>> I've been told by TKT that HMR licensed the CEGE patents to cover all angles, however the technology is not being used for it <<
I believe you, of course, but I'm not certain that I believe the person that you were talking to.
From my first-blush look (about 1 1/2 years ago), I got the distinct idea that the breadth of the CEGE claim did cover methods that were used to construct the TKTX cell line, and that TKTX had used YAC libraries. Haven't seen anything since that convinces me otherwise, and Hoechst wouldn't give away even a low, single-digit royalty without plenty of study.
The question of whether or not TKTX is infringing AMGN is another issue, however, and will boil down to definitions of "heterologous", "exogenous", etc. and to the bucks thrown at attorneys. My very preliminary view is that TKTX does not infringe, and that anything that is produced in a heterologous host and where composition of matter is not available is free for the picking.
BJ.... sorry, but I misunderstood one of your earlier questions..... the first claim of the patent clearly covers in vitro production from mammalian cell lines.
Since you mentioned FSH (imagine you've seen this, from the CEGE 10-K)........
In February 1997, Cell Genesys executed a license agreement with Hoechst Marion Roussel for erythropoietin and a second, undisclosed protein. The agreement provides for up to $26 million in milestone payments and fees, in addition to any royalties on future sales of these two potential gene-activated protein products. Cell Genesys has earned $5.1 million through December 31, 1997 under this license. In February 1994, Cell Genesys signed a licensing agreement with Theriak A.G., a subsidiary of Akzo Nobel N.V. ("Akzo Nobel"), to develop and market Cell Genesys' therapeutic protein product, gene-activated follicle stimulating hormone ("FSH") for the treatment of infertility. Akzo Nobel was granted worldwide rights to develop and market gene-activated FSH in exchange for licensing fees, royalties and other payments to Cell Genesys. During 1995, Akzo Nobel settled a patent dispute with another party related to recombinant FSH and is now marketing this form of FSH subject to regulatory approval. Cell Genesys has received $8.1 million in payments under the agreement and a 1996 amendment. |