Which Way is the CIRM IP Task Force Heading On Stem Cell Research?

A post by David Jensen in californiastemcellreport on(iii) maintains the potential to differentiate into
April 25 had some quotes relevant to CIRM's IPderivatives of endoderm, mesoderm, and ectoderm
(intellectual property) Task Force meeting in Marchtissues throughout the culture, and
2006 and to a meeting schedulued for San Diego on(iv) will not differentiate when cultured on a
Thursday, April 27.--> Ed Penhoet, chair of the taskfibroblast feeder layer.First claim of US 6,200,806 (the
force, said last month's hearing raised someapplication leading to the '806 patent was a divisional
fundamental questions."What are we reallyof the application leading to the '780 patent) :A
attempting to do? Are we trying to drive therapiespurified preparation of pluripotent human embryonic
as rapidly as possible? Are we trying to stimulatestem cells which(i) will proliferate in an in vitro culture
business in California? Do we want to grow smallfor over one year,
companies? There (is) a whole set of potentially(ii) maintains a karyotype in which the chromosomes
conflicting aims," Penhoet said.As a comment, oneare euploid and not altered through prolonged culture,
notes the CIRM people need to get their act
together to spend their money in a coherent manner,(iii) maintains the potential to differentiate to
and not have conflicting aims. It's one thing if this is aderivatives of endoderm, mesoderm, and ectoderm
WPA project for biologists; it's another thing if one istissues throughout the culture, and
trying to get royalties from patents, and it's still(iv) is inhibited from differentiation when cultured on
another thing to focus on getting a useful product toa fibroblast feeder layer.Looking carefully, one will
market. The WPA project model is the easiest tonote that the basic preparation (first line) and all
accomplish ("we spent a lot of money in an importantelements (i-iv) are different between the basic claims
area and employed lots of scientists") but is mostof the two patents. For someone to get the type of
likely to lead to disappointment.--> Brad Margus, CEOpatent protection to encourage the investment to
of Perlegen Sciences of Mountain View, Ca., told thebring a product to market, the person will need to
task force that if CIRM wants to be an agent thatget a broad claim, one that is not limited to the
produces the next big thing in stem cells, it needs tospecific patient who will be the recipient of the
minimize nonfinancial restrictions and heavy"patient-specific" stem cells. This need is apt to foster
royalties."I'd like California to try to do it differentlya patent-thicket problem.Geron has exclusive rights in
....and think a little smarter. If there really is athe Thomson patents in certain areas. For
company out there that has the next thing that youinvestment, Geron has sought private investors,
need in stem cell research to happen, and yourlargely ignoring the Congressional debates over
objective scientific advisors say this is what weexpanding federal research dollars and the vast
want, you should be really, really aggressive in gettingbureaucracy that has held up state funding in
it. And I'm concerned that some of these things thatCalifornia. "Given their financial acumen, they are
we're throwing out there, like revenue sharing or thepretty much self-sustaining for the foreseeable
capping what a company (can earn), will only defeatfuture," says Steve Brozak, an analyst at WBB
that purpose."As a comment, one "next big thing inSecurities, a brokerage based in San Diego. "They've
embryonic stem cells" is to do what Hwang Woo-Sukmanaged that by tapping into the capital markets.
claimed to have done in 2005: create patient specificThese folks have learned very well; they don't want
embryonic stem cell lines. All the "objective scienceto be caught at the mercy of anybody." Geron has
advisors" in the world failed to counsel anyone thatspent about $100 million in stem cell research over
Hwang's work was fraudulent, so one has to takethe last 10 years, small in comparison to California's
advice in this area with a grain of salt. Beyond doingpotential of $3 billion over the next 10 years. Geron
patient-specific stem cells, one still needs to use suchannounced it expects to file for permission from the
things in some beneficial way to actually help humanFood and Drug Administration [FDA] to begin trials for
beings. That objective may be more than 10 years inan embryonic-stem-cell-based therapy for spinal-chord
the future. Most venture capitalists seem to think theinjuries this year. [information and quote from
time line for a real product is long.--> One executivesmartmoney.com] Keep in mind, under 35 USC
from Genentech, which has only a peripheral stem cell271(e)(1) as interpreted in the Merck v. Integra case,
interest, told the task force that it takes somethinganyone is pretty much free to infringe anyone else's
like $1 billion to push a product to market. He saidpatents for purposes of obtaining information needed
that for every dollar in research, another $5 is needby the FDA.The Washburn article was discussed in a
for development. And the odds of developing aprevious ezine piece: Ebert, Lawrence. (2006, April 12).
successful product once it starts clinical testing onLos Angeles Times Article Way Off Base on Stem
humans range from one in three to one in five.As aCell Issues. EzineArticles. Retrieved April 27, 2006,
comment, one has to be careful to note that anfrom reluctance of venture capitalists to invest in
effective business model for patient-specific stemstem cell research is discussed in an ezine piece:
cells (geared to INDIVIDUALS) is apt to be differentEbert, Lawrence. (2006, April 24). MIT Technology
from a business model for blockbuster drugs (gearedReview Concern Over WARF Patent Royalty
to MANY PEOPLE taking the SAME drug).As someDemand To CIRM Over Stem Cells Is Misguided.
guidance, one can contemplate the basic compositionEzineArticles. Retrieved April 27, 2006, from B. Ebert
of matter claims of the Thomson/WARF patents,is a registered patent attorney located in central New
recently strongly criticized by Washburn in the LosJersey. He holds a Ph.D. from Stanford, a J.D. from
Angeles Times.First claim of US 5,843,780:A purifiedthe University of Chicago, maintains a blog at
preparation of primate embryonic stem cells which(i)IPBiz.blogspot.com, and is the author of LESSONS TO
is capable of proliferation in an in vitro culture forBE LEARNED FROM THE HWANG MATTER:
over one year,ANALYZING INNOVATION THE RIGHT WAY,
(ii) maintains a karyotype in which all thepublished in the Journal of the Patent & Trademark
chromosomes characteristic of the primate speciesOffice Society [88 JPTOS 239 (March 2006)]. Ebert is
are present and not noticeably altered throughlisted in Marquis Who's Who in America, Diamond
prolonged culture,Edition, 2005. Ezine draft submitted April 27, 2006.