Fresh Comments

Lawrence Ebert has posted fresh comments on the "Lee Letter" and "Baristas" items below. Ebert has written at more length on what he calls "Cha-gate" on his blog – Ipbiz. See "CIRM grant" and "Fulminations." Ebert also links to the article in The Scientist on the plagiarism issue, which also has additional commentary from readers, including Sook-Hwan Lee's letter.

Harvard's Kim Responds on the Cha Matter

Following publication of the British Medical Journal item below, we queried one of those mentioned, Kwang-Soo Kim, whether he had anything further to say on the matter. He forwarded the following via Tony Knight of Sitrick and Company, a public relations firm.

"After learning about this incident, I was quite frustrated and concerned
with the situation and, thus, personally investigated the matter by carefully discussing the details with each of the authors of the paper. My conclusion is that this is a most unfortunate situation stemming from a disgruntled junior scientist's unprofessional conduct which appears to have been unnecessarily amplified by an all-too-eager reporter who was either misinformed or is not properly reporting all the facts of the case.

"However, we are hopeful that with the disclosure and consideration of all the facts involved, a fair outcome will result not only in the pending legal proceeding but also with Fertility and Sterility.

"As a fellow research scientist with more than 23 years of research experience in the U.S., as well as knowledge of the scientific community in Korea, I feel some background information may prove to be helpful and insightful regarding the dual- publication issue.

"I personally have very strong objections to this practice where the dual publication in a non-SCI Korean journal and an SCI journal were pursued. I do not know for certain how widespread this practice has been in recent years. But I am pleased that it was halted in 2006 with the publication of a new guideline by Korean scientific leaders.

"Given that the practice of publishing in both a non-SCI domestic journal and a SCI international journal was accepted by some in Korean, it is somewhat understandable that Dr. Lee followed this practice, although I think it was a terrible mistake. All the other authors were not even aware of the fact that this paper was previously published in a Korean journal and, thus, are innocent.

"We at Pochon CHA University believe the matter should be corrected, and Dr. Lee is planning to retract the first paper from the Korean journal. The paper's scientific integrity is without question and it should remain in F&S.

"Based on my conversations with all of the other authors, I believe that Dr. Kim's contribution was marginal compared to the research project in total. Authorship of a scientific paper is based less on who drafted the text than on who performed the scientific work and whose original idea and investigative thought went into the research. In particular, in this type of genetic studies, it is crucial how the samples are organized and collected, including both patient and control samples. Dr. Kim deserves authorship because of his partial but direct contribution, and Dr. Lee did credit him as an author in her submission of the manuscript to F&S.

"Needless to say, the data and results produced from a lab are attributable to the principal investigator and the rightful, proprietary property of the sponsoring institution. The fact of the matter is that Dr. Lee was the principal investigator and director of the lab and all of the resulting data was attributable to Dr. Lee and the rightful property of CHA Hospital. It is also a fact that Dr. Kim took this data without anyone's knowledge or proper permission which was a huge violation of trust with Dr. Lee, the other researchers and the entire organization, as well as a serious breach of company policy and that of the implicit rule regarding research data and intellectual property within every research lab. I believe this is why he did not leave any contact information and could not be reached."

Text of CHA Response to a Variety of Issues

The three following items were provided today by a representative of CHA in response to queries by the California Stem Cell Report. One is a letter to the editor of the Los Angeles Times, which has not been published as of the date of this writing. The other was sent to The Scientist magazine and is posted on their web site. The final document is information prepared in connection with the grant by the California stem cell agency to CHA RMI.

All of the items are posted verbatim as received from Tony Knight of Sitrick and Company, a Los Angeles "strategic communications" firm.

Cha Letter to Los Angeles Times

Text of letter to Los Angeles Times

Letters to the Editor

Los Angeles Times
202 W 1st Street
Los Angeles, CA 90012

Fax- 213-237-7679
letters@latimes.com

Dear Editor:

Your stories, “Stem cell grant OKd for L.A. center linked to allegations” (March 26) and “Credit for U.S. journal article at issue” (February 18), inaccurately portrayed the controversy over an article in the journal Fertility & Sterility as a “plagiarism dispute.”

As the one who originated the idea for the project and provided guidance and oversight for the collection of the patient samples, I was entitled under the relevant rules to a “first author” credit.

Dr. Jeong-Hwan Kim says he should have been listed as an author. In fact, Dr. Sook-Hwan Lee’s Feb. 5, 2005 letter to F&S, enclosing the manuscript, credited Dr. Kim with “clinicopathological analysis and statistical analysis." Even so, the sample data collection work had begun well before Dr. Kim became involved.

