News & Analysis as of

Orange Book Hatch-Waxman Patents

Venable LLP

Playing Chess and Ice Hockey Makes Me a Better Lawyer

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The foundational comic premise of walk-into-a-bar jokes is the underlying differences among the characters walking in. The three characters—in this case a chess player, a hockey player, and a patent litigator—may appear...more

Fish & Richardson

Preparing Your Company for Hatch-Waxman

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The Hatch-Waxman Act regulates the relationship between branded and generic drugmakers and attempts to strike a balance between two competing policy interests — encouraging pioneering drug development and facilitating market...more

Haug Partners LLP

FTC Opens Investigation for Orange Book Listing of Medical Device Patents After Teva v. Amneal in District of New Jersey

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Summary - On June 10, 2024, the District Court for the District of New Jersey ordered Teva to delist five patents from the Orange Book for ProAir® HFA (albuterol sulfate) Inhalation Aerosol. The patents were directed to...more

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

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

Mintz - Intellectual Property Viewpoints

Federal Circuit Affirms Obviousness of Rifaximin Polymorph Patents and Denial of Motion to Modify Judgment After Post-Trial...

In a precedential opinion issued on April 11, 2024 in Salix Pharmaceuticals, Ltd. v. Norwich Pharmaceuticals Inc., Nos. 22-2153, 23-1952, the U.S. Court of Appeals for the Federal Circuit affirmed the U.S. District Court for...more

Hogan Lovells

FTC continues to highlight FDA Orange Book patent listings

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With the recent filing of an amicus brief in a private pharmaceutical patent infringement case, the Federal Trade Commission (FTC) has continued its focus on allegedly “improperly listed” patents in the Food and Drug...more

Knobbe Martens

The Federal Trade Commission Put Brand Drug Manufacturers on Notice About Improperly Listing Patents in the Orange Book and Then...

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The Federal Trade Commission (FTC) issued a policy statement on September 14, 2023, stating that “[b]rand drug manufacturers may be harming generic competition through the improper listing of patents in the Food and Drug...more

Wilson Sonsini Goodrich & Rosati

FTC Disputes Patent Listings of 10 Brand Drug Makers as Improperly Listed in FDA’s Orange Book

On November 7, 2023, the Federal Trade Commission (FTC) sent notice letters1 to 10 brand drug manufacturers of drug-device combination products, including drugs delivered by asthma inhalers, epinephrine autoinjectors, and...more

Fish & Richardson

District of Delaware Finds Non-Orange Book-Listed Patents Subject to the Same Pleading Standard as Listed Patents in ANDA...

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As part of the Hatch-Waxman Act, given the lack of information on the allegedly infringing product, courts have found that patentees can satisfy the pleading requirements of Twombly/Iqbal without having access to the accused...more

Troutman Pepper

FTC Issues Policy Statement Confirming Its Position That Improperly Listing Patents in the Orange Book May Be Considered a...

Troutman Pepper on

The Federal Trade Commission (FTC) has released a new Policy Statement addressing one of its long-standing concerns in the pharmaceutical industry: the improper listing of patents in the Orange Book. In an open meeting of the...more

Dechert LLP

FTC Issues Policy Statement on Patent Listing

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The FTC is focusing its attention on the listing of pharmaceutical patents in the FDA’s Orange Book. Patent listing may be the subject of FTC inquiry even absent infringement litigation enforcing the relevant patents....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

Knobbe Martens

Patent on Controlling Access to Drug Delisted from Orange Book

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On February 24, 2023, in Jazz Pharms., Inc., v. Avadel CNS Pharms., LLC, the U.S. Court of Appeals for the Federal Circuit affirmed the United States District Court for the District of Delaware’s grant of an injunction...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

Robins Kaplan LLP

Jazz Pharms., Inc. v. Avadel CNS Pharms.

Robins Kaplan LLP on

Case Name: Jazz Pharms., Inc. v. Avadel CNS Pharms., LLC, No. 21-691-GBW, 2022 WL 17084371 (D. Del. Nov. 18, 2022) (Williams, J.)  Drug Product and Patent(s)-in-Suit: Xyrem® (sodium oxybate); U.S. Patent No. 8,731,963 (“the...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

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

2021 PTAB Year in Review: Analysis & Trends: Biologics at the PTAB: Statistics and Insights into Notable Biologics Decisions

In June 2021, the US Patent and Trademark Office (USPTO) published an update to its study of America Invents Act (AIA) trials involving challenges to Orange Book-listed and biologic patents from September 16, 2012, through...more

Fish & Richardson

Orange Book 101

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Prescription drug prices have long been a source of frustration for the American public and the subject of intense political debates about the best way to lower them without stifling innovation. One of the most significant...more

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

2021 PTAB Year in Review: Analysis & Trends

[co-author: Jamie Dohopolski] Love it or hate it, ignore the USPTO Patent Trial and Appeal Board (PTAB) at your peril. The introduction of the PTAB as part of the America Invents Act over ten years ago has forever changed...more

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