Fremanezumab / Galcanezumab – USA

Fremanezumab / Galcanezumab – USA

IPR decision: Feb 18, 2020

AIA Review #
Filing Date
Institution Date
Petitioner
Patent
Respondent
FINAL WRITTEN DECISION
IPR2018-01422
08/08/2018
02/19/2019
Eli Lilly and Company
9,340,614
Teva Pharma
Challenged Claims Unpatentable
IPR2018-01423
08/08/2018
02/19/2019
Eli Lilly and Company
9,266,951
Teva Pharma
Challenged Claims Unpatentable
IPR2018-01424
08/08/2018
02/19/2019
Eli Lilly and Company
9,346,881
Teva Pharma
Challenged Claims Unpatentable
IPR2018-01425
08/08/2018
02/25/2019
Eli Lilly and Company
9,890,210
Teva Pharma
Challenged Claims Unpatentable
IPR2018-01426
08/08/2018
02/25/2019
Eli Lilly and Company
9,890,211
Teva Pharma
Challenged Claims Unpatentable
IPR2018-01427
08/08/2018
02/25/2019
Eli Lilly and Company
8,597,649
Teva Pharma
Challenged Claims Unpatentable
US  9,340,614 (Labrys Biologics, Inc.; Exp:11/02/2026):

1. A human or humanized monoclonal anti-CGRP antagonist antibody that preferentially binds to human .alpha.-CGRP as compared to amylin.

US  9,266,951 (Labrys Biologics, Inc.; Exp:11/02/2026):

1. A human or humanized monoclonal anti-CGRP antagonist antibody that (1) binds human .alpha.-CGRP and (2) inhibits cyclic adenosine monophosphate (cAMP) activation in cells.
US  9,346,881 (Labrys Biologics, Inc.; Exp:11/02/2026):

1. A human or humanized, monoclonal anti-CGRP antagonist antibody that (1) binds human .alpha.-CGRP and (2) inhibits human .alpha.-CGRP from binding to its receptor as measured by a radioligand binding assay in SK-N-MC cells.

US  9,890,210 (Teva Pharmaceuticals International GmbH.; Exp: 11/02/2026):

1. A humanized monoclonal anti-Calcitonin Gene-Related Peptide (CGRP) antagonist antibody, comprising: two human IgG heavy chains, each heavy chain comprising three complementarity determining regions (CDRs) and four framework regions, wherein portions of the two heavy chains together form an Fc region; and two light chains, each light chain comprising three CDRs and four framework regions; wherein the CDRs impart to the antibody specific binding to a CGRP consisting of amino acid residues 1 to 37 of SEQ ID NO:15 or SEQ ID NO: 43.

US  9,890,211 (Teva Pharmaceuticals International GmbH; Exp: 11/02/2026):

1. A humanized monoclonal anti-Calcitonin Gene-Related Peptide (CGRP) antagonist antibody, comprising: two human IgG heavy chains, each heavy chain comprising three complementarity determining regions (CDRs) and four framework regions, wherein portions of the two heavy chains together form an Fc region; and two light chains, each light chain comprising three CDRs and four framework regions; wherein the CDRs impart to the antibody specific binding to a CGRP consisting of amino acid residues 1 to 37 of SEQ ID NO:15 or SEQ ID NO: 43, and wherein the antibody binds to the CGRP with a binding affinity (K.sub.D) of about 10 nM or less as measured by surface plasmon resonance at 370C.

US  8,597,649 (Labrys Biologics, Inc.; Exp:11/02/2026):

1. An isolated human or humanized anti-CGRP antagonist antibody with a binding affinity (K.sub.D) to human .alpha.-CGRP of 50 nM or less as measured by surface plasmon resonance at 370C.

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