Dr. Kim’s name was dropped when he left Korea and he could not be found to sign the paperwork required by F&S. When Dr. Kim was located in 2006, Dr. Lee wrote letters to F&S asking his inclusion as an author.

The research was done at the Human Genetics Laboratory of CHA Hospital, where Dr. Lee was the director. Lab documentation shows that Dr. Kim’s contribution to the actual research was marginal. He collected two of the 30 patient samples, and none of the control samples. Other CHA doctors and laboratory scientists collected the other specimens and accomplished all DNA extraction. Dr. Kim compiled the basic statistics
and wrote the thesis in Korean.

As Dr. Lee informed The Times, Dr. Kim submitted the paper in Korean to the Korean Journal of Obstetrics and Gynecology (KSOG), listing himself as first and corresponding author, without her knowledge or consent. She translated the article into English for F&S, and she was the only author who knew of the prior KSOG publication.

None of the other authors, including myself, were aware of the article’s prior publication. Dr. Lee was correctly listed as an author on both papers, so plagiarism is also out of the question with regard to Dr. Lee.

Finally, your article said I had improperly used M.D. after my name on web sites of U.S. clinics and laboratories that are part of the CHA family of institutions. The web sites that refer to me are aimed at an international audience. I am the Chancellor of the College of Medicine at Pochon CHA University, a trained physician, licensed to practice medicine in Korea. I do not practice medicine in California and have never held myself out as a physician practicing in California.

Regards,

Kwang Yul Cha, M.D.
Chancellor
Pochon CHA University College of Medicine

Lee Letter to The Scientist

Text of letter to The Scientist

March 22, 2007

Richard Gallagher
Editor
The Scientist

Dear Editor:

Your February 20 article “Fertility journal censures scientists” contained inaccuracies and omitted important facts regarding a paper by myself and my colleagues in the journal Fertility & Sterility titled The Quantitative Analysis of Mitochondrial DNA Copy Number in Premature Ovarian Failure Patients Using the Real-Time Polymerase Chain Reaction (2005).

It is not true that Dr. Jeong Hwan Kim “performed the bulk of the research,” nor is it true the paper was submitted to F&S without Dr. Kim listed as an author. As of this writing, F&S has not censured me or any other authors. And Dr. DeCherney’s comment that all of the authors of the paper “perjured themselves” is baseless, as I will explain below.

The concept for this research originated with Dr. Kwang-Yul Cha in 1998. Dr. Cha and I designed and wrote the research proposal in 2001. Korea’s Ministry of Health and Welfare funded the research. My intent from the beginning was to seek publication in an SCI journal.

Most of the research was accomplished by myself and other researchers in the Human Genetics Laboratory of CHA Hospital. Dr. Kim became involved in 2002 when he asked for my guidance on his doctorate thesis and joined us as a part-time researcher.

I am told that he claims to have collected all 30 of the POF patient samples. We have documented proof he collected only two patients’ samples, and he collected no control samples. Other CHA Hospital doctors collected most specimens, and other scientists at the Human Genetics Laboratory accomplished all DNA extraction, prerequisite for real-time PCR. Dr. Kim compiled the basic statistics and wrote the thesis in Korean.

I agreed to help Dr. Kim with his doctoral thesis and permit him to participate in the research on the condition that any resulting paper would be submitted to an SCI journal. Upon receiving his degree from another institution, however, Dr. Kim submitted the thesis in Korean to the non-SCI Korean Journal of Obstetrics and Gynecology (KSOG), listing himself as first and corresponding author, without my knowledge or consent.

He also took all of our data without authorization and moved out of Korea leaving no forwarding address. I subsequently filed a legal complaint against Dr. Kim that is being investigated by the Korean Public Prosecutors Office.

Unable to locate Dr. Kim, KSOG recognized my name among the authors listed and contacted me. This was the first I was aware the paper had been submitted to KSOG.

Perhaps I should not have done so for my student, but I agreed to be the corresponding author when KSOG could not find Dr. Kim. (I am told that Dr. Kim says locating him would have been easy, but KSOG was unable to find him. More recently, an official Korean Public Prosecutors Office document stated that his whereabouts were “unverifiable.”)

The loss of our original data deprived me of an ability to write a second paper, yet I remained committed to submitting the research to an SCI publication. I translated the KSOG paper into English and submitted it to F&S with myself as the corresponding author.

Dr. Cha was listed as the first author on the F&S article because he originated the idea for the project and provided guidance and oversight for the collection of the patient samples. He was entitled under the relevant rules to “first author” credit.

