example, Glaxo states that “[t]he state of the art of both expression of recombinant antibodies
and therapeutic use of antibodies was in its infancy in 1983" (Paper 56 at 18).
Glaxo states that “[r]ecombinant antibodies expressed in a CHO cell expression system”
were not known until 198723 (Paper 56 at 3). Dr. Vitetta testified that one skilled in the art
“would not have been enabled to practice the invention which is recited in Claims 53-60 in
1983" (Exh. 2018 at ¶ 20) and that “it would have required undue experimentation (4 years) to
express a glycosylated recombinant antibody in CHO cells based on the disclosure of Cabilly
and the available technology in 1983.” (Exh. 2028 at ¶ 25).
Dr. Youle’s testimony is consistent with Dr. Vitetta’s as to the state of the art in 1983
(Exh. 2012 at ¶ 19). In addition Dr. Youle stated that as of the filing date of the ‘419 application,
he believes “that separate inventive effort would have been required to make recombinant
antibodies in CHO cells and determine if they were therapeutically active” (Exh. 2012 at ¶ 20).
Neither Glaxo’s arguments nor Dr. Youle’s and Dr. Vitetta’s testimony address the state
23 When asked about Cabilly’s enablement at oral hearing, Glaxo counsel Gerald
Murphy answered:
Well, the prior art developed between ‘83 and ‘88. I would like to really emphasize that
Glaxo, really its main attack on Cabilly is written description (Paper 203 at 57);.
I’m not prepared to state when they [Cabilly] were enabled. I know we’ve
attacked the ‘83 enablement filing date (Paper 203 at 16-17);
and
There was some technology developed between ‘83 or ‘86 or ’87, the second
Cabilly filing date. So the enablement issues with respect to ‘83 and ‘87 are
different because the technology developed (Paper 203 at 17).
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