Intellectual Property Rights

by Cambia (author Carol Nottenburg)

Plant Breeding Methods (HS 541ZZZ)

1. Patent Claims on Plants

In some countries (including the United States, Australia and Europe) plants can be covered by patent claims provided that the patent applications are able to meet all of the necessary standards and requirements that exist in that country for patentability. Under the Trade-Related Aspects of Intellectual Property Agreement which binds World Trade Organization members, member countries that choose not to provide such mechanisms for plants under their national patent system must provide an alternative way in which an entity may claim that it has a legal right to intellectual property, to the partial exclusion of the rights of others, in plants and plant products. Some examples other than patents per se are discussed in section 2.

Utility Patents

In most countries, plants and inventions directed to plants or plant products (e.g. seed) are not eligible for a patent grant, but some (including the United States and Australia) provide that an entity may make claims to a time-limited right to exclude others from use of plants and plant products, provided that the legal criteria for patentability are met. While the patent legislation of each jurisdiction is different, the requirements and rights awarded to patentees are substantially similar.

* The term “Utility Patent” is used to distinguish between patents and other specific forms of intellectual property claims that exist in some jurisdictions, “Plant/Petty/Innovation Patents”. Utility patents in the United States are comparable to the standard patents that are awarded both in Australia (under the Patents Act (1990)) and in Europe.

i) What can be patented?

In the United States, any living organism that is the product of human intervention (such as by some breeding process or laboratory-based alteration) qualifies as a composition of matter, which is patentable (Diamond v Chakrabarty (1980) 447 US 303). As a result, plants are patentable subject matter (35 U.S.C. 101). Furthermore, the United States has extended patent protection to plants produced by either sexual or asexual reproduction and to plant parts including seeds and tissue cultures (Ex parte Hibberd (1985) 227 USPQ 433).

In Australia, the Patent Act (1990) allows all technologies to be patented (except ‘human beings and the biological processes for their production’) provided that there is an “invention”, defined as ‘an innovative idea which provides a practical solution to a technological problem’.

In addition or as an alternative to obtaining a patent through the patent office in individual European countries, patent grants in nearly all European countries can be gained from filing at the European Patent Office and registering the allowed claims in national patent offices. This means of patenting is controlled by the European Patent Convention (EPC). Historically, each European country was governed by their own national patent laws, however the introduction of Directive 98/44/EC (effective in all European Union Member States 30th July 2000) aims to harmonize protection for biotechnological inventions (including plant protection) amongst the European Union members. Thus, each member country is required to bring their national laws in line with the Directive, although some may not yet be fully in compliance.

ii) Types of allowable claims

Utility and standard patents may be used to claim exclusionary rights in

• new varieties of plants (U.S. only),
• transgenic plants,
• plant groups,
• individual plants and their descendants,
• particular plant traits,
• plant parts,
• plant components (e.g. specific genes or chromosomes),
• plant products (e.g. fruit, oils, pharmaceuticals),
• plant material used in industrial processes (e.g. cell lines used in cultivation methods),
• reproductive material (e.g. seeds or cuttings),
• plant culture cells,
• plant breeding methodologies, and
• vectors and processes involved in the production of transgenic plants.

Note that this list provides examples and is not exhaustive.

iii) Inclusions and Exclusions

Natural source material should not be coverable by patents as exclusionary rights in any country in the world, because natural source material is not novel (see below).

In the U.S. and Australia individual plant varieties are patentable. In Europe, individual plant varieties per se are not patentable, however, a plant which is characterized by a particular gene (as opposed to its whole genome) is not included in the definition of a plant variety and is therefore patentable.

In Europe, transgenic plants are patentable if they are not restricted to a specific plant variety, but represent a broader plant grouping. The European Directive considers plant cells to be “microbiological products” and as a result are patentable.

