Ajovy® (fremanezumab-vfrm)

BL 761089

Ajovy® (fremanezumab-vfrm)

BL 761089

U.S. License Holder:

Teva Pharms. USA

Date of License:

September-14-2018

Last Update:

Nov-15-2024

approved_indications FDA-Approved Indications

AJOVY (fremanezumab-vfrm) is a calcitonin gene-related peptide antagonist indicated for the preventive treatment of migraine in adults.

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

Related News

Venable’s BiologicsHQ Monthly Injection – September 2023
Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
October 16, 2023
Venable’s BiologicsHQ Monthly Injection – November 2022
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D.
December 14, 2022
Venable’s BiologicsHQ Monthly Injection – October 2022
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D.
November 14, 2022
Venable’s BiologicsHQ Monthly Injection – September 2022
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D.
October 11, 2022
Venable’s BiologicsHQ Monthly Injection – April 2022
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
May 9, 2022
Venable’s BiologicsHQ Monthly Injection – March 2022
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
April 18, 2022
Venable’s BiologicsHQ Monthly Injection – August 2021
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D.
September 8, 2021
Venable’s BiologicsHQ Monthly Injection – June 2021
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
July 13, 2021
Venable’s BiologicsHQ Monthly Injection – June 2020
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
July 9, 2020
Venable’s BiologicsHQ Monthly Injection – April 2020
April Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D. Ha Kung Wong
May 6, 2020
Venable’s BiologicsHQ Monthly Injection – March 2020
April Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D. Ha Kung Wong
April 8, 2020
Venable’s BiologicsHQ Monthly Injection – February 2020
April Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D. Ha Kung Wong
March 12, 2020
Venable’s BiologicsHQ Monthly Injection – April 2019
April Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D.
May 7, 2019
Venable’s BiologicsHQ Monthly Injection – February 2019
April Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D.
March 6, 2019
Venable’s BiologicsHQ Monthly Injection – October 2018
April M. Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D.
November 12, 2018
Venable’s BiologicsHQ Monthly Injection – September 2018
April M. Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D.
October 6, 2018

Methodology

Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

Disclaimer

The individuals who maintain this site work for Venable LLP. The information, comments and links posted on this site do not constitute legal advice. No attorney-client relationship has been or will be formed by any communication(s) to, from or with the site and/or the author. For legal advice, contact an attorney at Venable LLP or an attorney actively practicing in your jurisdiction. Do not send any confidential or privileged information to the author; neither Venable LLP nor the author will assume any liability or responsibility for it. If you send any information, documents or materials to the site, you give permission for the author to include them on or in the site. No information, documents or materials you send to the site will be considered confidential or privileged by Venable LLP or its lawyers. Also, no such information, documents or materials will be returned to you. All decisions relating to the content belong to the author.

Subscribe for Future Updates

    captcha