One essential function of a technology transfer office (TTO) is the proactive management of intellectual property related to crops and germplasm. A crop variety can be protected by more than one form of IP protection, and often two or more forms of protection can be used simultaneously. These chapters provide an overview of the different types of IP protection available for plants: patents, plant variety rights, trade secrets, copyrights, and trademarks. These chapters give the reader a working knowledge of the guidelines established by relevant international treaties, how these guidelines are reflected in certain national legislation, and how they can be incorporated into a system of best practices in IP management for plants, germplasm, and other types of plant materials. These chapters also offer a practical guidelines for setting up a national PVP office.
International treaties on plants
Under guidelines established by the International Convention for the Protection of New Plant Varieties (Union pour la Protection des Obtentions Végétales, commonly known as UPOV), in order to be worthy of protection, a plant variety must be new and distinct from pre-existing varieties and sufficiently uniform and stable in its essential characteristics. UPOV established guidelines for dedicated or “sui generis” systems of IP rights that provide for plant variety protection (PVP). UPOV is the only international treaty focused on PVPs. Its most recent revisions obligate member states to provide IP protection to all plant genera and species, so long as they fulfill the necessary criteria. Furthermore, UPOV grants breeders’ rights to all seed production of protected varieties (though individual governments can ignore this stipulation if they so choose). UPOV also grants commercial breeders the rights to the harvested material of the variety in some cases.
The UPOV guidelines have been twice revised, once in 1972 and again in 1991; each revision required the approval of member countries. In 1972, the guidelines were amended to permit member countries to allow the protection of plant varieties under both a national patent system and a UPOV-style sui generis system. The 1991 revisions expanded the scope of protections to include second-generation varieties that are “essentially derived” from the variety in question and discarded the list of “allowable” plant genera, thereby ensuring that any and all plant genera could be protected under the UPOV aegis. The 1991 revisions gave national systems the right to limit farmers’ rights and require that they save only as many seeds as they need to replant their own land.
The TRIPS agreement, signed in 1994, establishes standards for IP protection in WTO member countries and addresses the relationship between plant variety protection and patent systems. According to TRIPS, WTO members must grant some kind of IP protection for plant varieties, whether through patents, “an effective sui generis system,” or both. TRIPS does not define what constitutes an “effective” sui generis system. Proponents of the UPOV guidelines have declared that their system is the most workable example of a sui generis plant variety protection system. Be this as it may, it surely meets the standards of TRIPs.
What sort of sui generis system would satisfy the TRIPS requirement? More than 50 countries have embraced UPOV. However, it has been argued that some of the terms of the Convention on Biological Diversity (CBD), particularly the provisions concerning informed consent to biological materials and equitable benefit-sharing following that access, may be in tension with the TRIPS requirement. The truth is that no single type of sui generis system is guaranteed to work in all contexts, thanks to local variations in agricultural conditions, seed-producing industries, and biodiversity.
An initiative known as the International Undertaking on Plant Genetic Resources was first launched at the FAO conference in 1983. It was modified several times to incorporate the terms of UPOV, the CBD, and TRIPS, and was consummated as the International Treaty on Plant Genetic Resources for Food and Agriculture (known familiarly as “the Treaty”) in 1994. The Treaty entered into force in 2004. It established a multilateral system that allows member states to exchange the germplasm of major crop varieties: in other words, a kind of “genetic commons.” The Treaty limits the rights of recipients to seek IP rights for donated material; it also supports the rights of donors to share in the recipients’ profits. The centers of the Consultative Group for International Agricultural Research (CGIAR) placed their germplasm collections under the trusteeship of the FAO, and agreements allow the provisions of the Treaty to govern access to those collections.
The Treaty recognizes that agrobiodiversity depends on the contributions of traditional farmers and indigenous peoples. Agrobiodiversity can only be maintained by developing and conserving landraces, primitive cultivars developed to deal with the local climate and diseases and cater to local tastes, by interbreeding locally occurring undomesticated plants with cultivated plants, as well as exchanging different genotypes among farmers and farms. The Treaty makes national governments responsible for acknowledging the rights of their own farmers. It requires countries to pass legislation that protects traditional agricultural knowledge, requires recipients to share the benefits that are derived from the use of plant genetic resources, and includes farmers in national decisions on conservation and the sustainable use of plant genetic resources. The Treaty does not specify how farmers’ rights must be protected. Most Treaty members have passed national legislation on farmers’ rights that combines one of the versions of UPOV with some of the access principles of the CBD.
Options for IP protection of plants
For innovators developing new plant varieties, patent systems offer two advantages over PVPs. Patent laws, unlike PVP laws, do not allow farmers to save seeds or breeders to use a plant variety as parental stock for breeding new varieties. Patents also cover more inventions and discoveries than do PVPs (plants, seeds, genetic constructs, and enabling technologies). There is no conflict between U.S. patent law and plant variety protection under the PVP Act. Both patents and PVPs can be used to protect plant varieties. In Canada, the courts have determined that plant varieties can be patented. However, the European Patent Convention (EPC) has determined that plant varieties and “essentially biological processes” are not patentable. Some have protested the patenting of plants on ethical grounds. One argument states that it is immoral to appropriate or “own” plant breeding stocks or genetic resources that are the common heritage of humankind. Others argue that private ownership is dangerous because it means that key enabling technologies (and therefore possible solutions to problems of public health and food security) are withheld from public research institutions.
