march-in rights) will face considerable political pressure to exercise those rights more aggressively in order, for example, to address rising health care costs. Like the requirement for access plans, the march-in rights provisions thus raise considerable uncertainty about the future implementation of rights that may outlive CIRM itself.
Another distinctive feature of CIRM’s intellectual property policies is the requirement for distribution of publication-related biomedical materials,50 a term that is broadly defined to include “tangible research material of biomedical relevance first produced in the course of CIRM-Funded Research including but not limited to unique research resources (such as synthetic compounds, organisms, cell lines, viruses, cell products, cloned DNA, as well as DNA sequences, mapping information, crystallographic coordinates, and spectroscopic data), as described in a published scientific paper.”51 Grantees must share publication-related biomedical materials “for bona fide purposes of research in California” for free or at cost within 60 days of receiving a request unless CIRM determines that doing so is unduly burdensome52 or approves an alternative method of dissemination (such as making the materials broadly commercially available).53 A grantee may also comply by providing requesters with the information necessary to reconstruct or obtain identical material.54 Transfers of materials may be made subject to a “university standard or industry standard Materials Transfer Agreement.”55 Compliance with this requirement is fortified by the further requirement that grantees submit abstracts of publications to CIRM for disclosure to the general public, and that such abstracts include “the URL of a website where a Materials Transfer Agreement (or similar document) can be accessed to facilitate requests for Publication-related Biomedical Materials.”56
The Bayh-Dole Act does not address the dissemination of unpatented materials. However, NIH requires grant applicants to address plans for dissemination of research results in grant applications seeking more than
5017 California Code of Regulations § 100604. Proposed versions of the regulations had included a broader “research use exemption” that would have allowed researchers in California to use patented inventions covered by the regulations without liability, but CIRM retreated from this proposal in the face of objections from commercial firms.
5117 California Code of Regulations § 100602dd.
5217 California Code of Regulations § 100604(c)(1).
5317 California Code of Regulations § 100604(e).
5417 California Code of Regulations § 100604(d).
5517 California Code of Regulations § 100604(f).
5617 California Code of Regulations § 100603.