Saturday, August 01, 2009

The patent world of iPS (stem cells): Yamanaka, Bayer, and iZumi

Note to californiastemcellreport:

A question a California taxpayer might ask is "how" has CIRM improved the life of average folks in California? You seem to say financing (ie spending money) and training are justifications. What is CIRM giving back? In defeating the stem cell bond proposal, people in New Jersey seemed to have figured out there weren't good answers. When Prop. 71/CIRM was passed, the available knowledge was that Hwang Woo Suk's discoveries were real. Years have passed, and no one has shown Hwang's claims are real. Of the "sperm" incident, NPR noted: "Critics at the time sniffed to reporters that the would-be sperm-makers were over-claiming. That the wiggling cells in a dish indeed had tails, but there was no proof that they were truly potent (or had other important sperm-like characteristics)."

Of the "financing" matter, there were earlier claims that CIRM financed Yamanaka. There is no evidence of this, and when questioned, stemcellreport did an "el-foldo." There is a separate matter: whether Yamanaka was scooped by Bayer AG on iPS, and what might have happened because of this.

TMCNet wrote of the Bayer application:

The application was submitted around three months before a Japanese team led by Kyoto University professor Shinya Yamanaka announced the successful generation of iPS cells from human cells.

The data showed that Bayer submitted patent applications for more than one method, in addition to the technique employed by the Kyoto University team.

[IPBiz mentioned the issue of Yamanaka being scooped on iPS.]

As a followup, Breitbart reported on 12 Feb 09:

The Japanese unit of German chemical giant Bayer A.G., Bayer Yakuhin Ltd., said Thursday it would sell a set of patents on producing iPS cells, regarded as key in regenerative medicine, to a U.S. venture firm.

The three patents to be sold to iZumi Bio Inc. include Bayer Yakuhin's main method of producing iPS, or induced pluripotent stem cells, which have the potential to grow into any type of human body tissue. Bayer Yakuhin filed for Japanese and international patents on the method in June 2007.


U.S. venture iZumi Bio, based in Mountain View, California, was founded in 2007. It is funded through equity investments by Kleiner Perkins Caufield and Byers and Highland Capital Partners

[IPBiz suspects these are patent applications, not issued patents.]

BUT, the plot gets still more interesting. In a post titled iZumi Bio's Pact with Kyoto U May Help Bolster Firm's Position as Early Leader in iPSC Tech , Ben Butkus wrote on 22 April 09:

California-based biotech startup iZumi Bio said last week that it will collaborate with Kyoto University's Center for iPS Cell Research and Application to explore using induced pluripotent stem cells to develop new drug-discovery tools and cell-based therapies, particularly in the area of neurological disorders.

The announcement comes approximately one month after iZumi acquired from German pharma giant Bayer rights to what it believes to be a seminal patent application related to methods for inducing pluripotent stem cells. The deal also follows by about a year iZumi licensing from San Francisco's Gladstone Institutes certain patents related to the use of iPSCs in cardiovascular disease as part of a research partnership between the two organizations.

Text of the Butkus article that should be of interest to californiastemcellreport:

However, the company [iZumi], based in South San Francisco, Calif., does appear to be amassing pertinent IP and allying itself with key players in what is shaping up to be a complicated IP landscape surrounding iPSCs.

"You want to be careful trying to build your company only on IP," Walker told BTW. "It's important to have an ability to operate and continue to practice your science, and we believe we clearly have that."

According to Walker, iZumi was founded in 2007 as a culmination of discussions between Shinya Yamanaka, director of CiRA and professor of stem cell biology at Kyoto's Institute for Frontier Medical Sciences, and Beth Seidenberg, a partner at Bay Area life-sciences venture-capital firm Kleiner Perkins Caulfield and Byers.

Yamanaka, who also has a joint appointment at the Gladstone Institute, had been working with Seidenberg to identify commercial opportunities in the area of stem cells and regenerative medicine.

KPCB, along with Highland Ventures, co-led a $20 million financing round in iZumi last summer to specifically explore such opportunities based on breakthrough work that Yamanaka was conducting in iPSC induction.

