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
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
THE COURT GRANTED PLAINTIFFS’ MOTION TO DISMISS DEFENDANT’S ANTITRUST AND PATENT MISUSE COUNTERCLAIMS AND RELATED AFFIRMATIVE DEFENSES.
Case Name: Duke Univ. v. Akorn, Inc., Civ. No. 3:18-cv-14035-BRM-TJB, 2019 U.S. Dist....more
12/11/2019
/ Abbreviated New Drug Application (ANDA) ,
Counterclaims ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Motion to Dismiss ,
Noerr-Pennington Doctrine ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patent-Misuse ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
Prescription Drugs ,
USPTO
Please see full Chart below for more information....more
12/6/2019
/ Abbreviated New Drug Application (ANDA) ,
Counterclaims ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Litigation Fees & Costs ,
Motion to Dismiss ,
Orange Book ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Settlement ,
Summary Judgment
RELYING ON PLAINTIFFS’ TESTING OF DEFENDANT’S ANDA PRODUCT, AND FINDING THAT THE PRIOR ART TAUGHT AWAY FROM THE CLAIMED INVENTION, THE COURT HELD THE ASSERTED CLAIMS VALID AND INFRINGED.
Case Name: Bausch Health Cos. v....more
12/4/2019
/ Abbreviated New Drug Application (ANDA) ,
Actavis Inc. ,
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
THE COURT DENIES DEFENDANT’S MOTION FOR JUDGMENT OF NON-INFRINGEMENT IN RESPONSE TO ANDA HOLDER MODIFICATION OF ITS ANDA SPECIFICATION AFTER TRIAL.
Case Name: Forest Labs., LLC v. Sigmapharm Labs., LLC, No. 14-1119- MSG...more
12/3/2019
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Forest Laboratories ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
BECAUSE PLAINTIFFS FAILED TO SHOW SPECIFICALLY HOW DEFENDANTS COMMITTED ANY ACT OF INFRINGEMENT IN NEW JERSEY—PARTICULARLY BY FILING AN ANDA IN WEST VIRGINIA WITH THE FDA IN MARYLAND—OR THAT ANY FUTURE, INTENDED ACTS WERE A...more
12/2/2019
/ Abbreviated New Drug Application (ANDA) ,
Declaratory Judgments ,
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 ,
Valeant ,
Venue
THE ASSERTED CLAIMS OF 1% IVERMECTIN FORMULATION ARE INVALID ON THE BASIS OF ANTICIPATION IN LIGHT OF A PRIOR ART REFERENCE THAT TEACHES APPLICATION OF 1-5% IVERMECTIN FORMULATION FOR TREATMENT OF THE SAME INDICATION.
Case...more
11/26/2019
/ 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 ,
Teva Pharmaceuticals
THE COURT DENIED DEFENDANT’S MOTION TO ENFORCE ITS SETTLEMENT AGREEMENT WITH PLAINTIFF AFTER THE AT-RISK LAUNCH AND SUBSEQUENT SETTLEMENT OF ANOTHER DEFENDANT.
Case Name: Amgen Inc. v. Amneal Pharms. LLC, No. 16-853-MSG...more
11/25/2019
/ Abbreviated New Drug Application (ANDA) ,
Amgen ,
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
WHERE THE DEFENDANTS SOUGHT OUT A CLAIM CONSTRUCTION IN THE DISTRICT COURT, THE FEDERAL CIRCUIT AFFIRMED A FINDING OF NON-INFRINGEMENT, AND WHERE THE DEFENDANT DID NOT SEEK A CLARIFYING CLAIM CONSTRUCTION, THE FEDERAL CIRCUIT...more
11/22/2019
/ Abbreviated New Drug Application (ANDA) ,
Dr. Reddy’s Labs. ,
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