Saturday, August 26, 2006

Sacramento Bee article on ACT stem cell work seriously flawed

The Sacramento Bee, which has produced many insights into Proposition 71 and embryonic stem cell research in California, came up with a real turkey in the August 25 article entitled Patent foes get a break in fight; Breakthrough in stem-cell engineering may weaken group's lock on research.

The "breakthrough" is the use of previously-known technology in the IVF area (methods for removing one cell of a blastocyst for PGD) to isolate the cell and then to grow a cell line from the REMOVED cell, leaving the remaining CELLS of the blastocyst viable.

One stupidity in the Bee article is: If the new method does help to invalidate the Wisconsin patents, it would be an unintended byproduct of the research, said Advanced Cell Technology President Michael West. Work that is done LATER, as here, is NOT PRIOR ART to work done EARLIER (the Thomson/WARF work in the 1990's). If it's not prior art, it's not going to be used to INVALIDATE the earlier patents.

Another problem is found in the text: Now, though, if the new method announced Thursday holds up under further testing, there may be a way around those patent restrictions, said Greely, an expert on legal issues related to stem cell research.

"The mere fact … of having a new way to make embryonic stem cells weakens the WARF (Wisconsin Alumni Research Foundation) patents, which I think is a good thing," he said.

Whether the patent is "weakened" when no challenge is made to the composition claims may be questioned. The Bee didn't get into the composition claims, so IPBiz will present them (again).

The first claim of US 5,843,780:

A purified preparation of primate embryonic stem cells which (i) is capable of proliferation in an in vitro culture for over one year, (ii) maintains a karyotype in which all the chromosomes characteristic of the primate species are present and not noticeably altered through prolonged culture, (iii) maintains the potential to differentiate into derivatives of endoderm, mesoderm, and ectoderm tissues throughout the culture, and (iv) will not differentiate when cultured on a fibroblast feeder layer.

The first claim of US US 6,200,806:

A purified preparation of pluripotent human embryonic stem cells which (i) will proliferate in an in vitro culture for over one year, (ii) maintains a karyotype in which the chromosomes are euploid and not altered through prolonged culture, (iii) maintains the potential to differentiate to derivatives of endoderm, mesoderm, and ectoderm tissues throughout the culture, and (iv) is inhibited from differentiation when cultured on a fibroblast feeder layer.

IF the PRODUCT of the ACT METHOD falls within the scope of these two patents claims (which to date no one has denied), THEN in theory WARF could take legal action against practitioners of the ACT method who operate without a license from WARF. Whether WARF would take such action is not clear. However, the legal analysis in the Sacramento Bee article is simply wrong in suggesting there is an "alternative."

A related problem is in the text: The Alameda firm, Advanced Cell Technology, has applied for patent protection for its work, as well. Still, as a rule, licensing fees should come down as the number of choices for researchers grows, said Ann Hanham, managing director for Burrill & Co., a San Francisco life sciences venture capital firm.

"Competition is always good," she said.

Of the text: By contrast, he [Greely] said, "WARF is making enemies."

The matter could be decided in court. If the Wisconsin foundation felt that its patents were being infringed, it could sue, and the judge's ruling would effectively establish the validity of the patents, Greely said.

One questions, what "matter"? WARF has already said it is not suing anyone until there is some commercial product, and the research exemption of 35 USC 271(e)(1) would be the most likely defense of any researcher.

Things omitted by the author Jim Downing:

--> Comments by British researchers on problems with the ACT "invention". Ian Wilmut, of Dolly the Sheep fame, said: "the authors make unjustified claims for their techniques."
--> The mere presence of a re-exam request on the Thomson patents, and the weakness of the arguments for invalidity therein
--> The obvious issue that if the Thomson patents cover the composition itself, there is no "way around" the patent claims merely by having a different method to make the same composition. Licensing fees are NOT going to go down, because there is no alternative to the composition claim.
--> Previous (and current) interactions between WARF and Geron.

UPDATE, August 29.

The californiastemcellreport suggests I called the Sacramento Bee a turkey. Look above and see what you think.

As to quotes of individuals in the Bee article, I have no idea if they were quoted in context, etc., so I do not comment on the people quoted. Of the substance, the new work by ACT in 2006, as reported, does nothing to invalidate the Thomson WARF patents from the 1990's. Something else might, but not work in 2006. Separately, how the Thomson WARF patents are "weakened" by the ACT work is not clear if claims of Thomson WARF patents "cover" the product of the ACT method. If someone wants to suggest the Thomson composition claims don't cover the product of the ACT method, that is a different story.

If, however, the claims of the Thomson WARF patents do cover products of the ACT method, then one might argue that the Thomson WARF patents are "strengthened" by the ACT work. Thomson WARF would be getting royalties for use not specifically contemplated by them in the 1990's.

[IPBiz post 1898]


Post a Comment

<< Home