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Retraction Watch

Tracking retractions as a window into the scientific process

Fraud, retractions no barrier to US cloning patent for Woo-Suk Hwang

with 17 comments

science 2005Woo-Suk Hwang is having quite a comeback.

The cloning researcher’s fall from grace in 2005 and 2006 was covered worldwide, featuring two high-profile retractions from Science and convictions (now under appeal) on charges he embezzled government funds and broke South Korea’s bioethics law. But as Nature reported last month in a profile focusing on Hwang’s Biotech Research Foundation:

Despite his legal troubles — and the widespread belief that his career was over — Hwang continued to work, thanks to the supporters who amassed US$3.5 million to launch Sooam. About 15 scientists followed Hwang from SNU, and around half of those remain today among Sooam’s 45 staff. His team now creates some 300 cow and pig embryos per day, and delivers about 15 cloned puppies per month.

And now, the U.S. Patent and Trademark Office has awarded Hwang a patent based on a cell line described in his retracted Science papers, as the Korea Times reports. The New York Times picked up the story Friday:

Despite all that, Dr. Hwang has just been awarded an American patent covering the disputed work, leaving some scientists dumbfounded and providing fodder to critics who say the Patent Office is too lax.

“Shocked, that’s all I can say,” said Shoukhrat Mitalipov, a professor at Oregon Health and Science University who appears to have actually accomplished what Dr. Hwang claims to have done. “I thought somebody was kidding, but I guess they were not.”

(An aside: Mitalipov’s work, published last year in Cell, was subjected to extensive corrections.)

The patent cites both of Hwang’s retracted Science papers, without noting they’re retracted. Apparently that wasn’t a problem, notes the Times:

But a spokesman for the United States Patent and Trademark Office, and some outside patent lawyers, said the system operates on an honor code and that patent examiners cannot independently verify claims.

The patent is “definitely not an assertion by the U.S. government that everything he is claiming is accurate,” the U.S.P.T.O. spokesman, Patrick Ross, said of Dr. Hwang. He said the agency was aware of Dr. Hwang’s history and took steps to make sure the claimed invention complied with patent statutes.

One of those citations has what we might consider a Freudian slip: Instead of “Patient-Specific Embryonic Stem Cells Derived from Human SCNT Blastocysts,” the reference reads “Patent-Specific Embryonic Stem Cells Derived from Human SCNT Blastocysts” (emphasis ours).

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Written by Ivan Oransky

February 16, 2014 at 4:30 pm

17 Responses

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  1. I wonder whether patents are ever retracted?

    Miguel Roig

    February 16, 2014 at 4:49 pm

  2. Jeanne Loring

    February 16, 2014 at 5:05 pm

  3. I’ve been to Hwang’s lab in Korea. He’s a high strung and commanding, but totally serious about the product.

    Zachary David

    February 16, 2014 at 5:51 pm

    • Nobody question that, just that he falsified and fabricated results. He ashamed a whole country…!
      He might be serious about the product, but trustworthy?…nope

      jjpaff

      February 17, 2014 at 9:29 am

      • haha he’s well known as a great cloner. His lab even got the contract for the wooly mammoth.

        When they were pitching their facility to us we sat through a lovely propaganda lunch that included some slides on the overreaction Hwang received compared to similar instances.

        I got to see him insert embryos into a surrogate and even play with some cloned puppies. I have a bunch of pictures from the lab.

        Zachary David

        February 17, 2014 at 3:41 pm

  4. “critics who say the Patent Office is too lax”

    This is a common complain, but is completely wrongheaded. The Patent Office is not in the business of determining the functional utility of applications. Instead the key issue is novelty. In other words, the invention need not work, it must only be different.

    It’s complicated because ‘nonoperability’ is a reason to invalidate a patent. But at the examination of your patent, the examiner will have no means to tell whether what you claim is functional, practical, or useful. They are principally interested in whether it is sufficiently different from ‘prior art’ to make you invention ‘non-obvious’.

    What I mean to say is it is not use to ‘blame’ the USPTO for allowing patents of bogus technology because that isn’t in their remit.

