$500,000 in direct costs (NIH, 2003). NIH and the Association of University Technology Managers encourage universities to retain the right to share “research tools” for noncommercial purposes (AUTM, 2007).57
The provision on sharing biomedical materials for research purposes is the sole remaining vestige of an earlier proposal in draft intellectual property regulations for a broader research exemption for the use of all CIRM-funded intellectual property for research purposes. Many comments criticized this earlier proposal, arguing that it would undermine the commercial dissemination of research tools (ARI, 2007; CHI, 2007b; Invitrogen, 2007). CIRM responded with revisions that allow it to approve alternatives to the sharing requirement when the requirement is onerous and that allow grantees to discharge their sharing obligations by disclosing how to reconstruct the materials or by making them “broadly commercially available.”58
Texas has a broader research exemption within the CPRIT program, requiring that patented inventions resulting from CPRIT funding be shared on reasonable terms with other CPRIT award recipients for noncommercial purposes. The comparable provisions of the Connecticut stem cell program are more similar to those of CIRM, setting an expectation that grant recipients and their institutions, hospitals, and companies will share reagents, data, and protocols developed as part of state-funded stem cell research. The Connecticut program specifies in its requests for proposals that such resources shall be made freely available to other Connecticut-based researchers. Similar to California and Connecticut, New York stipulates that resources, materials, and methods created through its sponsorship should be made easily available at reasonable cost to the research community. Maryland also requires grantees to share research results, including new cell lines as well as other materials developed with state funding, with qualified researchers. Grant recipients are permitted to request reasonable compensation for these materials.
More recently, CIRM has proposed Interim Regulations for the iPSC Banking Initiative to facilitate worldwide dissemination of a comprehensive collection of disease-specific human induced pluripotent stem (iPS) cell samples. These interim regulations would exempt grantees from the usual intellectual property and revenue-sharing regulations and provide for CIRM to own human iPS cell lines in the CIRM human iPS cell bank. The repository could charge a reasonable fee for the lines so that it could become self-sustaining, and CIRM could receive a share of revenues generated by the repository under the terms of a licensing agreement with the grantee (Baum, 2012).
5764 Fed. Reg. 72090 (1999).
5817 California Code of Regulations § 100607(c), (d), (e).