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IP Issues and Transactivation

Manipulation of gene expression, as it is done in most labs, uses multiple technologies which have been patented. Although not-for-profit researchers are rarely subject to infringement actions for using patented technologies, any later improvements or commercially viable developments can be jeopardized by these choices early in the research.

Transactivation1

Rice florets showing anther-specific GUSPlus expression.
Photo by Lijun Tian, CAMBIA.

This is because permissions must be obtained from patent holders and licensing and royalty arrangements must be in place before development toward commercialisation can be done. The cost of obtaining these permissions after the fact, when added to field testing and scale-up work, can be prohibitive. Accordingly, sometimes even after years of valuable research work, virtually all public good output or commercialisation is blocked, to the detriment of the global community (see see Connett and Jefferson 2005).

Normally the patent claims for promoters specify that the isolated promoter sequence must be operably linked to a specific gene or genetic sequence. Therefore, many promoters can be used without infringement of the patents when not operably linked to those specific sequences.

This transactivation project has created proprietary tools that are being released under the BiOS license and a BiOS-compliant MTA to the BioForge commons (contact licenses@cambia.org). The tools include an artificial transcription factor with a strongly plant-active DNA binding domain and activation domain, and a vector containing the corresponding upstream activation sequence and a minimal promoter, constructed by CAMBIA (see a 2004 published abstract describing Thach Tran's thesis work; enabling description has been presented in a variety of public fora since 2000 and is in his not-yet-accepted Ph.D. thesis, which we are able to make available together with the vectors to any BiOS licensee on request). This transcription factor/activation sequence pair, not linked, may enable, in many jurisdictions, methods to legally circumvent many existing promoter patents.

By using these constructs under license, a license that includes covenants to maintain the technology available to others and the right to commercialise, researchers will be taking steps to reverse the trend by which the researcher is unable to influence deliverability of good work.

Another means of circumvention is the method of sexually crossing a plant that contains a transactivation sequence with a plant that contains a UAS sequence; offspring containing both vectors may not be infringing on a patent that may preclude researchers from introducing both components into the same plant. See our patent application, WO 01/21781. All CAMBIA technology and know-how related to this work is freely available for use by anyone who agrees to the terms of the BiOS license.

The goal of the BioForge is to create ways to work around patents that are stifling innovation, via collaboration, sharing patented knowledge and unpatented know-how, and making available leveraged access to other essential information and materials for a shared platform of capability to use.

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