EXAMPLE While bushwalking, Amy discovers a plant which nobody has ever previously seen or documented. Can Amy obtain a patent for the plant? No. Amy can not patent the plant as it is natural source material and is not novel (see below).

iv) Standards of patentability and the rights granted

The legal criteria for patentability are substantially similar across all jurisdictions. In order to show that the plant, plant technology or plant product of interest is an invention:

the patent application must show: 1) novelty 2) non-obviousness, or an inventive step 3) usefulness (United States) or industrial applicability (Europe, Australia) 4) enablement 5) claim clarity 6) written description 7) best mode (United States only)

From the date that a patent is granted, the patent holder has the exclusive right to exploit the invention or authorize another person to do so until the patent expires. Patent rights are considered personal property and may be assigned to other parties.

A utility patent grants the owner the right to exclude others from: 1) making, 2) using, 3) selling or offering for sale or 4) importing the protected invention for a 20 year period* from the earliest file date.

*If a patent application was filed prior to June 8, 1995, the patent term of protection in the United States is 17 years from the date of issuance.

EXAMPLE John is the sole owner of a patent for herbicide resistant corn plants. He becomes aware that his former co-worker Julie is making and selling the same patented corn plant. What can John do? John, as the patent owner has the exclusionary right to stop others from making and selling his invention. Julie is therefore infringing John’s patent, and John can bring a lawsuit for infringement or ask that Julie take out a llicense.

v) Exemptions

Exemptions to patent infringement that are relevant to patenting of plants are provided in some jurisdictions.

In United States case law, an ‘experimental use exception’ to patent infringement was thought to exist which allowed researchers free access to the invention in order to use it for experimental purposes. However, based on the decisions in recent cases the doctrine certainly no longer exists and it is highly doubtful whether the doctrine ever actually existed.

In Australia, limited exemptions are defined within the legislation. The ‘prior use’ exemption allows someone who was utilizing the patented product or process before the priority date of a claim to continue using the patented product without infringement. The use of a patented product on board a foreign vessel that accidentally comes into the patent area is also exempted from infringement.

The EU Directive 98/44/EC provides a ‘farmer’s privilege’. Under the Directive, farmers are allowed to use patent protected seeds freely for their own use and the resulting plant material is free from protection. Farmers are not permitted however, to re-sell the patented seed. Member States are able to define their own exemptions to patent infringement (see, for example, Patents Act 1977 (UK), s60 (5))

Although not an exemption per se, in the United States but not in Australia or Europe, an inventor has a grace period allowing for retrospective application for a patent. Patent rights are not automatically foregone by public disclosure, such as publication or commercialisation, provided that a patent is applied for within 12 months of the disclosure. Note that other countries (e.g., Japan) have a limited grace period, and other countries are considering instituting one.

EXAMPLE Tom, a U.S. resident, was the first person to extract oil from sunflower plants. He presents his findings at a biotechnology conference. It is not until after his presentation he realizes that his sunflower oil may be of commercial significance. Is it too late for him to patent his invention? Tom can still obtain a patent in the United States provided he applies within twelve months of the conference and the oil or its method of extraction meets the requirements for patentability.

B. Plant Patents

Specific plant patents are only available in very few countries.

The Plant Patent Act was enacted by US congress in 1930. It was introduced primarily to benefit the horticulture industry by encouraging plant breeding and increasing plant genetic diversity.

i) Limited types of plants are eligible for protection

The Plant Patent Act 1930 (35 U.S.C. 161) provides for:

patent protection of all asexually reproduced plants EXCEPT: 1) tuber-propagated plants and 2) plants found in an uncultivated state.

Plant patents encompass newly found plant varieties as well as cultivated spores, mutants, hybrids and newly found seedlings on the proviso that they reproduce asexually. Asexual reproduction is defined as any reproductive process that does not involve the union of individuals or germ cells. It is the propagation of a plant to multiply the plant without the use of genetic seeds. Modes of asexual reproduction in plants include grafting, bulbs, apomictic seeds, rhizomes and tissue culture.

