Transgenic crops, biotechnology and ownership rights: what scientists need to know

Abstract

SummaryOwnership of intellectual and tangible property (IP/TP) rights in agricultural biotechnology (ag-biotech) and transgenic plants has become critically important. For scientists in all institutions, whether industrialized or developing country, public or private sector, an understanding of IP/TP rights is fundamental in both research and development. Transgenic plants and ag-biotech products embody numerous components and processes, each of which may have IP/TP rights attached. To identify these rights, a transgenic plant or ag-biotech product must be dissected into its essential components and processes, with each`piece' analysed under the IP/TP`microscope'. This product deconstruction is an integral step in product clearance (PC) analysis leading to freedom to operate (FTO). To facilitate a PC analysis, the following points are important: (1) knowing what one has and where it's from, (2) organizing material transfer agreements and licences, (3) researching scienti®c and patent databases and relevant literature, (4) instituting a laboratory notebook policy, (5) keeping track of ownership of germplasm and plant genetic resources, and (6) promoting ongoing IP/TP management, awareness and training. However, a FTO opinion does not solve the IP/TP issues of releasing a transgenic plant or ag-biotech product; rather, it is a management tool for assessing the risks of litigation. When transferring transgenic plants or ag-biotech to developing nations, scientists from industrialized countries have the heightened responsibility of verifying that IP/TP issues are fully addressed and documented. Successful technology transfer goes beyond research, development and licensing; it is an holistic package leading to long-term partnerships in international development. Managing IP/TP requires capacity-building in scientists and technology transfer of®ces, in both industrialized and developing countries.

Identification and freedom to operate analysis of potential genes for drought tolerance in maize

“…It is also important to consider the legal and IP landscape as dynamic and evolving, so FTO analyses must be continuous in time and their results should be validated and updated periodically. Change can come from expired, published, invalidated or reassigned patents; licenses can be issued or terminated (Kowalski, 2002). This preliminary analysis of the IP status of the selected genes and all related elements in the designed expression cassettes suggests that they can be used in Colombia.…”

“…A proper FTO analysis reduces the risk of infringing third-party rights and possible future lawsuits, which can be expensive and may even impede the commercialization of an innovation (Kowalski, 2002;Wolff, 2008). Some authors argue that doing an FTO analysis from the onset of a research project allows developers to plan intellectual property (IP) rights management strategies, which can lead to the redesign of expression cassettes, negotiate royalty-free licenses for humanitarian purposes, negotiate individual licenses or the formation of consortia (Kryder et al, 2000;Chi-Ham et al, 2010).…”

TRIPS-Related Patent Flexibilities and Food Security: Options for Developing Countries

“…There may be a patent on promoters, another on terminator sequences and others on sequences used for "transportation" and "reporter genes" needed for the genetic transformation of a plant, and in the case of transgenic plants and agrobiotechnology products, each of their numerous components and processes, each may be protected by an IPR. 44 This leads to "[t]he development of large patent portfolios of more or less overlapping claim files ('patent thickets')." 45 The presence even of one single patented component in a plant or plant variety may create a barrier against the utilization of the latter, including for research and breeding.…”

Diffusion du coton génétiquement modifié en Chine : leçons sur les facteurs et les limites d’un succès

“…89 Un très grand nombre de brevets couvrent la propriété des gènes et des procédés de transformation et d'introgression dans le génome (Kowalski et al, 2002). La contrainte et le coût du respect de cette propriété sont reconnus comme les freins à la diffusion des variétés génétiquement modifiées, justifiant ainsi les appels à leur assouplissement (ICAC, 2004 ;Taylor et al, 2003).…”