WARF Stem Cell Patent Claims Rejected

The federal government has rejected three embryonic stem cell patent claims by the Wisconsin Alumni Research Foundation, upholding a challenge led by a California watchdog group, the Foundation for Taxpayer and Consumer Rights.

The challenge to the work done by the University of Wisconsin scientist James Thomson was upheld by the U.S. Patent and Trademark Office, the FTCR group said Monday.

John M. Simpson, stem cell project director for FTCR, said, "This is a great day for scientific research." Numerous groups and scientists had complained that the WARF patents placed roadblocks in the way of research.

WARF had no immediate comment. The organization has two months to respond to the ruling, which came more quickly than expected. Geron, a California company that has an exclusive license involving the patents, had no immediate comment. The California stem cell agency also had no comment on the case, a position it has maintained since it began.

The decision said,

"It would have been obvious to one skilled in the art at the time the invention was filed to the method of isolating ES cells from primates and maintaining the isolated ES cells on feeder cells for periods longer than one year. A person skilled in the art would have been motivated to isolate primate (human) ES cells, and maintained in undifferentiated state for prolonged periods, since ES cells are pluripotential and can be used in gene therapy."

The Public Patent Foundation was a partner in the challenge to the WARF patents. Dan Ravicher, executive director of that organization, said,

“Now that the PTO has ruled, WARF should simply drop all its claims."

Jeanne Loring, a stem cell researcher at the Burnham Institute in California, had filed documents in support of the patent challenge. She was once quoted as saying,

"WARF's stance that Thomson's work is worthy of patents, 'is like saying that just because heating in water works for cooking a chicken egg, it's novel to consider using heating in water to cook a duck egg.'"

Loring also wrote last spring in Science magazine that Geron funded the patented HES cell derivations and "received an exclusive license for broad therapeutic use in the United States of HES cell–derived cardiac, nervous system, and pancreatic cells."

More background on the WARF patents can be found by searching on "WARF patents" in the "search blog" window in the upper left hand corner of this page.

A Look Behind the WARF Patent Announcement

The folks who challenged the WARF stem cell patents and triggered a fresh wave of negative publicity for one of Wisconsin's more sacrosanct institutions deserve credit for this week's surprising announcement concerning more liberal access to the critical keys for ESC research.

That credit is deserved despite WARF's predictable assertion that the organization really has not changed its position. Additionally, part of the backdrop to its announcement seems to involve the abrupt departure last year of WARF's longtime counsel, Beth Donley.

Previously WARF had taken a hardline position on its ESC cell patents, serving notice that it would defend them aggressively. Donley was in the forefront of that position, which is where an attorney should be when her job is to defend an organization's IP. But the ultimate question for WARF really was whether it wanted to appear to be standing in the way of research that could benefit millions of ailing persons all because WARF was grubbing for dollars. We suspect that was a position that made WARF's directors uncomfortable.

Nonetheless, Andrew Cohn, government relations manager for WARF, in response to questions from the California Stem Cell Report, said:

"Our position has not changed. People completely overreacted to comments made (last spring) by a WARF staff person (Donley) in response to a question. They did not report the second sentence of her response which was WARF has no intention of interfering with the CIRM grant process. The policy announced this week was just a clarification on a policy that was misunderstood many people."

Of course, if WARF wanted to clarify its position it could have made its announcement concerning its patents last spring instead of this week.

Following Donley's statement last year, John M. Simpson, stem cell project director of the Foundation for Taxpayer and Consumers Rights in Santa Monica, Ca.; Jeanne Loring, a stem cell scientist with the Burnham Institute in La Jolla, Ca., and the Public Patent Foundation legally challenged the WARF patents, triggering a spate of articles that did not portray WARF as a benign non-profit.

The Simpson alliance is still not satisfied with WARF's position and plans to continue their efforts.

The Sacramento Bee said that Simpson, Loring and the Patent Foundation deserve credit for WARF's "change." It also noted, in an editorial, the benefits of having a friendly critic (Simpson et.al.):

"The California Institute for Regenerative Medicine -- apparently unwilling to pick a fight with WARF -- hasn't joined the patent challenge. Now, ironically, it may benefit from the activism of Simpson and Loring."

In addition to Simpson's coalition, others do not think WARF went far enough. Writing in The Scientist, Alison McCook said,

"Jonathan Auerbach, president of GlobalStem, Inc., agreed that the patents remain a significant 'roadblock' for research. The changes to the licensing terms don't affect in-house industry research, and if GlobalStem receives, for example, an NIH small business grant of $100,000 for human ES cell research, the company would still have to turn over a sizeable proportion -- perhaps in the range of $75,000 -- to WARF in licensing fees, Auerbach noted. Loosening the restrictions 'is progress, but it's not enough,' he told The Scientist. "

Aaron Lorenzo of Bioworld Today additionally reported:

"Some industry sources told BioWorld Today that the new policy doesn't go far enough - WARF said companies still will need a license when they want to conduct internal research, which potentially is debatable given recent Supreme Court rulings on patent law, or develop a product for the market. But those same critics nonetheless feel that the overall bent of the change in attitude represents a positive step."

As for Donley's role in all this, scuttlebutt is floating around in the stem cell world that one of the reasons for her departure from WARF involved a re-examination of the foundation's position on stem cell patents. One report has it that she gave only three days notice.

Whatever the reasons for its announcement, WARF is doing the right thing, and it should receive credit for moving in the right direction. So should Simpson and company for lighting the way.

WARF Softens Stem Cell Patent Position, Critics Not Satisfied

In a surprising move, WARF says it is making changes in its embryonic stem cell patent program that should have a "positive" impact on the California stem cell research effort and others as well.

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.