Home > IP Topics Index > Putting Intellectual Property to Work: Experiences from Around the World > How Intellectual Property and Plant Breeding Come Together: Corn as a Case Study for Breeders and Research Managers > Editor's Summary, Implications and Best Practices

The rapid increase in patented inbred lines and traits during the 1990’s significantly and permanently changed maize breeding programs. Before the explosion of patents on germplasm and the introduction of patented traits in transgenic corn, germplasm was generally more accessible. Maize breeders were not concerned with contracts, licenses or Material Transfer Agreements (MTAs). Conventional breeding programs could freely move advanced generations abroad for off-season nurseries, thereby accelerating the breeding timetable. Each parental line developed was maintained as a single version. With the advent of increased proprietary protection (due to transgenic lines and other related developments) access to lines and genes has become increasingly subject to legal instruments, such as MTAs or contractual agreements. Contracts controlling access to molecular traits can be quite complex, requiring significant record keeping. In addition, regulatory approval hurdles have restricted where transgenic line off-season nurseries can be established (they are predominantly now under the American flag: Hawaii, Florida, Puerto Rico).

During the late 1990’s, the conversion of elite parent lines with genes for insect resistance and herbicide tolerance was prioritized. The introduction of molecular marker assisted backcrossing accelerated breeding programs from 8 to 4 (or less) generations. After elite parent lines are converted with a gene of interest, they require sufficient back-crossing so as to recover the entire genetic complement of the inbred line, as well as testing for purposes of quality control (that is, the transgenic inbred must perform exactly as does the non-transformed line, but must additionally express the gene of interest). Combinations of two or more genes are now stacked in transgenic hybrids, which increases the technical, financial, and proprietary complexity. Each new (transgenic) version of an inbred line must be assiduously maintained. Of course, this entails considerable expense for breeding, parental seed maintenance, and related production activities.

Managers and breeders must assess whether the genetic materials they utilize in their source populations are legally available. This means that they must have capacity in negotiating, understanding, executing and developing legal instruments (contracts, licenses, etc.) that provide access to materials critical for breeding programs (for example, genes of interest). Research, sales, and marketing managers must also decide which genes/traits to use, what the overall proprietary landscape is for each, and then establish any attached legal/proprietary obligations, for example proprietary rights pursuant to the terms of an MTA.

Therefore, to advance modern maize breeding programs, IP management and breeding must be synchronized aspects of a single endeavor. Properly conducted IP management will facilitate technology access via licensing of intellectual property, and also, importantly, enable breeders, managers and sales to avoid potentially costly errors in managing intellectual property (for example, genes and gene product patents), so as to avoid infringement or third party IP rights. This will be done within the context of setting priorities, identifying and managing intellectual property, and remaining aware of the importance of fully informed decisions regarding technological inputs into the breeding program. This type of coordinated program can contribute to the standard target of new hybrids with enhanced performance of 5-10%.

An important aspect of IP management is Freedom to Operate (FTO). This entails assessing whether or not any genes, lines, or related technologies that will go into the development of a new inbred line have unlicensed proprietary rights of others attached. FTO, therefore, is when the research, development, and commercialization of a new inbred line can proceed with a minimal risk of infringing another’s proprietary rights (for example, patents, trade secrets, tangible property, and plant variety protection (PVP)). From a very practical perspective, this will involve seeking and then managing agreements that facilitate access to IP rights, and hence to desired technological components and/or processes. For example, genes of interest might be transferred contingent to several types of agreements: contracts, MTAs, licenses, or research agreements. Each of these must be carefully negotiated, drafted, and executed, so that onerous provisions do not later haunt the program. Whenever possible, therefore, patent counsel should be sought.

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

• A desirable system of intellectual property for plant germplasm allows for protection from commercial use of proprietary genetics yet allows for a research exemption to maintain the flow of genetic improvements (for example, the current UPOV system).
• Management of intellectual property relating to maize (or any other crop) improvement programs will require a foundation of statutory IP law, (for example, patent and plant variety protection), a means to enforce these laws, systems for fostering IP awareness, training and education, and institutions for IP management. As a critical part of this, it will be essential to establish and support technology transfer offices.
• Appropriate regulatory mechanisms will also be necessary to enforce rules. This might be accomplished by implementing administrative legal structures, akin to federal agencies in the U.S. (for example, the Department of Agriculture, which oversees and controls various aspects of transgenic crop development).
• It is important to support long-term plant breeding programs, possibly by funding the National Agricultural Research Centers where breeding takes place. This support will not only materially advance program objectives, but also build morale and esprit de corps, intangible assets essential for sustained success.

For Senior Management (university president, R&D manager, etc)

• Plant breeders should be made aware of the rules for using patented genes, traits, plant materials, and other in-licensed materials. This might involve setting up awareness training programs.
• Working together with the technology transfer office, establish a policy for patenting university lines and traits, managing intellectual property, and for maintaining records dealing with proprietary issues. This essentially entails providing leadership and guidance to faculty in the area of IP management.

For Scientists

• In order to adhere to IP management policy guidelines mandated by the research institution and implemented by the technology transfer office, it is important to manage patented genes, traits and lines very carefully in your breeding programs, for example, maintaining precise records of any materials and how they were used.
• Educate staff as to proper IP management protocols, for example, not to “borrow” materials from other laboratories, research programs, or—perhaps worst of all—from other institutions or organizations, without properly documented authorization for use (that is, cleared through the technology transfer office).

For Technology Transfer Officers

• Technology transfer officers implement IP policy. This is accomplished by establishing clear policy guidelines concerning managing intellectual property, in-licensing of external intellectual property, out-licensing of your institution’s intellectual property, patent disclosures, patent and PCT applications and publishing guidelines that preserve novelty and/or priority.
• Maintain precise records of any patented materials, contracts, MTAs and other related documentation. Technology transfer officers should also be good negotiators.
• Officers must also develop focused programs for assisting faculty in patenting germplasm and other technological innovations arising from their research. Naturally, this will involve raising IP awareness and capacity building.