Jeanne Loring’s take on Hwang’s Approved US Patent of SCNT embryonic stem cells

By Jeanne Loring

If you’ve been paying attention to the stem cell world, you’ll remember Woo Suk Hwang, who nearly derailed the future of stem cell research by very publically proclaiming that he had made human embryonic stem cells by somatic cell nuclear transfer (SCNT).

No, this has nothing to do with Shoukhrat Mitalipov’s report of successful generation of SCNT hESCs last year (reported by Paul at http://www.ipscell.com/tag/shoukhrat-mitalipov/). The difference is that Shoukhrat really did make human SCNT ESCs.

Hwang did not.  He claimed that he had made SCNT hESCs in two high profile papers in Science in 2004 and 2005  (W. S. Hwang et al. Science 303, 1669–1674; 2004 and W. S. Hwang et al. Science 308, 1777–1783; 2005). Both have turned out to be complete and deliberate fakes.  The discovery that the results were fraudulent were devastating to the stem cell scientific community; we’ve never quite gotten rid of the tarnish that rubbed off on us all and has made the public suspicious of stem cell research ever since.  Nature did a very nice post-mortem on the events, which can be found at http://www.nature.com/news/specials/hwang/index.html.

Now, Hwang is back.  He confessed to making up the results, but he didn’t withdraw the patents he’d filed on this falsified work.  Yesterday, his patent (see actual USPTO patent file here) on the fake work, was issued by the U.S. Patent Office. Below is the front page of the patent.

Hwang SCNT patent

You might ask, how can someone get a patent on something that doesn’t exist?

There was an article written on this question in 2006 in the New Scientist http://www.newscientist.com/article/dn8601-disgraced-cloning-pioneer-could-keep-his-patents.html – .Uvqi8v1BCAc.  I didn’t have to search hard to find this article- it’s referenced, right on the front page of the patent (see the list on the right side)!

This is one of those things that scientists can’t get their arms around.  I have patents, but they are all on real things, so they make sense.  But it turns out that you don’t have to create something real to get a patent.  Hwang’s patent claims are broad, claiming “an embryonic stem cell (ESC) line derived from a nucleus-transferred oocyte prepared by transferring a nucleus of a human somatic cell into an enucleated human oocyte”.

So is this just so much silliness, like the patent issued on a flying saucer by the British Railways Board in 1973?

Unfortunately not, as the New Scientist article points out: “The Hwang (patent) could block subsequent patents on work that constitutes an obvious extension of what Hwang described, even if the Hwang work proves unworkable itself.”  This means that Hwang’s patent will be considered to be “prior art” for any other patent application on SCNT hESCs, and may make it difficult to patent real SCNT hESCs.

My take on this?  My challenge of the WARF patents made me learn a great deal about patents and patent law, and trust me, the principles you cherish as scientists simply don’t apply for patents. The fact is that Hwang’s patent could impede further work on SCNT hESCs.  The patent owners may demand a licensing fee for use of any SCNT hESCs and collect royalties on any commercial application of SCNT hESCs.  This is not out of the realm of possibility: those are the terms that WARF imposed on blastocyst-derived hESCs, but at least those were real. 

10 thoughts on “Jeanne Loring’s take on Hwang’s Approved US Patent of SCNT embryonic stem cells


  1. Jeanne is right and we should attack on the ignorance of Australia’s IP authority, but this one is a little bit different.

    If u look closely the claim section, the window for their claim is so narrowed down, it won’t affect us at all unless we use KCLRF-BP-00092.

    Seriously, would you? haha

    Unfortunately, we can’t do anything about Australia’s bs, but who cares about Australia?

    James Lee


  2. I still don’t understand the legitimacy of Hwang’s patent of something he has not done. Does this mean that Mitalipov is not going to be able to get a patent for his real work on SCNT-hESCs?


    • I don’t know. The patent office works in mysterious ways. In response to my question, which is much like yours, a patent expert I know said: “the PTO doesn’t have the time or money to do experiments, and doesn’t have the skill to read newspapers”.
      Shoukhrat has a patent on primate (monkey) SCNT that was filed in 2007 and issued in 2011. Hwang’s patent on human SCNT was first filed in 2003 and issued in 2014. As far as the patent office is concerned, both patents are valid, but Hwang’s has an earlier “priority date”, which essentially says that it was invented first. If either one of the groups tries to get money from their patent I can predict one thing with certainty: the lawyers will win.


  3. A couple of things to remember here- First, the prior art issue does not depend on whether or not the patent is granted because all patent applications are published within 18 months after filing and become prior art (regardless of whether or not they are granted). Second, although inoperable prior art can still be used in a rejection, if the prior art is not enabling, i.e., if it does not give enough information to practice the invention without undue experimentation, it is not supposed to be usable as prior art. Third, a quick look at the claims reveals that they are very narrow- they only cover a single oocyte line KCLRF-BP-00092.