Specifically excluded from protection under the Plant Patent Act are tuber-propagated plants and plants found in an uncultivated state.

ii) Patentability requirements are less stringent for plant patents

The requirements that must be fulfilled in order to obtain a Plant Patent are the same as those for utility patents (see Patents (iv) above). However, the IMPLEMENTATION of these requirements is LESS STRINGENT.

For example, the Plant Patent Act provides that plant patents will not be rejected or invalidated if the plant is not fully described or enabled. It does however, require that the new variety is described as complete as reasonably possible.

It is also not necessary to deposit the claimed plant at an official depositary.

The ordinary test of ‘non-obviousness’ is not applied to plant patents. This is primarily due to the fact that it is extremely challenging to develop a new plant variety that is stable and can be preserved by asexual reproduction.

iii) Plant patents confer an exclusionary right

A plant patent gives the patent holder the right to:

exclude others from asexually reproducing, using, selling, offering for sale or importing into the United States the reproduced plant (or any of its parts)* for a period of 20 years.

In contrast to utility patents, plant patents only protect a single plant or genome and the protection conferred is quite limited. It does not protect the plant characteristics, mutants of the patented plant nor technologies associated with its cultivation. Because plant patents are granted on the entire plant, it follows that only one claim per plant patent is permitted.

U.S. courts have held that a twelve month grace period also applies to plant patents (35 U.S.C ?102(b)) whereby a disclosure of a new plant variety or a granted patent of the new variety in a foreign jurisdiction does not destroy patentability provided that the disclosure or foreign patent occurred less than 12 months prior to the plant patent application being lodged in the U.S. If publication has occurred in any other country prior to the 12 month grace period, the plant patent application will be refused (Ex parte Thomson, 25 USPQ 2d 1618 (BPAI 1992)). This interpretation of the law has met with proposals to increase the grace period to 10 years on the basis that often times plants from foreign jurisdictions are held in quarantine by the USDA for a period of more than 12 months, thereby nullifying patentability. To date this idea remains a proposal.

*The Plant Patent Act was amended on 27 October 1998 to extend the exclusive right to plant parts obtained from protected varieties but it is not applied retroactively.

iii) Dual protection is allowed

A utility patent and a plant patent can both be obtained to protect the same plant.

It is possible to obtain protection for the same plant under both a utility patent and a plant patent in the United States at the same time, provided that the requirements for patentability for both types of patents are fulfilled.

EXAMPLE Marc and Crystal want to obtain protection in the U.S. for their new variety of asexually reproducing plant. They also wish to protect a special aluminum device that contains specific amounts of hormones and other nutrients needed to ensure the plants survival. What types of protection are available? Marc and Crystal can obtain a plant patent for the new variety plant provided they meet the requirements for patentability. However the device required to guarantee survival of the plant is unable to be protected by this system. Utility patents would provide protection to BOTH the special device and the plant variety provided the criteria for patentability are fulfilled.

2. Plant Breeder’s Rights* (PBRs)

While in the U.S. plant varieties can be protected under the patent system, in the majority of jurisdictions including Australia, the protection of plant varieties under the patent legislation is not permitted. Having a form of protection in place that is available to new plant varieties is thought to be important in order to encourage and promote plant breeding, encourage the importation of foreign varieties, promote the exportation of plant varieties and generally benefit the market place.

* The term Plant Breeder’s Rights is synonymous with Plant Variety Rights.

A. Requirement for plant protection under TRIPs

Members of the World Trade Organisation (WTO) are bound by their membership to adhere to the Agreement on Trade-Related Aspects of Intellectual Property (TRIPs). The Agreement sets out the minimum standards of intellectual property protection the member countries are required to provide.

One of the most controversial provisions of the Agreement surrounds protection of plant varieties. Article 27(3)(b) of the Agreement allows countries to exclude plants and essentially biological processes for their production from their patent system of protection. The same Article however, states that countries must “provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof”. Under the Agreement, a country can implement more than one form of plant protection.

The meaning of “sui generis” is one of the contentious issues surrounding the agreement. It is generally believed that the term enables member countries to design their own system of protection for plant varieties if they have elected not to use their patent system for plant protection. What is a sufficient system to qualify as “sui generis” remains to be seen.

