In preparing this report, the Working Group has gathered information on problems encountered in the dissemination and use of proprietary research tools and the competing interests underlying these problems from three sets of stakeholders: bench scientists, university technology transfer professionals, and private firms. Our goals have been to understand and explain the problems that arise in negotiating the terms for transferring research tools to and from recipients of NIH funds and to identify possible NIH responses that might help relieve these problems. Some of our information-gathering has involved systematic and deliberate queries directed to categories of stakeholders through established channels; some of it has been more casual and anecdotal, relying on extensive conversations with individuals identified through the professional networks of the Working Group members; and some has been passive and receptive, responding to offers to participate from people who learned of the activities of the Working Group through accounts in the scientific and trade press.
The earliest and most extensive responses to our queries have come from technology transfer professionals, primarily from universities. Through the staff of the NIH Office of Technology Transfer, the Working Group put out a request for information from this group of professionals through the techno-L listserve on the internet. This request was promptly followed by a letter from the Council on Government Relations (COGR) urging its members to respond. We received many thoughtful and extensive responses summarizing the main problems from the perspective of universities, including many examples of problematic agreements. Members of the COGR Committee on Technology Transfer and Research Ethics separately collected samples of incoming patent license agreements and material transfer agreements (MTAs) that universities found objectionable and summarized their objections to the terms of these agreements for the Working Group. Some members of the Working Group met with the COGR Committee on Technology Transfer and Research Ethics and attended a session on MTAs at the annual meeting of the Association of University Technology Transfer (AUTM). Other members of the Working Group met with technology transfer professionals within their own institutions and reported their perspectives, and one member gathered further information from a sample of universities through an inquiry from his own institution's technology transfer office.
Systematic information gathering from the private sector proved somewhat more difficult. The Biotechnology Industry Organization (BIO) sent out a set of questions to over 100 members of its intellectual property committee seeking to identify the importance of and rationale behind the restrictive provisions that universities had identified as problematic from the prospective of private sector owners of proprietary research tools. Another set of questions concerned problems encountered by private firms in seeking access to research tools owned by universities. Although the response rate was quite low (between ten and fifteen percent), the information gathered was interesting, revealing substantial consensus on some points and substantial divergence on others. We also conducted numerous interviews (mostly by telephone) with individuals engaged in technology transfer on behalf of a range of pharmaceutical and biotechnology firms identified through BIO and through the professional networks of the members of the Working Group. We also interviewed representatives of a number of firms that contacted members of the Working Group seeking an opportunity to provide us with their perspectives.
The most elusive stakeholder perspective to document proved to be that of bench scientists. We established a website on the NIH Director's Policy Forum and advertised it extensively through the scientific press and through listserves aimed at multiple subpopulations of biomedical researchers. These efforts generated a disappointing response, perhaps due in part to delays in getting the website running. We supplemented this information through interviews and informal communications with individual scientists in the institutions of the members of the Working Group and other individuals identified through our colleagues and professional networks, but the resulting sample may not be broadly representative of the perspective of scientists whose research is funded by NIH.