Challenge of Yamanaka Patent by BioGatekeeper Fails

The still mysterious BioGatekeeper had challenged Yamanaka’s IPS cell patent claiming that it was obvious. The potential implications were huge given the commercial interest in translating IPS cell technology. For background see here, here, and here. There’s pretty much zero information on BioGatekeeper otherwise.

Despite the potential seriousness of this patent challenge, just a few days ago the Patent Trial and Appeal Board (PTAB) denied the challenge so for all intents and purposes BioGatekeeper’s effort is dead. A big hat tip to reader Shinsakan.

BioGatekeeper

You can read the decision here. More information is available here (input case # IPR2014-01286 to get the search results).

Notably coverage of BioGatekeeper on this blog was cited by Kyoto University attorneys: go to page 2 of search records when you get your results from the search above and you can see the blog cited 3 times by Kyoto University.

Overall, this new material is also notable as it suggests that Kyoto believed that Rongxiang Xu (and MEBO International) was involved in BioGatekeeper as previously rumored, but the answers given by the BioGatekeeper legal team (see document here) don’t seem to support that notion. Still, the identity of BioGatekeeper as well as the person Jonathan Zhu, named as its owner, remain nebulous.

Regardless of who BioGatekeeper might be, at this point it would seem their effort to challenge Yamanaka’s patent is at an end barring some unexpected turn of events. This more concretely solidifies the strength of the Yamanaka patent.

Slowly Removing the Mask of the Phantom of the Stem Cell Opera: BioGatekeeper

BioGatekeeperThe 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”.

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).

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.

Top 10 questions for stem cell field bouncing around on a Friday morning

top ten listWhat are the most interesting questions for the stem cell field in 2014 right now?

What’s on your mind?

I’m not going to give this deep thought, but rather just list those questions bouncing around at the moment in no particular order. You can see a lot of translational/clinical things are on my mind. I’ve put possible answers, but these are highly speculative and/or based on hope in some cases.

  • What’s next for ACT’s hESC-based clinical trials and Takahashi’s iPS cell-based clinical study for macular degeneration? I’m optimistic on safety for ACT and hopeful on efficacy, while it’s harder to predict for the iPS cell study.
  • How will ViaCyte’s new early hESC-based trial for Diabetes go? I’m cautiously optimistic.
  • In a year, where will the iPS cell IP/patent arena stand and who is BioGatekeeper? I expect no more clarity in a year overall, but BioGatekeeper will be outed by then or much sooner.
  • Will the trend of for-profit networks of stem cell clinics exploding across America continue? Unfortunately, yes.
  • Is the FDA planning to get back into the ballgame of regulating such stem cell clinics or has it punted due to (fill in the blank: budget problems at the agency, other priorities, a change of philosophy, etc.) Who knows? It’s been a disappointing year for the agency in this area.
  • Will the FDA apply Fast Track, Accelerated or Priority Review or Breakthrough Therapy Designation to any emerging stem cell products? It’s about time. They should.
  • What will the impact of the likely growing number of state Right To Try laws be? I expect it will increase both risk and innovation, but unfortunately much more of the former than the latter.
  • Was the flood of very high profile stem cell paper retractions so far in 2014 an aberration or will it painfully continue? I hope it does continue, but it’s a worry as the field needs public trust and respect.
  • Will a big pharma acquire a small biotech like Athersys, ACT, StemCells, Inc., Neostem, in the coming year? More money is sure flowing from big to small (witness ViaCyte’s new influx of money) and we saw this with happen California Stem Cell. I think we’ll see this trend of money flow or even acquisitions accelerate although there are structural obstacles to being acquired for certain companies.

What questions are on your mind right at the moment related to stem cells and regenerative medicine?

Note this post is simply informational and is not financial advice. Only make financial decisions after consulting with a certified financial planner, which I am definite not. I hold no stake in any of the companies mentioned.

Blog readers investigate BioGatekeeper, the Yamanaka patent challenger

The readers of this blog never cease to amaze me. What an informed, energetic, bright group.

Within just days they may have collectively shed some light on an intriguing mystery in the stem cell field surrounding this question:

Who is trying, via the name BioGatekeeper, Inc., to nullify Yamanaka’s patent on cellular reprogramming to produce induced pluripotent stem (iPS) cells?

This past week the mysterious organization BioGatekeeper, Inc. filed a challenge to the Yamanaka Patent. The basis of the challenge is the assertion that cellular reprogramming was supposedly obvious based on pre-existing art, in this case meaning previous work and intellectual property (IP) on cellular reprogramming by others.

More specifically, BioGatekeeper focused on one other patent as the leverage for its argument to cancel the Yamanaka Patent: the Whitehead Institute Patent on reprogramming (aka The Whitehead Patent). The Whitehead Patent pre-dated Yamanaka’s. Like Yamanaka’s, the Whitehead Patent also focused on reprogramming of cells to pluripotency.

The Whitehead Institute has indicated that it has no involvement in BioGatekeeper.

A logical question then is why the people behind BioGatekeeper, whoever they might be, chose to focus on the Whitehead Patent as the driving force in their argument? That remains unclear at this time.

Who might be behind BioGatekeeper? The most logic candidates would be those who have been involved in cellular reprogramming over the years, particularly in the early days even before iPS cells. Read on on Page 2!

Challenge could cancel Yamanaka iPS cell patent

Yamanaka Patent challengeA new patent dispute has exploded in the stem cell field.

What’s going on?

In 2006, Shinya Yamanaka reported cellular reprogramming to create mouse induced pluripotent stem (iPS) cells in Cell and the next year multiple groups along with Yamanaka’s reported creating human iPS cells.

It’s no exaggeration to say this was a blockbuster development for the cell and developmental biology fields and Yamanaka later went on to win the Nobel Prize for this discovery.

Another element to the iPS cell story is the intellectual property (IP) related to iPS cells.

There have been numerous IP claims and patents related to cellular reprogramming and iPS cells, but the dominant patent has been U.S. Patent No. 8,058,065 to Yamanaka et al. that was issued on November 15, 2011, which has been commonly known as the “Yamanaka Patent”.

The common perception in the stem cell/regenerative medicine field has been that the cellular reprogramming sector would be mostly dominated at the IP level by the Yamanaka Patent despite there being other patents in this arena.

However, I just learned of a serious challenge to the Yamanaka Patent, which could really turn things upside down. I predicted an iPS cell patent war back in a post this May.

The iPS cell patent challenge was filed by a mysterious entity called BioGatekeeper, Inc.

What is BioGatekeeper? Read on on Page 2!