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.

Alternative Sources of Stem Cells? How About the Garage Refrigerator!

Greg Dahlman pointed me to perhaps the weirdest take on how to isolate your own human amniotic epithelial cells from the placenta - at home (mmmmm. Will there be placenta left for lunch?) Here are the instructions. The creator of the method wrote in to give us a link to an even better page. Knock yourself out.

The Do Not Show Me State

The Scientist is reporting that Missouri has all but decided that it does not want to even entertain real arguments about stem cell research, and is very close to passing a law that will ban SCNT stem cell research entirely.

And the Next State to look into Embryonic Stem Cell Research is ...

Connecticut may be the next state to look into funding embryonic stem cell research. For Connecticut State Senator Larry Miller, who is spearheading the issue, the issue strikes particularly close to home: after being diagnosed with multiple myeloma several years ago, he believes that his life was saved with an autologous bone marrow transplant, using his own adult stem cells from his bone marrow. Although this treatment is not controversial, Miller's personal experience and concern for others with serious diseases, is what drives him to push for stem cell research in Connecticut. He and another senator wrote a bill last year to allow stem cell research; the Senate approved the bill, but the House opted to study the issue for another year. There is a possibility that the research might be funded with $10 to $20 million from the state’s surplus, as a one-time expense toward stem cell research.

Asia Is Stem Cell Central

This piece elaborates on the role of some major Asian cities and nations in effectively beginning a drive to dominate stem cell research. Not much new here but it is comprehensive and there are some interesting examples of scientists who went east for the gold instead of west for the rush. [From Business Week]

Wesley Smith has Lots of Nerve

Wesley Smith has made a serious bid for the 2004 chutzpah award. in a new column he complains that proponents of embryonic stem cell research using cloned embryos are playing word games in how they describe cloned embryos. This coming in the context of a year's worth of conniving on the part of proponents of a ban on cloning for research to say they are not opposed to 'stem' cell research when what they mean is adult stem cell research and intentionally confusing reproductive cloning with cloning for research. Wesley--stones, glass houses, c'mon now! - Art Caplan

Wired News: Stem-Cell Method May Cheat Death

"Stem-Cell Method May Cheat Death" reports on the potential derivation of stem cells from a single cell removed from a morula, which we mentioned a week or two ago on this list. Note, though, that they think it will solve the problem of killing embryos, because the embryo it was removed from would persist. The philosophical conundrum is that, if you believe any totipotent cell is human life, when you remove that blastomere from the morula all you have really done is twinned the morula. To someone believing in the sanctity of embryonic life, it might not be enough that the parent morula is not destroyed. The blastomere itself can be considered life worthy of protection. There is a point at which the cells cease to be totipotent as the morula transforms into a blastocyst. If someone could culture stem cells from a blastomere taken from a morula/blastocyst that has ceased to be totipotent -- then we will have really solved the stem cell problem to everyone's satisfaction, I believe. I think the ultimate point is that the stem cell problem may go away soon, leaving us only with enhancement, abortion, and PVS to distract us from health care reform.

Geron: Behemoth of the Stem Cell Race

Sacremento Bee reports on the importance of Geron and its patents for the race to acquire and license stem cell research technologies. It is a field in which there is a great deal of patent protection, as I wrote in a survey of the existing patents for a book Magnus, Caplan and I co-edited: Who Owns Life?. And now there are three billion dollars available for research that will in many cases produce licensing arrangements that filter automatically through Geron. This will be an interesting time for those who invest in biotechnology, but more interesting still for those who follow patent law in the life sciences, where the patent and trade offices in the US and European Union seem to have lost their minds. GM

Real Estate Investor to Run California Stem Cell Program

Just out from the official Governor's Office press release:

Governor Arnold Schwarzenegger today announced his selections for leadership of the Independent Citizens Oversight Committee (ICOC) which oversees the California Institute for Regenerative Medicine created by the passage of Proposition 71. The proposition, supported by the Governor, was approved by voters in November and will fund stem cell research that may offer cures for ailments ranging from Alzheimer’s disease to diabetes and cancer. The Governor announced his nomination of Robert Klein for chairman and Edward Penhoet for vice chairman of the ICOC.

Whoa Thar Little Stem Cells. Stop Tryin' to Leave the Dang State!

Texas needs stem cell policy, and Sen. Kay Bailey Hutchison, likely candidate for governor of Texas, is pushing to save Texas from stem cell obscurity. It is difficult to imagine that the state - dominated by conservative protestants and Catholics - would ever embrace any serious stem cell research plan that includes embryonic cells. Hey ... they execute lots of disabled people in Texas. If that passes must with the Texas pro-life constituency, maybe they'll go for Hurlbut's "kill a disabled embryo" approach! Or maybe not, pardner. Not in Crawford. [thanks Arthur Caplan]

WANTED: Czar for California Stem Cell Research Agency ... Must Be Rested & Ready to Be Most Powerful Person in Biotech

LA Times reports:

With less than a week before the debut of California's new $3 billion stem cell institute, intense behind-the-scenes debate is growing over who should head the agency and whether a Friday deadline for filling the post will allow the best candidates to be considered. The debate is expected to crest Monday when Gov. Arnold Schwarzenegger and three other state elected officials must, under the tight deadlines set by the state's embryonic stem cell initiative, put forward their nominee to chair the new agency.

