Background Briefing

Complex licensing and contracts around the physical materials of science have created a world in which it is difficult for scientific investigators to define the terms under which their work is re-used. Science Commons’ Materials Transfer project brings together funders of neurodegenerative research, technology management professionals, and seasoned attorneys to address this problem.

We are guided in our work by the Materials Transfer Working Group.

Background: Biological Materials Transfer

Biological materials are essential to the practice of modern life science. Cell lines, probes, and DNA represent tools for testing and validating hypotheses of biological function and human health. Each offers a perspective into biology that cannot be replicated without access to the material. Yet despite the importance of biological materials for scientific research and despite impressive initial efforts to standardize the terms for transfer, the manner of their transfer remains overly complex – with significant impacts on the quantity and quality of research.

Owners of these materials transfer them to other institutions for use in biological research, drug development and evaluation, creation of diagnostics, and more. The materials move about under contractual agreements known as material transfer agreements (“MTAs”). MTAs formalize the relationship between the provider and the recipient of the material and answer such questions as: who has the right to commercially exploit the material, and materials derived from it? Who receives publication credit for research generated from use of the materials? Who bears liability for damages from transfer and use of the material? Who owns any intellectual property rights associated with the material, and materials derived from it? (see more background on MTAs)

Technology managers and scientists alike have undertaken significant efforts to solve licensing problems. The Uniform Biological Materials Transfer Agreement (or UBMTA) is in wide use, having been adopted by over 250 institutions since 1995. And the Organization for Economic Co-operation and Development has issued guidelines for licensing such materials that go well beyond existing efforts. However, these efforts have not prevented the rise of a complex web of variations made to the standard agreements; nor have they sufficiently addressed the problem that thickets in life sciences research are created because of these complex and inter-locking variant agreements.

The UBMTA and other efforts have run into several difficulties.

  • Firstly, a single, standard contract does not cover enough types of biological materials transfer – one size does not fit all, so institutions substitute their own MTAs.
  • Secondly, the terms of the UBMTA are overly complex for the scientific community. Many scientists are unaware of its existence and carry memories of bruising negotiations over non-standard material transfer. This both steers scientists away from transfers and places undue strain on technology licensing offices, which frequently negotiate both the business terms and the science on behalf of their faculty clients.

The gap between the technology manager community and the scientific community here has real impact: research is catalyzed most when resources are easy to find, share, and the scientist makes use of the largest possible set of materials. Research is inhibited when that set of materials is unnecessarily restricted by complex licensing.

Negotiations for materials transfer can be so protracted and painful that in many cases scientists find it easier to re-make the material, often at taxpayer expense. Wendy Streitz and Alan Bennett, of the University of California Office of Research Administration and Technology, capture the problem eloquently from the scientist’s perspective: “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…”

The UBMTA had limited impact in solving the problems posed by material transfer agreements despite the large community of adopters. This was recognized by a Working Group commissioned in 1998 by the National Institutes of Health which noted that “efforts to standardize license terms for research tools have had limited success despite the clear support for the UBMTA, at least in terms of signatories.”

In further support, empirical research hints at the scope of the problem. Eric Campbell’s study on data withholding among academic geneticists in the Journal of the American Medical Association asserts there “is a pressing need to clarify and expedite the process of sharing biomaterials.” The pressing need carries over into transfer of materials between for-profit and non-profit researchers as well. Consequently, the goal of the UBMTA – low transaction costs and easily shared materials – remains elusive.

What would a solution look like?

The success of the UBMTA in gaining signatories demonstrates a demand for standardization. However, the single standard agreement has yet to create an environment of low transaction costs or easily negotiated transfer of materials between institutions, even universities, much less for-profit entities.

To the extent that the variations on the UBMTA actually form patterns, which may be expressed differently by each technology transfer office, scientific researcher and related attorneys, those variations could be identified and expressed in standard language. Currently the discovery of common ground between parties uses valuable negotiating resources. Thus, any solution would necessarily need to overcome the collective action problem facing standardization: all might benefit from committing to limit custom solutions to standard problems. In order to overcome defection we must have significant participation from the technology manager community to build a new set of norms.

A solution must be designed to create an environment of low transaction cost, easily negotiated transfer of materials between institutions, including academic institutions and for-profit entities; a solution that avoids the pitfalls encountered by the single standard agreement approach. Thus, Science Commons envisages a solution that involves using the existing UBMTA as a baseline agreement, but with a standard set of options – creating in effect an entire suite of legally binding, standard contractual terms that can be mixed and matched to create a customized agreement, tailored to fit the large variety of transfer situations.

Furthermore, the contractual term suite and final customized agreements should exist not only in complex, “lawyer-readable” form, but also in human-readable form and in a machine-readable form. This will promote the use of the agreement among non-legally trained scientists and researchers and may also promote knowledge-sharing along with the transfer of the materials once the agreement has been entered into.

  • First, the human-readable form will enable scientists to participate in the discussion of the materials to be transferred. Science Commons believes that any standard agreement should travel with clear, layperson-readable summaries of the rights and obligations in the agreements, giving the individual researcher a voice in the discussion – “I’d like the standard agreement that allows for free sharing to the academic world, and a standard license to the commercial world.” This is crucial to bringing the scientist back into the discussion of the materials to be transferred.
  • Second, the machine-readable form of the agreement will address an additional consideration in scientific research, namely, how scientists find biological materials. The status quo is a traditional system in which a scientist reads a paper, contacts the author’s laboratory, asks for the materials and triggers a negotiation (in some cases, there is no formal agreement at all). Despite the tremendous technological advances in recent decades, there is slow uptake of online material repositories and it is difficult to link materials from within papers in any open, standard form. Nor do those repositories utilize transparent licensing methods. The machine-readable form will make strides in overcoming this deficiency in the system by enabling a digital rights description that can be linked in from papers and databases using standard web technologies.
  • Third, it should not only be feasible but easy for researchers to simply publish, on their laboratory websites, a list of the materials available along with their licensing terms. Such an ability would create a decentralized index of open-license materials and address the current practice that scientists deposit materials in a central resource before those materials can be searched. Creating an agreement with a machine-readable component by which search engines such as Google and Yahoo can index biological materials as available under standard terms would mark a significant improvement over today’s practices.

Science Commons is creating just such a solution. If you are interested in hearing more, contact us.

Pro bono legal services provided by Edwards Angell Palmer & Dodge LLP.

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