A CCST led group is helping the state plan the first comprehensive set of state-level intellectual property (IP) policies in the country. Along the way, the IP Study Group has released an interim report with suggestions for the newly-formed California Institute for Regenerative Medicine (CIRM).
Development of innovative technologies, and the underlying ownership of intellectual property (IP), is fundamental to the California economy. However, the state of California does not have a uniform policy in its approach to managing IP. Each agency is free to negotiate its own contracts with the universities, and small and large businesses that perform research and development under state sponsorship. This inefficiency and lack of coordination costs the state valuable time and money. As a result, the Legislature requested that CCST form a study group to plan and recommend the first comprehensive set of state IP policies in the country.
The IP Study Group is co-chaired by Alan Bennett, associate vice chancellor for Research, UC Davis, and Stephen Rockwood, executive vice president, Science Applications International Corp. It consists of 17 leaders from academia, industry, public interest groups, and federally funded research labs, as well as the venture capital community, which is a key component of technology transfer. Five of the members are CCST affiliated. In addition, the study group is receiving assistance from a working group of 11 subject matter experts familiar with IP issues and with the policy interface between the state government and the research community. The two groups represent a broad spectrum of IP related expertise from many of California's leading institutions, both public and private.
Assembly Concurrent Resolutions 252 and 24, authored by Assembly Member Gene Mullin, requested that CCST create a study group to develop recommendations on how the state should treat intellectual property arising from state supported agreements, contracts and grants, and requests CCST to work with the Office of the Attorney General, the Department of General Services as well as other state and federal government experts in contract and licensing, research and development practitioners, experts in technology transfer, and individuals representing the public interest. While there are standard policies at the federal level such as the Bayh-Dole Act which provide guidance on the handling and ownership of IP, policies at the state level in California are not uniform and do not have a common clearly stated set of goals.
IP generated by CIRM will in some ways be no different than that of any state-funded biotechnology IP generated in California, and hence will in many respects fall under whatever statewide policies may be adopted following the release of CCST's final recommendations to the Legislature in December 2005. However, there are some aspects of potentially generated CIRM IP which merit special consideration, because of the nature of the research and because of the nature of the institution. In particular, the campaign which led to the passage of Proposition 71 raised significant expectations among California citizens regarding the state's return on investment from CIRM research.
In its interim report, the IP Study Group addresses these expectations and puts them into context with the realities of funding biotech ventures, and proposes recommendations designed to ensure that CIRM policies will enable optimal development of its research while retaining reasonable and consistent rights for the state. The final report of the IP Study Group will provide a more comprehensive set of recommendations intended for consideration at the state level.
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 state 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 state funded 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 state funding.
|