    • Shinsakan: What really bothers me is that the PTO issued the patent- I can say: “oh well, the PTO doesn’t think, etc”.- but the fact is that they DID issue the patent, and patents have the force of law.
      Just FYI, in response to our challenge of the WARF patents, they narrowed their claims to include only preimplantation embryo-derived cells (which should cover the SCNT cells as well…). The original claims were so broad that they would have covered iPSCs as well as hESCs. The point is that if patent holders get greedy, their patents can be challenged, and sometimes that changes everything.


      • Dr. Loring,

        Thank you for your response! I believe that the USPTO actually carefully considered the allowance; the fact that a report of the falsified data was cited by the examiner on the published patent (as you have pointed out above) 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 and it is very difficult to question the veracity of the data, as the USPTO does not have the time or facilities to actually try to replicate the findings. Thus, the final allowance may have actually been based on data other than those published in the retracted papers. I guess I am just trying to say that the allowance may not be as crazy as it looks on the surface, depending on what actually happened during the course of prosecution. I totally agree with you that the ability to challenge patents is a great advantage of the system; it is necessary to have proper checks and balances to make sure that society and the inventor are simultaneously protected.


  4. So this information appears to me to say that a perceptive theorist who can write technical patents could lock down the progression of science in a specific field. Just because this was narrowed down to KCLRF-BP-00092 people learn from their mistakes and broaden the base for the next round.

    As Shinsaken says “the USPTO does not have the time or facilities to actually try to replicate the findings”. Also the definition of prior aer not linked to a working product is troubling too.

    I agree with Jeanne. I think we can find similarities in the smartphone world and this monopoly does indeed narrow the prospects for future innovation and increase resource costs. An active Think Tank is needed to keep scientific insight viable.


    • Dr. Price,

      It seems unlikely that a theorist would be able to lock down research in a given field (at least in biotech/chemistry) in the USA by filing purely conceptual patents. A purely theoretical application that does not present data, especially for a technique in an unpredictable art or a radically new technique that is not at all known in the art, will probably not meet the enablement requirement. In the unlikely case that such a patent were issued, it would likely be subject to invalidation- similar to what happened with the invalidation of US6048850 (for COX-2 inhibitors). In the case of the Hwang patent, it is quite possible that the scope of the claims had to be narrowed to KCLRF-BP-00092 not because of a mistake by the applicant but rather because that’s all that the presented data would enable (one oocyte line). There is little reason to believe that someone in the future would be able to utilize some kind of tactic or strategy to patent non-enabled material. Of course, the underlying assumption is that the data presented by patent applicants are valid. However, 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. For the prior art aspect, if it is inoperable and insufficient information is provided to make it operable without undue experimentation, it is typically not supposed to be used as prior art in an anticipation rejection. For obviousness rejections, in contrast to anticipation, the point is not whether the invention has actually been made/done before; it’s about whether enough information existed at the time of invention for it to have been obvious for one working in the field to make it/do it. That is why the reference in an obviousness rejection can be inoperable; regardless of operability, it still provides teachings. However, it is still possible for the applicant to use the inoperability of the prior art as a secondary consideration to overcome the obviousness rejection and support patentability. I agree with you that independent and active think tanks can help to protect innovation.


  5. What’s cell line KCLRF-BP-00092? That’s what the patent claimed. Is that a fake cell line too? If so, the patent’s effect is zero, as it covers a non-existent cell line. One the other hand, if KCLRF-BP-00092 exists, then how can we say that he didn’t make it?

    As far as prior art is concerned, any publication can be prior art, whether it is a granted patent or not. So, for prior art purpose, the patent should just be considered a publication.


  6. Dr. Hwang’s patent

    http://www.google.com/patents/US8647872

    Human embryonic stem cell line prepared by nuclear transfer of a human somatic cell into an enucleated human oocyte

    US 8647872 B2

    “As shown in FIGS. 6A to 6D, it was observed that the karyotype of the ntES cells derived from the nucleus-transferred oocyte prepared in accordance with Examples 1 to 5 above was identical to that of the nuclear donor cell. This result demonstrates that the ntES cells of the present invention have been indeed derived from the nucleus-transferred oocyte prepared by transferring a nucleus of a female somatic cell into an enucleated human oocyte, not from a parthenogenetically activated oocyte.”

    It’s incorrect (XXXX note edit here).

    DNA fingerprinting DATA of doner cell(Fig. 6A) is deifferent from DATA of NT-1(Fig. 6B and Fig. 6C).

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