WARF previously had taken an aggressively combative position in relation to California and challenges to its ESC patents. Its move, however, did not satisfy opponents, who said the changes do not go far enough.
WARF said:
"Industry-sponsored stem cell research will be facilitated by a new WARF policy that will enable companies to sponsor research at an academic or non-profit institution without a license, regardless of location and regardless of intellectual property rights passing from the research institution to the company. This will enable companies to get started with stem cell research in a low-cost, visible manner and increase funding of stem cell research by for-profit companies. Companies will still need a license when they want to bring the research into their company laboratories or when they want to develop a product for the market."WARF continued:
"Second, while ensuring provisions related to informed consent for embryo donations are communicated and honored, WARF is changing the cell transfer provisions in its academic and commercial licensing. The new policy will allow easier and simpler, cost-free cell transfers among researchers. This will facilitate collaborations within the human embryonic stem cell research community and thus advance the field."WARF added:
"WARF is also clarifying its position with regards to the California Institute for Regenerative Medicine (CIRM). As a not-for-profit, grant-making organization, CIRM does not require any license or agreement from WARF to pursue its grant making policies. Further, WARF does not expect CIRM to remit to WARF or WiCell any portion of payment that CIRM receives from its grantees. WARF has been and will continue to be supportive of CIRM’s efforts to fund human embryonic stem cell research and move the technology forward."John M. Simpson, stem cell project director for the Foundation of Taxpayer and Consumers Rights of Santa Monica, Ca., which is challenging WARF´s patents, said:
"WARF’s action demonstrates that their previous stance was indeed detrimental to stem cell research in the United States. While I welcome this step forward, the best thing would be for WARF to abandon its claims to these over-reaching patents that are recognized nowhere else in the world."Jeanne Loring, a stem cell scientist at the Burnham Institute in La Jolla, Ca., said,
"This change in policy is a step in the right direction and academic scientists will be pleased that they can collaborate with other scientists without interference from WARF. But a change in licensing policy of the human ES cell patents doesn't solve the fundamental problem that the patents should not have been issued in the first place."CIRM did not have an immediate reaction to the news from WARF but the California Stem Cell Report has queried the agency.
Of the text --WARF clearly softened its position on the patents as a result of this challenge, FTCR said.-- it is anything but clear that WARF softened its position BECAUSE OF the pending re-examinations, which will proceed to completion no matter what licensing policy WARF has.
ReplyDeleteResearch done to meet federal requirements, as would be the case with research done by non-profits in this area, is insulated from infringement claims under 35 USC 271(e)(1), as discussed by the Supreme Court in Merck v. Integra.
As Professor Noll at Stanford has published, it will be a long time before there is an FDA-approved commercial product out of Proposition 71 funding. The odds are that the first two WARF patents will have expired by then.