News & Analysis as of

Summary Judgment Abbreviated New Drug Application (ANDA)

Goodwin

Court Grants Summary Judgment Ending AstraZeneca’s Lawsuit Challenging the IRA

Goodwin on

Today, the district court for the District of Delaware (Judge Connolly) granted the government’s motion for summary judgment on all claims brought by AstraZeneca in its Complaint challenging the Drug Price Negotiation Program...more

Cozen O'Connor

Notice of Appeal - A quarterly newsletter reviewing Third Circuit opinions impacting white collar defense lawyers - Fall 2023

Cozen O'Connor on

BACKGROUND- A sugar distributor sought to acquire a sugar producer. The district court determined that the relevant product market included distributors as sources of refined sugar, in addition to sugar producers. The...more

Sheppard Mullin Richter & Hampton LLP

2023 Federal Circuit Case Summaries

We are excited to share Sheppard Mullin’s inaugural quarterly report on key Federal Circuit decisions. The Spring 2023 Quarterly Report provides summaries of most key patent law-related decisions from January 1, 2023 to March...more

Robins Kaplan LLP

ANDA Litigation Settlements - Fall 2019

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

Akin Gump Strauss Hauer & Feld LLP

“Consisting Essentially Of:” Expanding the Scope of Indefiniteness

The Federal Circuit recently affirmed a district court’s determination, holding a group of patents invalid for indefiniteness. In December 2014, HZNP Medicines LLC (“Horizon”) brought suit against Actavis Laboratories UT,...more

Robins Kaplan LLP

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

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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

McDermott Will & Emery

Allergan’s Infringement Positions Don’t Gel with Proper Claim Construction

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Addressing non-infringement on a summary judgment motion, the US District Court for the Eastern District of Texas ruled that Mylan and Teva’s accused generic products did not infringe as a matter of law because water is not a...more

Foley & Lardner LLP

CAFC Finds ANDA Infringement Despite Differences Between FDA Labeling And Claim Language

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In a non-precedential decision issued in Braintree Labs., Inc. v. Breckenridge Pharmaceutical, Inc., the Federal Circuit reversed the district court’s grant of summary judgment of noninfringement in favor of Breckenridge, and...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 - Volume 2, Number 2

McDermott Will & Emery on

180-Day Notice Period for Biosimilar Approval Is Always Mandatory and Enforceable by Injunction - Amgen Inc., v. Apotex Inc., (Fed. Cir. July 5, 2016) - A year after analyzing the patent dance and notice...more

McDermott Will & Emery

Second Circuit Affirms Dismissal of Sham Citizen Petition Claim, Summary Judgment on False Advertising Claims **WEB ONLY**

Addressing Sherman Act and Lanham Act claims arising out of an Abbreviated New Drug Application (ANDA), the US Court of Appeals for the Second Circuit upheld the district court’s dismissal of the plaintiffs’ Sherman Act claim...more

WilmerHale

Federal Circuit Patent Updates - May 2016

WilmerHale on

Ruckus Wireless, Inc. v. Innovative Wireless Solutions (No. 2015-1425, 1438, 5/31/16) (Prost, Reyna, Stark) - May 31, 2016 3:11 PM - Reyna, J. Affirming summary judgment of non-infringement of patents based on...more

McDermott Will & Emery

Supplier to ANDA Filer Is Not Liable for Induced Infringement Until After ANDA Approval - Shire LLC v. Amneal Pharms., LLC

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Addressing the scope of the safe harbor provision of § 271(e)(1), the U.S. Court of Appeals for the Federal Circuit reversed the district court, holding that supplying an active pharmaceutical ingredient (API) to the filer of...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.

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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

McGuireWoods LLP

Abilify®’s Saga Continues: Otsuka’s Eight-Day Streak of Generic-Free Competition Ends, For Now

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On May 27, 2015, the U.S. District Court for the District of Maryland granted FDA and the Defendant-Intervenors summary judgment against Otsuka Pharmaceutical Co., Ltd. Otsuka Pharmaceutical Development and Commercialization,...more

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