Emgality® (galcanezumab-gnlm)

BL 761063

Emgality® (galcanezumab-gnlm)

BL 761063

U.S. License Holder:

Eli Lilly & Co.

Date of License:

September-27-2018

Last Update:

Dec-15-2024

approved_indications FDA-Approved Indications

EMGALITY (galcanezumab-gnlm) is a calcitonin-gene related peptide antagonist indicated in adults for the:

Preventive treatment of migraine;

Treatment of episodic cluster headache.

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

IPR2018-01422

U.S. Patent No.
9,340,614 (Antagonist Antibodies Directed Against Calcitonin Gene-related Peptide and Methods Using Same)

Patent Owner
Teva Pharmaceuticals International GmbH

Petitioner(s)
Eli Lilly & Co.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-7, 15-20

Claim Types Challenged Under § 103
Composition of Matter Formulation

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
20-1747

IPR Status
Final Written Decision (All Challenged Claims Found Unpatentable); Federal Circuit Appeal Affirmed

IPR2018-01423

U.S. Patent No.
9,266,951 (Antagonist Antibodies Directed Against Calcitonin Gene-related Peptide and Methods Using Same)

Patent Owner
Teva Pharmaceuticals International GmbH

Petitioner(s)
Eli Lilly & Co.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-6, 14-19

Claim Types Challenged Under § 103
Composition of Matter Formulation

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
20-1748

IPR Status
Final Written Decision (All Challenged Claims Found Unpatentable); Federal Circuit Appeal Affirmed

IPR2018-01424

U.S. Patent No.
9,346,881 (Antagonist Antibodies Directed Against Calcitonin Gene-related Peptide and Methods Using Same)

Patent Owner
Teva Pharmaceuticals International GmbH

Petitioner(s)
Eli Lilly & Co.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-6, 14-19

Claim Types Challenged Under § 103
Composition of Matter Formulation

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
20-1749

IPR Status
Final Written Decision (All Challenged Claims Found Unpatentable); Federal Circuit Appeal Affirmed

IPR2018-01425

U.S. Patent No.
9,890,210 (Antagonist Antibodies Directed Against Calcitonin Gene-related Peptide)

Patent Owner
Teva Pharmaceuticals International GmbH

Petitioner(s)
Eli Lilly & Co.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-15

Claim Types Challenged Under § 103
Composition of Matter

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
20-1750

IPR Status
Final Written Decision (All Challenged Claims Found Unpatentable); Federal Circuit Appeal Affirmed

IPR2018-01426

U.S. Patent No.
9,890,211 (Antagonist Antibodies Directed Against Calcitonin Gene-related Peptide)

Patent Owner
Teva Pharmaceuticals International GmbH

Petitioner(s)
Eli Lilly & Co.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-15

Claim Types Challenged Under § 103
Composition of Matter

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
20-1751

IPR Status
Final Written Decision (All Challenged Claims Found Unpatentable); Federal Circuit Appeal Affirmed

IPR2018-01427

U.S. Patent No.
8,597,649 (Antagonist Antibodies Directed Against Calcitonin Gene-related Peptide and Methods Using Same)

Patent Owner
Teva Pharmaceuticals International GmbH

Petitioner(s)
Eli Lilly & Co.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-9

Claim Types Challenged Under § 103
Composition of Matter Formulation

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
20-1752

IPR Status
Final Written Decision (All Challenged Claims Found Unpatentable); Federal Circuit Appeal Affirmed

IPR2018-01710

U.S. Patent No.
8,586,045 (Methods of Using Anti-CGRP Antagonist Antibodies)

Patent Owner
Teva Pharmaceuticals International GmbH

Petitioner(s)
Eli Lilly & Co.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1, 3, 4, 8-17, 19, 20, 24-31

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
20-1876 (lead, consolidated with 20-1877 and 20-1878)

IPR Status
Final Written Decision (No Challenged Claims Found Unpatentable); Federal Circuit Appeal Affirmed

IPR2018-01711

U.S. Patent No.
9,884,907 (Methods for Treating Headache Using Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide)

Patent Owner
Teva Pharmaceuticals International GmbH

Petitioner(s)
Eli Lilly & Co.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-18

