Re: "End this Stem Cell Racket" ¹ and "Working with Stem Cells? Pay Up" ² : The novelty of claim one in Thompson's (WARF) patent is not in parts (i) through (iii), but in the final clause: "is inhibited from differentiation when cultured on a fibroblast feeder layer." Is it not possible to inhibit from differentiation using other techniques than a fibroblast feeder layer (e.g., see US Patent No. 6,800,480)? New approaches such as this one have been addressed not only because of Thompson's '806 patent, but because of the presence of impurities (such as viruses) in the feeder cells. If the non-feeder cell techniques do not work and using a fibroblast feeder layer is truly novel, then the patent is probably worth its reputed $400,000 license.

Further, the patent covers cells isolated from the blastocyst stage; cells derived either prior to or after the blastocyst stage may not be covered. For a discussion of the patent and possible ways around it, see Taymor et al. in Nature Biotechnology. ³
Jonathan Coffman
Wyeth Biotech, Andover, MA

Richard Gallagher's piece ¹ is wide of the mark. His comments appear to be based on how much it costs to license the WARF patents, and not at all on how these patents fit into the bigger picture of innovation, competitiveness, and the modern university's role therein.

The WARF patents are not exceptional in terms of the subject matter claimed, and follow much precedent established since the seminal US Supreme Court ruling in Diamond v. Chakrabarty (see overview at http://en.wikipedia.org/wiki/Diamond_v._Chakrabarty). It is disingenuous, at best, to infer that the WARF patents are part of a "racket," which suggests that these patents may be illegal. They are not.

The challenge to the patents by a consortium of non government officials (who, after all, have interests of their own to protect) must be balanced with consideration of the risks taken and innovation resulting from the efforts/investments of Geron, the UW scientist, and WARF. It is impossible to say whether the innovation represented within WARF's claimed subject matter would have happened as soon as it did absent the patent incentives, but I doubt it. It is common to mount legal challenges to successful patents, and the fact that the WARF patents have survived intact suggests that the claims are in fact novel, non-obvious and useful.

Finally, human embryonic stem-cell research is exceptional from a bioethical standpoint, but is not so from a legal one. When compared to claims and licensing fees for other innovative biomedical patents, the WARF patents appear rather ordinary.
Ben Prickril
Kenbar Consultants, Lyon, France

Wisconsinites like me are some of the highest taxed citizens in the country just to support this kind of research and the expected return on investment. Now, everyone who feels entitled wants to lift our wallets. Hands off!
Bill Lang
Milwaukee, WI

While briefly dealt with in a piece of otherwise comprehensive reporting, ¹ the notion of HIV eradication is a bit of a red herring - and has been ever since Diamond's David Ho stood in front of the world (10 years ago this year) and tantalized the world (not to mention thousands of HIV+ individuals desperate to rid their bodies of the infection) with its prospect.

The whole point of PCATs and this terrible new term, "elite controllers," is that host factors (HLA types and immune activation among others) turn out to be more important than viral ones. (It is interesting that no mention was made in the article about SIV infected sooty mangabeys and other primates who live normal lives with normal immune systems even though they are infected with the simian equivalent of HIV.) The Typhoid Mary scenario, alluded to albeit only half seriously, it seems, in your piece, would appear unlikely in that research has already shown that HIV is transmitted only at considerably high levels of plasma viral load.

Teasing out the various immune responses that defang HIV is the most important research effort going on today. Deeks, Lederman, Walker and their colleagues are to be commended for their persistence and ingenuity in pursuing this line of research in a field otherwise suffocated by the mindless development of the next "new and improved" (and at twice the price) antiviral drugs du jour.
Mike Barr
Project THAMES
www.projectthames.org

Re: Getting your Gates. ¹ The non-profit sector, especially Gates-funded product development partnerships, are playing an increasingly powerful role in drug development, including with small, innovative companies. This is also true in the area of diagnostics. The Foundation for Innovative New Diagnostics (FIND), has moved with Gates funding to accelerate the development, evaluation, or use of improved diagnostics for infectious diseases in developing countries. Financial support from FIND, along with a clear understanding of developing world markets, makes feasible the development of innovative products that may have looked financially marginal. At the same time, novel intellectual property management and costing strategies ensure the affordability of the products for impoverished sectors of society in disease endemic countries.
Mark Perkins, CSO
FIND, Cointrin, Switzerland