Policy Framework for Intellectual Property Derived from Stem Cell Research in California

This report was released in partial response to Assembly Concurrent Resolutions (ACR) 252 and 24 authored by Assembly Member Gene Mullin. ACR 252, which was chaptered in September 2004, requested that CCST conduct an analysis on how and whether to implement a set of consistent statewide IP policies. Following the November 2004 passage of Proposition 71 (the Stem Cell Research and Cures Initiative), which allocated $3 billion over 10 years to establish CIRM, CCST also agreed to prepare an interim report tailored specifically to CIRM’s needs and faster timetable.

The IP Study Group, convened by CCST to recommend intellectual property guidelines for the state, released the interim report to begin a discussion and provide policymakers with a framework for consideration in the development of policies for the handling of intellectual property developed with state funds, especially in relation to stem cell research.

Overall the committee recommended that CIRM adopt an approach to managing intellectual property that would be consistent with related federal policies. As there are no other states as yet which have established a comprehensive set of IP policies, the federal model was felt to be most appropriate. These recommendations include permitting ownership of the intellectual property to reside with the grant recipients, with CIRM retaining rights to use the research, and focusing on maximizing access to the research rather than controlling prices of the ultimate products of this research.

Principal recommendations:

The IP Study Group’s recommendations in the interim report are consistent with general principles likely to be recommended for state-funded research in the final report to be completed later this year. These general principles assert that the IP policy:

• Is to be consistent with the Bayh-Dole Act. (This principle can play out in many ways that are of benefit to the public. In particular, ownership of IP resides with the grantee, who is required to diligently develop IP for the public. In addition, the balance of any net royalties must be used to support research and education activities.)
• Creates incentives for commerce in California from state-funded research to the greatest extent possible.
• Encourages timely publication of results to diffuse knowledge widely, and provide guidance on the kinds of data that are desired to be placed in the public domain or available under open source, Creative Commons, or other broad-use licenses, including software and special databases.
• Requires diligent development of IP into products that benefit the public.

With these general principles in mind, the IP Study Group recommends that CIRM consider policies that accomplish the following:

• Permit grantees to own IP rights from CIRM-funded research.
• Require grantees (institutions, individuals, or both) to provide a plan describing how IP will be managed for the advancement of science and benefit to California.
• Grant basic research funds without requiring grantees to commit to providing a revenue stream to the state. If, however, a revenue stream develops over time, revenues will be reinvested in research and education.
• Generally make CIRM-developed research tools widely available to other researchers.
• Require diligent efforts to develop CIRM-funded IP into therapeutics and diagnostics that can benefit the public.
• Retain within CIRM Bayh-Dole-like rights to step in if the owner of IP is not undertaking appropriate steps to transfer technology to benefit the public.
• Leave license particulars to the owner who is in the best position to judge how best to ensure that discoveries are made widely available through commercialization or otherwise.
• Reserve the right to use IP by or on behalf of CIRM.
• Establish and maintain a CIRM database to track all IP generated through CIRM funding.