Consumer groups say researchers ‘handcuffed’
The San Diego Union-Tribune
Two consumer groups yesterday asked the U.S. Patent and Trademark Office to re-examine and revoke three patents that give the rights to all human embryonic stem cells used for research to the Wisconsin Alumni Research Foundation, known as WARF.
A lawyer for WARF, a nonprofit group affiliated with the University of Wisconsin, called the allegations “a red herring” presented by people who want to use the university’s groundbreaking discoveries for nothing.
The consumer advocates say the patents, and the fees being charged to use the science they cover, are driving researchers and philanthropic funding overseas, where the patents are not legally recognized.
The Carlsbad-based biotechnology company Invitrogen, for example, is planning to conduct its embryonic stem cell program at its offices in China, unfettered by the WARF patents.
The Juvenile Diabetes Research Foundation is giving more money to researchers overseas because its philanthropic dollars go further where scientists are unfettered by the WARF patents, Richard Goldstein, the organization’s chief scientific officer, said earlier this year.
Many scientists and biotech insiders contend that this brain drain is giving other countries an advantage in the research that many hope may one day lead to a lucrative industry providing treatments for some of society’s most devastating diseases.
“WARF needs to get the dollar signs out of their eyes and stop impeding vital research that needs to go forward,” said John Simpson, of the Foundation for Consumer and Taxpayers Rights.
Simpson said he began exploring the idea of a WARF patent challenge after hearing numerous scientists complain. He said he was further motivated several months ago when WARF announced that it would seek a share of revenue if California’s taxpayer-funded stem cell initiative led to patents that could be licensed.
At issue are patents issued to University of Wisconsin researcher James A. Thompson in 1998, 2001 and last April. The patents cover the scientific recipe for pulling embryonic stem cells out of days-old primate embryos that are a cluster of 100 to 200 cells. These embryonic stem cells eventually morph into all cell types in the body, including nerve, blood and bone.
The hope and hype is that these cells can be used to test new drugs that are problematic to test on people, and that they might eventually be used to produce new cells to cure diseases such as diabetes, Parkinson’s and Alzheimer’s.
The consumer groups contend the patents should never have been issued because Thompson was not patenting something unique. They point to a patent issued in November 1992 and scientific articles published even earlier detailing how to derive embryonic stem cells from mouse embryos.
Thompson concedes in his patent application that a previously published recipe for deriving embryonic stem cells from mice works on human embryos, the groups said in their filing with the patent office.
Neither the earlier patent nor the articles were reviewed by the office when it considered whether to grant Thompson his patent, the groups said.
“WARF was not the first to do human embryonic stem cell research,” said Dan Ravicher, of the Public Patent Foundation. “They were just the first to run to the patent office and try to get such a broad patent.”
The nonprofit Public Patent Foundation, made up of patent lawyers and scientists, will handle all the legal wrangling for the requested re-examination, Ravicher said.
At the time Thompson’s first patent request was filed, “it was obvious to one of ordinary skill in the art of embryonic stem cell derivation that the process taught by (the earlier patent and published articles) could be used to isolate embryonic stem cells of other mammals, including humans,” said Burnham Institute researcher Jeanne Loring, who filed a declaration to support the re-exam request.
Elizabeth Donley, a WARF lawyer, was not familiar with the cases brought forth by the consumer advocates and could not say whether they were reviewed in Thompson’s patent application.
Until recently, WARF charged nonprofit research institutes $5,000 for a license to use embryonic stem cells. After the National Institutes of Health tapped the University of Wisconsin to be the home of a national embryonic stem cell bank, the license fee for nonprofit research was dropped to $500, which WARF said only covers its costs to issue the license.
The fee charged to commercial researchers, however, starts at $75,000 and is known to run as high as $250,000, Simpson said. That does not include annual maintenance fees and royalties, he added.
The consumer groups expect that within three months the patent office will decide whether to grant a re-examination. The office receives about 450 requests each year, and about 70 percent of those cases result in a change to the patent, Ravicher said.