| A post by David Jensen in | | | | differentiate into derivatives of endoderm, |
| californiastemcellreport on April 25 had some | | | | mesoderm, and ectoderm tissues throughout the |
| quotes relevant to CIRM's IP (intellectual | | | | culture, and |
| property) Task Force meeting in March 2006 | | | | |
| and to a meeting schedulued for San Diego on | | | | (iv) will not differentiate when cultured on |
| Thursday, April 27.--> Ed Penhoet, chair of | | | | a fibroblast feeder layer.First claim of US |
| the task force, said last month's hearing | | | | 6,200,806 (the application leading to the |
| raised some fundamental questions."What are | | | | '806 patent was a divisional of the |
| we really attempting to do? Are we trying to | | | | application leading to the '780 patent) :A |
| drive therapies as rapidly as possible? Are | | | | purified preparation of pluripotent human |
| we trying to stimulate business in | | | | embryonic stem cells which(i) will |
| California? Do we want to grow small | | | | proliferate in an in vitro culture for over |
| companies? There (is) a whole set of | | | | one year, |
| potentially conflicting aims," Penhoet | | | | |
| said.As a comment, one notes the CIRM people | | | | (ii) maintains a karyotype in which the |
| need to get their act together to spend their | | | | chromosomes are euploid and not altered |
| money in a coherent manner, and not have | | | | through prolonged culture, |
| conflicting aims. It's one thing if this is | | | | |
| a WPA project for biologists; it's another | | | | (iii) maintains the potential to |
| thing if one is trying to get royalties from | | | | differentiate to derivatives of endoderm, |
| patents, and it's still another thing to | | | | mesoderm, and ectoderm tissues throughout the |
| focus on getting a useful product to market. | | | | culture, and |
| The WPA project model is the easiest to | | | | |
| accomplish ("we spent a lot of money in an | | | | (iv) is inhibited from differentiation when |
| important area and employed lots of | | | | cultured on a fibroblast feeder layer.Looking |
| scientists") but is most likely to lead to | | | | carefully, one will note that the basic |
| disappointment.--> Brad Margus, CEO of | | | | preparation (first line) and all elements |
| Perlegen Sciences of Mountain View, Ca., told | | | | (i-iv) are different between the basic claims |
| the task force that if CIRM wants to be an | | | | of the two patents. For someone to get the |
| agent that produces the next big thing in | | | | type of patent protection to encourage the |
| stem cells, it needs to minimize nonfinancial | | | | investment to bring a product to market, the |
| restrictions and heavy royalties."I'd like | | | | person will need to get a broad claim, one |
| California to try to do it differently | | | | that is not limited to the specific patient |
| ....and think a little smarter. If there | | | | who will be the recipient of the |
| really is a company out there that has the | | | | "patient-specific" stem cells. This need is |
| next thing that you need in stem cell | | | | apt to foster a patent-thicket problem.Geron |
| research to happen, and your objective | | | | has exclusive rights in the Thomson patents |
| scientific advisors say this is what we want, | | | | in certain areas. For investment, Geron has |
| you should be really, really aggressive in | | | | sought private investors, largely ignoring |
| getting it. And I'm concerned that some of | | | | the Congressional debates over expanding |
| these things that we're throwing out there, | | | | federal research dollars and the vast |
| like revenue sharing or the capping what a | | | | bureaucracy that has held up state funding in |
| company (can earn), will only defeat that | | | | California. "Given their financial acumen, |
| purpose."As a comment, one "next big thing in | | | | they are pretty much self-sustaining for the |
| embryonic stem cells" is to do what Hwang | | | | foreseeable future," says Steve Brozak, an |
| Woo-Suk claimed to have done in 2005: create | | | | analyst at WBB Securities, a brokerage based |
| patient specific embryonic stem cell lines. | | | | in San Diego. "They've managed that by |
| All the "objective science advisors" in the | | | | tapping into the capital markets. These folks |
| world failed to counsel anyone that Hwang's | | | | have learned very well; they don't want to be |
| work was fraudulent, so one has to take | | | | caught at the mercy of anybody." Geron has |
| advice in this area with a grain of salt. | | | | spent about $100 million in stem cell |
| Beyond doing patient-specific stem cells, one | | | | research over the last 10 years, small in |
| still needs to use such things in some | | | | comparison to California's potential of $3 |
| beneficial way to actually help human beings. | | | | billion over the next 10 years. Geron |
| That objective may be more than 10 years in | | | | announced it expects to file for permission |
| the future. Most venture capitalists seem to | | | | from the Food and Drug Administration [FDA] |
| think the time line for a real product is | | | | to begin trials for an |
| long.--> One executive from Genentech, which | | | | embryonic-stem-cell-based therapy for |
| has only a peripheral stem cell interest, | | | | spinal-chord injuries this year. [information |
| told the task force that it takes something | | | | and quote from smartmoney.com] Keep in mind, |
| like $1 billion to push a product to market. | | | | under 35 USC 271(e)(1) as interpreted in the |
| He said that for every dollar in research, | | | | Merck v. Integra case, anyone is pretty much |
| another $5 is need for development. And the | | | | free to infringe anyone else's patents for |
| odds of developing a successful product once | | | | purposes of obtaining information needed by |
| it starts clinical testing on humans range | | | | the FDA.The Washburn article was discussed in |
| from one in three to one in five.As a | | | | a previous ezine piece: Ebert, Lawrence. |
| comment, one has to be careful to note that | | | | (2006, April 12). Los Angeles Times Article |
| an effective business model for | | | | Way Off Base on Stem Cell Issues. |
| patient-specific stem cells (geared to | | | | EzineArticles. Retrieved April 27, 2006, from |
| INDIVIDUALS) is apt to be different from a | | | | reluctance of venture capitalists to invest |
| business model for blockbuster drugs (geared | | | | in stem cell research is discussed in an |
| to MANY PEOPLE taking the SAME drug).As some | | | | ezine piece: Ebert, Lawrence. (2006, April |
| guidance, one can contemplate the basic | | | | 24). MIT Technology Review Concern Over WARF |
| composition of matter claims of the Thomson | | | | Patent Royalty Demand To CIRM Over Stem Cells |
| WARF patents, recently strongly criticized by | | | | Is Misguided. EzineArticles. Retrieved April |
| Washburn in the Los Angeles Times.First claim | | | | 27, 2006, from B. Ebert is a registered |
| of US 5,843,780:A purified preparation of | | | | patent attorney located in central New |
| primate embryonic stem cells which(i) is | | | | Jersey. He holds a Ph.D. from Stanford, a |
| capable of proliferation in an in vitro | | | | J.D. from the University of Chicago, |
| culture for over one year, | | | | maintains a blog at IPBiz.blogspot.com, and |
| | | | is the author of LESSONS TO BE LEARNED FROM |
| (ii) maintains a karyotype in which all the | | | | THE HWANG MATTER: ANALYZING INNOVATION THE |
| chromosomes characteristic of the primate | | | | RIGHT WAY, published in the Journal of the |
| species are present and not noticeably | | | | Patent & Trademark Office Society [88 JPTOS |
| altered through prolonged culture, | | | | 239 (March 2006)]. Ebert is listed in Marquis |
| | | | Who's Who in America, Diamond Edition, 2005. |
| (iii) maintains the potential to | | | | Ezine draft submitted April 27, 2006. |