News & Analysis as of

Hatch-Waxman Abbreviated New Drug Application (ANDA) Summary Judgment

McDonnell Boehnen Hulbert & Berghoff LLP

Metacel Pharmaceuticals LLC v. Rubicon Research Private Ltd. (Fed. Cir. 2025)

The Federal Circuit affirmed a District Court decision that the label for a generic drug obtained from an ANDA would not induce infringement by reciting optional drug storage conditions the read on the NDA holder's Orange...more

Robins Kaplan LLP

ANDA Litigation Settlements - Fall 2019

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Please see full Chart below for more information....more

Robins Kaplan LLP

Pernix Ir. Pain DAC v. Alvogen Malta Operations, Ltd.

Robins Kaplan LLP on

Case Name: Pernix Ir. Pain DAC v. Alvogen Malta Operations, Ltd., Civ. No. 16-139-WCB, 2018 U.S. Dist. LEXIS 81419 (D. Del. May 15, 2018) (Bryson, C.J.)....more

Patterson Belknap Webb & Tyler LLP

Two reverse-payment appeals to watch

It has been over three years since the Supreme Court’s Actavis decision. Since then, numerous putative class actions alleging harm to competition as a result of “reverse-payment” settlements have flooded the courts. The...more

McDermott Will & Emery

ANDA Update - October 2015

McDermott Will & Emery on

Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more

Robins Kaplan LLP

Baxter Healthcare Corp. v. HQ Specialty Pharma Corp.

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Case Name: Baxter Healthcare Corp. v. HQ Specialty Pharma Corp., Civ. No. 13-6228 (JBS/KMW), 2015 U.S. Dist. LEXIS 128002 (D.N.J. Sept. 23, 2015) (Simandle, C.J.)...more

Robins Kaplan LLP

Braintree Labs., Inc. v. Novel Labs., Inc.

Robins Kaplan LLP on

Case Name: Braintree Labs., Inc. v. Novel Labs., Inc., Case No. 3:11-cv-01341-PGS-LHG, 2015 U.S. Dist. LEXIS 70993 (D.N.J. June 2, 2015) (Sheridan, J.) - Drug Product and Patent(s)-in-Suit: Suprep® Bowel Prep Kit (sodium...more

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