Wednesday, March 30, 2005

"Magnificent Obsession" in Science

The March 18, 2005 issue of Science has an article about the saga of antibody anti-CD-154, potentially of use in MS treatment. Although Science mentions a court action, they did not give the cite, which is NOELLE v. LEDERMAN, 355 F.3d 1343, 69 U.S.P.Q.2D 1508 (CAFC 2004). Although the gist of the article is captured by the title [Magnificent obsession. converting an idea for a new MS drug into the real thing], there are some other issues present, but not discussed by Science. Both Noelle and Lederman were operating on federal funding, and their respective universities (Dartmouth; Columbia) took title to the inventions through the Bayh-Dole Act. Did Senators Bayh and Dole (and others) contemplate that the Bayh-Dole Act would be used for one federal grant recipient to fight another federal grant recipient? How does this serve the public, who paid for the research? Columbia University was aligned with Biogen; Dartmouth with Idec. By the time of the CAFC decision in 2004, Biogen and Idec were merged (June 2003), so that the CAFC decision had little impact on the marketplace; one company could use both inventions.

A further irony is the case BIOGEN IDEC MA INC. v. THE TRUSTEES OF COLUMBIA UNIVERSITY IN THE CITY OF NEW YORK, 332 F. Supp. 2d 286 (D Mass 2004), wherein the Biogen/Columbia "partners" of the CD-154 saga are at opposite ends in the "Axel Patents" saga, with Columbia University the defendant in a DJ action. Therein the court found that plaintiffs have, on the present record, made a strong showing that they are likely to prevail in proving that the US 6,455,275 patent of Columbia[the '275 patent] is invalid pursuant to the doctrine of non-statutory double patenting and, if valid, is unenforceable because of the equitable doctrine of prosecution laches. The research giving rise to this patent was federally-funded [In the 1970s, the National Institutes of Health ("NIH") provided funding for, among other things, research conducted by Drs. Richard Axel, Michael Wigler, and Saul Silverstein at Columbia relating to co-transformation of cells.]

Donald Kennedy wrote an editorial on the Bayh-Dole [B-D] Act in the March 4, 2005 issue of Science:

We want technology transfer, but we resent those who take federally supported work, add some value, and receive a return on their investment. ... B-D has neither a sunset nor a reauthorization requirement, but after a quarter-century it may be time to measure the innovation it has created and to balance that against the costs to universities, their faculties, and public trust in science.


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