Dr. Kim was included as an author on the original submission to F&S. My Feb. 5, 2005 letter to the editor of F&S, enclosing the manuscript, credited him with "clinicopathologica1 analysis and statistical analysis."

But Dr. Kim could not be found to sign paperwork required by F&S. His name was dropped for this reason only. When Dr Kim surfaced in 2006, I wrote two letters to F&S requesting his inclusion as an author. F&S never replied.

The paperwork F&S required the authors to sign was related to “financial” conflict of interests, not prior publication. None of the other authors, except myself, knew that the article had been published in KSOG. Hence, Dr. DeCherney’s ‘perjury’ allegation against the authors is without merit.

I express my sincere regret for the controversy and assume full responsibility as the corresponding author of the paper. No one else is to blame. No harm, sanctions or reputational damage should be directed to my co-authors.

I ask that you publish this letter in full in order to set the record straight.

Sincerely,

Sook-Hwan Lee, M.D., Ph.D

CHA RMI Statement on CIRM Grant

Text of the CHA RMI Statement:

March 24, 2007

Statement CHA Regenerative Medicine Institute

CHA Regenerative Medicine Institute is a non-profit organization
incorporated in California on Dec. 21, 2005 and has been engaged in
adult and embryonic stem cell research at its Los Angeles laboratory.

CHA RMI's mission is to develop regenerative cell and gene therapies for
the treatment and cure of human diseases. CHA RMI focuses its research
on advancing therapeutic cloning technology to create patient-specific
stem cells using fresh and frozen human eggs.

CHA RMI is able to bring to California patented vitrification technology
first developed at CHA BIOTECH and other advanced proprietary stem cell
technologies, which would otherwise not be available in the state,
because of its association with CHA Stem Cell Institute. All of CHA
RMI's facilities and research staff are located in California and all of
its work will be done in the state.

CHA RMI's research scientists are presently focused on:
* Production of embryonic stem cell lines from somatic cell
nuclear transfer- embryos
* Establishment of embryonic stem cells from donated eggs
* Differentiation of embryonic stem cells into specific cell
types.
* Investigation of adult stem cells for diabetes

CHA RMI's articles of incorporation state that it is organized under the
Nonprofit Public Benefit Law for charitable purposes and is not
organized for the private gain of any person. The articles further state
that the property of this corporation is irrevocably dedicated to
charitable purposes and no part of the net income or assets of this
corporation shall every inure to the benefit of any director, officer or
member thereof or to the benefit of any private person.

CHA RMI is associated with CHA BIOTECH, a leading stem cell research
institute in Korea, established in September 2000 by Pochon CHA
University College of Medicine and CHA General Hospital Group in order
to create a central, multidisciplinary research facility where the
university's scientists and hospital physicians could come together and
focus their efforts on developing stem cell, gene therapy and
regenerative medicine technology.

CHA BIOTECH, however, does not have any ownership interest in CHA RMI
nor does it have any voting rights on the Board. None of the member
companies belonging to CHA Health Systems have any ownership interest in
CHA RMI and none of the companies have any voting rights on CHA RMI's
Board.

Dr. Kwang Yul Cha, Chancellor of Pochon CHA University College of
Medicine, was listed as the initial chief executive and a member of the
Board of CHA RMI during the time when the non-profit laboratory was
being established. He has since resigned from these positions according
to the reorganization plan that was intended from the inception of the
institute. Dr. Cha does not hold any administrative or managerial title
at CHA RMI.

Dr. Cha is an internationally known fertility specialist with more than
100 articles published in peer-reviewed scientific journals. He received
his medical degree from Yonsei University in Seoul, Korea, and performed
his postdoctoral fellowship in endocrinology and infertility at the
University of Southern California. He also served as a visiting
professor at Columbia University

Dr. Cha succeeded with Korea's first Gamete Intra Fallopian Transfer,
Asia's first pregnancy in a woman without ovaries and the world's first
pregnancy from in vitro culture of immature oocytes collected from
unstimulated ovaries.

His research has received awards from the American Society for
Reproductive Medicine and the International Federation of Fertility
Societies. His research accomplishments have been featured in stories by
Time magazine, The New York Times and The Wall Street Journal.

Since its establishment in December 2005, CHA RMI has received approval
from the Western Institutional Review Board (WIRB) to conduct embryonic
stem cell research using frozen human eggs. This approval makes CHA RMI
the first research institute in the world to receive permission to
conduct stem cell research using frozen human eggs.

