Phantom of the Stem Cell Opera: BioGatekeeper


A mysterious organization called BioGatekeeper, Inc. has filed a legal challenge to the Yamanaka Patent seeking to cancel it (for more on this see here and here).

The technology to change just about any human cell into a super powerful kind of stem cell called induced pluripotent stem cells (iPS cells or iPSC) has great potential not only to help millions of patients, but also to make companies millions or even billions of dollars.

Many scientists have been on the trail of cellular reprogramming, as this process of making powerful stem cells is called, but it was Dr. Shinya Yamanaka who finally got it to work first and the predominant intellectual property in this area so far has been the so-called “Yamanaka Patent”.

Who is BioGatekeeper?

So far the stem cell field does not know, but I’m convinced the truth will come out.

Another question is why BioGatekeeper would want to hide. The seemingly obvious answer is they want to avoid potential negative PR. However, another perhaps complimentary notion is that BioGatekeeper wants to avoid being identified because it is really a team effort, there are several parties behind it, and frankly some of this group do not want to publicly be associated with the others.

One of the most fascinating things for me as I’ve been following this story is the large number of different possible people and companies that have been suggested to me by people in the know as being behind BioGatekeeper.

Even if none of these are behind BioGatekeeper (whether alone or collectively) it is intriguing that there are so many companies who might want a slice of the iPS cell pie and so might be very happy to see the Yamanaka Patent nullified.

I suppose it is also possible that BioGatekeeper chose that name not only to put on the appearance of a do-gooder, but also using some kind of reverse psychology they wanted to attract attention and get publicity via this mystery. If the latter is the case, then I guess I’ve fallen for their trick.

Whatever their motivations, it’s also interesting how quite a few of these potential BioGatekeepers can one way or another be linked to the same law firm(s) that seem to be involved.

The cell reprogramming intellectual property arena has many players, is interconnected, and brings into play some of the say attorneys over and over.

The best current prediction is that behind the mask of BioGatekeeper, behind that temporary curtain of anonymity, are several different parties who each have a financial interest in nullifying the Yamanaka Patent. As the clues continue to pour in, the stem cell field will determine who they are and what they are up to soon enough.

7 thoughts on “Phantom of the Stem Cell Opera: BioGatekeeper”

  1. I am not interested in who is behind the BioGatekeeper because it is irrelevant to the determination on whether or not Yamanaka’s patent is valid. I am more interested in whether or not Yamanaka’s invention can indeed reprogram ANY (terminally differentiated non-stem adult) cells into (embryonic stem cell-like) pluripotent stem cells. If his invention cannot do that (with reasonable efficiency to rule out other explanations) then his invention should not be given a patent.

    1. Agree with you that the identity of BioGatekeeper is irrelevant to determining whether the patent is valid- it is just entertaining to speculate. However, patentability does not depend on “whether or not Yamanaka’s invention can indeed reprogram ANY (terminally differentiated non-stem adult) cells into (embryonic stem cell-like) pluripotent stem cells.” Indeed, this is just as irrelevant to the outcome of current petition as the identity of BioGatekeeper. The issue introduced by the petition is whether or not it would have been obvious to make iPS cells, not whether or not iPS cells exist. If you want to redirect the discussion to addressing whether or not the patent is valid, it may be useful to focus on the aspect actually petitioned for review of patentability.

  2. Well certainly the choice of firm strongly suggests that BioGatekeeper is at least partly locally based. Obviously they couldn’t retain Knobbe (Yamanaka did), but there are plenty of other bigger players in OC…so perhaps familiarity and / or cost savings come into play.

    The timing definitely lends credence to the MEBO / Xu angle.

    That said, someone else mentioned Primegen and that really wouldn’t be a complete shock all things considered.

    I can also think of a very new, very local, entity that’s trying to raise money without necessarily having…any unique research of their own, so that’d my long shot I suppose.

    Interested in hearing evidence that might point towards a joint venture, though.

  3. Based on their choice of attorney and the contents of the petition, I am still predicting that BioGatekeeper is not a player in the field or someone with a significant financial interest. I still expect that this will turn out to be a case of hurt feelings and delusions of grandeur more than anything else. It will be interesting to see what happens, at the very least for the entertainment value. As for the secrecy, I agree with the idea of preventing bad publicity, but the flip side of that is that by being essentially anonymous, whoever is responsible would seem to lose the ability to appeal the decision of the PTAB to a higher court should the PTAB affirm the patent (correct me if I’m wrong). That would seem like unnecessarily shooting yourself in the foot in a major way if you have a real financial interest. On the other hand, someone without a real financial interest wouldn’t have the right to appeal anyway, and the anonymity may give credibility to someone who people would not take seriously otherwise. Beyond that, an individual can only challenge a patent once in inter partes review. Maybe they think that by using a shell corporation, they could try to challenge the patent again if this petition fails by simply shutting down the company and forming another one (BioKeymaster? Sorry, Ghostbusters joke). As an unrelated comment, it is also interesting that the challenge to the Jaenisch/Whitehead patent seems to have mostly flown under the radar.

    1. Thanks as always, Shinsakan, for your valuable perspective. Your knowledge and logic are very strong. I would only add that perhaps one other thing to consider is that the parties involved in this case and their choices may not be so logical or rational (they may not make sense to you or me) and so they could still be someone with in the field with a financial interest. In other words don’t discount the possibility that the parties behind BioGatekeeper might make what you view as puzzling or illogical decisions that do not necessarily fit with how you think certain entities would proceed if they were the ones behind BioGatekeeper. We have seen numerous examples of apparently irrational decision making by some in the stem cell field that leave everyone scratching their heads.

      1. Dr. Knoepfler, I totally agree with you- once irrationality enters the equation, predictability goes out the window. I was just thinking that someone with a real financial stake or some “skin the game” would invest more in making sure that the patent gets invalidated. Regardless, it will be interesting to see what happens. The next step will be to see whether or not Kyoto University files a response to get the petition thrown out and then whether the PTAB decides to actually hear the case. As for the identity of BioGatekeeper, I think we have probably uncovered all of the publicly available information; I think that the true identity of BioGatekeeper may remain hidden unless some kind of inside information comes out. What do you think?

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