for access plans was subsequently codified by the California Legislature, subject to certain qualifications.6
Third, CIRM’s intellectual property policies call for sharing of biomedical research materials within California after publication.7 Although sharing of such materials is consistent with aspirational norms of the scientific community that NIH attempts to facilitate through guidance documents, it is not required by federal law (NIH, 2003).
Finally, to monitor and enforce compliance with its intellectual property policies, CIRM has established reporting requirements that allow it to keep track of CIRM-funded inventions and related patents, patent applications, licenses, commercialization efforts, and revenues.8 As noted, CIRM also has march-in rights that allow it to grant licenses to use CIRM-funded inventions in certain circumstances, including if a grantee, collaborator, or exclusive licensee has not made reasonable efforts to achieve practical application of an invention or has failed to provide or comply with an access plan.9 To the extent that these march-in rights allow CIRM to enforce obligations with no counterpart in federal law (such as the access plan requirement), they go beyond the scope of march-in rights under the Bayh-Dole Act.
Each of these features of CIRM’s intellectual property policies has been a source of controversy, as reflected in public comments submitted to the Institute on drafts of those policies. These comments reveal the complex landscape of competing concerns that CIRM has had to reconcile in establishing its intellectual property policies. Constituencies that made their views known include the California legislature, universities, scientists, and the business community. Their comments, submitted at an early stage before any actual intellectual property was on the table, were necessarily conjectures about the future impact of proposed policies that had not yet taken effect for activities that had scarcely begun.
Although CIRM’s intellectual property policies are now in effect, there is still little track record with which to evaluate their actual performance. CIRM reports a total of 90 invention disclosures, 69 patents, and 2 license agreements as of January 2012. At this stage, concerns about the impact of CIRM’s intellectual property policies remain largely confined to the realm of speculation. But it is in the realm of speculation that patents do their work, motivating new investments by offering an expectation of future monopoly profits on products that do not yet exist. If concerns at this
6California Health and Safety Code § 125290.80.
717 California Code of Regulations § 100604.
817 California Code of Regulations § 100602.
917 California Code of Regulations § 100610.