WASHINGTON, Feb. 27 (UPI) -- The proliferation of patents in the emerging stem-cell field may impede the development of new medical therapies and a consumer advocate is proposing a radical solution that involves placing the patents in an open source pool that is overseen by a non-profit organization.
Industry is resistant to the proposal, but a bill that incorporates some of these ideas has already been introduced into Congress. In addition, the legislature in California has focused on intellectual property issues, which is significant because the state could turn out to be one of the biggest funders of stem cell research in the world when Proposition 71 gets up and running.
The author of the proposal --Merrill Goozner, of the Center for Science in the Public Interest -- said he anticipated industry would not respond favorably to his proposal but called their reticence a short-sighted view.
"The cost of medicine is ultimately a barrier to their own success," Goozner told United Press International. "If what they bring to the market can't be afforded by the healthcare system, then they're not going to have the blockbusters they want and people won't be able to afford them," he said. "That's a stupid business plan, not to mention immoral."
Goozner said his pooled open-source patent concept, which is described in the journal PLoS Medicine, is different from the current system of patent protections but not antithetical to the goals of investors.
However, the Biotechnology Industry Organization views the proposal as not being industry friendly.
"From an industry perspective, it would be counterproductive," Lila Feisee, director of intellectual property at BIO, told UPI.
Feisee noted that "the biotech industry relies very heavily" on the current system of intellectual property and patent protections, so attempts to change that would create barriers to commercialization and likely force companies to go in a different direction.
"It's a tough situation, but the answer isn't to weaken intellectual property or to force non-exclusivity of licenses," Feisee said.
Goozner noted that a different approach to the patent system is needed in the stem cell field because there are already indications patent protections have stymied research. He cited the example of Jeanne Loring, a researcher at the Burnham Institute in La Jolla, Calif., who attributed the collapse of her start-up firm to the high priced embryonic stem cell lines supplied by the Wisconsin Alumni Research Foundation, which owns essential patents on the cells.
In addition, the law firm of Sterne Kessler Goldstein and Fox has warned clients that companies or researchers working in the stem cell field may be forced to acquire licenses for their research due to blocking patents.
Under Goozner's proposal, which is based on open source licensing arrangements used in the software arena, intellectual property patents would be placed in a central pool. The technology covered by those patents could be used by other researchers at a minimal cost and the company or institution that initially developed it would retain its ownership.
If a company develops a product based on the use of a technology in the pool, they would then have to grant an unrestricted license on that new product or technology for use by other researchers. If the product eventually becomes a medical therapy, then a prize system would go into effect. Those whose technology contributed to the development of the product would be granted financial rewards based on how successful the product is, the significance of their contributions and other factors.
"One could imagine prizes in the billions of dollars based on considerations such as the prevalence and public health impact of the disease, the difficulty in developing its cure, and the capital investment required to achieve results," Goozner wrote in the journal.
Governments could help finance the prizes by using tax-exempt bonds, he suggested.
California could incorporate the pool concept as part of the grant distribution system under Proposition 71, he said. If this happened, it could impact how the rest of the country handles stem cell research, he said.
"By combining a patent pool, an open-source model of (intellectual property) development, and a shared prize system for developing stem cell therapies, the California state stem cell program can point the way to a new medical innovation system for the 21st century," he wrote.
The patent pool and prize concepts have started to gather attention in the past year. California Senator Deborah Ortiz, D-Sacramento, has proposed an amendment to the state's constitution that would incorporate some these concepts, and Rep. Bernard Sanders, I-Vt., introduced the Medical Innovation Prize Act in the U.S. House in 2005.
In addition, the California Council on Science and Technology last year recommended broad-use licenses in the stem cell field to facilitate the sharing of software, databases and other research tools.
Henry Greely, professor of law at Stanford University, wrote in a separate article that appears in the journal that existing patents in the stem cell field also must be dealt with in order for this field to progress.
"All those interested in (human embryonic stem cell) research will also have to decide how to deal with existing patents in the area," Greely wrote, referring to The Wisconsin Alumni Research Foundation's patents.
"Research institutions will have to make decisions about how to respond to these and other relevant patents by reaching an agreement with the Wisconsin Alumni Research Foundation to license them, by trying to 'invent around' them, or possibly by litigating their validity," Greely wrote.
Another patent issue is ownership of the physical cells. "One of the usual consequences of ownership -- the power to sell -- may not apply to hESC lines," Greely stated, noting that California law bans the purchase or sale of embryonic tissue and the National Academy of Sciences guidelines issued last year contain similar recommendations.
"When obtaining gametes and other cells for hESC research, providing hESCs to others, and obtaining them for their own research, institutions will have to make sure that the payments involved are only for the kinds of reimbursement that fall within the statutory exceptions," he wrote.
