Empirical Data about Materials Transfer Problems

How long are the delays that result from negotiations over biological materials transfer agreements?

They are significant. In the university – to – university setting, estimates range from delays of over a month for between 11% and 16% of requests, “a substantial delay in a fast-moving field,” to estimates that there are routine delays of over 6 months for 20% of requests and over 2 months for 42% of requests. Studies also show increasing rates of outright denial of requests, and of abandonment of “promising research projects” because materials are not received. In the commercial-university arena, with no standardized agreements at all, most observers believe the situation is worse. Commercial-academic denial rates are estimated to be nearly twice those in the academic-academic context (33% to 18%). If the most conservative estimates in each context are correct, and the Science Commons project eliminates some of the legal transaction costs in even 25% of cases of current delay, it would save hundreds of thousands and perhaps millions of hours of wasted research time every year, and would also save a substantial number of promising research projects which at the moment are simply abandoned. Of course, legal transaction costs are only one reason for delays and denials. The second and third phases of the Science Commons plan – which envisage direct links from journal articles to repositories that could provide the materials discussed in those articles under the appropriate pre-chosen machine-readable license – would provide an even more dramatic saving of time, money and effort. Publication of sharing statistics derived from the machine readable licenses would create a competitive scientific incentive to increase rather than decrease sharing levels. One prestigious set of journals and several repositories are already pursuing with us the possibility of implementing these phases.

Precise Data and Details:

The Science Commons Materials Transfer Project deals with both university-university transfers and university-commercial transfers. Its first phase deals mainly with reducing delays caused by legal transaction costs. Its next phases, which try to automate the material transfer permission process, connect it to the journal literature and keep statistics on the labs which offer the larges number of samples have the promise of cutting down not only delays caused by negotiations but also some of the delays caused by the physical burden of transfer, and even unwillingness to transfer because of scientific competition.

University-university transfers

Scholarly and empirical research shows a range of estimates. The lowest estimate is that 1 in 6 suffer a delay of more than one month – “a substantial delay in a fast-moving research field…” (Walsh, Cohen, Cho 2005, 2007). The higher estimates (from a large survey conducted by the AAAS) are that 25% of those researchers seeking materials through MTA’s suffer delays of 1-2 months, 23% 2-6 months, and 19% over 6 months.(Hansen AAAS SIPPI 2006.) Most of the literature falls between those extremes, but closer to the second estimate. Articles published by tech transfer officers, and interviews with scientists offers support for negotiation delays being significant and widespread. (Streitz & Bennett 2003, University of California 2001, Dove 2002, Campbell 2002)

Separating the purely legal negotiating delays from other delays in the MTA process (which are addressed by the later stages of the Science Commons MTA project) is difficult, however. The lowest estimate on this factor was 11% suffering delays of more than a month. (Walsh 2005) (This amount of time was assessed as “a substantial delay.”) TTO estimates and other surveys here suggest that legal/licensing delays of 2-6 months are routine. The AAAS figures also support this conclusion. Finally, some requests are not simply delayed. They are denied. 47% of all academic geneticists who had asked “other faculty for additional information, data, or materials regarding published research reported that at least one of their requests had been denied in the preceding 3 years.” (Campbell 2002) That number is increasing, according to Campbell’s study. Walsh, Cohen and Cho believe the evidence also shows this.

These delays persist despite the existence of the UBMTA. One article summed the evidence up thus.

“Despite the numerous signatories pledging to use the standard agreement, the UBMTA has delivered only “limited success.”64 Instead of adhering to a standard agreement, many institutions have merely “substituted their own form agreement for the UBMTA,” adding “more restrictive” terms.65 Critics see these deviations as “unsurprising” because “university technology transfer officials . . . tend to see their primary job as bringing licensing revenue into the university,”66 not lowering the transaction costs of collaboration. Furthermore, even the creators of the UBMTA realize that it “may not be appropriate for every material transfer,”67 conceding the potential need for contractual customization.” (Ristau Baca 2006 – and sources cited therein.)

The goal of the Science Commons MTA project is to build on the existing UBMTA structure but to add social norm pressure, technological ease and practical incentives towards more sharing on standardized terms.

