This chart summarizes the case name, drug, patents-in-suit, and publicly available terms for reported settlements in federal district court cases that are filed pursuant to the Hatch-Waxman Act....more
8/5/2020
/ Abbreviated New Drug Application (ANDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Settlement Agreements
This chart tracks the date, drug, reference-listed company, and applicant of Abbreviated New Drug Applications and 505(b)(2) Applications receiving final approval by the FDA....more
8/4/2020
/ Abbreviated New Drug Application (ANDA) ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Life Sciences ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Amgen Inc. v. Amneal Pharms. LLC, 2018-2414, 2019-1086, 2020 U.S. App. LEXIS (Fed. Cir. Jan. 7, 2020) (Circuit Judges Newman, Lourie, and Taranto presiding; Opinion by Lourie, J.) (Appeal from D. Del., Goldberg,...more
5/27/2020
/ Abbreviated New Drug Application (ANDA) ,
Amgen ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Biogen Int’l GmbH v. Banner Life Sciences LLC, No. 18-2054-LPS, 2020 U.S. Dist. LEXIS 3639 (D. Del. Jan. 7, 2020) (Stark, J.)....more
5/26/2020
/ Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patent Term Extensions ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Hospira, Inc. v. Fresenius Kabi USA, LLC, 946 F.3d 1322 (Fed. Cir. Jan. 9, 2020) (Circuit Judges Lourie, Dyk, and Moore presiding; Opinion by Lourie, J.) (Appeal from N.D. Ill., Pallmeyer, J.)....more
5/22/2020
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Fresenius ,
Generic Drugs ,
Hatch-Waxman ,
Hospira ,
Intellectual Property Protection ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Takeda Pharms. U.S.A., Inc. v. Mylan Pharms., Inc., No. 19-2216-RGA, 2020 U.S. Dist. LEXIS 12753 (D. Del. Jan. 27, 2020) (Andrews, J.)....more
5/21/2020
/ Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Life Sciences ,
Mylan Pharmaceuticals ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Takeda Pharmaceuticals
Case Name: Galderma Labs., L.P. v. Teva Pharms. USA, Inc., No. 2019-2396 (Fed. Cir. Jan. 29, 2020) (Circuit Judges Moore, O’Malley, and Stoll presiding; Opinion by O’Malley, J.) (Appeal from D. Del., Andrews, J.).
...more
5/20/2020
/ Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Teva Pharmaceuticals
Case Name: Takeda Pharms. Co. v. Torrent Pharms. Ltd., No. 17-3186 (SRC)(CLW)(cons.), 2020 U.S. Dist. LEXIS 18069 (D.N.J. Feb. 4, 2020) (Chesler, J.)....more
5/19/2020
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Takeda Pharmaceuticals
Case Name: Piramal Healthcare US Ltd. v. Novartis Pharms. Corp., No. 19-12651 (SRC), 2020 U.S. Dist. LEXIS 38849 (D.N.J. Mar. 5, 2020) (Chesler, J.)....more
5/16/2020
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Life Sciences ,
Mootness ,
Novartis ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Boehringer Ingelheim Pharms., Inc. v. Mylan Pharms., Inc., No. 2019-1172, 2020 U.S. App. LEXIS 8393 (Fed. Cir. Mar. 16, 2020) (Circuit Judges Dyk, Moore, and Hughes presiding; Opinion by Moore, J.) (Appeal from...more
5/14/2020
/ Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Galderma Labs., L.P. v. Amneal Pharms. LLC, No. 2019-1021, 2020 U.S. App. LEXIS 9341 (Fed. Cir. Mar. 25, 2020) (Circuit Judges Lourie, Moore, and Stoll presiding; Opinion by Moore, J.) (Appeal from D. Del., Stark,...more
5/13/2020
/ Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Amarin Pharma, Inc. v. Hikma Pharms USA Inc., No. 16-cv-02525, 2020 WL 1517568 (D. Nev. March 30, 2020) (Du, J.)....more
5/13/2020
/ Abbreviated New Drug Application (ANDA) ,
Amarin ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Belcher Pharms., LLC v. Hospira, Inc., No. 17-775-LPS, 2020 WL 1650535 (D. Del. Mar. 31, 2020) (Stark, J.) -
Drug Product and Patent(s)-in-Suit: epinephrine injection; U.S. Patent No. 9,283,197 (“the ’197...more
5/11/2020
/ Generic Drugs ,
Hatch-Waxman ,
Hospira ,
Intellectual Property Protection ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Please see Chart below for more information.