The chairperson will immediately become among the most influential officials in the field of biological research, running much of the day-to-day operations of an institute that will dole out some $300 million a year in grants, more than 10 times what the federal government now spends yearly in the stem cell field.

Bernard Lo is quoted.

No Comment from the Plaintiff, Who is Still a Tiny Frozen Glob

KRT newservice reports on the dismissal by a federal appeals court of a 1999 lawsuit that alleged that all U.S. frozen embryos (400,000) are threatened by stem cell research, which required that they be destroyed. The suit, by Hagerstown, Minnesota based National Association for the Advancement of Preborn Children ("an embryo is a terrible thing to waste") - NAAPC - "sued the federal government on behalf of "Mary Doe," a name it chose for the nation's estimated 400,000 frozen embryos.

"You see, Mary Doe is coming into court and she says, 'I'm alive, and I'm a human being. Stem cell research is killing my brothers and sisters, and I may be next in line,'" said Rudolph M. Palmer, who founded the Hagerstown organization about 15 years ago.

In its appeal, NAAPC argued that present policies threaten the embryo every bit as much as the Clinton policies. "But a three-judge panel of the 4th U.S. Circuit Court of Appeals declined to address the ethics of stem-cell research, agreeing Tuesday with a lower court that the issue was moot since it hinged on outdated Clinton administration policies."

A Man in Search of an Audience

Updated 12/5, 12/9 (We just can't slow this story down!): The Culture of Life people reported 12/1 on the news that the stem cell debate will soon be 'solved':

A member of the President's Council on Bioethics believes he may have found a way to obtain stem cells with the same potential as embryonic stem cells without creating or destroying a human embryo.

At last, a brilliant idea for getting around the big problem with embryonic stem cell research. It comes from President's Council on Bioethics member William Hurlbut, who constantly complains that those who favor embryonic stem cell research are - his term - "not morally serious" enough (take a listen). But he's had his idea vetted by "prominent Catholic clerics and other ethicists," to see if the technology he proposes is morally acceptable. The idea? Gushes the prolife newsletter:

in Hurlbut's method the gene responsible for creating the placenta is turned off. Hurlbut contends that this prevents an embryo from ever being created. But like traditional cloning, the egg still generates inner cell mass, or the "blank" cells, that some scientist believe have the greatest research potential. The [Boston] Globe reports that parts of the technique are currently being performed on mice.

Sounds great, right? It even sounds oddly familiar, probably. That is because it has been proposed in several forms by at least a dozen scientists who actually work in the area, and published in (among other places) Nature, although not by Hurlbut. Some of the papers are catching on to the idea that maybe the suggestion isn't so novel. But Hurlbut thinks his solution is important and scientifically significant, and conservatives are everywhere trumpeting the significant scientific breakthrough.

There's just one problem with taking him at face value: He has no publications in stem cell biology, ethics, theology or any part of clinical IVF. Nor is he, an MD, in clinical practice in that or any other area. Stanford faculty who have asked the president of that institution to release him point out that he has allowed and personally encouraged the description of him as a "Stanford scientist."

Hurlbut bases the moral utility of his claim on the fact that he vetted it with priests

The Boston Globe covered his theory, and right to lifers are beside themselves with joy at the morally serious solution. (UPDATE: Actually, some of the pro-life leaders are beginning to see the fix Hurlbut's idea puts them in) But there are many, many problems with Hurlbut's claims that even a visit to the Pope won't fix: 1) he makes assumptions about what counts as an embryo, a matter on which no ten embryo researchers agree, 2) he thus makes assumptions about when the destruction of embryonic material would count as destruction of an embryo, a person, or a human life for either scientists or clerics, 3) he makes no effort whatever to describe why his proposal is somehow less objectionable than other nuclear transfer technologies that he has campaigned against so vigerously.

UPDATE: Washington Post reports that Hurlbut's idea was mocked by a visiting scientist at the council, but that nonetheless the council is trading on the prominence afforded to it by Hurlbut's "big ticket idea," and as a direct result Leon Kass did in fact hold hearings on "solutions" to the stem cell problem, which (surprisingly to me, anyway) were hailed by Kass himself (chair) as important stuff. One might have guessed that Professor Kass would be a bit embarrassed that his handpicked council would advance ideas as potentially repugnant (following his analysis in his own writing) as Hurlbut's, designed to sidestep rather than engage a debate. And Kass does try his best to make the ideas sound thoughtful:

Kass said the ideas raise the possibility that "the partisans of scientific progress and the defenders of the dignity of nascent human life can go forward in partnership without anyone having to violate things they hold dear."

