LAWRENCE — The development of a new “open language,” or standard means for communicating data and results between researchers, to guide collaboration in the cutting-edge science of synthetic biology shows valuable potential. But it must take intellectual property issues into account at the outset to avoid legal problems that can be destructive to the process of standards setting, a University of Kansas law professor argues.
Andrew Torrance, also a visiting scholar at the MIT Sloan School of Management, co-authored a commentary in the leading journal Nature Biotechnology, arguing that if intellectual property concerns are not included in the development of a Synthetic Biology Open Language, or “SBOL,” scientific progress could be thwarted and wasteful legal battles ensue. The commentary was written as a response to an SBOL proposal written by Galdzicki et al., previously published in Nature Biotechnology. Torrance co-authored the commentary with professors Jorge L. Contreras of the University of Utah and Arti K. Rai of Duke University. All three specialize in law, biology, intellectual property and technical standards setting.
The Synthetic Biology Open Language is a set of technical standards intended to serve as a common language to allow diverse research groups to collaborate in the field of synthetic biology without need for technical translation. The language would be part of standards “accelerating scientific progress in synthetic biology and for the eventual commercialization of resulting technologies,” Torrance and co-authors wrote. However, patent and other intellectual property issues highly relevant to the adoption of SBOL were not mentioned and should be considered.
“Standardization and the standards setting process has greatly benefited other fields of scientific endeavor, such as engineering and computer science, and is similarly important to synthetic biology,” Torrance said. “Just as standard worldwide language for air traffic control has enhanced both efficiency and safety, thus spurring air travel, standard language for information exchange should lead progress in synthetic biology to be faster and more meaningful. However, the biological research landscape is replete with patent rights, so standard setting must grapple about intellectual property at the outset.”
Torrance and colleagues recommend including patent holders and legal experts in ongoing negotiations to develop standards such as the Synthetic Biology Open Language. Failing to do so could result in patent holders filing lawsuits, either immediately or once the standard has been adopted, thereby slowing, frustrating or thwarting scientific progress. Such dangers could also drive up the cost of innovation. Failing to consider legal issues has “bedeviled standard developers over the past two decades in industries ranging from wireless networks telecommunications to computer networking to semiconductor memory,” the authors wrote.
Designing standards without considering legal implications would be like designing a top-of-the-line automobile without ensuring there will be a road system on which to drive it, Torrance said. Not only would the vehicle be unable to show off its power and speed, it would almost certainly hit damaging potholes before it got anywhere.
One of the guiding philosophies in the field of synthetic biology is to be open and to share progress with all who are interested. The authors salute and support the “fair, reasonable and non-discriminatory” ethos this reflects, but they urge those trying to set technical standards not to overlook intellectual property issues with the potential to derail progress in service of that ideal.
“In general, I think the synthetic biology community has shown impressive awareness of potential legal hazards,” Torrance said. “Our letter was a way of reminding the synthetic biology community that issues of law, especially patents, are of vital importance and impossible to ignore. We urge such issues to be considered as an integral part of the standards-setting process so that technical standards are free from legal impediments from their initial adoption. Synthetic biology promises to be one of the great beneficial technologies, generating powerful medicines, more efficient and cleaner industrial processes, and perhaps even self-repairing consumer goods. We want to help ensure that legal impediments to achieving such worthy goals are avoided.”