Miljenko,
Want to echo V1 and your sentiments - it's the molecule that matters here.
That said, let's beat on the patents some more <g>:
I had said earlier that there was another reason that I believed that the CLTR ,542 patent does not block Zev, and it is even referenced inboth the ,542 and IDPH ,137 patents.
Many people have been reading the CLTR ,542 claims as covering any anti-CD20 (or even any specific anti-B cell) antibody conjugated to a radioisotope for lymphoma therapy. As I said yesterday, as far as CD-20 goes I believe that it can only cover the B1 antibody. The reason is prior art, and quoting form the ,137:
Murine (mouse) monoclonal antibody 1F5 (an anti-CD20 antibody)... Press, O. W. et al., "Treatment of Refractory Non-Hodgkin's Lymphoma with Radiolabeled MB-1 (Anti-CD37) Antibody" J. Clin. Onc. 7/8:1027-1038 (1989) (indication that one patient treated with .sup.131 I-labeled 1F-5 achieved a "partial response")
Thus we have a published clinical use of a radio-labeled anti-CD20 antibody (though not 2B8 or B1) to treat NHL that predates the filing of the ,542 predecessor by four years. Not a patent lawyer but that seems to say that the ,542 patent can not cover all anti-CD20 antibodies, only B1 and any others it calls out. As for broader claims on antibodies to other receptors, can't say.
The only blocking possibility remaining then is that the CLTR ,542 patent specifies in Claim 1:
wherein the amount of radioactivity that labels the antibody or antibody fragment is less than the amount which causes myelosuppression severe enough to require the reintroduction of hematopoietic stem cells into said patient in order for the patient to recover hematopoietic function
Is that novel and non-obvious? The IDPH patents actually state that pre-collection of stem cells for re-introduction is preferred; but also cites specifically non-bone marrow ablative doses. If Zev launches with labeling that its myelosuppression does not require stem cell support would that be infringement?
Most interesting is this quote from the IDPH patents:
Additionally, it is most preferred that prior to treatment a diagnostic dosimetry study using a diagnostic labeled antibody (eg, using indium ð111!) be conducted on the patient, a purpose of which is to ensure that the therapeutically labeled antibody (eg, using yttrium ð90!) will not become unnecessarily "concentrated" in any normal organ or tissue.
As PB suggested do the CLTR patents prevent IDPH from using diagnostic dosimetry with Zev, and does this partially explain why they don't use it?
biowa |