On March 16th, 2007, CHA RMI was awarded a $2,556,066 grant from the
California Institute for Regenerative Medicine (CIRM) to conduct
research in the "Establishment Of Stem Cell Lines From Somatic Cell
Nuclear Transfer-Embryos in Humans." The purpose of the research is to
provide a novel resource to the biomedical research community to study
and understand how genes correlate with the development of diseases such
as Amyotrophic Lateral Scelerosis (ALS), also known as Lou Gehrig's
disease.

CIRM's President and Chief Scientific Officer Zach W. Hall, Ph.D.,
stated: "These grants provide substantial support to a pool of very
distinguished researchers in human embryonic stem cell research." He
added that because of the size of the grants, "Our reviewers had higher
expectations and more rigorous standards for judging this set of
applications."

In its review of the "impact and significance" of the proposed research,
CIRM wrote: "As no ALS embryonic stem cells are currently available, the
isolation and characterization of such a diseased line will not only
provide the beginning of a proof of concept for this technology, but
more importantly will establish a realistic platform to study the
molecular basis of ALS, a devastating disease which remains incurable.
The other main significance of this work is the use of frozen oocytes
instead of fresh oocytes, which alleviates a number of ethical issues
regarding payments for donations to patients. This should not be
underestimated, as this simple fact is one of the major limitations of
SCNT approaches."

The principal investigator of the CIRM sponsored research is Jang-Won
Lee, Ph.D., who received his doctoral degree in animal science from the
University of Connecticut. Dr. Lee had been a research fellow at Wake
Forest Institute Regenerative Medicine, Winston Salem, NC and at
Children's Hospital & Harvard Medical School, Boston, MA. Before
assuming his post at CHA RMI, Dr. Lee holds an assistant professor
position at Pochon CHA University College of Medicine.

A full copy of the CIRM review can be found at:
http://www.cirm.ca.gov/publicsummaries/RFA_06-02/summary/RC1-00123-1.htm
l

British Medical Journal Discloses More Details in Cha Matter

The British Medical Journal has taken up the matter of Kwang Yul Cha and allegations of plagiarism against him, an issue that has raised concerns from two stem cell watch dog groups in California.

The four-page article in the April 7 issue of BMJ begins like this:

"A bitter dispute over the authorship of a twice published medical paper has pitted a 35 year-old Korean doctor against one of the most powerful players in the country’s struggle for biotech supremacy. The battle is threatening to disrupt Korea’s efforts to recover scientific credibility in the wake of the recent scandal over Woo-Sok Hwang’s stem cell research."

Cha is of special interest in California because the state's stem cell agency last month approved a $2.6 million research grant to a non-profit subsidiary, CHA RMI, of the CHA Health Systems organization, which is headed by Cha. The Oversight Committee of the California stem cell agency approved the grant with little discussion and no public notice prior to approval that it was for CHI RMI. CIRM's standard practice is to withhold the names of grant applicants. Following public disclosure six days later of the linkage between CHA RMI and Cha, two watchdog groups raised questions about grant.

The BMJ article was written by Jonathan Gornall, who added details and new information to what already has been reported concerning Cha. Gornall wrote:

"Now, as the dispute escalates into a series of allegations and counter allegations, the editor in chief of Fertility and Sterility has been accused of defamation and threatened with legal action by Dr. Cha. However, the BMJ has also learnt that following an investigation by the public prosecutor’s office in Korea, Dr. Sook Hwan Lee, one of Dr. Cha’s coauthors on the disputed paper, has been charged with criminal copyright infringement. The dispute is a major embarrassment for the CHA organisation, which only recently hired Professor Kwang Soo Kim, a respected Harvard professor, to boost its credibility in stem cell research."

Gornall continued:

"On 7 March, Dr.(Alan) DeCherney (editor of Fertility and Sterility) received a letter from lawyers acting on behalf of Dr. Cha. It quoted comments attributed to him in the LA Times on 18 February and in The Scientist on 20 February and accused him of having made 'false and defamatory statements' about Dr. Cha. It threatened legal action and demanded that Dr. DeCherney sign a statement of retraction. The letter, seen by the BMJ, calls for Dr. DeCherney to 'acknowledge that 1) Dr. Cha was entitled to be credited as an author of the F&S [Fertility and Sterility] article; 2) you have no reason to disbelieve Dr. Cha’s statement that he was unaware of the prior publication in the KSOG Journal; and 3) Dr. Cha did not plagiarise Dr. (Jeong Hwan) Kim’s work, in that Dr. Kim’s name was on the list of authors initially submitted to F&S by Dr. Lee, and was only omitted because he could not be located.'"

