Human Practice

For our team's Human Practice, we have resolved several legal questions related to working with commercial biotechnology. Because of our project's subject matter: the purification and use of a process and enzymes which are commercially patented, produced and sold, our project had the potential involve interesting issues related to patent law. Were we legally allowed to purify the patented Taq ligase at all? Could we use the enzymes to do other experiments? Was it legal for us to synthesize the genes for gibson assembly and to make them available to other iGEM teams? Seeking answers, we turned to the University of Wisconsin-Madison Law and Entrepreneurship Clinic.

Following a legal analysis by a University of Wisconsin-Madison Law School student attorney, we were given the following answer. "In general, a patent holder can use legal means to prevent others from making, using, selling, or importing the claimed invention (i.e., patent infringement). However, in very narrow experimental settings, an individual can freely infringe patents. An individual can use a patented invention and claim the experimental use defense to patent infringement if the use was “for amusement, to satisfy idle curiosity, or for strictly philosophical inquiry. Additionally, the experimental use defense does not shield non-profit projects undertaken to further goals such as publication or monetary grants." Because our team was using the synthesis and purification of Gibson enzymes as an educational tool, we did not stand to gain financially from this endeavor. Making these enzymes satisfied our curiosities regarding basic molecular biology and biochemical laboratory practices and as such falls under the idea of "experimental use defense." If any team is interested in using these parts, it is advised that they consider the legalities of their intended use.

We would like to thank the UW-Madison Law School for their assistance, and we hope that our parts, as well as this analysis, can benefit other iGEM teams in years to come.