An article by Jennifer Washburn in the April 12, 2006 issue of the Los Angeles Times entitled “The legal lock on stem cells;
Two patents covering a major area of research are regressing science,” addresses the issue of patent royalties surrounding California’s Proposition 71/CIRM previously discussed in this ezine (“Future Bumps In The Road For State-Funding Of Stem Cell Research,” http:// ezinearticles .com/?id=171034.) However, unlike themes in ezines, which suggest that patent royalty issues are a solvable obstacle, the Washburn article suggests that stem cell patents are problematic themselves.
Washburn wrote: “Foundation [WARF’s] the patent is based on the work of James Thompson, a University of Wisconsin professor who was the first scientist to isolate embryonic stem cells, in 1998. But the patent is very broad — doesn’t make much sense — that they cover all human embryonic stem cell lines in the US, not just the specific line that Thompson developed.”
Indirectly, Washburn suggested that CIRM California should challenge the validity of WARF’s patents: “The Foundation
for Taxpayers and Consumer Rights, based in Santa Monica, has urged the California stem cell agency to challenge the Wisconsin patent.”
The basic WARF patent is US 5,843,780 (issued Dec 1, 1998 to James A. Thomson, based on application 591246 filed Jan. 18, 1996; the application is a continuation of US application No. Ser. 08/376,327 filed Jan. 20, 1995. The invention This was created with United States government support granted by NIH NCRR Grant No. RR00167. So if CIRM California were to challenge the ‘780, someone would use California state taxpayer money to challenge a patent held by the Wisconsin agency (WARF), based on research paid by the federal National Institutes of Health (NIH). It is doubtful that state taxpayers in California or Wisconsin, or federal taxpayers, would consider this a useful expenditure of money.
A previous ezine article stated: An important message to appreciate is that money from state funding for stem cell research that is meant to create new horizons in medical care can be directed to paying rightsholders already made. There may be legitimate patents in the stem cell area, and countries working in those areas will have to negotiate with the rights holders. Separately, the Hatch-Waxman Act created 35 USC 271(e)(1) safe harbors for research used to provide information to federal agencies (such as the FDA). The Supreme Court granted this safe harbor wide in the Merck v. Integra.
Separately, it’s ironic for Washburn to complain that WARF asserted its patents while, at the same time, CIRM would seek to get patents to apply to others. Although the distribution of patent royalties under Proposition 71 was confounded by federal tax issues related to the planned use of tax-exempt bonds, California voters were informed that there would be income from patent royalties.
As a minor addition to the Washburn article, the two patents discussed therein, US 5,843,780 and 6,200,806, are part-continuations and divisions, respectively; because there is no continuation, comments about the applicant can apply for a “continuation” with another until it is approved inconsistent with these facts. The USPTO is currently studying changes to the “continuation” process, but even changes, as currently proposed, will have no impact on either of these applications. A discussion of the effect of recurring continuation on patent grant rates has been discussed in 4 CHI.-KENT J. INTELL. SUPPORT. 186 (available at http://jip.kentlaw.edu); ironically, a misunderstanding of the rate of patent grants underlies some of the arguments about the lack of reliable patent quality in the Washburn article.