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Published online 17 September 2008 | Nature 455, 269 (2008) | doi:10.1038/455269b
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Japan fast-tracks stem-cell patent
Kyoto University secures first award for induced pluripotent cells.
Kyoto University in Japan has acquired the world's first patent for induced pluripotent stem (iPS) cells. The university paid registration fees for the patent (2008-131577), which is of only limited coverage and applies only in Japan, on 2 September, after it was approved by the Japanese patent office.
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A patent for an unproven "discovery"? ---Come on! Has Yamanaka answered the following questions that were posted earlier in the Nature News "Stem cells: a national project" (http://www.nature.com/news/2008/080116/full/451229a.html): WHICH OF THE FOLLOWING STATEMENTS IS TRUE?------------ 1. "Disclosed is a means for inducing the reprogramming of a differentiated cell without using any embryo or ES cell and establish an inducible pluripotent stem cell having similar pluripotency and growing ability to those of an ES cell in a simple manner and with good reproductivity." (Shinya Yamanaka, Patent application filed on December 6, 2006, WO 2007/069666 A1) ------ 2. "Takahashi and Yamanaka have successfully reprogrammed terminally differentiated cells to a pluripotent state." (Rodolfa and Eggan, Cell 126: 652, 2006) ------ 3. "We have never claimed that we generated iPS cells from terminally differentiated cells. We agree that the origin of iPS cells may be tissue stem or progenitor cells co-existing in fibroblast cultures." (Shinya Yamanaka, formal response on July 20, 2007 to my Communications Arising submitted to Nature which was eventually rejected by Nature after a lengthy peer review). ------ Could any iPS cell researcher and stem cell expert tell me NOW which of the above statements is true? Many Many Thanks! ----- Shi V. Liu (http://im1.biz; http://blog.sina.com.cn/im1) SVL@logibio.com
How could Japan's PTO ignore the challenges stated in comments under the Nature News "Japan ramps up patent effort to keep iPS lead" (http://www.nature.com/news/2008/080618/full/453962a.html)?----Shi V. Liu (http://im1.biz; http://blog.sina.com.cn/im1) SVL@logibio.com
Can anyone translate the abstract and claims of this fast-track Japanese patent (2008-131577) and post it here for the whole world to see? Based on the ambiguous statements in this news, I can guess that this patent, even if it withhold the challenge, will have very limited value because the iPS cells as made by integrating four oncogenic factors and thus are Incorrectly Programmed Stem (iPS) cells or, in other word, the man-made cancer stem cells. Thus, this method will have no future for generating therapeutically useful and clinically safe stem cells. Of course, people may say that the "evil" of iPS cells may be removed if these oncogenes and even that virus are not used. But any cells created by other means without involving these famous four factors should not be considered as iPS cells any more. We have seen report that "turn copper into gold" than using these four factors to "turn lead into gold". So depending on which "gold" you want, you may be free or restricted by this "incredible" patent. ---Shi V. Liu (http://im1.biz; http://blog.sina.com.cn/im1) SVL@logibio.com
Promoting a "freely" use of iPS cell technology by getting a patent on the method of creating iPS cells, how? If "it will be very hard to claim" novelty in using other "different combinations of genetic factors" to create iPS cells, then how this iPS patent promote research which is should be novel? The international patent on iPS cells will "cover iPS cells from all species". Great, how about directly reprogram a bacterium to make it an iPS cell that can "develop into almost any of body's cell types"? Do those iPS cell-creators and patent examiners on iPS cell really know what they were doing? If not, why not paying the much needed attention to many criticisms on iPS cells ?http://im1.biz/Cloning.htm??---Shi V. Liu (http://im1.biz; http://blog.sina.com.cn/im1) SVL@logibio.com
Opening the dialogs with Nature correspondent.///The following dialogs are based on true events. I know this is not a right place for tell the full story so I will keep it as short as possible./// 1. Cyranoski sent me an email on July 18th, 2008 after seeing my review on iPS cells published in Stem Cells and Developments (17: 391-397, 2008). He stated: "Thank you for your active support of the Nature website and your many thoughtful on-line comments on my articles. Congratulations on the publication in Stem Cells and Development. I was hoping to ask a few questions about it. (1) Is the following accurate: The main thrust of your article is a refutation of the evidence that iPS cells have been reprogrammed through induction. (2) Do you believe that reprogramming does not occur? (Or just that the evidence does not support that conclusion?) (3) In April, Dr. Jaenisch's group published an article in Cell (Cell, Vol 133, 250-264, 18 April 2008; "Direct Reprogramming of Terminally Differentiated Mature B Lymphocytes to Pluripotency") that seems to give solid evidence that the cells are in fact reprogrammed. How does that study affect your main conclusions about reprogramming?"