Interestingly, all the scholars we have identified who have written on MTA-imposed delays see them as a possible candidate for reform activity, including those who do not believe that widespread patenting practices cause negotiation delays. (Walsh & Cohen 2005, 2003.) A typical assessment is provided by two distinguished tech transfer officers from Berkeley:

“One of your colleagues at BigAg, Inc. (or at BigAg University) says that she’d be happy to send you her transposon insertion lines that saturate the right arm of chromosome 9; you’ll just need to have a material transfer agreement (MTA) signed by your institution. Six months later, the terms of the agreement are still under negotiation, you’ve missed the field season, your grant has expired and there is now a better resource that’s been developed at LittleAg University —and if you start negotiating an MTA now. . .” (Streitz and Bennett 2003). “Immediate efforts to alleviate the high transaction costs of collaboration in science research must focus on simplifying the process of sharing. If scientists could use an MTA to share valuable materials without significant effort or expense, they would have much greater incentive to do so.” (Ristau Baca 2006)

University – Commercial/ Commercial University Transfers – Negotiation Delays

There is less numerical information here because there are currently no standardized agreements to study. Science Commons would introduce the first ones. Thus each negotiation is carried out on a case-by-case basis – common sense suggests substantial time savings for that percentage of these transfers which could be brought under the Science Commons modular agreements. There is widespread consensus – from industry, philanthropists, and universities – that licensing delays are a major problem. Walsh Cohen and Cho found that rates of outright denial for materials were 18% for academic-academic transfers, and nearly twice that (33%) for industry-academic transfers. (Walsh, Cohen & Cho 2007) Again a comment from Streitz and Bennett is informative.

“The nine campuses of the University of California system executed almost 2,000 MTAs in 2002, up 30% from the previous year. At the same time that the numbers of MTAs are increasing, so is their complexity, with restrictions and obligations potentially reaching far beyond the material itself, to data or inventions made using the material and/or to derivative materials. Because MTAs are contractual agreements between two parties, they typically do not have the geographic or temporal limitations of patented technologies and can consequently be much farther reaching than the scope of patent rights. It is interesting to note that an evaluation of the property rights associated with “GoldenRice” [A genetically engineered rice variety aimed at ending vitamin deficiency disorders in the global South] indicated that 44 patented products or processes and at least 15 materials, many of which were governed by MTAs, were potentially used in its development (Kryder et al., 2000). In navigating the intellectual and technical property landscape surrounding “GoldenRice,” Potrykus (2001) reported that the unfair use of one MTA had been particularly problematic.” (Streitz and Bennet 2003).

Other Delays & Denials related to Materials Transfer: Physical Difficulty and Scientific Competition

The Science Commons Materials Transfer Project also aims to reduce other transaction costs associated with materials transfer, including those related to finding the material in the first place, having it made, and on the current competitive incentives towards secrecy and denial of requests. We are discussing with Dr. Varmus of the Public Library of Science the incorporation of direct links from the text of published PLoS journal articles discussing a particular material, plasmid or reagent, to a site from which the materials, pre-licensed under Science Commons licenses, could easily be obtained. A scientist would list the materials referred to in his or her article, and a hyperlink in the article would allow other researchers to find the details of the material, the license under which it was provided and perhaps even be able to purchase it directly from an approved respository in, or out of the scientist’s institution. Since all Science Commons and Creative Commons licenses are machine readable, the materials could be tracked and requests enumerated, creating a positive feedback effect in which scientists would gain reputation and scientific prestige from supplying many requests for materials, just as they now do for cite counts. No such positive incentive currently exists.

References:
Campbell, Eric G., Brian R. Clarridge, Manjusha Gokhale, Lauren Birenbaum, Stephen Hilgartner, Neil A. Holtzman, and David Blumenthal. 2002. “Data Withholding in Academic Genetics.” JAMA 287:473480.

Dove, Alan “When Science Rides the MTA” J. Clin. Invest. 110:425-427 (2002). doi:10.1172/JCI200216546

Hansen, Stephen et al., American Association for the Advancement of Science Project on Science & Intellectual Property in the Public Interest (see esp page 33.)

Ristau Baca, Megan, “Barriers To Innovation: Intellectual Property Transaction Costs In Scientific Collaboration” 2006 Duke Law. & Tech. Rev. 0004

Streitz, Wendy D., Bennett, Alan, 2003 “Materials Transfer Agreements a University Perspective” Plant Physiology, September 2003, Vol. 133, pp. 10–13, http://www.plantphysiol.org/cgi/reprint/133/1/10

Walsh, John P, Charlene Cho, and Wesley M Cohen. 2005. “The View from the Bench:
Patents, Material Transfers and Biomedical Research.” Science 309:20022003.

Walsh, John P, Charlene Cho, and Wesley M Cohen. 2007 “Where Excludability Matters: Material v. Intellectual Property in Academic Biomedical Research”

University of California Technology Transfer Office 2001 “Materials Transfer in Academia”