News & Analysis as of

Orange Book Food and Drug Administration (FDA) Patent Litigation

A&O Shearman

New Jersey District Court Orders Delisting Of Teva Inhaler Patents From The Orange Book

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On June 10, 2024, Judge Stanley R. Chesler of the United States District Court for the District of New Jersey granted the Amneal defendants’ motion for partial judgment on their counterclaims in a Hatch-Waxman dispute, and...more

Skadden, Arps, Slate, Meagher & Flom LLP

The FTC Challenges Companies’ Allegedly Improper Orange Book Patent Listings

The Federal Trade Commission (FTC) has called attention in the past year to its perception of the influence that branded pharmaceutical companies have over the price of beneficial drugs. Most recently, the agency has asserted...more

Fenwick & West LLP

New Jersey Federal Court Weighs in on Orange Book Patent Listings

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In recent months, the issue of whether certain patents are appropriately listed in the Food and Drug Administration (FDA) Orange Book, associated with the Hatch-Waxman Act, has garnered the attention of the Federal Trade...more

WilmerHale

The Interplay: Key Decisions at the Intersection of Antitrust & Life Sciences - May 2024

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Second Circuit Affirms “Pay for Delay” Dismissal:  On May 13, 2024, the Second Circuit affirmed dismissal of antitrust claims brought by wholesalers, retailers, and employee benefit funds that alleged they overpaid for the...more

American Conference Institute (ACI)

[Webinar] 3rd Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA - October 10th - 26th, 1:00 pm EST

Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials, a critical competency for legal and business professionals in the biopharmaceutical arena. Attend ACI’s Hatch-Waxman and BPCIA Proficiency Series...more

Morrison & Foerster LLP - Federal Circuitry

Last Week In The Federal Circuit (July 31 – August 4): Federal Circuit Reminds To Focus On The Claims

This week’s case of the (recent) week could serve as a crash course in several areas of patent law. It touches on Hatch-Waxman litigation and the Orange Book, claim construction, anticipation/obviousness, written description...more

Haug Partners LLP

Orange Book Listing of System Claims Clarified by Jazz Decision

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On February 24, 2023, the U.S. Court of Appeals for the Federal Circuit issued a precedential opinion in Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC that affirmed a district court’s injunction requiring Jazz...more

A&O Shearman

Federal Circuit Upholds Judgment Delisting System Patent From Orange Book

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Procedural History - Jazz Pharms., Inc., v. Avadel CNS Pharms., LLC, Case No. 2023-1186 (Fed. Cir. February 24, 2023) is an appeal by Jazz Pharmaceuticals, Inc. (Jazz) from a District of Delaware order granting a motion...more

Knobbe Martens

Patent Directed to System for Controlling Access to Drugs Is Not Listable in the Orange Book

Knobbe Martens on

JAZZ PHARMACEUTICALS, INC. v. AVADEL CNS PHARMACEUTICALS, LLC - Before Lourie, Reyna, and Taranto. Appeal from the United States District Court for the District of Delaware. Summary: A patent directed to a system to reduce...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

MarkIt to Market® - January 2023: Watching the Pot™

High Stakes: Hatch-Waxman Litigation Comes for Cannabis - GW Pharma, now a subsidiary of Jazz Pharmaceuticals, is no stranger to patent litigation. It previously found itself on the receiving end of a patent infringement...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

MarkIt to Market® - January 2023

Thank you for reading the January 2023 issue of Sterne Kessler's MarkIt to Market® newsletter. This month, we discuss an ongoing trademark dispute between the band OK Go and cereal company Post, how to stay vigilant about...more

Robins Kaplan LLP

Jazz Pharms., Inc. v. Avadel Pharms. Plc

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Case Name: Jazz Pharms., Inc. v. Avadel Pharms. Plc, Civ. No. 21-691 (MN), 2021 WL 4860682 (D. Del. Oct. 19, 2021) (Noreika, J.) - Drug Product and Patent(s)-in-Suit: Xyrem® (sodium oxybate); U.S. Patent No. 8,731,963 (“the...more

Fish & Richardson

Biosimilars 2021 Year in Review

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2021 saw several important milestones in the biosimilars space, including the much anticipated first interchangeable designations by FDA and the approval of the first ophthalmology biosimilar. The biosimilar market also...more

Hogan Lovells

Federal Circuit affirms GSK labeling carve-out ruling in favor of innovator

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Earlier this month, in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., a panel of the U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed (2-1) upon rehearing its October 2020 decision that a labeling...more

Robins Kaplan LLP

New ANDA Cases - Spring 2021

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This chart summarizes the case name, presiding judge, drug, and patents-at-issue in all federal district court cases that are filed pursuant to the Hatch-Waxman Act. It also includes the same information for proceedings...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Federal Circuit Appeals from the PTAB and ITC: Summaries of Key 2020 Decisions: Amneal Pharm. LLC v. Almirall, LLC, 960 F.3d 1368...

Abbreviated new drug (ANDA) applicant Amneal petitioned for an inter partes review (IPR) of Almirall’s patent listed in the Food and Drug Administration’s (FDA) Orange Book for a prescription drug to treat acne. Almirall...more

Robins Kaplan LLP

New ANDA Cases - Winter 2021

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Federal District Court Cases That Are Filed Pursuant To The Hatch-Waxman Act - This chart summarizes the case name, presiding judge, drug, and patents-at-issue in all federal district court cases that are filed pursuant to...more

McDermott Will & Emery

An Early Holiday Present for Generics? Legislation Requiring Greater Disclosure by Brands Passes the Senate

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Earlier this month, two bills intended to promote generic competitiveness by presenting a clearer idea of the patent landscape covering reference products passed the full Senate, albeit with amendments. These laws, if...more

Dunlap Bennett & Ludwig PLLC

ANDA in Action: Merck’s Diabetes Drug is At the Center of Another Patent Infringement Case

Nearly two years before patent expiration, Merck, Sharp & Dohme Corp’s (Merck) diabetes drug, Janumet, is at the center of another patent infringement case. In response to an Abbreviated New Drug Application (ANDA) filed with...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

Amgen Inc. v. Amneal Pharms. LLC

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Case Name: Amgen Inc. v. Amneal Pharms. LLC, Civ. No. 16-0853 (MSG), 2018 U.S. Dist. LEXIS 125631 (D. Del. July 27, 2018) (Goldberg, J.)....more

Schwabe, Williamson & Wyatt PC

Fresh From the Bench: Latest Federal Circuit Court Cases

In an ANDA applicant’s appeal from a bench trial judgment of validity and infringement, the Court affirmed the district court’s judgment on all counts. The case presented unusual procedural circumstances in a Hatch-Waxman...more

Robins Kaplan LLP

Sanofi v. Glenmark Pharms. Inc.

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Case Name: Sanofi v. Glenmark Pharms. Inc., Civ. No. 14-264-RGA (Consolidated), 2016 U.S. Dist. LEXIS 116950 (D. Del. August 31, 2016) (Andrews, J.) - Drug Product and Patent(s)-in-Suit: Multaq® (dronedarone); U.S....more

McDermott Will & Emery

ANDA Update - October 2015

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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

GlaxoSmithKline LLC. v. Glenmark Generics Inc.

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Case Name: GlaxoSmithKline LLC. v. Glenmark Generics Inc., USA, Civ. Nos. 14-877-LPS-CJB; 14-878-LPS-CJB, 2015 U.S. Dist. LEXIS 52525 (D. Del. Apr. 22, 2015) (Burke, J.) - Drug Product and Patent(s)-in-Suit: Coreg®...more

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