The Wisconsin Alumni Research Foundation (WARF) has filed three supplemental amendments to its disputed embryonic stem cell claims, which are undergoing re-examination by the US Patent Office.
But the changes will have little impact on the point at issue, which is whether the techniques described were original enough to be patented, according to William L. Warren, an intellectual property lawyer with Sutherland Asbill & Brennan in Atlanta.
WARF said the changes filed Tuesday are meant to clarify language in the claims following meetings with patent examiners late last month, and are not a reversal in WARF's stance in the patent dispute. "We are clarifying the claims and improving the consistency among the three claims," said Janet Kelly, a spokeswoman for WARF. "It's not unusual to clarify language in existing patents."
The three supplemental amendments total 27 pages of new clauses, as well as changes made earlier this year. Kelly declined to describe the key changes because the patent case is still in litigation.
The major change states that stem cells "will proliferate" in an in vitro culture as opposed to merely being "capable" of proliferating as was stated in the original patent language, according to Grady Frenchick, a patent lawyer with Whyte Hirschboeck Dudek in Madison and an instructor at the University of Wisconsin's law school.
The patents are under reexamination by the US Patent Office following a challenge by the Public Patent Foundation in New York and the Foundation for Taxpayer and Consumer Rights in Los Angeles. In April, the patent office issued a preliminary ruling that the patents were not valid. WARF is now challenging that ruling.
"The current claim amendments do not appear to have addressed the primary outstanding prior art rejections, but only some ancillary indefiniteness issues," Warren told The Scientist in an Email. "It is noteworthy that following the last round of interviews [last month], the examiner still indicated that no agreement had been reached regarding patentability of the claims."
Dan Ravicher, executive director of the Public Patent Foundation, said any change in the patent claim is an indication that WARF's case is weak. "Amending the claims is an admission that the original claims don't deserve to exist," he said. "If they deserved to exist they would stand by them, but they haven't."
The patents, filed in 1998, 2001 and 2006 stem from work conducted by James Thomson, a University of Wisconsin-Madison developmental biologist who isolated human embryonic stem cell lines. Scientists contend the patents are overly broad and hinder research in the United States because they require investigators to pay licensing fees to WARF.
Susan Warner
mail@the-scientist.com
Links within this article:
Wisconsin Alumni Research Foundation
http://www.warf.ws/
C. Tran, "WARF stem cell patents challenged," The Scientist, October 10, 2006.
http://www.the-scientist.com/news/display/25037/
Grady Frenchick
http://law.wisc.edu/faculty/biog.php?iID=274
US Patent and Trade Office
http://patft.uspto.gov/
Foundation for Taxpayer and Consumer Rights
http://www.consumerwatchdog.org
A. McCook, "Stem cell patent dispute: Wisc. fights back," The Scientist, April 4, 2007.
http://www.the-scientist.com/blog/display/53054/
James Thompson
http://www.news.wisc.edu/
R. Gallagher, "End this stem cell racket," The Scientist, November 1, 2006
http://www.the-scientist.com/article/display/25131