Gornall continued:

"Professor Kwang Soo Kim, director of the molecular neurobiology laboratory at Harvard’s Mclean Hospital and the newly recruited codirector of the CHA Stem Cell Institute, now finds himself having to defend his new employer. No fewer than three of his new colleagues at the institute including his fellow codirector, Hyung Min Chung are among the disputed authors on the paper. In February he wrote to Dr. DeCherney of Fertility and Sterility on behalf of the CHA organisation as 'a fellow research scientist with more than 23 years of research experience in the US as well as first-hand knowledge of standard practices in the scientific community in Korea,' to express regret about the incident.

"In his letter, a copy of which the CHA organisation sent to the BMJ, he suggests that 'The main issue that appears to be at the center of this controversy is the multiple publication of the paper.' But he then makes a disturbing disclosure: 'In Korea, it has been a customary practice and an accepted procedure by the scientific community to submit top-quality research outcomes concurrently (or subsequently) to internationally-recognized journals in an effort to promote and advance the work of Korean scientists, which was also the case when Dr Lee submitted her paper to Fertility and Sterility.

"'I personally have very strong objections to this practice and have been trying to convince the scientific leaders in Korea to put a stop to this. It was only recently in 2006 that this guideline was in fact revised in Korea to prohibit this practice.'

"Professor Kim’s intervention leaves little doubt about how seriously the CHA group views the potential of the incident to damage its bid to inherit Hwang’s crown: 'The reputation and credibility of our university and that of its researchers and scientists are also at stake,' Professor Kim writes. 'This is an extremely critical issue in light of the fact that I believe our institution will serve a pivotal role in restoring the severely damaged reputation and credibility of stem cell and life science research in Korea after the Hwang scandal.'"

We have queried DeCherney concerning his response to the letter from Cha's lawyers.

For previous items on the the CHA story, see "Secrecy," "Example," "CGS" and "FTCR."

Time to Give Fax Machines a Decent Burial

Fascimile transmission seems akin to the Linotype. At least to this writer, who is boggled by several recent communications that could only be received via antiquated technology. (This item, by the way, is not really about CIRM or stem cells.) Why anyone would want to use fax instead of email or other electronic transfer methods is hard to understand. It seems a waste of time and particularly a waste of physical storage space, which is undoubtedly more expensive than digital storage. Perhaps we are missing something concerning the use of fax. If so, hopefully someone can enlighten us.

Criticism: The Price for a CIRM Grant

The California stem cell agency is breaking into some of the cloistered halls of science with criticism that publicly labels one scientist "naïve" and calls another scientist's proposal potentially irrelevant.

Of course, the sting of the criticism is soothed with the balm of multimillion dollar research grants.

Reporter Carl Hall of the San Francisco Chronicle recently sliced a bit deeper than other reporters into the public summaries of the grants won by California scientists, noting that they "offer a rare glimpse into the traditionally cloistered world of scientific peer review. He quoted Arlene Chiu, director of scientific programs at CIRM, as saying,

"The NIH doesn't show any of this kind of thing going on, This is the first time you can see how people criticize one another."

Arnold Kriegstein, chief of the UC San Francisco stem cell program, was the target of a comment that he was "naïve" on some technical matters. He told Hall he was a victim of his own brevity and may have been misunderstood "in certain technical aspects." His bruises were nicely tended with a $2.5 million grant.

Alice Tarantal, a pediatrics professor at UC Davis, described the review as a "very fair process" although some reviewers questioned how relevant her model was from a clinical perspective. She received a $2.3 million grant.

The names of those criticized are only publicly released after the grants are approved, although some persons very familiar with stem cell research could identify at least some of the scientists in advance based on the nature of their work. The names of those who fail to win grants are not released.

We have written often about unwarranted secrecy in the grant process. But the public summaries are an excellent step in the right direction and CIRM should receive ample credit for providing them.

Hall should also receive credit for bringing them to a higher level of public visibility.

In another grant-related story, reporter Terri Somers of the San Diego Union-Tribune looked more closely at some of the recipients of CIRM grants, including those relatively new to the field. She described how their research is cutting across specialities with the hope of transforming the field.

One example is a $638,000 grant to UC San Diego professor Shu Chien, a medical doctor and pioneer in bioengineering. Somers wrote:"'His team will use a testing system he helped to develop so they can simultaneously look at thousands of proteins and their effects on different cells.

"'So instead of doing these tests one by one in a test tube, which could take years, we can do them all at once,' Chien said."