...more
Please see Chart below for more information.
...more
Please see Chart below for more information.
...more
5/4/2020
/ Abbreviated New Drug Application (ANDA) ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Life Sciences ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Please see Chart below for more information.
...more
THE DISTRICT COURT’S FINDINGS REGARDING INDEFINITENESS, NON-INFRINGEMENT, AND NON-OBVIOUSNESS WERE AFFIRMED BY THE APPELLATE COURT.
Case Name: HZNP Medicines LLC v. Actavis Labs. UT, Inc., No. 2017-2149, -2152, -2153,...more
2/14/2020
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Life Sciences ,
Obviousness ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Product Labels
BECAUSE DELAWARE WAS AN IMPROPER VENUE FOR DEFENDANT MYLAN, AND DEFENDANT 3M DEMONSTRATED THAT VARIOUS FACTORS WEIGHED IN FAVOR OF A TRANSFER, THE CASE WAS TRANSFERRED TO THE NORTHERN DISTRICT OF WEST VIRGINIA.
Case...more
2/13/2020
/ 3M Company ,
Abbreviated New Drug Application (ANDA) ,
AstraZeneca ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Mootness ,
Motion to Dismiss ,
Mylan Pharmaceuticals ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
RELYING ON A FEDERAL CIRCUIT DECISION THAT INVALIDATED FOR LACKING AN ADEQUATE WRITTEN DESCRIPTION A PATENT FROM WHICH THE PATENTS-IN-SUIT DESCEND, THE COURT DENIED PLAINTIFF’S MOTION FOR A PRELIMINARY INJUNCTION FOR FAILING...more
2/12/2020
/ Abbreviated New Drug Application (ANDA) ,
Dr. Reddy’s Labs. ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
WHILE ITS DECISION WAS A “CLOSE CALL,” THE COURT WAS NOT PREPARED TO FIND THAT PLAINTIFF’S TACTICS ENTIRELY BASELESS OR ITS LITIGATION CONDUCT SO EGREGIOUS AS TO WARRANT FEES.
Case Name:Reckitt Benckiser LLC v. Amneal...more
2/11/2020
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
SUMMARY JUDGMENT OF NO CONTRIBUTORY INFRINGEMENT GRANTED BUT DENIED WITH RESPECT TO INDUCED INFRINGEMENT.
Case Name: Amarin Pharma, Inc. v. West-Ward Pharms. Int’l Ltd., No. 2:16-cv-02525-MMD-NJK, 2019 U.S. Dist. LEXIS...more
2/10/2020
/ Abbreviated New Drug Application (ANDA) ,
Amarin ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
AFTER A FIVE-DAY JURY TRIAL FINDING NON-INFRINGEMENT, PLAINTIFF’S RULE 59(E) MOTION FOR A NEW TRIAL WAS DENIED.
Case Name:Orexo AB v. Actavis Elizabeth LLC, No. 17-205-CFC, 2019 U.S. Dist. LEXIS 213415 (D. Del. Dec. 11,...more
2/7/2020
/ Actavis Inc. ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Motion For New Trial ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Persion Pharms. LLC v. Alvogen Malta Operations Ltd., 2018-2361, 945 F.3d 1184 (Fed. Cir. Dec. 27, 2019) (Judges O’Malley, Reyna, and Chen presiding; Opinion by Reyna, J.) (Appeal from D. Del., Bryson, J.)....more
2/6/2020
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Please see Chart below for more information.
...more
2/5/2020
/ Abbreviated New Drug Application (ANDA) ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs