Friday, October 5, 2018

Rituximab - USA


IPR decision (Oct 04, 2018):

AIA Review

Filing Date
Institution Date
Petitioner
Patent No.
Final Written Decision
IPR2017-01095
03/15/2017
10/06/2017
Celltrion Inc.
9,296,821
Claims 1–6 are unpatentable
On US’821 patent, Pfizer previously filed IPR (IPR2018-00186) which was instituted on 06/14/2018.

US 9,296,821 (Biogen Inc; Exp: Jun 11, 2019)

1. A method for treating low grade or follicular non-Hodgkin's lymphoma (NHL) comprising administering to a patient a therapeutically effective amount of rituximab during a chemotherapeutic regimen, wherein the chemotherapeutic regimen consists of cyclophosphamide, vincristine, and prednisone (CVP therapy), wherein the method comprises administering 375 mg/m.sup.2 of rituximab, and wherein the method provides a beneficial synergistic effect in the patient.

2. A method for treating low grade or follicular non-Hodgkin's lymphoma (NHL) comprising administering to a patient 375 mg/m.sup.2 of C2B8 during a chemotherapeutic regimen consisting of cyclophosphamide, vincristine, and prednisone (CVP therapy).

3. A method for treating low grade or follicular non-Hodgkin's lymphoma (NHL) comprising administering to a patient 375 mg/m.sup.2 of a chimeric anti-CD20 antibody during a chemotherapeutic regimen consisting of cyclophosphamide, vincristine, and prednisone (CVP therapy), wherein the chimeric anti-CD20 antibody is produced from nucleic acid encoding a light chain variable region comprising the amino acid sequence in SEQ ID NO: 1 and a heavy chain variable region comprising the amino acid sequence in SEQ ID NO: 2, and comprises human gamma 1 heavy-chain and kappa light-chain constant region sequences.

4. A method for treating low grade or follicular non-Hodgkin's lymphoma (NHL) comprising administering to a patient a therapeutically effective amount of rituximab during a chemotherapeutic regimen, wherein the chemotherapeutic regimen consists of cyclophosphamide, vincristine, and prednisone (CVP therapy), wherein the method comprises administering 375 mg/m.sup.2 of rituximab once every 3 weeks for 8 doses, and wherein the method provides a beneficial synergistic effect in the patient.

5. A method for treating low grade or follicular non-Hodgkin's lymphoma (NHL) comprising administering to a patient 375 mg/m.sup.2 of C2B8 once every 3 weeks for 8 doses during a chemotherapeutic regimen consisting of cyclophosphamide, vincristine, and prednisone (CVP therapy).

6. A method for treating low grade or follicular non-Hodgkin's lymphoma (NHL) comprising administering to a patient 375 mg/m.sup.2 of a chimeric anti-CD20 antibody once every 3 weeks for 8 doses during a chemotherapeutic regimen consisting of cyclophosphamide, vincristine, and prednisone (CVP therapy), wherein the chimeric anti-CD20 antibody is produced from nucleic acid encoding a light chain variable region comprising the amino acid sequence in SEQ ID NO: 1 and a heavy chain variable region comprising the amino acid sequence in SEQ ID NO: 2, and comprises human gamma 1 heavy-chain and kappa light-chain constant region sequences.

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