Thus, iZumi, with ties to Yamanaka, bought up the Bayer intellectual property on iPS which scooped Yamanaka. Where does this leave the California taxpayer and CIRM on iPS?

***On the reporting by californiastemcellreport about the funding of Yamanaka:

Spinning in action: Yamanaka funding and CIRM
, including the text: An ignoring of the fact that Gladstone SPECIFICALLY DID NOT WANT Yamanaka to take CIRM money, EXPLICITLY BECAUSE OF CONCERNS about CIRM's IP policy.

On the absence of evidence that Yamanaka accepted a CIRM grant

**Further comment:

The iZumi funding of Yamanaka's iPS research area illustrates that there will continue to be a strong California connection to Yamanaka. More importantly, the iZumi story illustrates why the CIRM approach to intellectual property (and on return on investment to California taxpayers) is fundamentally flawed. The most promising stem cell research areas will be privately funded, and disconnected from CIRM. California taxpayers won't get a return on these efforts, but will get an accounting of papers published on secondary or derivative work. Voters in New Jersey figured out that the NJ stem cell bond was more about academic empire building than about cures, and just said no, producing the first rejected NJ bond proposal in years. Maybe they figured something out that Californians are missing.

US published application 20090047263, titled Nuclear reprogramming factor and induced pluripotent stem cells


20090068742, Nuclear Reprogramming Factor (371 Date: October 24, 2008 )

**Post about Klein on 19 March 2010:

Although you characterize Klein as "a successful businessman with a background in land development," you neglect to mention that he is a 1970 graduate of Stanford Law School (and a graduate of the college). Stanford University is of course one of the many beneficiaries of CIRM funding. As to the point about recusals, one notes that there is a conflict of interest on a more general level, that of the common interest in promoting research in embryonic stem cells. Everyone involved has an interest in keeping the ball rolling (somewhat analogous to the concept of regulatory capture), and no one is operating as a check valve to question whether one has changed technical and economic circumstances in 2010.

***See 2009 postiZumi Bio's Pact with Kyoto U May Help Bolster Firm's Position as Early Leader in iPSC Tech which includes

In November 2007, Yamanaka's lab reported that it had also generated human iPS cells — as did human embryonic stem-cell pioneer James Thomson at the University of Wisconsin-Madison, who was able to generate similar cells using different genetic factors.

The breakthroughs, which were published in the same week, immediately prompted the scientific community to explore how the technology might be used in developing drug-discovery tools and cell-based therapeutics, as companies such as Cascade LifeSciences and Fate Therapeutics announced that they had begun amassing university IP for exactly that reason (see BTW, 12-3-2007).

The announcements also ignited immediate debate over which organization would control pertinent intellectual property surrounding the method for human iPS cell induction — a debate that was intensified last September when Japan used a fast-track procedure to grant Kyoto University a domestic patent on human iPSCs based on Yamanaka's work.

However, in June 2007, unbeknownst to most of the general public and scientific community at the time, Bayer's Japanese branch had applied for a patent in Japan to protect a technique that can generate iPSCs based on the work of then-employee Kazuhiro Sakurada.

The Bayer patent application is still under review in Japan and other countries. In the meantime, however, Yamanaka made Seidenberg and others at iZumi aware of Sakurada's work, Walker said, and last month iZumi licensed the IP portfolio from Bayer, betting on the idea that it may become the seminal IP in the field.

"What I think people are not aware of is that a pharma company such as [Bayer], where this work was done, usually doesn't publish quite as quickly as would an academic institution," Walker said. While Bayer did not publish Sakurada's work, it did file patents on it, and it is those patents that have been assigned to iZumi, he added.

"We feel we have some very important precedent to [Yamanaka and Thomson's] work, and it really became the founding IP of the company," Walker said. And with the CiRA research agreement, iZumi "also now believes that we have the lead in establishing the application of cellular reprogramming in a new paradigm for drug discovery and development," he added.

However, Walker cautioned that it is far too early to know who will end up owning the seminal iPSC patents, or whether such patents will even exist, as only Kyoto University has an actual patent in hand, and even then only in Japan. No related patents have been issued in the US and Europe.


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