cies apply to a broader range of research outcomes than is covered by the Bayh-Dole Act.
Moreover, CIRM’s intellectual property regulations, unlike Bayh-Dole, call for revenue sharing, with provisions designed to generate direct financial returns to the state treasury. Perhaps the most controversial aspect of CIRM’s intellectual property provisions is the requirement that grantees and their exclusive licensees submit to CIRM “access plans” that will afford access to any drug resulting from CIRM-funded research to “Californians who have no other means to purchase the drug.”9 Federal law and other state-funded stem cell programs have no comparable provisions. Uncertainty about how the system will work could make industry cautious about licensing and investing in CIRM-funded inventions, especially if they have the option of turning to other sponsors that do not impose similar requirements.
CIRM holds “march-in rights” that allow it to enter into license agreements on behalf of a grantee or its exclusive licensee with respect to a CIRM-funded invention under three circumstances: (1) the grantee, collaborator, or exclusive licensee is failing to exercise reasonable efforts to achieve practical application of the invention; (2) the grantee, collaborator, or exclusive licensee has failed to submit or comply with an access plan; or (3) the grantee, collaborator, or exclusive licensee has unreasonably failed to use a CIRM-funded invention to alleviate a public health emergency declared by the governor.10
Overall, CIRM’s intellectual property policies reflect a reasonable effort to balance conflicting interests of different constituencies, each with a legitimate stake in these policies. The actual impact of the policies may not be clear for many years, but the concerns of stakeholders are already apparent. Some of the more contested provisions attempt to address competing views by giving CIRM discretion over implementation, but this flexibility cuts two ways: it allows for adaptation to particular circumstances, but it also creates uncertainty and risk for potential developers of commercial products. CIRM might reduce some of the uncertainty arising from the unfamiliarity of its policies by modifying those policies to conform more closely to the more familiar Bayh-Dole approach. Departures from the Bayh-Dole approach may put CIRM-funded invention at a growing disadvantage in the future as funding from other states and the federal government yield competing candidates for commercial development that are available for licensing on more favorable terms.
9California Health and Safety Code § 125290.80; 17 California Code of Regulations § 100607.
1017 California Code of Regulations § 100610(b).