MAJOR NEWS:Sorry, Wisconsin: The Jig is Up on Patents in Embryonic Stem Cell Research

From The Foundation for Taxpayer and Consumer Rights in California and The Public Patent Foundation (PUBPAT) via Jon Merz comes the most important news in stem cell research since 2000:

PTO REJECTS HUMAN STEM CELL PATENTS AT BEHEST OF CONSUMER GROUPS:

Santa Monica, CA -- April 2, 2007 -- The U.S. Patent and Trademark Office has upheld challenges by consumer advocates to three over-reaching patents on human embryonic stem cells and rejected patent claims by the Wisconsin Alumni Research Foundation (WARF), the Foundation for Taxpayer and Consumer Rights (FTCR) said today.

"This is a a great day for scientific research," said John M. Simpson. FTCR stem cell project director. "Given the facts, this is the only conclusion the PTO could have reached. The patents should never have been issued in the first place."

The challenges were filed last July by FTCR and the Public Patent Foundation (PUBPAT) because the three WARF patents were impeding scientific progress and driving vital stem cell research overseas. FTCR and PUBPAT argued that the work done by University of Wisconsin researcher James Thomson to isolate stem cell lines was obvious in the light of previous scientific research, making his work unpatentable. To receive a patent, something must be new, useful and non-obvious. The PTO agreed with the groups.

Its 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 PTO decisions were dated Friday, March 30 but were received today. WARF has two months to respond to the PTO ruling and seek to change it. Third party requests for patent re-examination, like the ones filed by FTCR and PUBPAT, are ultimately successful in having the subject patent either changed or completely revoked roughly 70% of the time.

Dr. Jeanne Loring, a stem cell researcher at the Burnham Institute for Medical Research, filed statements in support of the re-examination requests.

"The real discovery of embryonic stem cells was by Martin Evans, Matt Kaufman, and Gail Martin in 1981, and none of these scientists considered patenting them," said Loring. "It is outrageous that WARF claimed credit for this landmark discovery nearly 15 years after it was made."

In the face of the challenges by FTCR and PUBPAT WARF announced in January that it would ease its licensing requirements on human embryonic stem cells. "Now that the PTO has ruled, WARF should simply drop all its claims," said Dan Ravicher, PUBPAT Executive Director. [ed: yeah, hold your breath indeed...]

The groups said the patents' dubious validity is underscored by the fact that no other country in the world honors them. As a result, U.S. researchers have sent research monies abroad where they can avoid paying royalties to WARF. California voters approved the nation's largest publicly funded stem cell research program in 2004 with Proposition 71, which allocated $3 billion in grants over the next 10 years.

More information about FTCR and PUBPAT's challenges to the WARF stem cell patents (U.S. Patents Nos. 5,843,780, 6,200,806 and 7,029,913), including copies of the Patent Office's Orders rejecting the patents, can be found here, and you canr ead John Simpson's Op-Ed explaining the need for the patent challenges here.

What's Up Roundup

Not enough organs in Scotland, and fewer are going to be available.

More about how the world will end, or at least it will feel like that in Wisconsin, if the state doesn't kick up its stem cell spending.

Wisconsin should be more worried about New Jersey, whose new acting governor is going to be asking voters to approve borrowing "hundreds of millions of dollars" to fund embryonic stem cell research.New Jersey's last governor, in early retirement, is being eulogized all over the place for his role in advancing stem cell research there.

A new novel from Jodi Picoult examines purposeful birth for organ donation and Courtney Devores likes it. AJOB will have a review; anybody want to do it?

Seattle PI discusses moral surprise in the election.

Go figure that fewer people want hormone replacement therapy after a study showed that they might harm women. Who would have guessed?

I love this piece in OregonLive about the Seventh-day Adventists' role in Operation Whitecoat, the long-running biologic research program between 1954 and 1973. The courage of these who were exposed to all sorts of horrific germs is interesting. Moreno is quoted.

I love university fluff about professorial accomplishments, because it means that the university recognizes that it actually has a faculty. Here's a nice piece about Bob Levine's appointment to the CDC vaccine task force.

Speaking of university press, this short one by a Princeton undergrad looks at Peter Singers' class' visit to a NICU. Singer visits a NICU. What does he say in his ethics consults??

Leave it to an evangelical to coin a new bioethics term: the bioethics porkfest.

Wisconsin is Petrified of Stem Cell Migration UPDATED

Wisconsin Business reports that California's Prop 71 will create a "giant sucking sound" as big stem cell labs and important scientists are vacuumed up by California. The article asks how much will it take to lure James Thomson? Interesting question...several weeks ago we blogged Alta Charo's comments regarding the threat of Bush policies to Wisconsin. One could be cynical about that threat, given that Wisconsin holds so much intellectual property in stem cell research that Wisconsin profits no matter who is doing the work. But Alta is clearly right that Wisconsin could lose its key figures in stem cell research to Prop 71 and to California.

Wisconsin Worries it Will Fall Behind in Stem Cell Research?

Gazing at the California initiative proposed in Proposition 71, the Wisconsin Journal Times speculates that Wisconsin may fall behind. Now, this would be a reasonable fear in most US states. But Wisconsin? As Alta Charo acknowledges, "UW-Madison has strong adult and embryonic stem cell programs for now because all the federally allowed embryonic cell lines are at the university..." Finally, someone comes close to admitting that Wisconsin benefits enormously from the policy presided over by its former governor, HHS head Tommy Thompson. It is arguably a huge advantage, giving enormous intellectual property protection to the corporation started by Wisconsin's alumni association to hold (and collect fees for licensing) patents on the discoveries of James Thompson and colleagues at Wisconsin, and to collect fees for the use of Wisconsin's "Bush-approved" cell lines. Those patents, by the way, cover a huge range of activities in embryo engineering and science - virtually ensuring Wisconsin a place at the table in any embryonic stem cell-based IP dispute. So it is a surprise that Charo notes that Wisconsin "should be, by far, the single state everybody in the world looks to for the first, best discoveries on both embryonic and adult stem cells. And we're not."