    Dan Zabetakis

    February 16, 2014 at 7:46 pm

    • Dan, if I understand your logic correctly, would that be like analogously saying just because a journal or a book holds articles or chapters with fraudulent data, plagiarism, duplication or other academic misconduct, that we should not hold the ISSN and the ISBN partially accountable simply because misconduct is not part of their “remit”? I am of the opinion that journals and books use the ISSN and the ISBN, respectively to give one measure of academic validity to their products. When scientists see these numbers, they feel “safe” that there is some measure of quality, even if these numbers have absolutely nothing to do with quality, and are only a “filing” system. But since academic validity is intractably related to quality, as is academic integrity, when academic misconduct is allowed to remain in the literature to which an ISSN and/or an ISBN is assigned, then surely we should hold the ISSN and the ISBN international centers accountable for not removing the ISSN or ISBN when academic misconduct is not resolved or improved? For example, imagine we find several papers in a journal published by one of Jeffrey Beall’s so-called “predatory” OA publishers that carry plagiarism or data or figure duplication. Or maybe even in a famous journal that carries an impact factor. And let’s imagine that that journal carries an ISSN. And, let’s further imagine that complaints to the journal about such cases of academic misconduct (and/or flawed science) and calls for retraction to correct the literature go by unheeded by the editor board and/or publisher. Then surely, one “corrective measure” (euphemism for punishment) would be by the ISSN or ISBN center to “retract” the ISSN or ISBN until such time the academic errors are corrected, provided that the claims are valid, and validated. In other words, the ISSN and ISBN derive fame from their numbers being associated with a famous book or publisher. So, too, should they also be held partially accountable for the quality, scientific and academic, of the content within those journals and books.

      The same parallel could be made about the impact factor and Thomson Reuters. If a journal carries an impact factor, and if problems with the scientific content and/or misconduct are ignored, or remain uncorrected, simply because the editors and/or publisher fail to or refuse to correct the literature appropriately, then surely Thomson Reuters has the moral and ethical obligation of retracting the impact factor from that journal until a satisfactory resolution to correcting the literature is found?

      And, by extension, should the voice of a scientists who is not a paying member of COPE, but who takes a valid and substantiated claim of abuse, misconduct or ethical violations to COPE, not be heard? Should COPE, if formally informed of a case of lack of ethics within a journal or book of one of its members, not take ethical and moral action, even against one of its members, if such a member was shown to not be correcting the literature? Would it not be reasonable to say that a scientist has the right to hold COPE accountable for COPE members that may be showing bias, foul play, lack of ethics, failure to correct the literature, failure to remove duplicated data, text, tables or figures (i.e., to eliminate unethical cases of misconduct)? Should COPE not be held partially responsible for the lack of accountability when there is sufficient proof to show that a COPE member is not correcting the literature? After all, COPE members pay well for “services” rendered, so COPE should be held partially accountable for the publishing and ethical stature of its members, should it not?

      Similarly, to claim that the Patent Office is not partially responsible for overlooking ethical issues that are related to patent applications is to claim that a patent is free of ethical issues, which it is logically not. If a patent is derived from misconduct, based on fraud, or is processed based on manipulated data or unethical principles at the research or publishing stages, I am of the opinion that the Patent Office has the MORAL obligation of turning such an application down. I believe that we cannot say that originality holds a superior higher ground to ethics, or that it is disjointed from it. I have not seen the patent in question by WS Hwang, but if indeed the patent was filed, and given, based on a retracted paper, on fraudulent data, or on any other data or publication that was previously deemed to be unethical, then yes, we should also hold the Patent Office accountable for setting “originality”, even if flawed or manipulated, above ethics. If the allegations are true, would this not be a classical case of crony capitalism? After all, it does cost money to file for and obtain a patent, doesn’t it?

      So, whether we are talking about the ISSN, the ISBN, Thomson Reuter’s impact factor, COPE or a COPE member, or the Patent Office, surely they all have a part to play in the ethical nature of a publication or a product such as a patent that bases itself on the academic integrity of scientific information? That implies that even if their official “remit” does not consider such issues, or does not officially cover such aspects, they are integrally interrelated with the ethics of the issue. Thus, they should use their “limited power” to reinforce an ethical position rather than sit in a corner and ignore the plea by the scientific community.

      Thus, the International ISSN Center should retract an ISSN of a journal that fails to or refuses to correct scientific errors, that fails to retract papers that carry clear cases of duplication or serious plagiarism.
      Thus, the International ISBN Center should retract an ISBN of a book that fails to or refuses to correct scientific errors, that fails to retract papers that carry clear cases of duplication or serious plagiarism.
      Thus, Thomson Reuters should retract the impact factor of a journal that fails to or refuses to correct scientific errors, that fails to retract papers that carry clear cases of duplication or serious plagiarism.
      Thus, COPE should retract the membership of a paying member that fails to or refuses to correct scientific errors or that fails to retract papers that carry clear cases of duplication or serious plagiarism in its books or journals.
      And finally, the Patent Office, US, or other, should not grant a patent if there is clear evidence of foul play, academic misconduct (in the research or publishing phases) or fraud (in all cases provided that evidence and facts can be provided to show such misconduct).