Salon.com Looks at Industry Opposition to SB771

The headline on Salon.com read: "Biomedical industry to California legislators: 'Don't you dare tell us what to do with your money!'"

Andrew Leonard, a California author and regular on Salon.com, continued:

"The horror! To CHI (California Healthcare Institute), SB 771 is unwarranted state intervention in their profit-making potential, an act of robbery that must be resisted with extreme prejudice."

Leonard referred to the excerpts of a CHI letter seen on the California Stem Cell Report in the "Biomedical Industry" item below.

He wrote:

"As a citizen of California who voted for the state's landmark stem cell initiative, and whose tax dollars will go toward paying off the bonds issued to pay for it, I fully support legislative efforts to ensure that some of the revenue generated by the commercialization of research paid for with my money return to the state....

"If the biomedical companies don't like it, they can just go find someone else's money to play with."

Leonard also said,

"Whatever happens, I look forward to following the twists and turns of California's ambitious attempt to bootstrap stem cell research via the reporting at the California Stem Cell Report blog. I have a particular weakness for blogs that obsessively cover every iota of news about a single, highly circumscribed topic -- they seem to regularly expose me to information that is not easily found elsewhere."

Baristas to Bioworld: More on WARF Ruling Impact

More coverage and commentary on the WARF patent ruling is filtering in today.

From Randall Osborne, west coast editor of Bioworld, comes this:

"'It's a big thing,' said Paul Lesko, patent attorney with SimmonsCooper in East Alton, Ill. 'Most times there will be at least an amendment, if the patent survives,' although the process could take years.

"'When it comes to a [final PTO action], I'd say a wholesale rejection is more common than anything else,' Lesko said, especially with patents that contain claims that are fewer in number, like WARF's.

From the Patent Baristas blog, Stephen Albainy-Jenei writes:

"I don’t think anyone should go out and throw a party just yet. The patent office grants over 90 percent of the requests for reexamination and many of those patents are issued with substantially the same claim(s) as before reexamination. WARF, a nonprofit group that acts as UW’s tech transfer office, will have a chance to prove the cells are novel. And, if the claims are ultimately rejected, it can still appeal or narrow the claims. This could take years to resolve."

Joff Wild, editor of Intellectual Asset Management magazine, says WARF is now on the "defensive" and adds:

"Although WARF changed its licensing policy earlier this year, 20 years worth of income from its stem cell portfolio still potentially represents a colossal amount of money."

California's Biomedical Industry Lays Out Opposition to SB771

The chief lobbying group for the California biomedical industry Tuesday detailed its strong opposition to legislation that seeks to guarantee that California reaps an economic and health-related return on its $3 billion stem cell research investment.

David Gollaher, president of the 250-member organization, said the bill, SB771, will "create significant disincentives for firms to commercialize inventions funded with CIRM money. And without company participation, basic stem cell science cannot be developed into treatments for patients."

CHI's opposition was laid out in a five-page letter to Sen. Sheila Kuehl, D-Santa Monica, co-author of the bill and chair of the Senate Health Committee. It was also sent to Senate Republican leader George Runner of Antelope Valley, co-author of the measure, and all Republican members of the California Senate.

CHI is also unhappy with CIRM's own provisions for sharing the wealth on any inventions that stem from CIRM-funded research.

CHI's letter said:

"Because commercialization is essential for the development and production of new medicines that can be used by Californians and others, CHI believes that the basic goal of intellectual property policies should be to minimize barriers to transfer technologies from basic research laboratories to the private sector for commercialization into products. Moreover, while we strongly support policies to improve patients’ access to advanced medicine, we maintain that IP policies and regulations are not the way to improve access and cost.

"Investment in biotechnology is inherently very risky. Any aspect of a technology transfer contract that increases risk, particularly by adding an element of uncertainty, makes it less attractive to potential partners and investors and thus reduces the prospects for successful commercial collaboration.

"We believe the intellectual property policies in your measure would reverse the improvements thoughtfully considered and accepted by the ICOC (CIRM's Oversight Committee) during several public meetings. SB 771 would impose more stringent revenue sharing and pricing and access provisions than those finally adopted by the ICOC.

"Additionally, we believe that codifying IP provisions in statute will deny the ICOC the flexibility it may need to amend its IP policies in the event they prove to be unworkable. As you know, the CIRM has just begun to issue research grants and it will likely be a number of years before any discoveries from this research moves to the commercialization stage. Thus, the ICOC may not know for some time if the IP policies it has adopted are effective and will need flexibility to change its IP policies if the situation warrants."

