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.