California Biomed Still Concerned About CIRM IP

The California biomedical industry wants changes in the state's stem cell agency's plans to divide up the spoils from inventions created by nonprofit research funded by CIRM.

The California Healthcare Institute, BIOCOM, five different California-linked biomed firms and a national group, BIO, all filed objections last week to various aspects of the proposed intellectual policy regulations, which are up for discussion on Tuesday.

Arrayed against them virtually alone was the Foundation for Taxpayer and Consumer Rights of Santa Monica, Ca., which said:

"In essence, taxpayers ought not to pay for the same research twice, and research institutions that they fund should not be prevented from non-commercial access to publicly funded research."

The foundation referred to the controversy over an IP provision that would allow California research institutions to use CIRM funded inventions at no cost. But the California Healthcare Institute, which represents the state's biomedical industry, also objected to attempts to provide CIRM-funded therapies at low cost and to provisions for the state to receive roughly 25 percent royalties on CIRM-funded inventions.

David Gollaher, president of the institute, said aspects of the proposed regulations "present unnecessary, improper or overly burdensome requirements likely to undermine the commericail collaboration necessary for the development of new products."

Lila Feisee, managing director of BIO, wrote that "damaging provisions" in the IP rules place CIRM in the position of "standing in the way of the goals it seeks to achieve."

A key item for the businesses is a change in language involving what is known as the research use exemption. In July, the businesses said, the CIRM IP Task Force removed language that would have would have required grant recipients to allow California research institutions use CIRM-financed inventions for research purposes at no cost."

The IP group deleted the provision after business groups objected that it would remove incentives to develop commercial research tools. Somehow similar language has crept back into the proposed rules, in a move that "appears to contradict the public record," according to a letter signed by Applied Biosystems, BIOCOM, Invitrogen Corp., Isis Pharmaceuticals, Sangamo Biosciences and Target Discovery.

Joydeep Goswami, vice president of stem cells and regenerative medicine for Invitrogen, warned that taxpayers should not have to pay "four times" for use of CIRM research.

"If licensing is made unattractive by overbroad...patent protection carve outs, taxpayers will pay four ways: First, they will fund the development of the invention; second, they will have to pay for the development and distribution of the IP; third, they will pay for the royalty revenues lost to the state because the IP has not been commercialized, and finally, they will suffer the costs of not getting research tools and therapeutics to researchers an patients as rapidly and effectively as possible."

John M. Simpson, stem cell director of the taxpayer foundation, told the California Stem Cell Report:

"While we might like to think that universities are benevolent and act in the broad public interest, you just need to look at the way the Wisconsin Alumni Research Foundation is asserting its stem cell patents to understand this isn't so.

"I think administrators at California institutions are just as likely to be blinded by dollar signs in their eyes as those in Wisconsin.

"We need a research use exemption. It's possible to craft one that meets biotech's concerns and fulfills the vital public interest of keeping all publicly funded research available to other researchers."

Simpson also spoke to the issue of IP for businesses:

"For-profit IP regulations are going to be much more difficult to craft because there is a greater possibility of abuse.

"Funds will almost certainly be given for projects that are much closer to developing products for commercialization and clinical use than is the case with grants to universities and nonprofit institutions.

"That means it's imperative that provisions in the for-profit IP regulations guarantee access and affordability for all Californians to any drugs and cures that are developed as a result of Prop 71 funding to companies. There must be a provision that prevents unfair, egregious profiteering."

On Tuesday, the IP Task Force is scheduled to meet in San Francisco, with remote sites in Los Angeles, Stanford and Irvine, to discuss both non-profit and for-profit regulations. Here is the Task Force Agenda.