The letter concluded by saying that CHI questions

"...the appropriateness of commercial companies being forced to pay royalties, beyond what they negotiate with basic research institutions. If additional payments like this are required, along with the revenue sharing, pricing and access clauses mentioned above, they will only serve as an additional disincentive to commercial participation in CIRM-funded research."

The CIRM Oversight Committee is scheduled to discuss SB771 on April 10. Three members of that group are also directors of CHI. They are Ted Love, CEO of Nuvelo; Richard Murphy, head of the Salk Institute, and Philip Pizzo, dean of the Stanford School of Medicine.

The Senate Health Committee takes up the legislation on April 11. We have asked Kuehl's office if it would like to comment on the CHI letter.

Fresh Comments

John M. Simpson has posted a comment on the "secrecy" item from Monday. Lawrence Ebert has posted a comment on the "NY Times" item, also from Monday.

Ruling Endangers $3.2 Million WARF Cash Stream

One commentator said that the WARF patent ruling "marks a welcome turning point in the battle against the unnecessary and unproductive privatization of mankind's quest to understand the natural universe."

Another called it a "victory for the patent law freedom fighters."

But in the Wisconsin State Journal, reporter David Wahlberg, said it could cut off the spigot that has poured $3.2 million into the Wisconsin Alumni Research Foundation. He was the only reporter to identify the cash flow from the ESC patents.

It was all part of the news coverage today of ruling by the federal Patent Office concerning WARF's ESC patents. (For coverage of the issue on Monday see the earlier items below.)

Wahlberg quoted Dan Ravicher, executive director of the Public Patent Foundation, as saying,

"Although these patents aren't dead, they have been diagnosed with severe cancer."

Ravicher's group and the Foundation for Taxpayer and Consumers Rights were the two organizations that challenged the WARF patents, which remain in place pending an appeal by WARF.

Walhberg said,

"The patents have brought in at least $3.2 million to WARF and could net much more money before they expire in 2015. Companies wanting to study the cells must buy licenses costing $75,000 to $400,000, though since January, WARF waives the fees if the research is conducted at universities or by nonprofit groups."

Merrill Goozner, writing on the Huffington Post, called the patent ruling a "turning point." Goozner, who is with the Center for Science in the Public Interest, continued,

"Discovering human embryonic stem cells, which have been around since man first walked the earth, is more like Isaac Newton discovering gravity than the Wright Brothers building the first airplane.

"The Public Patent Foundation and the California Foundation for Taxpayer and Consumer Rights, which challenged the Thompson patents, have provided a valuable service for the entire science community. Unfortunately, the PTO ruling relied on the traditional tenets of patent law. The examiners, upon reexamination, claimed the patent was obvious based on previous papers that had appeared in the literature. Obviousness and previous publication are cause for rejecting a patent application.

"WARF's top officer immediately restaked their claim on those grounds.

Goozner continued:

"Basic science that may ultimately lead to useful products should be free and open to all who would build those useful products. Its inventors should not be allowed to become toll collectors on the road to innovation. Hopefully, the PTO decision yesterday is the first step on the road back to a reasonable standard for establishing where basic science ends and commercial invention begins."

Andrew Leonard, writing on Salon.com, declared that the "patent law freedom fighters" had won.

Terri Somers of the San Diego Union Tribune quoted Cathryn Campbell, an intellectual-property lawyer with Needle and Rosenberg, as saying it is significant that the patent office went beyond the cases cited by the challengers and found two more examples of prior science in the area.

Steve Johnson of the San Jose Mercury News touched on the impact on Geron, a California stem cell company that helped finance the research. Johnson wrote:

"If the patents are rejected permanently, Geron wouldn't have to pay license fees to use the technology, said David Greenwood, Geron's executive vice president and chief financial officer. And while Geron would lose its exclusive right to the technology, the company has other stem-cell licensing rights and patents that give it an edge on other stem-cell companies, Greenwood said."

Geron's stock dropped 3.64 percent on Tuesday, closing at $7.15 in above average volume. The stock has ranged from $5.66 to $10.00 over the last 12 months.

Missing from today's coverage was the Wall Street Journal, which only carried a blog item based on the New York Times story (see the item below from Monday on that.)

Here are links to other stories: Associated Press, Ipbiz blog, Los Angeles Times, Milwaukee Journal Sentinel, Sacramento Bee. The San Francisco Chronicle carried the AP story.

Geron Statement on WARF Patent Rulings

Here is the full text of Geron's statement on the ruling on the WARF ESC patents.

