An important part of the press release below is the text:
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.
Given that stem cell research is within the area covered by the exemption of 35 USC 271(e)(1) as interpreted by Merck v. Integra, this isn't too surprising. Further, patentees, like bank robbers, go "where the money is."
Press release -->
JANUARY 22, 2007
FOR IMMEDIATE RELEASE
CONTACT: Andy Cohn
Director of Government Relations and Public Relations
Wisconsin Alumni Research Foundation
Wisconsin Alumni Research Foundation changes stem cell policies to encourage greater academic, industry collaboration
Academic leaders applaud initiative
(Madison, WI) The Wisconsin Alumni Research Foundation (WARF) announced today three policy changes and clarifications that are expected to have a positive affect on stem cell research. The new policies will affect industry-sponsored stem cell research, academic and commercial licensing, and WARF’s relationship with the California Institute for Regenerative Medicine (CIRM), and will apply to current and future license agreements.
“WARF’s stem cell policies have evolved over the years, always in favor of increasing access and making it easier for scientists to move the technology forward,” said Carl Gulbrandsen, managing director of WARF. “These latest changes reflect an ongoing dialog with researchers and university administrators across the country.”
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.
“These policy changes should help universities engage industry sponsors in human embryonic stem cell research projects,” said Jon Soderstrom, managing director of the Office of Cooperative Research at Yale University. “Our collective research efforts will benefit from this new approach.”
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.
“These policy changes will facilitate further research and discovery in a very exciting area of life sciences,” said James Severson, vice provost of intellectual property and technology transfer at University of Washington. “WARF is a respected leader in moving science from the laboratory bench to the marketplace.”
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.
Stanford University and other academic and non-profit institutions in California are in the process of making proposals to CIRM for collaborative efforts in stem cell research, according to Katharine Ku, director of the Office of Technology Licensing at Stanford University.
“We are delighted to have such a clear statement from WARF about the intellectual property implications for institutions funded by CIRM and who uses cells from WARF,” Ku said. “We believe that the best way to advance knowledge and ultimately to commercialize stem cell technology for the benefit of human health is to allow non-profit organizations to pursue stem cell research without licensing constraints. This change in policy is a thoughtful, responsible approach to licensing these patents.”
The WARF policy changes are effective immediately. Documents reflecting these changes are now available on the WiCell and NIH Web sites (www.wicell.org and http://stemcells.nih.gov/research/registry, respectively.)
WARF holds the basic patents on James Thomson’s method of isolating and defining human embryonic stem cells and has made those rights available free of charge to academic researchers. WiCell Research Institute, a WARF subsidiary, hosts the National Stem Cell Bank, which provides cells from University of California–San Francisco, ES Cell International and WiCell.
WiCell has distributed cells to more than 360 research groups in 40 states and 24 countries. It has trained more than 350 scientists in how to work with the finicky cells. In a recent article in the journal Nature Biotechnology, Jason Owen Smith found that of all of the academic papers published in scientific journals between 2002 and 2004, a full 67 percent used cells from WiCell.
Over the past year, the number of WARF commercial licenses has doubled, reflecting an increase in industry-supported research and development. Geron, a WARF licensee, has announced that they will begin clinical trials using human embryonic stem cells later this year.
The Wisconsin State Journal
got down to the specifics:
#1. WARF will no longer require companies that fund stem-cell research at universities or nonprofit groups to buy licenses
. The licenses cost $75,000 to $400,000, depending on the size of the company.
#2. WARF will allow scientists to share stem cells, meaning some can forgo a $500 access fee.
The Journal noted:
Last year, the institute [CIRM] said its grantees must give 25 percent of royalties to the state on discoveries that yield more than $500,000. That prompted Beth Donley, then a WARF attorney, to say at a biotech meeting in San Francisco that WARF may assert its patents and seek license fees from commercial partners
of California grantees.
Though Donley's comment caused a stir among researchers in California, Andy Cohn said WARF never said the state itself would have to get a license
. Monday's statement clarifies that.
"This will move the science forward," Cohn said of the three moves. "It will get more companies interested, and that will bring more funding to academic researchers."Jim Downing at the Sacramento Bee wrote
: In a peacemaking move, a Wisconsin foundation that holds several key embryonic stem cell patents announced Monday [Jan. 22] it would let scientists conduct their research without having to negotiate a license. Under the new policies announced Monday, California's stem cell institute and its grantees specifically will not be required to negotiate a license with the Wisconsin group. However, the foundation did not give up its right to claim a share of royalties from stem cell therapies developed using state funding that are eventually commercialized, spokesman Andy Cohn said.Terri Somers wrote on January 23
: Scientists expect access to human embryonic stem cells for research to improve thanks to new policies announced yesterday by a University of Wisconsin agency that controls the patents on the cells.
Researchers are also now free to provide their colleagues with copies of embryonic stem cells that they received from WARF.
“I couldn't even share cells with colleagues before, so this is good,” said Jeanne Loring, an embryonic stem cell researcher at the Burnham Institute in La Jolla.
Loring and two taxpayer advocate groups have filed a challenge of the WARF patents with the U.S. Patent and Trademark Office, citing exorbitant licensing fees [IPBiz: irrelevant in a re-exam] and arguing that Thomson's work was not unique enough to qualify for a patent [IPBiz: the stronger challenge is obviousness, not novelty, tho probably neither will work at the USPTO].
She suspects that the patent challenge and publicity about it contributed to the new policies. [IPBiz: the challenge didn't contribute; maybe the publicity did.]
But despite the policy changes, the patent challenge will not be dropped, said Loring and John Simpson, of the Foundation for Taxpayer and Consumer rights, one of the groups challenging the patents.
“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,” Simpson said. “The right thing for WARF to do is admit that it doesn't deserve the patents and abandon them in their entirety.” [IPBiz: don't hold your breath, John.]
The Washington Post reported
Harvard University researchers Kevin Eggan, Chad Cowan and Douglas A. Melton wrote members of Congress earlier this month to complain that the White House domestic policy office's report "Advancing Stem Cell Science Without Destroying Human Life" was a "misuse and misunderstanding"
of their research. Excerpts:
"We are surprised to see our work on reprogramming adult stem cells used to support arguments that research involving human embryonic stem cells is unnecessary. On the contrary, we assert that human embryonic stem cells hold great promise to find new treatments and cures for diseases. . . .
***Separately, C&E News stated -->
The first policy change
will allow industry-sponsored research to be done at academic or nonprofit institutions without a license from WARF. The sponsoring companies will still need to obtain a license once the work moves into company labs or the work enters the product development phase. Another change
in policy will allow researchers to transfer WARF cells to others for free. Previously, such transfers required a license.
The final change
clarifies WARF's position related to the California Institute for Regenerative Medicine (CIRM), a nonprofit, grant-making organization set up to distribute stem cell research funds created by the state's $3 billion bond initiative. The change clears CIRM to make grants to and collect funds from its grantees without remitting any payment to WARF.
"WARF's stem cell policies have evolved over the years, always in favor of increasing access and making it easier for scientists to move technology forward," said Carl E. Gulbrandsen, WARF's managing director. "These latest changes reflect an ongoing dialogue with researchers and university administrators across the country."
**C&E News made no mention of Merck v. Integra.