It does not appear to be disputed that altered CDR-grafted and chimeric antibodies
against T-cell antigens such as CDw52 and CD4 and cancer cell antigens such as CD33 and
CD38 were known in the art at the time the Glaxo applications were filed (e.g., ‘404 at 3:51-61).
For example, Glaxo states in its ‘404 patent that the CDw52 antibody CAMPATH-1H13 was
known and described in EP 0 328 40414 (“EP ‘404) (‘404 at 3:59-67). EP ‘404 discloses the use
of CAMPATH-1H for the treatment of cancer, in particular non-Hodgkins lymphoma in
leukaemic phase (EP ‘404 at 11), and for immunosuppression purposes (EP ‘404 at 4 ). EP ‘404
discloses that antibodies for treating particular conditions associated with transplant rejection,
e.g., graft-vs. host disease, were known (‘404 at 4).
Moreover, the form of the Glaxo claims indicate that Glaxo considers its invention to lie
in the expression and glycosylation of known antibodies in CHO cells and not in the selection of
a condition to be treated and an antibody effective in treating the condition. In particular, the
condition to be treated and the antibody effective in treating the condition are part of the
preamble of Glaxo’s claims that appear to be drafted in accordance with 37 CFR § 1.71(e) (i.e.,
the Glaxo claims are presented as Jepson claims). The preamble of a Jepson claim is impliedly
admitted to be prior art . 37 CFR § 1.71(e)(1) and Sjolund v. Musland, 847 F.2d 1573, 1577, 6
USPQ2d 2020, 2023 (Fed. Cir. 1988).
Count 2 includes a method of treating cancer and T-cell mediated disorders using
chimeric and CDR-grafted antibodies that are expressed and glycosylated in CHO cells (FF 27).
13 CAMPATH is said to be a trademark of the Wellcome Foundation Ltd. (‘403 at
3:66-67)
14 EP 0 328 404 A1 (copy attached) is said to have been published on 16 August
1989.
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