"Geron Corporation (Nasdaq: GERN) supports the position of the Wisconsin Alumni Research Foundation (WARF) that  U.S. patents  covering Dr. James Thomson’s pioneering work with human embryonic stem cells were properly granted. Thomson’s success in isolating human embryonic stem cells is recognized by the scientific community as a significant breakthrough, and the scope of the patents granted to WARF is commensurate with that achievement.  Three patents issued to WARF based on Dr. Thomson’s research are being reexamined by the U.S. Patent and Trademark Office (USPTO).

"It is routine for the USPTO to grant patent re-examination requests.  Furthermore, it is common for the USPTO to issue preliminary rulings that reject patent claims, only for the USPTO to terminate re-examinations and uphold patent claims in later stages of the review and appeals process.

"As the world leader in the development of human embryonic stem cell-based therapeutics, Geron holds a broad portfolio of intellectual property rights.  This portfolio includes the WARF patents in re-examination, additional WARF patents that are not subject to the re-examination proceedings and patents exclusively licensed from the University of California and the University of Oxford.  In addition, Geron’s portfolio includes patents and patent applications filed by Geron to cover technologies developed internally by Geron scientists for the production and differentiation of embryonic stem cells."

NY Times On WARF Patent Case

The New York Times has posted a piece by Andrew Pollack on the rulings in the WARF ESC patent case.

The story generally covers much of what you have read on the California Stem Cell Report, but also says:

"It is now much more likely, however, that the patents will be narrowed or revoked, and some scientists or companies might become more confident in undertaking research that would infringe the patents."

Pollack continues:

"Companies are charged $75,000 to $400,000, depending on their size and the terms of the license.

"The Geron Corporation, which financed some of Dr. Thomson’s research, has exclusive commercial rights to heart, nerve and pancreatic cells derived from the human embryonic stem cells. So if the patents remain in effect, any company wanting to market a treatment for heart attacks, Parkinson’s disease or diabetes using human embryonic stem cells would eventually have to come to terms with Geron. "

WARF's Gulbrandsen Holds Federal Patent Advisory Post

The managing director of WARF currently sits on an advisory committee to the federal Patent and Trademark Office, which will hear WARF's appeal of an unfavorable ruling on WARF ESC patent claims.

Carl Gulbrandsen was appointed to the Patent Public Advisory Committee by the secretary of commerce in February 2005.

John M. Simpson, stem cell project director for Foundation for Taxpayer and Consumers Rights, said that Gulbrandsen should resign from the advisory committee. Simpson's group challenged the patent claims.

We have queried WARF and the Patent Office for comment.

(Editor's note: One reader suggested the first sentence of this item is ambiguous. To be perfectly clear, the committee in question is an advisory body. The patent office is the agency directly involved in the patent dispute.)

Links to WARF ESC Patent Rulings

The Foundation for Taxpayer and Consumer Rights has posted the rulings of the Patent Office on the WARF ESC patents. Here are the links:

www.consumerwatchdog.org/resources/780rejected.pdf

www.consumerwatchdog.org/resources/806rejected.pdf

www.consumerwatchdog.org/resources/913rejected.pdf

WARF Staying the Course on ESC Patents

WARF said today that it is confident that its ESC patents will ultimately be upheld despite rejection of its claims Friday by the U.S. Patent Office.

The organization released the following press release:

"With regard to the preliminary denial of the existing claims, WARF Managing Director Carl E. Gulbrandsen issued the following statement:

"'WARF has absolute confidence in the appropriateness and legitimacy of these patents. It is inconceivable to us that Dr. Thomson’s discovery, which Science Magazine heralded as one of the greatest scientific discoveries in history, would be found to not be worthy of a patent. This discovery captured the imagination of people all over the globe from every discipline.'

Gulbrandsen pointed out that the former director of the National Institutes of Health predicted the discovery would change the face of medicine.

"'We are confident that, when all of the facts are known and the process runs its course, our patents wil be upheld,' he said.

"The PTO granted the reexamination request and issued a preliminary ruling rejecting the patent claims in question, which is not at all unusual, according to Gulbrandsen, who pointed out that the patent reexamination process provides for multiple layers of review. This first rejection, for example, gives WARF the opportunity to respond directly to the examiner, a response in which WARF will vigorously defend its patent claims. That response could persuade the examiner to sustain the patents and terminate the reexaminations. If the examiner maintains the rejection, WARF could, and most probably would, appeal the examiner’s decision to the PTO Board of Patent Appeals. And, if that body fails to sustain the patents, WARF can then appeal to the courts.

"This process can take many months, or even years. But while the review is underway, all of WARF’s patents remain in place and are legally viable."

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.