Semglee® (insulin glargine-yfgn)

aBL 210605 / aBL 761201

Semglee® (insulin glargine-yfgn)

aBL 210605 / aBL 761201

U.S. License Holder:

Mylan Pharms. Inc.

Date of License:

June-11-2020; July-28-2021 (Interchangeable)

Last Update:

Nov-15-2024

approved_indications FDA-Approved Indications

SEMGLEE (insulin glargine) is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.

approved_indications Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In The E.U.

Semglee® (Mylan / Biocon) (March-2018)

Biosimilars Approved In Australia

Semglee® (Mylan / Biocon) (March-2018)

Biosimilars Approved In Japan

Insulin glargine BS (Biocon / Fujifilm Pharma) (March-2016)

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

IPR2017-01526

U.S. Patent No.
7,476,652 (Acidic Insulin Preparations having Improved Stability)

Patent Owner
Sanofi-Aventis Deutschland GmbH

Petitioner(s)
Biocon Limited; Biocon Research Ltd.; Mylan GmbH; Mylan Inc.; Mylan NV; Mylan Pharmaceuticals Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-25

Claim Types Challenged Under § 103
Formulation

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
19-1368 (Lead appeal, consolidated with 19-1369)

Supreme Court Appeal(s)
19A886; 19-1451

IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable); Federal Circuit Affirmed, Petitions for Panel Rehearing and Rehearing En Banc Denied; Supreme Court Denied Stay of Federal Circuit Mandate; Writ of Certiorari Denied

IPR2017-01528

U.S. Patent No.
7,713,930 (Acidic Insulin Preparations having Improved Stability)

Patent Owner
Sanofi-Aventis Deutschland GmbH

Petitioner(s)
Biocon Limited; Biocon Research Ltd.; Mylan GmbH; Mylan Inc.; Mylan NV; Mylan Pharmaceuticals Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-20

Claim Types Challenged Under § 103
Formulation

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
19-1369 (Consolidated with lead appeal 19-1368)

Supreme Court Appeal(s)
19A886; 19-1451

IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable); Federal Circuit Affirmed, Petitions for Panel Rehearing and Rehearing En Banc Denied; Supreme Court Denied Stay of Federal Circuit Mandate; Writ of Certiorari Denied

IPR2018-01670

U.S. Patent No.
8,679,069 (Pen-Type Injector)

Patent Owner
Sanofi-Aventis Deutschland GmbH

Petitioner(s)
Biocon Limited; Biocon Research Ltd.; Mylan GmbH; Mylan Inc.; Mylan Pharmaceuticals Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claim 1

Claim Types Challenged Under § 103
Other (Drug Delivery Device)

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
20-1871 (Lead appeal, consolidated with 20-2029, 20-2032, 20-2033, 20-2034, 20-2159)

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

IPR2018-01675

U.S. Patent No.
8,603,044 (Pen-Type Injector)

Patent Owner
Sanofi-Aventis Deutschland GmbH

Petitioner(s)
Biocon Limited; Biocon Research Ltd.; Mylan GmbH; Mylan Inc.; Mylan Pharmaceuticals Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 11, 14, 15, 18, 19

Claim Types Challenged Under § 103
Other (Drug Delivery Device)

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
20-2029 (Consolidated with lead appeal 20-1871)

IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable); Federal Circuit Appeal Dismissed as Moot

IPR2018-01676

U.S. Patent No.
8,603,044 (Pen-Type Injector)

Patent Owner
Sanofi-Aventis Deutschland GmbH

Petitioner(s)
Biocon Limited; Biocon Research Ltd.; Mylan GmbH; Mylan Inc.; Mylan Pharmaceuticals Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 11, 14, 15, 18, 19

Claim Types Challenged Under § 103
Other (Drug Delivery Device)

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
20-2032 (Consolidated with lead appeal 20-1871)

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

IPR2018-01677

U.S. Patent No.
8,992,486 (Pen-Type Injector)

Patent Owner
Sanofi-Aventis Deutschland GmbH

Petitioner(s)
Biocon Limited; Biocon Research Ltd.; Mylan GmbH; Mylan Inc.; Mylan Pharmaceuticals Inc.

