Stem Cell Task Force Releases Intellectual Property Policy Proposal
Not-for-profit research institutions would have to develop a plan to make new therapies available to low-income and uninsured state residents to receive grants from Proposition 71 under a proposal released Monday by the California Institute for Regenerative Medicine intellectual property task force, the San Diego Union-Tribune reports. State voters in November 2004 approved Proposition 71 to fund stem cell research.
The proposed policy is similar to the Bayh-Dole Act of 1980, a federal law that returns money from publicly-funded discoveries to research institutions to fund additional research and education (Somers, San Diego Union-Tribune, 1/24).
Monday's proposal applies only to not-for-profit institutions; a separate policy will be developed for biotechnology and other commercial research firms that receive funds from CIRM (Kleffman, Contra Costa Times, 1/24). The proposal will be presented to the Independent Citizens' Oversight Committee on Feb. 10 (San Diego Union-Tribune, 1/24). If approved by ICOC, the recommendations will become interim state policy during a 270-day comment period before being finalized (Wasserman, Sacramento Bee, 1/24).
Under the task force's proposed intellectual property policy:
- Institutions that make more than $500,000 by licensing a discovery made using Proposition 71 funds would have to return 25% of revenue over that amount;
- Institutions that patent discoveries made using Proposition 71 funds must submit to the state a 500-word summary explaining the discovery in an understandable way;
- Patented research from Proposition 71 funds must be shared at no cost with any not-for-profit research institution in California (San Diego Union-Tribune, 1/24);
- Each institution would have to develop a plan to provide access to new therapies to Medi-Cal beneficiaries and the uninsured. The plans should be filed with the stem cell board annually and be subject to public review; and
- The state would be given "march-in rights," allowing it to license a discovery to other institutions if it is determined that an organization is not working within a reasonable time frame.
The plan does not state who would enforce the policy.
Ed Penhoet, chair of the intellectual property task force, said on Monday that CIRM officials now believe they can require royalty-sharing without violating federal tax laws by timing when the bonds are sold and issuing a combination of taxable and nontaxable bonds (Contra Costa Times, 1/24).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.