B. International Union for the Protection of New Varieties of Plants (UPOV)

The International Union for the Protections of New Varieties of Plants (UPOV) is an intergovernmental organization and not a ‘treaty’ as such. Countries are not obliged to join UPOV as a result of their affiliation with any other organization or the ratification of any specific treaty. Membership is purely voluntary.

Each member of the organization becomes bound to the UPOV Convention. The Convention requires member countries to provide an intellectual property right specifically for plant varieties. This form of IP protection is often referred to as Plant Breeder’s Rights (PBR). As a result of the PBR, the plant breeder is granted a legal monopoly over the commercialization of her plant varieties. Protection allows the breeder to try to recover the costs associated with the development of the variety. By conferring protection on plant varieties, UPOV also aims to provide an incentive to individuals or companies to invest in plant breeding, thereby providing a positive stimulus in the plant breeding industry. The rights granted are for a specific time only (depending on the plant variety), and upon expiration of the time period, the protected variety passes into the public domain.

The UPOV Convention has been revised three times, however not all member countries are bound by the latest convention (1991). Approximately 26 countries remain bound by the 1978 Convention, while Spain and Belgium are bound by the original Convention (1961). The main differences in the two latest agreements can be seen in the table below:

UPOV Convention	1978	1991
Requirements	Distinct, Uniform and Stable	Distinct, Uniform, Stable, New
Protects	Commercial use of reproductive material of the variety	All plant varieties and products including plants that are derived
Duration of Protection	15 years from application date for most species. 18 years for trees and vines	20 years from application date for most species. 25 years for trees and vines
Breeder’s Exemption	Yes. Acts for breeding and development of other varieties are not prohibited.	Optional. The decision to include an exemption is dependent on each members national legislation.

The requirements for protection under UPOV require distinctness. The variety must be distinguishable from any other variety which is publicly known at the time of filing the application. The variety must have predictable characteristics and be able to be reliably reproduced. The additional requirement under the 1991 Convention states that the variety must be ‘new’. The word ‘new’ is held to mean that the variety has not been sold or otherwise disposed of by the breeder for commercial purposes prior to filing for protection. However, similarly to a utility patent, natural source material is not protectable. The UPOV Convention does allow a 12 month ‘grace period’ for sales of the new variety before protection is no longer available (Article 6(1b)).

The latest Convention protects all plant varieties including those that are ‘essentially derived’ i.e. plants which require the protected variety for their production. The protection offered to the plant variety is an exclusionary right.

Protection confers the right to exclude others from: 1) producing or reproducing, 2) propagating, 3) offering for sale, 4) selling or other marketing, 5) exporting, 6) importing or 7) stocking for any of the above purposes the protected variety.

However, the protected plant can be used for non-commercial acts (provided they are done privately) and for experimental purposes without infringement.

Considering that many UPOV members are also bound to the TRIPs agreement (due to their WTO membership), UPOV provides a framework by which countries can implement a protection system that generally fulfills the TRIPs requirement of providing ‘an effective sui generis system’ (see s2A).

C. Plant protection mechanisms provided by sample countries

i) Plant Variety Protection Certificates (United States)

The United States is bound by the TRIPs Agreement and is also a UPOV member. Because the United States offers patents for plant varieties, technically it does not need to also provide a sui generis system.

In the U.S. the UPOV Convention is implemented by the Plant Variety Protection Act (1970). Changes to the Act made by Amendments in 1994 extended statutory protection to F1 hybrids and tuber propagated plants and generally brought the United States into compliance with the 1991 UPOV Convention. The Plant Variety Protection Act is administered by the U.S. Department of Agriculture, which issues Plant Variety Protection Certificates (PVPC) for qualifying plant varieties.

The Plant Variety Protection Act protects sexually reproduced plants, including first generation (F1) hybrids and tuber propagated plants (e.g. potato varieties). The requirements and term of this protection offered are exactly the same as those outlined in the UPOV Convention.

