(BIOCOM, 2007a,b; Geron, 2007; StemCells 2007a,b),46 which could make it difficult for universities to license their inventions.47 Similar arguments have been made in opposition to the statutory march-in rights retained by the federal government under the Bayh-Dole Act, although the federal government can now point to a track record of declining to exercise these rights. The University of California’s Office of Technology Transfer observed that CIRM does not have the same track record of decades of forbearing from the exercise of march-in rights and concluded, “We believe there is a legitimate concern that CIRM will be much more likely to exercise its march-in rights than the federal government has been” (O’Connor, 2006; UCOTT, 2006).48
Other comments from public interest groups favored strong march-in rights. Comments from the Center for Genetics and Society, echoed by individual e-mails, urged CIRM to empower the California attorney general to enforce march-in rights (Consumer Watchdog, 2008; Reynolds, 2006),49 while comments from the Berkeley Center for Law & Technology commended CIRM for improving on the Bayh-Dole Act by making march-in rights less cumbersome to exercise (Samuelson et al., 2006).
Concerns about march-in rights reflect a combination of unhappiness with the underlying rights they enforce (such as access plans) and uncertainty about how CIRM will exercise its discretion. Perhaps over time, CIRM can reassure licensees that it will use its march-in rights as sparingly as NIH has done, but CIRM may run out of time before commercialization begins. It is also possible that in the future, CIRM (or another enforcer of
46See, e.g., letters dated April 30, 2007, and November 21, 2007, from BIOCOM (noting that the march-in provisions are “so overly broad and all-encompassing that [they] would present an unacceptable level of risk to most companies” and would be better left to the federal government to avoid conflict between state and federal requirements); letters dated October 5, 2007, and November 21, 2007, from StemCells (arguing that the march-in rights, “especially those tied to public access and public health, are overly burdensome, unclear, unworkable, and risky as well as beyond the statutory mandate of Proposition 71”); and a letter dated April 30, 2007, from Geron (noting differences between CIRM and Bayh-Dole march-in provisions that create uncertainty for firms contemplating commercialization).
47See a letter dated August 1, 2009, from Burnham Institute for Medical Research (stating that march-in provisions “will have a chilling effect on the ability to license results” because they “invite legal challenges to every licensee’s efforts to commercialize licensed technology”).
48See a letter dated June 16, 2006, from the University of California Office of Technology Transfer. See also a letter dated June 19, 2006, from Sean O’Conner, Center for Advanced Study and Research on Intellectual Property, noting the potential for conflict if the federal government and CIRM chose to exercise march-in rights on the same invention in inconsistent ways.
49See an e-mail dated June 19, 2006, from Jesse Reynolds on behalf of the Center for Genetics and Society. See also a letter dated June 25, 2008, from Consumer Watchdog (urging a provision giving the attorney general the right to intervene in cases of unreasonable pricing of CIRM-funded projects).