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.


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.

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!

Winners of FLASH contest: Johnathon Anderson & Sai Vemula Going to World Alliance Stem Cell Forum

I recently held a flash 48 hour contest for free tickets to the World Alliance Forum on the future of stem cells at which Yamanaka and others will be speaking.

Congrats to the winners, Sai Vemula and Johnathon Anderson.

World Alliance Forum Stem Cells

Here are their winning entries.

Sai Vemula

Editor, SSSCR-International, UC Berkeley, Molecular and Cell Biology B.A.

This forum provides a unique opportunity to get a glimpse of the field from national and global perspectives and lets me go beyond the science and learn about various economical, regulatory and policy related issues. As an undergraduate I have been an instructor for a stem cell class, outreach educator and an advocate. Meetings like these offer me a platform to forge new connections with researchers from multiple disciplines to better develop my understanding, as I form the next steps in my career. In particular I am interested in learning about drug development process and designing of clinical trials.

Johnathon D. Anderson

I’m eminently interested in developing novel therapeutics, a spark of passion that was perhaps flamed by my mother’s passing from cancer some years ago. I’m attempting to marry my high-throughput sequencing and molecular biology backgrounds into characterizing and high-jacking a recently elucidated new cell to cell communication system that all mammalian cells, including stem cells appear to use (exosomes, microvesicles). I work in a translational lab on adult stem cells and I would absolutely love that opportunity to talk science and the future of the field with some of the great minds that will be there.

What was the strangest event for stem cells in 2012? Pick from top 5 in poll

Every year around this time I put my “best of” the year in stem cells including awards such as my Stem Cell Person of the Year Award. For example here are the 2011 awards.

This year I’m also trying with difficult to decide on what was the craziest thing for stem cells that happened in 2012. It was a freakin’ crazy year so I have 4 options and am curious of your thoughts so take the poll below if you want.

Here are my 5 candidates for oddest event for stem cells of 2012.

1. Moriguchi’s fake iPS transplant story and the fact it was presented at NYSCF meeting as a poster and the story was run by the largest circulation newspaper in the world front page above the fold.

2. The stem cell super model case. Life of luxury on the backs of patients injected with all sorts of crap, one of the two parties dies mysteriously, dramatic court testimony, etc.

3. The lawsuit filed against the Nobel Committee by the scientist for not giving him the Nobel Prize.

4. The FDA issuing a warning letter against L’Oreal/Lancome (a very serious regulatory step) for stem cell facial cream (involving plant stem cell extracts), while many unlicensed clinics just in the U.S. alone are transplanting stem cells into patients including allogeneic and amplified autologous stem cells…without any FDA action whatsoever taken against them to my knowledge.

5. The notion that there are stem cells in Pepsi becomes established as a U.S. urban legend/myth.

All very strange in my opinion, but which is the strangest?