The Plant Variety Protection Act requires that a deposit of seeds of the new variety be made at an authorised depositary, and in the case of F1 hybrids, seeds of the parents must also be deposited.

The U.S. has in its national legislation only a limited farmer’s exemption. In the case of farmers, protected seed may be “saved” for replanting on their own individual holdings provided that it is not sold to any third parties who use it for reproductive purposes.

Simultaneous protection by both a utility patent and a PVPC is allowed. (J.E.M. AG Supply v Pioneer Hi-Bred International ((122 S. Ct. 593, 2001)).

*Any variety which was protected prior to the 1994 amendments is subject to the original Plant Variety Protection Act (1970)which only provides 18 years of protection for non-woody plants. However, applications submitted prior to April 4, 1995 (effective amendment date) may be re-submitted in order to secure the extended term of protection provided by the amendments.

ii) Plant Breeder’s Rights (Australia)

Similarly to the U.S., Australia is both a WTO and UPOV member and has implemented the UPOV protection system as a mechanism for complying with TRIPs. Australia is signed onto the 1991 Convention. As a result, plant varieties are protected in Australia by a Plant Breeder’s Right (PBR) under the Plant Breeder’s Rights Act (1994).

The requirements, term and rights conferred by the UPOV Convention are implemented under the Plant Breeder’s Rights Act.

In Australia, a PBR is obtained from and administered by the Plant Breeder’s Rights Office, in contrast to patents which are granted by IP Australia.  Recently the Plant Breeder’s Rights Office was brought within IP Australia.

A choice is usually made between the two protection systems depending on the level of protection sought and the ability to satisfy the necessary requirements. PBRs are generally obtained much faster than a patent due to the lack of examination and are also much cheaper to obtain. They are therefore desirable where protection is required in a short period of time and there is no need to acquire rights over the use of the variety for non-commercial purposes. Where comprehensive exclusive rights are desired, protection under the patent system would be more suitable.

iii) Community Plant Variety Rights (European Union)

Plant variety protection in the European Union is a result of the European Convention (Regulation 2100/94/EC), which is based on the 1991 UPOV Convention. It was introduced in order to harmonise and streamline the method of plant variety protection available throughout Europe.

The Community protection of plant varieties (CPVR) enables applicants, on the basis of one application, to be granted a single intellectual property right which is operative throughout all countries that are members of the European Union. A CPVR can only be transferred or ceased within the EU Community on a uniform basis. That is, a CPVR can only be valid (or cancelled) across all EU countries, not selected individual countries.

The CPVR exists alongside individual European countries’ national plant protection legislation as an alternative form of protection. As a result, it is not possible to hold protection for the same plant variety under both the Community and a national system at the same time. Where a CPVR is granted in r elation to a variety for which a national right has already been granted, the national right is suspended for the duration of the CPVR.

The CPVR confers protection to all ‘new’ botanical genera and species, including their hybrids, provided that the varieties meet exactly the same requirements as outlined under the UPOV Convention. A CPVR is issued by the Community Plant Variety Office in Angers, France.

EXAMPLE George wishes to obtain a CPVR for his new plant variety in Germany. He is unsure as to whether his CPVR will provide protection in Italy and Switzerland. The CPVR obtained by George will confer protection to George in ALL European Union countries. There is no need to register individually in each country. George will automatically be granted protection in Italy, however not in Switzerland as Switzerland is not a member of the EU.

iii) A sui generis system (India)

Many developing countries have an agricultural economy that is geared towards the domestic as opposed to the export market. Such an economy is dependent upon farmer-produced seed of varieties that are both maintained and further adapted to their local growing conditions by small-scale farmers. Developing countries with such an economy want to acknowledge the rights of farmers arising from their contribution to crop conservation and development and the sharing of their knowledge on adaptive traits. They also want to encourage farmer-to-farmer exchange of new crop/plant varieties that are adapted to the local growing conditions. As a result, some developing countries have chosen a sui generis system of plant protection that is not compliant with UPOV in that it allows farmers to improve and adapt the seed in order to make it more successful in the local conditions.

