A prestigious California advisory group today looked askance at proposals for royalty revenue sharing involving the California stem cell agency and was less than excited about "favorable pricing" for any therapies that might be developed.
Sharing revenues could be a disincentive to recipients of grants, both from the private and non-profit sector. Federal experience "strongly suggests" that efforts to control pricing "would actually hinder the availability of medical advances, rather than make them more widely available," the panel said.
The interim report by the Intellectual Property Study Group of the California Council on Science and Technology immediately came under criticism from the state's most influential legislator on stem cell issues, Sen. Deborah Ortiz, D-Sacramento.
She said the conclusions were "premature" and the group too narrowly based with a membership consisting of biotech and university representatives. The council is a nonprofit organization created by state legislation to recommend solutions on science-related issues.
Ortiz urged the council to begin an "objective, comprehensive study of other models that promote affordability and access to new therapies and medicines derived from research." (See below for full text of her comments as well as excerpts from the report.)
CIRM had no immediate comment on the study.
The CCST report repeatedly warned that expectations of quick profits and quick cures were "unrealistic" and verging on "hyberbole." Ten- and 20-year time frames are much more likely, it said.
Overall, the report said CIRM should be consistent with federal IP standards (Bayh-Dole Act). Specifically, ownership of IP should reside with the grantee, who would be "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."
CIRM should also:
"Permit grantees to own IP rights from CIRM-funded research."
"Require that grantees (institutions, individuals, or both) provide a plan describing how IP will be managed for the advancement of science and California public benefit."
"Grant basic research funds without requiring that grantees commit to providing 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."
"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."
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