MZ,
Thanks for posting the links.
Actually you'll note that I'm not proclaiming victory for CLTR. In fact, I'm very dubious of the analysis that says that the ,542 patent is a blocking patent.
I did read the IDPH patents, however, and they alone don't conclusively rebut the blocking patent theorists:
2) ,137 is the composition of matter patent, but fails to bear a claim on radioimmunoconjugates (it does recite them in the invention description), to wit:
Claims
1. Immunologically active, chimeric anti-CD20 antibody produced from a transfectoma comprising anti-CD20 in TCAE 8, ATCC deposit number 69119.
2. A pharmaceutical composition comprising the anti-CD20 antibody of claim 1 in a pharmaceutically acceptable carrier.
3. The composition of claim 2, which contains a pharmaceutically acceptable carrier or excipient selected from the group consisting of sterile saline, sterile buffered water,
propylene glycol and mixtures thereof.
4. The composition of claim 2, which contains a pharmaceutically acceptable dosage of the antibody which ranges from about 0.001 to about 30 mg/kg of human body weight.
5. The composition of claim 4, which contains a pharmaceutically acceptable dosage of the antibody which ranges from about 0.01 to about 25 mg/kg human body weight.
6. The composition of claim 5, which contains a pharmaceutically acceptable dosage of the antibody which ranges from about 0.4 to about 20.0 mg/kg human body weight.
2) ,456 is a methods patent not a composition of matter patent (but does include a claim to using a radio-labeled anti-CD20 antibody FOLLOWING a naked anti-CD20), to wit:
Claims
1. A method for treatment of B cell lymphoma comprising the step of administering a therapeutically effective amount of immunologically active chimeric anti-CD20 antibody to a
human, said antibody being derived from a transfectoma comprising anti-CD20 in TCAE 8, ATCC deposit number 69119.
2. The method of claim 1 wherein the amount of said antibody administered to said human is between about 0.001 to about 30 milligrams of antibody per kilogram body weight of
said human ("mg/kg").
3. The method of claim 1 further comprising the step of administering a second therapeutically effective amount of said chimeric anti-CD20 antibody to said human.
4. The method of claim 3 wherein said additional administration of said antibody to said human occurs within about seven days of said first administration of said antibody to said
human.
5. A method for the treatment of B cell lymphoma comprising the steps of:
1) administering, at a first administration period, an immunologically active chimeric anti-CD20 antibody to a human, wherein said chimeric anti-CD20 antibody is derived from a
transfectoma comprising anti-CD20 in TCAE 8 as deposited with the American Type Culture Collection as ATCC deposit number 69119; and,
2) administering, at a second administration period, a radiolabeled anti-CD20 antibody to said human.
6. The method of claim 5 wherein said radiolabeled anti-CD20 antibody comprises a monoclonal antibody secreted from a hybridoma identified by American Type Culture
Collection deposit number HB 11388.
7. A method for the treatment of B cell lymphoma comprising the steps of:
1) administering to a human having B cell lymphoma, at a first administration period, a first therapeutically effective amount of immunologically active chimeric anti-CD20
antibody produced by a transfectoma comprising anti-CD20 in TCAE8, ATCC deposit number 69119;
2) administering at a second subsequent administration period, a second therapeutically effective amount of said antibody; and
3) administering, at a third subsequent administration period, a third therapeutically effective amount of said antibody.
8. The method of claim 7, wherein said first, second and third therapeutically effective amount of said antibody is between 0.001 mg/kg to about 30 mg/kg.
9. The method of claim 7, wherein said second administration period is within about seven days of said first administration period.
10. The method of claim 7, wherein said third administration period is within about fourteen days of said first administration period.
11. The method of claim 1, which further includes the administration of at least one chemotherapeutic agent.
12. The method of claim 11, wherein the chemotherapeutic agent is administered after the administration of said immunologically active chimeric anti-CD20 antibody.
13. The method of claim 11, wherein the chemotherapeutic agent is administered prior to the administration of said immunologically active chimeric anti-CD20 antibody.
14. The method of claim 11, wherein the chemotherapeutic agents are selected from the group consisting of cyclophosphamide doxorubicin, vincristine and prednisone.
Thus, on the surface, IDPH does not have a composition of matter patent on radioimmunoconjugates for B-cell lymphoma. Both patents are also very specific in reciting the specific clone for the 2B8 antibody in the claims. Thus, IDPH from these patents does not have a blocking position on CLTR. Also, absent seeing the actual review files, these two patents would not seem to interfere with ,542.
I continue to believe that the ,542 patent does not constitute a blocking patent for other reasons, and that it covers B1 and the IDPH estate covers 2B8. It is interesting how much more broad the allowed claims are for ,542 vs. that of the previously issued ,137 (and ,456):
Claims
1. A composition comprising:
(1) a radioactively labelled monoclonal antibody or radioactively labelled monoclonal antibody fragment in an amount providing 1 to 200 mCi of radioactivity and providing irradiation in a dose range of 10 to 200 cGy to the whole body of a human patient, said amount being effective for achieving remission of B-cell lymphoma in the patient,wherein said antibody or said antibody fragment binds to CD20 antigen present on the surface of cells of B-cell lymphoma and 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 saidpatient in order for the patient to recover hematopoietic function, and
(2) a pharmaceutically acceptable carrier.<snip>
Once again, without seeing the file, we can't tell if this was intentional, or if the original claims were that different in scope, or if this reflects a difference in reviewers.
Two more observations not sure of their significance. First ,542 specifies an amount of radioactivity less than that which causes myelosuppression, while ,137 specifically includes stem cell harvest in the preferred embodiment. Second, both ,137 and ,456 specify a purging dose with naked anti-CD20 antibody, while ,542 does not.
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