§ 102 Challenge
Y: Claims 51-57

Claim Types Challenged Under § 102
Other (Drug Delivery Device)

§ 102 Challenge Instituted
Terminated Prior to Institution Decision

§ 103 challenge
Y: Claims 54-56

Claim Types Challenged Under § 103
Other (Drug Delivery Device)

§ 103 Challenge Instituted
Terminated Prior to Institution Decision

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Terminated Prior to Institution Decision - Petitioner Requested Dismissal Due to Clerical Error i

IPR Status
Dismissed at Petitioner's Request Prior to Institution Decision. Refiled as IPR2019-00122.

IPR2018-01678

U.S. Patent No.
8,992,486 (Pen-Type Injector)

Patent Owner
Sanofi-Aventis Deutschland GmbH

Petitioner(s)
Biocon Limited; Biocon Research Ltd.; Mylan GmbH; Mylan Inc.; Mylan Pharmaceuticals Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-6, 12-18, 20, 23, 26-30, 32-33, 36, 38-40

Claim Types Challenged Under § 103
Other (Drug Delivery Device)

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
20-2033 (Consolidated with lead appeal 20-1871)

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

IPR2018-01679

U.S. Patent No.
8,992,486 (Pen-Type Injector)

Patent Owner
Sanofi-Aventis Deutschland GmbH

Petitioner(s)
Biocon Limited; Biocon Research Ltd.; Mylan GmbH; Mylan Inc.; Mylan Pharmaceuticals Inc.

§ 102 Challenge
Y: Claims 51-57

Claim Types Challenged Under § 102
Other (Drug Delivery Device)

§ 102 Challenge Instituted
Y

§ 103 challenge
Y: Claims 54-56

Claim Types Challenged Under § 103
Other (Drug Delivery Device)

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
20-2066 (Lead appeal, consolidated with 20-2068, 20-2069)

IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable), Motion to Amend Denied; Federal Circuit Appeal Affirmed

IPR2018-01680

U.S. Patent No.
9,526,844 (Pen-type Injector)

Patent Owner
Sanofi-Aventis Deutschland GmbH

Petitioner(s)
Biocon Limited; Biocon Research Ltd.; Mylan GmbH; Mylan Inc.; Mylan Pharmaceuticals Inc.

§ 102 Challenge
Y: Claims 21-29

Claim Types Challenged Under § 102
Other (Drug Delivery Device)

§ 102 Challenge Instituted
Y

§ 103 challenge
Y: Claims 24-30

Claim Types Challenged Under § 103
Other (Drug Delivery Device)

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
20-2068 (Consolidated with lead appeal 20-2066)

IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable), Motion to Amend Denied; Federal Circuit Appeal Affirmed

IPR2018-01682

U.S. Patent No.
9,526,844 (Pen-type Injector)

Patent Owner
Sanofi-Aventis Deutschland GmbH

Petitioner(s)
Biocon Limited; Biocon Research Ltd.; Mylan GmbH; Mylan Inc.; Mylan Pharmaceuticals Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 21-30

Claim Types Challenged Under § 103
Other (Drug Delivery Device)

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
20-2069 (Consolidated with lead appeal 20-2066)

IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable), Motion to Amend Denied; Federal Circuit Appeal Dismissed as Moot

IPR2018-01684

U.S. Patent No.
9,604,008 (Drive Mechanisms Suitable for Use in Drug Delivery Devices)

Patent Owner
Sanofi-Aventis Deutschland GmbH

Petitioner(s)
Biocon Limited; Biocon Research Ltd.; Mylan GmbH; Mylan Inc.; Mylan Pharmaceuticals Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1, 3, 7, 8, 11, 17

Claim Types Challenged Under § 103
Other (Drug Delivery Device)

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
20-2071; 20-2139 and 20-2144 (Cross appeals) (Cross appeals consolidated with lead appeal 20-2071)

IPR Status
Final Written Decision (Some Instituted Claims Found Unpatentable); Federal Circuit Appeals 20-2139 and 20-2144 Withdrawn; Federal Circuit Appeal 20-2071 Affirmed

