Well, as I suspected I might, I received volumes of requests for our policy/position paper on this issue. We are constantly battling industry requirements to retain title to inventions under MTAs. As tech transfer administrator for the NYS Department of Health we had to go to an internal committee (IPRC) at the Department of Health and then to the Commissioner of Health to accept such MTAs. The following was written to present the issue to this committee and to the Commissioner and to request that they delegate the authority to accept such agreements to HRI under certain defined conditions. (The final policy ended up dealing only with the title issue per se, but the precursor draft of the policy is presented below --as I think it deals with more of the issues and we use it here internally as our "guidance" in dealing with restrictive MTAs. It would be nice to think the NIH guidance says it all, but unfortunately, there are companies out there that could care less what the NIH has to say on the issue. Also, we do deal with situations where we are negotiating MTAs when there are no federal funds involved in the research. BTW - we realize the part about no patentable inventions are expected is a a real hoot ;-) HRI is requesting IPRC approval to authorize acceptance of Material Transfer Agreements which include restrictive terms that are in conflict with current DOH/HRI Patent Policy. An overview of the circumstances warranting this delegation of authority to HRI and the conditions under which it would be this applied is presented below: Background Technology transfer staff negotiate the terms of Material Transfer Agreements (MTAs) which govern receipt by DOH scientists of research materials (clones, cell lines, new compounds, etc.) from researchers at other institutions and in private industry. These agreements set out the terms and conditions under which we agree to accept and use the research materials. Such materials are generally unique and not commercially available. Due to the growth of the biotechnology industry, "cutting edge" research once performed exclusively in academic settings is now routinely a part of corporate R&D. The results of this corporate research frequently open up new avenues of inquiry for academic researchers that often cannot be explored without access to the unique materials developed in the course of corporate research. The Problem: In the academic setting, the motivation to share research materials stems mainly from the need to allow duplication--and thereby validation-- of research results. Concerns in the corporate sector tend to revolve around the need to control rights to materials and any technology that might be derived therefrom in order to establish a competitive market position. Holding title to an invention gives an organization the ability to patent that invention and to subsequently license the invention and collect royalty income. More importantly, owning a patent allows the owner to prevent others from selling products based on that patent. Federal policies in the 1980s allowed university and non-profit organizations to retain title to inventions developed with federal support. As a result, such organizations have developed policies and procedures to retain proprietary rights in new technologies and to commercialize those technologies through licensing. The DOH Patent Policy is an example of such a policy. Conflict often results from attempts to share materials between industry and academia -- with both the commercial entity and the non-profit wanting to retain rights to inventions developed through use of the industry provided materials. Regardless of attempts at the federal level to develop a Uniform Biological Materials Agreement for use by both academic and industrial organizations, MTA's with restrictive terms designed to protect the proprietary interests of the industrial owner are becoming more common, Restrictive conditions that conflict with the established patent policy of the Department include requirements that the company retain title to or receive an exclusive royalty-free license to all inventions arising from or related to work with the material. Restrictive confidentiality or publication clauses that can potentially interfere with the Department's freedom to disseminate research results are also common. Because the materials are often not available from any other source, and failure to obtain the materials can rule out an entire line of research, HRI is frequently in a poor negotiating position. More often than not, the technology transfer office is successful in negotiating terms reconcilable to the DOH patent policy; however, we often (5 times in the past year) encounter companies unwilling to negotiate less restrictive terms. Under current DOH/HRI policy, when companies insist on holding title to inventions, HRI must obtain IPRC and Commissioner approval in order to sign such Material Transfer Agreements. HRI has general conditions under which it recommends approval of such MTAs: The company refuses attempts to negotiate less restrictive terms. The material is not available elsewhere and the research cannot be conducted without the material. Research is NOT funded in whole or in part by federal funds or any other funding source that requires retention of title. (Federal law prohibits grant recipients from giving away title to inventions developed in whole or in part with federal funds). The research is not considered likely to produce any patentable inventions. Management responsible for oversight of the particular research agrees that the terms are acceptable under the circumstances. There is no prior approval authority over scientific publications granted to the provider of the material. (Prior review for a defined time period is acceptable). The incidence of restrictive MTAs appears to be on the rise. Processing such MTAs for IPRC/Commissioner approval is time consuming for both HRI staff as well as for members of the IPRC and the Commissioner, and often the need for expedited approval results from the protracted negotiations involved in trying to reconcile the agreement to DOH/HRI policies. Because the circumstances under which such MTAs can be approved can be clearly defined, HRI requests authority to approve MTAs when all of the above conditions are met. * Elizabeth (Liz) Mazzella xxxxxx@HEALTH.STATE.NY.US* * Director, Technology Transfer & Contract Programs * * Health Research, Inc. (A Non-Profit Corp.) Albany NY 12209 * * Voice: (518) 431-1200 Fax: (518)431-1234 *