/// 2. I replied him the next day (also CCed Nature's editor-in-chief Campbell and other editors) as: Thank you for the congratulations on my publication in SCD. As to your specific questions here are my straight forward answers:(1) My SCD article IS a more polite way to convey my strong SUSPICION on the major claim made in the iPS research - iPS cells are DIRECTLY reprogrammed from (terminally) differentiated (adult) cells into pluripotent (embryonic or embryonic-like) stem cells by a so-called "induction". My more direct and sharp criticisms can be found in many other publications collected at http://im1.biz/Cloning.htm. (2) I believe that reprogramming can happen BUT that belief is case-specific and should be evidence-based. So far I have not seen any convincing evidence that adding just four or more oncogenic transcription factors can cause a cell type conversion from a differentiated cell to undifferentiated cell and cell age reversal from adult to embryonic. All the evidence presented so far can be best explained as a selection and expansion of pre-existing stem cells or other cells identified as stem cells. However, such a success of easily generating iPS cells is due to the fact that normal stem cells or progenitor cells are transformed into cancer cells. These man-made cancer stem cells have risks for any regenerative medicine and have limited value for understanding the normal therapeutic cloning.(3) Dr. Jaenisch's new publication in Cell (133:250-264, 2008) actually presented more evidence that iPS cells are selected and transformed pre-existing stem cells or cells identified as stem cells. As a matter of fact, I have already published a critical comment on this Cell paper (see HTM at http://im1.biz/albums/userpics/10001/LB2008V8N2A3_NewProof4iPS.htm and PDF at http://im1.biz/albums/userpics/10001/LB2008V8N2A3_NewProof4iPS.pdf ). Since iPS research has become a national project in Japan Yamanaka's research group has not yet published any new study on iPS cells. Why? Yamanaka was challenged by me to do some critical experiments but so far he has not published any results on those required experiments to prove his induction claim of direct reprogramming. On the other hand, the failed attempt as revealed in the above Cell paper by Jaenisch's group in experiments similar to what I have proposed to Yamanaka and later released to public (in various ways) just confirmed my suspicion on the induction claim. Compared with the very fast pace of publishing iPS research before my criticisms became noticeable the slow down of iPS publication may indicate a frustration experienced by the iPS researchers to live up to the scientific rigor as I demanded for prove their much hyped claims or the increased concerns with irresponsible publishing of unconvincing iPS researches. However, I noticed that Nature and some other journals recently still published a few new reports on iPS cells. But from what I read on these new "evidence" for the "induction" claim of iPS cells I can safely say that those iPS researchers are simply treating negative findings as positive support. So stay tuned for more critical reviews on these new iPS publications in my future papers to be published by Logical Biology (http://im1.biz). If you have more questions I would be more than happy to answer./// 3. After my reply, I did not receive a response from Cyranoski for quite a while. After my repeated inquiries he replied me on July 28, 2008 as: "Yes I have received your correspondence. I have been on the road so I have not had much time to look into that matter. I hope to find some time soon."/// 4. After leaving him plenty time to get off the "road" and come to the "home" of this matter, I sent him two more prompts on August 4th (also CCed Campbell) and 19th. My August 4th email contains the following statement: ?As to the most recent two Nature publications providing "evidence" for the induction of iPS cells, my careful evaluations showed me that they provided just more evidences for iPS cells as the transformed stem cells. My evaluations may be submitted to Nature as Communications Arising but, based on the history of Nature in rejecting my such Communications (on iPS cells) and other Communications (on other important discoveries), I may change my mind and to publish them directly in a truly top journal." My August 19th email simply urged him to "follow up a high ethical standard required for a truly scientific journal and dig out the real truth on the iPS cells"./// 5. I received no response form Cyranoski at all. Then I saw this news he wrote on the Japanese patent for iPS cells. So he has come back "home" on this matter but just closed all (nature's) windows to block the public view of my views on this important matter including my opinions on the patentability of this so-called "great discovery"?/// Now my question to all people around the world is: can science really progress in this way of promoting one idea while suppressing many other ideas? ---Shi V. Liu (SVL@logibio.com; http://im1.biz; http://blog.sina.com.cn/im1)