Oren Langer on Food and Drug Administration (FDA)

Bristol-Myers Squibb Co. v. Aurobindo Pharma USA Inc.

Eliquis®/apixaban - Case Name: Bristol-Myers Squibb Co. v. Aurobindo Pharma USA Inc., No. 17-374-LPS (Consolidated), 2020 WL 4500226 (D. Del. Aug. 5, 2020) (Stark, J.)...more

11/2/2020 / Abbreviated New Drug Application (ANDA) , Bristol-Myers Squibb , 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

Sun Pharm. Indus. Ltd. v. Saptalis Pharms., LLC

Riomet®/metformin HCl - Case Name: Sun Pharm. Indus. Ltd. v. Saptalis Pharms., LLC, No. 18-648-WCB, 2020 WL 5077412 (D. Del. Aug. 6, 2020) (Bryson, J.)... Drug Product and Patent(s)-in-Suit: Riomet® (metformin HCl);...more

10/30/2020 / 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

Noven Pharm., Inc. v. Amneal Pharms. LLC

Case Name: Noven Pharm., Inc. v. Amneal Pharms. LLC, No. 18-cv-00699 (D. Del. Sept. 2, 2020) (Stark, J.)... Drug Product and Patent(s)-in-Suit: Minivelle® (estradiol); U.S. Patents Nos. 9,833,419 (“the ’419 patent”),...more

10/28/2020 / 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

Biogen Int’l GmbH v. Amneal Pharmaceuticals LLC

Case Name: Biogen Int’l GmbH v. Amneal Pharmaceuticals LLC, Civ. No. 17-823 (MN), 2020 WL 5549084 (D. Del. Sept. 16, 2020) (Noreika, J.)... Drug Product and Patent(s)-in-Suit: Tecfidera® (dimethyl fumarate (“DMF”)...more

10/27/2020 / 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

Generic Launches - Fall 2020

This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications. ...more

10/23/2020 / 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

ANDA Approvals - Fall 2020

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

10/21/2020 / Abbreviated New Drug Application (ANDA) , Food and Drug Administration (FDA) , Generic Drugs , Hatch-Waxman , Intellectual Property Protection , Life Sciences , Patent Applications , Patents , Pharmaceutical Industry , Pharmaceutical Patents , Prescription Drugs

Celgene Corp. v. Sun Pharma Global FZE

SUBJECT-MATTER JURISDICTION UNDER THE HATCH-WAXMAN ACT DOES NOT REQUIRE (I) A PARAGRAPH IV CERTIFICATION BY THE ANDA HOLDER; OR (II) THE PATENTS-IN-SUIT TO BE LISTED IN THE ORANGE BOOK. Case Name: Celgene Corp. v. Sun...more

8/24/2020 / 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

Valeant Pharms Int’l, Inc. v. Mylan Pharms Inc.

BECAUSE THE PRIOR ART TAUGHT OVERLAPPING PH RANGES AND STRUCTURALLY SIMILAR COMPOUNDS AS THOSE CLAIMED IN THE PATENT-IN-SUIT, THE FEDERAL CIRCUIT REVERSED SUMMARY JUDGMENT OF NON-OBVIOUSNESS. Case Name: Valeant Pharms...more

8/21/2020 / Abbreviated New Drug Application (ANDA) , Food and Drug Administration (FDA) , Generic Drugs , Hatch-Waxman , Intellectual Property Protection , Life Sciences , Mylan Pharmaceuticals , Obviousness , Patent Infringement , Patent Litigation , Patent-in-Suit , Patents , Pharmaceutical Industry , Pharmaceutical Patents , Prescription Drugs , Prior Art , Valeant

Onyx Therapeutics, Inc. v. Cipla Ltd.

BECAUSE A POSA WOULD NOT HAVE SELECTED THE PRIOR-ART COMPOUND AS A “LEAD COMPOUND,” AND THERE WAS EVIDENCE THAT THE INVENTION MET AN UNMET NEED AND OVERCAME INDUSTRY SKEPTICISM, DEFENDANT FAILED TO PROVE THAT THE...more

8/17/2020 / 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 , Prior Art

Ferring Pharms. Inc. v. Lupin Inc.

BECAUSE THE PROPOSED LABEL OF THE ANDA PRODUCT DID NOT CONTEMPLATE THE CLAIMED TIMEFRAME IN THE ASSERTED PATENT FOR ADMINISTERING THE DRUG, THE COURT GRANTED DEFENDANT’S MOTION FOR JUDGMENT OF NON-INFRINGEMENT ON THE...more

8/12/2020 / 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

Adapt Pharma Operations Ltd. v. Teva Pharms. USA, Inc.

BECAUSE A SKILLED ARTISAN WOULD HAVE RECOGNIZED THE LIMITATIONS OF ONE PRIOR-ART REFERENCE AND WOULD HAVE BEEN MOTIVATED TO SELECT THE TEACHINGS OF ANOTHER REFERENCE TO OVERCOME THEM, THE PATENTS-IN-SUIT WERE OBVIOUS. Case...more

8/11/2020 / 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 , Teva Pharmaceuticals

H. Lundbeck A/S v. Apotex Inc.

CONVERTING FROM A PIV CERTIFICATION TO A PIII CERTIFICATION DOES NOT RID THE DISTRICT COURT OF SUBJECT MATTER JURISDICTION, BUT IT DOES WARRANT GRANTING DEFENDANT’S MOTION FOR JUDGMENT ON THE PLEADINGS. Case Name: H....more

8/10/2020 / Abbreviated New Drug Application (ANDA) , Apotex , 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

ANDA Approvals - Summer 2020

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

Amgen Inc. v. Amneal Pharms. LLC

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

Biogen Int’l GmbH v. Banner Life Sciences LLC

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

Hospira, Inc. v. Fresenius Kabi USA, LLC

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

Takeda Pharms. U.S.A., Inc. v. Mylan Pharms., Inc.

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

Takeda Pharms. Co. v. Torrent Pharms. Ltd.

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

Piramal Healthcare US Ltd. v. Novartis Pharms. Corp.

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

Galderma Labs., L.P. v. Amneal Pharms. LLC

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