      The bottom line is: these bodies must be held partially accountable for the services and products they provide and for the “clients” they protect and serve. We, the scientific community, MUST hold them more accountable, and demand more transparency.

      Jaime A. Teixeira da Silva

      February 17, 2014 at 12:50 am

      • What does COPE have to do with this?

        nskeptic

        February 17, 2014 at 7:17 am

  5. Interesting how the world works. Following Dan’s comment, and copying from the USPTO website:

    “A rejection on the ground of lack of utility is appropriate when (1) it is not apparent why the invention is “useful” because applicant has failed to identify any specific and substantial utility and there is no well established utility, or (2) an assertion of specific and substantial utility for the invention is not credible. Such a rejection can include the more specific grounds of inoperativeness, such as inventions involving perpetual motion. A rejection under 35 U.S.C. 101 for lack of utility should not be based on grounds that the invention is frivolous, fraudulent or against public policy.” (http://www.uspto.gov/web/offices/pac/mpep/s706.html)

    So a patent application based on a fraudulent description of a potentially useful invention will not be rejected; the natural consequence of this is that there must be very many successful patent applications based on fraudulent work.

    Presumably the office introduced the specific clause about the perpetual motion machines because our current understanding of the laws of physics indicates they are impossible and hence the whole idea is useless – the fact that all the claims to have produced perpetual motion energy were bogus is not actually the specific problem.

    The practical downside to this is of course when the patent inhibits work that genuinely achieves what Hwang claims to have done. It’s not my field – others might be able to comment on how likely this is, and what negative effect it might have on development of medical treatment for certain conditions.

    amw

    February 16, 2014 at 9:28 pm

    • Note Jeanne Loring’s blog (link provided above) indeed addresses these issues in considerable detail.

      amw

      February 16, 2014 at 9:34 pm

    • There’s a difference between the patent office accepting an application and that patent standing in court. While I assume that the patent office doesn’t reject for fraud… I bet that submitting a fraudulent patent application is probably a crime? And even if it’s not, I have to imagine that it would be nearly impossible to defend a fraudulent patent via a civil suit without perjuring yourself.

      QAQ

      February 17, 2014 at 11:03 pm

  6. I guess that, at the end, those affected by the patent (like another applicants) would have to sue the holder of the patent on the basis of fraud. I wonder if the Korean University that fired Woo-Suk Hwang is a partner in the patent…I guess not. If so, I wonder if the Korean Institution would have anything to say about this patent, event challenging it in court.

    jjpaff

    February 17, 2014 at 9:19 am

  7. First. It should be noted that the claims on the final issued patent are very narrow- they only cover a single oocyte line KCLRF-BP-00092.

    Second, the patent office does reject for fraud; an application based on fraudulent data should not meet the enablement requirement. In this case, the fact that a report of the falsified data was cited by the examiner on the published patent indeed means that the falsified data came up as an issue during prosecution. However, Dr. Hwang may have submitted a declaration with additional, new data during prosecution. When an applicant does that, the applicant is typically given the benefit of the doubt for the new data. Regarding how this may affect someone else who comes up with a system that actually works in the future, a scenario in which someone discloses a detailed method in which they had to include falsified data because the method was flawed and didn’t work otherwise, and where someone else then comes along and makes the same flawed method work without including a further innovative component, seems unlikely.

    Shinsakan

    February 18, 2014 at 2:47 am

    • Also, the first page of the patent shows that the examiner cited a document called “Disgraced Cloning Pioneer Could Keep His Patents;” therefore, the fraud likely came up and was considered during prosecution.

      Shinsakan

      February 18, 2014 at 3:57 am

  8. There seems to be a fair amount of hysteria regarding this patent based on media accounts without an analysis of the patent itself or the prosecution history- this is akin to discussing a secondary citation rather than the original study with the actual findings (or to discussing media reports of a paper rather than the paper itself) and thus seems to be less than productive.

    The patent and its prosecution history can be found at

    http://portal.uspto.gov/pair/PublicPair

    Shinsakan

    February 18, 2014 at 11:51 am


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