Wednesday, October 04, 2006

Feds Say 'Substantial Question' Exists on WARF Patents

The federal government will review Wisconsin's claims to patents on embryonic stem cells in a move that will probably take a few years to play out.

The agency agreed that "substantial questions" exist involving the patents.

Reporter Andrew Pollack of the New York Times wrote:
"Re-examinations brought about by a third party, as this one was, result in all the patent claims being canceled 12 percent of the time, said Brigid Quinn, a spokeswoman for the patent office. In another 59 percent of cases, smaller changes are made. Ms. Quinn said the patent office receives 400 to 500 requests for re-examinations each year and grants 90 percent of them.

"The Wisconsin Alumni Research Foundation, or WARF, a patent licensing organization affiliated with the university, provides academic researchers with free licenses and charges them $500 for cells. Companies are charged $75,000 to $400,000, depending on their size and the terms of the license. One company, the Geron Corporation, has exclusive commercial rights to heart, nerve and pancreatic cells derived from the embryonic stem cells."
Reporter Kathleen Gallagher of the Milwaukee Journal Sentinel quoted John M. Simpson of the Foundation of Taxpayer and Consumers Rights of Santa Monica, Ca., one of the two nonprofit groups challenging the patents, as saying his organization was not motivated by regional jealousy. Gallagher wrote:
"'If California had these patents with these claims, we'd be trying to challenge them,' said Simpson, who was born in Madison and whose mother worked in a research lab on the UW-Madison campus."
Here are links to other news stories and press releases: The AP(which appeared overseas), Terri Somers of the San Diego Union Tribune, Jim Downing of The Sacramento Bee, Bernadette Tansey of the San Francisco Chronicle, David Wahlberg of the Wisconsin State Journal, Rob Waters of Bloomberg, Foundation for Taxpayer and Consumer Rights press release.

1 comment:

  1. Of the comments in the Sacramento Bee:

    In a break with academic tradition that has stirred controversy, the foundation has required university researchers to negotiate licenses to do virtually any sort of embryonic stem cell research. In addition, it generally negotiates "reach-through" royalty rights, giving it the right to claim a share of the proceeds from cures developed through the research.

    The actions of WARF about licensing seem to be directed to non-profit (e.g., university) bodies who are affiliated with for-profit entities. WARF does not seem to be after entities who are totally non-profit, and research activities of such entities would likely be insulated from infringement through 35 USC 271(e)(1).

    As a result, the Patent Office's decision could have financial implications for California taxpayers, who will be funding $3 billion in embryonic stem cell research in the next decade -- if voter-approved Proposition 71 survives its ongoing legal challenges.

    About 70 percent of patents that are accepted for re-examination by the Patent Office are ultimately altered or thrown out, according to agency figures. It usually takes between two and 10 years for the office to issue a final decision, according to Dan Ravicher, executive director of the Public Patent Foundation.

    Re-examination itself should be concluded much closer to the "two year" point than the "ten year" point. In the face of an unfavorable decision, WARF would have the right of judicial review, which would add additional time.

    It is also possible that litigation could move in tandem with re-examination. In the case of the Eolas/Berkeley patent, Eolas survived re-examination at the USPTO without any claim amendment, but is still engaged in a litigation.

    Separately, note that it is claims, not patents, which are investigated in a re-exam. The majority (88%) of patents involved in re-examination survive with (some) valid claims.

    More information on the re-exam request is available at


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