nevertheless, regardless of these difficulties, the Nagoya Protocol to the CBD (agreed in Japan in 2010) will control research on (inter alia) all plant genetic resources. Before conducting research on such a genetic resource, the researcher must: 1) identify the "country of origin" of the genetic resource; 2) if required by the "country of origin", negotiate a benefit-sharing agreement with the appropriate authorities in that country. The Nagoya Protocol will be enforced in the EU by a Regulation, currently being negotiated, but likely to come into force in 2014. It is currently expected: 1) that the Regulation will not be retrospective4; 2) that it will not apply to most major crops. Nevertheless, it seems likely to inhibit research on genetic resources and slow down production of useful new plant varieties.

November 2013
 


1. European Patent Office  
2. It is speculated that the only EU countries who will enforce such rights are Spain and Denmark.
3. The CBD defines "country of origin" as the country where the species is to be found growing in situ. Often there is more than one such country. It may or may not be possible, in respect of a particular sample, to determine which country housed the plant from which that sample descends.
4. In its final form, it may require permission for future research on material acquired before the Regulation comes into force – this is not decided at the date of writing (November 2013)