IPR2018-01696

U.S. Patent No.
9,526,844 (Pen-type Injector)

Patent Owner
Sanofi-Aventis Deutschland GmbH

Petitioner(s)
Biocon Limited; Biocon Research Ltd.; Mylan GmbH; Mylan Inc.; Mylan Pharmaceuticals Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 21-30

Claim Types Challenged Under § 103
Other (Drug Delivery Device)

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted

IPR2019-00122

U.S. Patent No.
8,992,486 (Pen-Type Injector)

Patent Owner
Sanofi-Aventis Deutschland GmbH

Petitioner(s)
Biocon Limited; Biocon Research Ltd.; Mylan GmbH; Mylan Inc.; Mylan NV; Mylan Pharmaceuticals Inc.; Becton, Dickinson and Company

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-6, 12-18, 20, 23, 26-30, 32, 33, 36, 38-40

Claim Types Challenged Under § 103
Other (Drug Delivery Device)

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
20-2034 (Consolidated with lead appeal 20-1871)

IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable); Federal Circuit Appeal Dismissed as Moot

IPR2019-01657

U.S. Patent No.
RE47,614 (Drug Delivery Device and Method of Manufacturing a Drug Delivery Device)

Patent Owner
Sanofi-Aventis Deutschland GmbH

Petitioner(s)
Mylan Pharmaceuticals Inc.; Biocon Biologics Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-18

Claim Types Challenged Under § 103
Other (Drug Delivery Device)

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
21-1981

IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable); Federal Circuit Reversed

IPR2019-01658

U.S. Patent No.
RE47,614 (Drug Delivery Device and Method of Manufacturing a Drug Delivery Device)

Patent Owner
Sanofi-Aventis Deutschland GmbH

Petitioner(s)
Mylan Pharmaceuticals Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-18

Claim Types Challenged Under § 103
Other (Drug Delivery Device)

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted

approved_indications U.S. Patent Litigations

PACER

Case No(s):

2:17-cv-09105 (D.N.J.)

U.S. Patent Nos.
7,476,652 (Acidic Insulin Preparations having Improved Stability) 7,713,930 (Acidic Insulin Preparations having Improved Stability) 7,918,833 (Pen-Type Injector) 8,512,297 (Pen-Type Injector) 8,556,864 (Drive Mechanisms Suitable for Use in Drug Delivery Devices) 8,603,044 (Pen-Type Injector) 8,679,069 (Pen-Type Injector) 8,992,486 (Pen-Type Injector) 9,011,391 (Pen-Type Injector) 9,233,211 (Relating to a Pen-Type Injector) 9,408,979 (Pen-Type Injector) 9,526,844 (Pen-type Injector) 9,533,105 (Drive Mechanisms Suitable For Use In Drug Delivery Devices) 9,561,331 (Drive Mechanisms Suitable for Use in Drug Delivery Devices) 9,604,008 (Drive Mechanisms Suitable for Use in Drug Delivery Devices) 9,604,009 (Drive Mechanisms Suitable for Use in Drug Delivery Devices) 9,610,409 (Drive Mechanisms Suitable for Use in Drug Delivery Devices) 9,623,189 (Relating to Drive Mechanisms Suitable for Use in Drug Delivery Devices)

Plaintiffs
Sanofi-Aventis U.S. LLC; Sanofi-Aventis Deutschland GmbH; Sanofi Winthrop Industrie

Defendants
Mylan Pharmaceuticals, Inc.; Mylan GmbH; Mylan Inc.; Mylan NV

Federal Circuit Appeal(s)
21-1262

Status
652 and '930 Patents: PTAB Found All Claims Unpatentable in IPRs; Federal Circuit Affirmed; Supreme Court Denied Certiorari; '044 and '069 Patents: District Court Decision Finding Patents Not Infringed; '486 and '008 Patents: Parties Dismissed Challenges; '844 Patent: District Court Decision Finding Claims 21, 22, 25 and 30 Not Infringed and Invalid; Federal Circuit Appeal Dismissed as Moot

BPCIA
N

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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.

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