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
20-1877 (consolidated with lead appeal 20-1876)

IPR Status
Final Written Decision (No Challenged Claims Found Unpatentable); Federal Circuit Appeal Affirmed

IPR2018-01712

U.S. Patent No.
9,884,908 (Methods for Treating Headache Using Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide)

Patent Owner
Teva Pharmaceuticals International GmbH

Petitioner(s)
Eli Lilly & Co.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-18

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
20-1878 (consolidated with lead appeal 20-1876)

IPR Status
Final Written Decision (No Challenged Claims Found Unpatentable); Federal Circuit Appeal Affirmed

IPR2022-00738

U.S. Patent No.
11,028,160 (Treating Refractory Migraine)

Patent Owner
Teva Pharmaceuticals International GmbH

Petitioner(s)
Eli Lilly & Co.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-30

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

IPR Status
Final Written Decision (All Challenged Claims Found Unpatentable)

IPR2022-00739

U.S. Patent No.
11,028,161 (Treating Refractory Migraine)

Patent Owner
Teva Pharmaceuticals International GmbH

Petitioner(s)
Eli Lilly & Co.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-30

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

IPR Status
Final Written Decision (All Challenged Claims Found Unpatentable)

IPR2022-00796

U.S. Patent No.
10,392,434 (Treating Refractory Migraine)

Patent Owner
Teva Pharmaceuticals International GmbH; Teva Pharmaceuticals USA, Inc.

Petitioner(s)
Eli Lilly & Co.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-13

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

IPR Status
Final Written Decision (All Challenged Claims Found Unpatentable)

approved_indications U.S. Patent Litigations

PACER

Case No(s):

1:17-cv-12087 (D. Mass.)

U.S. Patent Nos.
8,586,045 (Methods of Using Anti-CGRP Antagonist Antibodies) 8,597,649 (Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide and Methods Using Same) 9,266,951 (Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide and Methods Using Same) 9,340,614 (Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide and Methods Using Same) 9,346,881 (Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide and Methods Using Same)

Plaintiffs
Teva Pharmaceuticals International GmbH, Teva Pharmaceuticals USA, Inc.

Defendants
Eli Lilly & Co.

Status
Dismissed

BPCIA
N

1:18-cv-10242 (D. Mass.)

U.S. Patent Nos.
9,884,907 (Methods for Treating Headache Using Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide) 9,884,908 (Methods for Treating Headache Using Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide) 9,890,210 (Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide) 9,890,211 (Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide)

Plaintiffs
Teva Pharmaceuticals International GmbH; Teva Pharmaceuticals USA, Inc.

Defendants
Eli Lilly & Co.

Status
Dismissed

BPCIA
N

1:18-cv-12029 (D. Mass.)

U.S. Patent Nos.
8,586,045 (Methods of Using Anti-CGRP Antagonist Antibodies) 8,597,649 (Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide and Methods Using Same) 9,266,951 (Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide and Methods Using Same) 9,340,614 (Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide and Methods Using Same) 9,346,881 (Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide and Methods Using Same) 9,884,907 (Methods for Treating Headache Using Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide) 9,884,908 (Methods for Treating Headache Using Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide) 9,890,210 (Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide) 9,890,211 (Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide)

Plaintiffs
Teva Pharmaceuticals International GmbH, Teva Pharmaceuticals USA, Inc.

Defendants
Eli Lilly & Co.

Federal Circuit Appeal(s)
24-1094 (Lead); 24-1149 (Cross appeal, consolidated)

Status
Challenges to '649, '951, '614, '881, '210, and '211 Patents Dismissed; Jury Verdict (Claims Valid and Infringed); JMOL Granted: All Asserted Claims of '045, '907, and '908 Patent Invalid; Federal Circuit Appeal and Cross Appeal Pending

BPCIA
N

1:21-cv-10954 (D. Mass.)

U.S. Patent Nos.
11,028,160 (Treating Refractory Migraine) 11,028,161 (Treating Refractory Migraine)

Plaintiffs
Teva Pharmaceuticals International GmbH, Teva Pharmaceuticals USA, Inc.

Defendants
Eli Lilly & Co.

Status
Stipulated Dismissal (Claims Found Unpatentable in IPRs)

BPCIA
N

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