Sean O'Connor, The Use of MTAs to Control Commercialization of Stem Cell Diagnostics and Therapeutics, 21 Berkeley Tech. L.J. 1017 (2006), https://digitalcommons.law.uw.edu/faculty-articles/208
The Use of MTAs to Control Commercialization of Stem Cell Diagnostics and Therapeutics
Berkeley Technology Law Journal
material transfer agreements, stem cells
The recent focus on patents as a hindrance to stem cell research may turn out to be a red herring. The real culprits are material transfer agreements (MTAs), which govern the transfer of cell lines and other biological materials. The MTA’s primary purpose in life sciences research is to set contractual rights and obligations between parties where one party transfers biological materials to the other. For example, MTAs often focus on the physical handling, use, and distribution of the materials by the recipient, ensuring that the recipient complies with regulations for research involving humans or animals.
Although these interests are legitimate, evidence indicates that owners of important biological research materials use their non-patent property rights to require recipient consent to arguably onerous MTAs, which include provisions governing intellectual property rights (IPR). When an intended recipient’s institution refuses to sign the MTA, the researcher cannot access the biological materials, and in some cases cannot pursue her research. One must understand the interaction between physical property rights and IPR in MTAs to achieve a proper balance among (1) rewarding innovators, (2) reducing obstacles to next generation innovators, and (3) ensuring that the public receives benefits in exchange for public research funding.
Part II of this Article works through the details of this interaction by placing life sciences MTAs in the context of a broader technology distribution model that I call the “lease-license model.” Part III examines Wisconsin Alumni Research Foundation’s (WARF) and WiCell Research Institute’s (WiCell) current dominant control of the stem cell research environment as a case study in the power of MTAs to control life sciences research. Part III also discusses some of the important counterbalancing government rights that can be used to provide for relatively unfettered research.
Part IV subsequently analyzes the impact that the current WARF/WiCell legal position will have on research funded by the California Institute for Regenerative Medicine (CIRM). In conclusion, Part V suggests legal strategies for moving beyond the current WARF/WiCell controlled research environment.