Under the Indian Protection of Plant Varieties and Farmers’ Rights Act 2001, plants are divided into four main classes: new varieties, extant varieties, essentially derived varieties and farmers’ varieties. The regime for plant protection is similar to that set out by UPOV and the requirements for protection are novelty, distinctness, uniformity and stability. Under Article 39(iv) the farmer is entitled to save use, sow, resow, exchange, share or sell his farm produce including seed of a protected variety. However he is unable to sell seed that has is branded with the Breeders name. In this way the breeder has control of the commercial marketplace without threatening the famers’ ability to practise his livelihood.

The Indian Act also contains provisions for “benefit sharing” whereby the local communities are acknowledged as contributors of land races and farmer vartieties in the breeding of “new” plant varieties.

It is these extra provisions granting rights to both breeders and farmers which makes the Indian system a sui generis method of protection. China and Thailand are other examples of countries that do not implement a UPOV style protection system.

3. Trade Secrets

A. A trade secret is confidential information

A trade secret is commonly regarded as:

any formula, pattern, device, or compilation of information that is used in a business and gives that business an opportunity to obtain advantages over competitors.

The information is kept from the public and from competitors, usually by the use of confidentiality agreements with employees. These agreements confer an obligation on the employees to keep the information secret. These agreements can be enforced by the court.

Generally for a trade secret to exist there must have been:

Secrecy: in the form of a confidentialtiy a greement or covenant. External forms of protection such as security systems etc also impart the necessary requirement of secrecy.

Novelty

: The subject of the secrecy must have been novel.

Value: The subject of the trade secret must be of some value or give some advantage over competitors.

For a breach of a trade secret to occur, there must have been an improper taking. That is there must have been a breach of the secrecy whether by theft or the breaking of a confidentiality agreement.

One advantage of using trade secret law to protect an invention is the unlimited time for protection. Some disadvantages however are that trade secret protection does not prevent competitors from legally reverse engineering a product to determine the secret or from independently duplicating the information. Inventions involving the use of DNA are now unlikely to be protected by trade secrets due to the ability to reverse engineer.

B. Trade Secret laws can be used to protect plants

Plants can be protected provided that reasonable efforts have been made to keep the plant variety confidential, secret and out of the public domain. In the United States, trade secrets have been used for decades to protect parental lines of hybrid corn.

Recently a United States court recognized that “genetic messages” of inbred plant varietal lines may be protected by trade secret law subject to the provision that reasonable effort has been taken to preserve the secrecy of the gene sequence (Pioneer Hi-Bred case). In the Pioneer Hi-Bred case it was held that the accidental inclusion of inbred seed in bags of commercially available first generation seed by Pioneer Hi-Bred was not enough to destroy the secrecy surrounding its “genetic message”. Reasonable precaution had been taken to keep the “genetic message” contained in the inbred seed out of the public domain.

Under Australian law it is theoretically possible that specific varieties of plants may be afforded protection under the doctrine of confidential information or trade secrets, however to date, no cases involving the doctrine and plant varieties have been brought before the courts. As a result it is currently unclear as to the extent of protection available under the doctrine of trade secrets.

4. Genetic Mechanisms

A. Hybrids

In some cases, specialized plant breeding can present an alternative to intellectual property protection.

Breeders often select individual plants that display beneficial or attractive traits such as a fast growth rate in comparison to other plants or an increase in either herbicide or disease resistance etc. The breeder then crosses these plants with individual plants of different varieties that also demonstrate attractive traits. The resulting progeny are called hybrids.

Seeds resulting from hybrids show an extremely poor ability to reliably reproduce the trait of interest in their progeny or next generation.

It therefore becomes necessary for the farmer to purchase new seed for subsequent plantings. Hybrid selection therefore becomes a way for the plant breeder to protect their varieties from exploitation as they are safe in the knowledge that the farmer or purchaser can only access the trait reliably for one generation. Farmers and others must obtain more seed from the breeder if they wish to continue to use the same hybrid plants.