But the idea is neither an artful dodge nor a successful one. - GM

On the Way to Regulating Stem Cells in California

News from the National Academies conference in Irvine, California this week. Moreno, Charo, Lo are quoted. "R. Alta Charo, a bioethics professor at the University of Wisconsin at Madison, told the audience that, for anyone who believes embryonic stem-cell research is unregulated and has slipped through the cracks, she had brought 35 slides dedicated solely to the field's current regulations."

President's Council Dignifies Stem Cell "Solutions"

Chris Mooney noticed this careful dissection of the ideas for "getting around" the ethical problems associated with using embryonic stem cells in research. It is a nice, thorough review of these ideas and how problematic they are. We're, frankly, much less impressed with the entire discussion than are either Chris or other critics. But we've already made that argument ad nauseum. It is an open question why the council has pursued the questions it has chosen to pursue.

Tommy Thompson's Parting Words

Chris Mooney blogs Thompson's last comments on stem cell research before he is to depart his Bush administration role. MSNBC/Newsweek covered the final conference by Thompson.

Why No Bioethics on the California Proposition 71 Governing Council?

Why doesn't California put a bioethicist on its Proposition 71 governing board dealing with the $3 billion to be allocated for stem cell research? University Chancellors and Presidents are being nominated up and down as schools' and institutes' top guns clamor to be public intellectuals on this big-ticket funding item, no doubt in part to ensure that their shop gets some of the money. The proposition guarantees seats on the board to some institutions (including the 5 UCal schools), but why in the world can't there be some slots dedicated to bioethics?

No matter what your position on stem cell research, there simply must be a dedicated stem cell ethics expert among the governors. If it weren't so serious a matter, one would have to laugh at the idea that these University and institute administrators are properly trained to think about how and whether to dispense the money and for which studies. It is a question several are beginning to ask anew, echoing concerns from those who opposed Prop 71 but themselves supported hES research. Bioethics in California has always been a developing phenomenon, although the Stanford center is arguably among the top programs in the nation. Hopefully at least some of the ballast for deliberations about which programs should be funded will be provided by people in stem cell bioethics in California. But that is a very, very short list of people.

Even more important, California should finally begin to build up some bioethics programs, particularly in the universities that plan to do significant new stem cell research. If the past is any predictor, that will not be easily accomplished in California, where bioethics has just never really taken a foothold in terms of university budgets and powerhouse faculties. There are plenty of good people in bioethics in California, but it is difficult to identify a group of major research centers in bioethics in the state, despite its preeminent place in biotechnology research. Proposition 71 should be the full employment act for California bioethics, to borrow Art Caplan's description of the role ethics money in the Human Genome Project had on bioethics in the 1990s. But if it is business as usual in the most populous state in the nation, bioethics may become an unfunded sport for university CEOs. That would not only hurt bioethics, it would hurt the people of California, who are clearly hoping for a careful, smart use of the $3 billion windfall for stem cells. For them, ethics has to stay in the mix in a serious way.

Asian Stem Cell Labs Dwarf Ours

Labs in Beijing, Shanghai, Seoul, and Singapore have begun to dwarf labs in the UK, and by extension the US, in terms of physical space, talent, and most important in terms of development of cell lines, and particularly across species lines. We've blogged to death about the insecurity in Wisconsin about other states, particularly California, hogging the stem cell research dollars. And yes, Advanced Cell Technology is moving there. But no state in the U.S. has spent half the money that is budgeted in the research groups in Asia, and it is beginning to show.

UN deadlock defeats cloning ban

After a number of delays and much maneuvering and politicking, a deadlocked United Nations has finally defeated a ban on therapeutic (research) cloning. The defeat is a blow to the Bush Administration, which has tried for years to get the international body to throw its weight behind a ban on the technology. While almost all nations support a ban on human reproductive cloning -- cloning procedures that result in a living child -- many nations support the use of cloning technology for medical research. In fact, much of the research goes on in the United States, and a three billion dollar bond issue in California promises to keep the US in the forefront of such research, unless our more conservative Congress passes a US ban.

Illinois' Stem Cell Aspirations Take a Dive

Illinois Senate has moments ago canned its amendment promoting stem cell work in the state. The story is still developing but Wesley Smith posted it on MCW. More:

The defeat of the amended version of HB 3859, which opponents argued would allow "laboratory cloning" as part of stem cell research, depended upon the votes of Downstate Democrats. Republican senators Kirk Dillard, Christine Radogno and Adeleine Geo-Karis broke ranks with the Republican caucus and voted to support the measure.