Simply stated, NW Bio's DCVax product and treatment regimen do not fall within the narrow sequence and timing covered by the '090 patent. The purpose and focus of NW Bio's clinical trials is to prove that DCVax is an effective treatment on its own. Moreover, when NW Bio's DCVax reaches commercialization, the treating physician, not NW Bio, will be the party who administers DCVax, and who determines what further treatment to use in the event of recurrence. NW Bio does not advise on post-recurrence therapies other than the use of its vaccine. It is the physician who will determine whether to administer chemotherapy and, if so, which type of chemotherapy and in what manner.
Additionally, all of these treatment activities can be undertaken by the physician free of the '090 patent in a variety of ways. For example, step (b) of the patent was narrowed following USPTO rejections so as to include only the specific drugs listed. This list does not include the chemotherapy that doctors usually prescribe today after glioma recurrence (Avastin).
Cedars Sinai/IMUC application sought a patent for "treating a disease condition in a mammal" but this was rejected by the USPTO. Indeed, the USPTO would not even allow coverage of all cancers, or even all cancers of the central nervous system. The patent claim was narrowed to just "treating a glioma in a mammal." Glioma is only one of multiple sub-types of one cancer: pr
|SOURCE Northwest Biotherapeutics|
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