Legal Approaches to Synthetic Biology

by Nihal Parkar, UMN Law Student, MJLST Note and Comment Editor

Synthetic biology is to biology what androids are to humans. Synthetic biology allows moving beyond the evolutionary constraints of life as we know it. Instead of being restricted to using or repurposing cellular genetic machinery, we can now shape our own genetic tools from the ground up. Instead of merely discovering genes, we can now fabricate genes and synthesize a genome, by restructuring the architecture of life itself.

Research institutions and corporations who have been at the forefront of synthetic biology have taken different approaches to protecting IP. Some institutions have taken up the mantle of promoting open source synthetic biology, having being inspired by the parallel open source software movement. On the other hand, corporations have largely played close to their chest, and have adopted the traditional practices of protecting their innovation through patents, copyrights, and trademarks. A recent MJLST article by Professor Andrew Torrance (Synthesizing Law for Synthetic Biology, Issue 11.2 of the Minnesota Journal of Law, Science & Technology) examines the challenges posed by intellectual property rights to the openness of the brave new world of synthetic biology.

Open-Source Biotechnology: Failed to Take Root or Waiting in the Wings?

by Joe McCartin, UMN Law Student, MJLST Staff

Biotechnology encompasses a wide range of cutting-edge fields, from the genetic modification of agricultural crops and energy producing bacteria, to immunology and medical device manufacturing. Rapid innovation in these areas has led to today’s most challenging ethical issues. One such concern is the fear that profits, rather than providing incentives for innovation, will slow down innovation by restricting the dissemination of new technologies, processes, and insights. In Volume 6, Issue 1 of the Minnesota Journal of Law, Science, & Technology, Robin Feldman outlined the problems an open-source biotechnology movement, one similar to the open-source computer programming world, faces in patent law, and ways that movement could navigate those complexities and potentially enhance the common good.

Feldman discussed the work of molecular biologist, Richard Jefferson, founder of Cambia and BioForge, who sought to democratize the field of plant genetics. The failure of those efforts was detailed by Sam Finegold in “The Hard Path to Open Source Bioinnovation.” Jefferson claimed that the financial incentives available to researchers were no match for an industry that had become dominated by a small handful of industrial chemical companies.

So, is there a future for open-source biotechnology? While it would seem that the pharmaceutical industry would present similar challenges to the open-source biotech movement, Connie Wong posits that open-source may be exactly what the pharmaceutical industry needs in the face of shrinking R&D budgets. She argues that small, lean players can fully utilize their competitive advantage and still protect their work by using open-source arrangements that create a fair-playing field that allows them to operate nimbly. Perhaps the Affordable Care Act may transform the pharmaceutical industry in a way that creates room for open-source innovations?

But perhaps open-source biotechnology’s real promise can be found in the work of Matthew Todd, who sought to bring the power of open-source to a neglected disease, flatworm infections. The World Health Organization documented the amazingly quick success Todd had finding more cost-effective methods of producing praziquantel, the preferred method of treating flatworm. While recognizing that the task far exceeded his abilities by himself, by tapping into not only researchers, but pharmaceutical and chemical companies, he found not one but two new methods of producing the drug! This appears to be the perfect example of the promise of open-source biotechnology. The profit motive focused attention on other diseases, restricting innovation until an open-source community sprung up. While open-source may not be the future of biotechnology innovation, it may end up playing a large role in a transformed pharmaceutical industry.