Abstract
U.S. universities and academic medical centers long have been important performers of research in the life sciences, but their role as a source of patented intellectual property in this field has changed significantly in the late 20th and early 21st centuries. The expanded presence of formal intellectual property rights within the academic biomedical research enterprise has occasioned numerous expressions of concern from scholars, policymakers, and participants. One widely expressed fear involves the effects of patenting on the conduct of the scientific research enterprise. There is also considerable concern over the possible role of Materials Transfer Agreements (MTAs) in raising research “transaction costs”. On the other hand, others suggest that the contractual structure provided by MTAs may reduce transaction costs and facilitate exchange. This paper undertakes a preliminary analysis of the role of MTAs in the biomedical research enterprise at the University of Michigan, a significant patenter and licensor of biomedical intellectual property. We examine the relationship among invention disclosures, patenting, licensing, and the presence or absence of an MTA. Although data limitations make any conclusions tentative, our analysis suggests that the increased assertion of property rights by universities through MTAs does not appear to impede the commercialization of university research through patenting and licensing.
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Notes
One celebrated controversy concerned the failure of the Gallo research team at the NIH to acknowledge that the pathbreaking isolation of the AIDS virus relied on a cell line established by another research team, at the Veterans Administration Clinical Oncology Branch (See Rubinstein, 1990 for further details). The Milstein-Kohler hybridoma technique for producing cell lines also was patented not by the discoverers but by another research team that requested and received a sample of the Milstein laboratory’s plasmacytoma cells (See Wade, 1980).
Respondents to the survey of University of California agricultural biotechnology researchers by Lei et al. (2005) report “moderately more” use of MTAs than in 1999.
The implications of a more diverse array of parties to these exchanges are complex, as the NIH Working Group on Research Tools (chaired by Professor Eisenberg) pointed out in its 1998 report: “The very term ‘research tool’ connotes a user perspective rather than a provider perspective. What a user sees as a research tool, a provider may see as a valuable end product for sale to customers”. (NIH, 1998, p. 4).
Consistent with this characterization, more than 73% of respondents to the survey by Lei et al. (2005) reported using MTAs for more than 60% of the research tools that they obtained from industry in 2004, while only 35% of respondents relied on formal MTAs for more than 60% of the research tools that they obtained from academic researchers.
“BRCs balance IP rights against the need for access through MTAs, which offer non-exclusive licensing rights to BRC users. By enhancing the effectiveness of the market for the exchange of licensed materials, BRCs have increasingly come to serve as key knowledge brokers for researchers throughout the life sciences”. (Stern, 2004, p. 82).
“This commercialization of research materials may actually increase access by creating market-based institutions for distributing them rather than relying on gift exchange among researchers. Several university scientists noted that the demand for important research agents can easily become overwhelming, and licensing these to a commercial firm was seen as a way of increasing, rather than limiting, access for the research community” (p. 322).
We do not consider the criteria employed by the University of Michigan for determining whether or not to file for a patent on a research disclosure. This university may employ unusual or idiosyncratic criteria for such decisions, but since this paper deals only with MTAs and disclosures at the University of Michigan, any differences between the University of Michigan and other institutions on patenting should not affect our findings. Obviously, however, the generalizability of our findings is limited by our focus on a single research university. We plan to collect invention-disclosure and MTA data from additional research universities, and hope to examine the importance of any differences among institutions in decisionmaking processes and criteria in this work.
If MTA requests from other academic or industrial researchers affect the decision by UM OTT officials to seek a patent for an invention, this could have important implications for the interpretation of the linkage between patents and MTAs. For the 19 MTA-linked inventions that were patented and for which we were able to ascertain the date of the earliest MTA, all but one invention reported a patent application date after the date of the earliest MTA. This suggests that a request for an MTA may spur the university to apply for a patent. However, only three of the MTA-linked and patented inventions in our sample generated patent applications within 12 months of earliest MTA request for the corresponding invention. The time difference between patent application date and MTA grant date for the 16 disclosures with differences greater than 12 months ranged from 1.2 to 9.5 years with a mean of 5.14 years. If patenting decisions by the university were driven primarily by requests for MTAs, we would expect the time lag between the first MTA request and a patent application to be shorter. For most of the disclosures in our sample therefore, MTA requests do not appear to drive the decision to apply for a patent.
As an anonymous reviewer of this paper has pointed out, it is possible that a single disclosure in our sample could generate more than one patent. But we are comparing the probability that a disclosure linked to MTAs is associated with at least one patent with the probability that a disclosure lacking an MTA is linked with at least one patent. The “multiple-patent” issue therefore should not affect our results.
We also constructed a subsample of disclosures linked to MTAs linked solely to other universities or non-profits. We discuss results from this subsample below.
We conducted but do not report a similar analysis considering the more restrictive group of patented disclosures linked to only non-profit MTAs, excluding the three patented disclosures that produced MTAs linked to both industry and academia. Citations to the MTA-linked patented disclosures are higher than the corresponding control patents. We were unable to determine whether this difference is significant however, because the control sample consists of only one patent, preventing us from calculating a standard error.
When we exclude the three patented disclosures that are linked to both industrial and academic MTAs, the mean citation lag for the “low industrial MTA ratio” patents (now consisting of patents linked to disclosures with to non-profit MTAs only) increases to 3.19 years. This change in sample construction increases the difference in the mean citation lag between this more restrictive subsample and the corresponding control by almost 9 months, but the single observation in the control sample prevents us from determining whether this larger difference is significant.
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Acknowledgements
We are grateful to participants at the “Bringing Science to Life" Symposium at the University of Toronto and the 2005 Western Economic Association Annual Meeting, San Francisco, an anonymous reviewer, and the editor for useful comments. Robin Rasor generously provided data for this study. Mary Braun provided excellent research assistance. Research for this paper was supported by the Andrew W. Mellon Foundation and the Kauffman Foundation.
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Mowery, D.C., Ziedonis, A.A. Academic patents and materials transfer agreements: substitutes or complements?. J Technol Transfer 32, 157–172 (2007). https://doi.org/10.1007/s10961-006-9011-1
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DOI: https://doi.org/10.1007/s10961-006-9011-1