Hybridisation therefore serves as a way of not only creating new plant varieties with attractive traits but ensuring some sort of protection for new commercial plant varieties. Although this method of protection is inexpensive and is not subject to legal requirements or restrictions, the breeder has no enforceable remedy available to him/her, except under trade secret law (see above) or by contractual agreement.

B. Genetic Use Restriction Technologies (GURTs)

Genetic Use Restriction Technologies (GURTs) is technology that allows the control of gene expression of an organism, further allowing constraints or restrictions on the use of the organism or trait.  The term GURT was developed by the Lead Author (CAMBIA’s CEO) of the first study commissioned by the United Nations Convention on Biological Diversity (CBD).

There are two main types of GURTs: variety-level GURT (v-GURT) and trait- level GURT (t-GURT).

v-GURT causes the seeds of the affected plant variety to be sterile in contrast to t-GURT which results in the expression of a selected trait. t-GURT introduces a mechanism for trait expression into the variety which can only be turned on, or off, by treatment with specific chemical inducers. The gene of interest can thus be expressed at particular stages or generations of the crop.

In addition to intellectual property rights, plant breeders in principle are able to use GURTS to strengthen the protection of newly developed plant varieties. The use of v-GURTs requires farmers to buy seeds from the breeder each season and therefore could be used as a way of avoiding the farmers privilege exception to patentability that exist in Europe. However, in some situations v-GURTS are advantageous to farmers as they reduce the need for tillage and do not sprout inappropriately. t-GURTs require the farmer to purchase chemical inducers from the breeder in order for the farmer to be able to make use of the specific traits of the variety ie herbicide resistance.

It should be emphasized that at the time of editing (2007) there are no commercial example of GURTs known anywhere in the world.  The initial example, dubbed Terminator by a Civil Society Organization, was from a prophetic patent application that had not reduced the technology to commercial practice.

5. Contracts

The following types of agreements are all governed by contract law as opposed to intellectual property law. There are no international agreements that regulate the law of contracts.

A. Material Transfer Agreements

Material Transfer Agreements (MTAs) are legal agreements made between a provider and a recipient party when research material is being transferred between institutions.

Material most often transferred includes plant varieties, transgenic plants, cell lines, germplasm, vectors, chemicals, equipment or software.

The MTA itself contains a written description of the material to be transferred and any limits on the material that the provider wishes. For example some providers may limit the use of the transferred material to non-commercial situations or to a specific field of research. In some cases where publication of results occurs which involve the material it may be necessary to acknowledge the source of the material.

The terms and conditions of the MTA also usually outline the ownership rights, confidentiality provisions and any third party transfer restrictions that the provider of the material wishes to impose.

The agreement acts as a contractual agreement that is often used to protect the rights of ownership of the provider and also to protect the material from unauthorized use.

B. Bag Labels

Bag label contracts are another form of legal protection which can be applied to plants, especially seeds. An explicit contract is described on a bag label which is normally sewn into the seal of a bag. By opening the bag and breaking the seal, the purchaser agrees to comply with the contract.

These contracts are similar to what is commonly known as “shrink wrap licenses” in software. As yet the strength of protection conferred by the bag label is not firmly established.

C. Technology Use Agreements

A technology use agreement is an agreement most commonly between technology suppliers and farmers which usually controls the right to plant a given seed on a specific area of land often for a certain period of time.

The agreement provisions can also include restrictions on the use of proprietary traits in the creation of new varieties and also gives permission for the technology supplier to access the farmers property to check for violations.

This form of property right enforcement has been implemented by producers of agronomic traits in the U.S. and other countries. In some cases, the producers reserve the right to inspect the field of the contracting farmer and to take samples to ensure the compliance of the farmer with the TUA.

A breach of a Technology Use Agreement gives rise to a claim for damages if a breach of contract occurs.