PVP is a statutory mechanism for the IP protection of plants. PVP gives the breeder exclusive rights to exploit a new and distinct plant variety. PVP is a form of IP rights protection that has potentially broad global applications and can help meet some of the unique needs of developing countries.
PVP regimes are implemented in order to:
- Give breeders (in both the public and private sectors) a reasonable return on their investments;
- Provide breeders with an incentive for continuing to invest (and hopefully increasing their investment) in breeding research;
- Recognize the legal right of the innovator to be recognized as such; and
- Acknowledge that breeders have the right to be remunerated for their efforts.
In general, there are two exemptions to the protection provided by a PVP: 1) research exemptions and 2) farmers’ exemptions. A research exemption allows breeders to use the variety as breeding stock to develop new varieties. A farmers’ exemption allows farmers to save seed of a protected variety for the sole purpose of replanting their own land.
Other options for IP protection of plants include trade secrets (to protect in-house breeding materials such as proprietary parental inbred lines), trademarks (to protect valuable variety brand names) and copyrights (increasingly used to protect databases that hold information about plant genes).
Establishing a PVP office
An office or subsection of the TTO should be devoted to plant IP management. This office is responsible for devising IP-protection strategies and effectively managing IP assets. It should also have a good understanding of gene bank management (for example, issues related to in-house, incoming and outgoing germplasm and related materials). Chapter 4.6 offers practical guidelines on how to establish a PVP office.
An essential responsibility of the PVP office, or PVP section of the TTO, is to determine, establish, and monitor best practices in the management of PVP applications; see Chapter 4.6 for basic guidance on these topics. A standardized PVP regime used by several different countries would be ideal: such a system would significantly lower users’ costs, increase returns on plant-breeding investments, and give farmers more choices.
Key Implications and Best Practices
Given that IP management is heavily context specific, these Key Implications and Best Practices are intended as starting points to be adapted to specific needs and circumstances.
For Government Policymakers
- Innovation and breeding are encouraged if there is a national system in place whereby innovators can obtain government-granted IP rights to biological materials (particularly plant varieties). The various international treaties offer several models for national IP-protection systems.
- Under the Convention on Biological Diversity (CBD), countries have the sovereign right to restrict access to genetic resources. Some countries have chosen to provide exceptions, from the multilateral system to be set up under the FAO International Treaty, for certain categories of plant genetic resources they consider strategically important.
- According to TRIPs Article 27, plant varieties can either be patented or excluded from patentability as long as another “effective sui generis” form of protection is implemented.
- A standardized plant variety protection (PVP) regime adopted by several different countries would be an optimal set-up, as such a regime would significantly lower users’ costs and increase returns on plant-breeding investments.
- In order to reinforce national policy initiatives, training is recommended to establish a PVP system. A standardized PVP system, adopted region-wide, would increase regional co-operation and harmony.
- IP-protection mechanisms are useless unless they are effectively and fairly enforced by national governments.
For Senior Management (university president, R&D manager, etc)
- Many institutions have both IP offices and plant variety protection (PVP) offices. The PVP office can be located where plant breeding activities take place. Similarly, many countries have a national patent and trademark office, as well as a national PVP office.
- The international exchange of biological materials is governed by national laws that implement a country’s obligations pursuant to the interlocking terms and requirements of at least four major international conventions.
- In order to support national PVP efforts, institutions can serve as centers for test-growing new varieties, or they can contract others to conduct those tests; furthermore, they can maintain germplasm collections.
- Be aware that research exemptions for the use of patented methods and materials may be quite restrictive. For example, in the U.S., a university undertaking commercial research contracts cannot avail itself of this exemption.
- Workshops may be helpful tools for exposing management staff to areas of conflict and teaching them about the strategic uses of PVPs. Also helpful might be an internship program in which selected individuals could collaborate with public and private institutions based in countries with well-established PVP systems.
For Scientists
- Most of the guidelines formulated by international conventions allow research exemptions or “breeders’ rights” exemptions, which allow public institutions to use biological materials for research or breeding programs. For this reason, large germplasm collections are available for research and breeding purposes. Remember that there are international obligations, such as for benefit sharing.
- If a biological invention cannot be patented in your own country, it may be patentable in another country. The U.S. and Canada tend to have the most unrestrictive laws regarding the patenting of organisms and biological materials.
For Technology Transfer Officers
- The international standardization of plant variety protection under UPOV means that a fairly uniform class of IP is available for you to make foreign filings to broadly protect valuable germplasm developed in your institution’s breeding program.
- Plant variety protection can be an effective way to commercialize new plant varieties that are developed at public institutions.
- Different countries interpret the TRIPS requirements in different ways. Therefore, not all countries grant patents for certain classes of biological materials, particularly plant varieties. Be familiar with foreign laws before attempting to file a foreign patent.
- Most of the guidelines formulated by international conventions allow research exemptions or “breeders’ rights” exemptions, which allow public institutions to use biological materials for research or breeding programs. For this reason, large germplasm collections are available for research and breeding purposes. Remember that there are international obligations, such as for benefit sharing.
- Gene bank management can be difficult. With good documentation, acquisition, and distribution procedures, most disputes over the ownership about genetic resources can be avoided.
- An office or subsection of the technology transfer office should be devoted to PVP management.
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