News & Analysis as of

Unfair Competition Food and Drug Administration (FDA)

Polsinelli

The FTC’s Challenge to the Listing of Device Patents in the Orange Book: What Challenge?

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On September 23, 2023, the FTC issued a policy statement advising it would be putting market participants on notice that it intends to scrutinize improper Orange Book listings to determine whether such actions constitute...more

Knobbe Martens

"Improper” Listing of Patents in the FDA’s Orange Book

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As we previously discussed, on November 7, 2023, the Federal Trade Commission (“FTC”) sent warning letters to certain drug manufacturers regarding their purportedly improper listings of device patents in the Food and Drug...more

McDonnell Boehnen Hulbert & Berghoff LLP

CVS Pharmacy Inc. v. Forest Laboratories Inc. (2d Cir. 2024)

In a decision characterized (somewhat remarkably) by the Circuit Court as being one of first impression, the Second Circuit affirmed dismissal with prejudice of an antitrust allegation by a class of plaintiffs* against Forest...more

Harris Beach PLLC

California Microplastics Mislabeling Case Dismissed on Preemption Grounds

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A nationwide class action lawsuit accusing a bottled water company of misleading customers by selling water allegedly containing microplastics has been dismissed on preemption grounds. The court’s decision looms large in...more

Sheppard Mullin Richter & Hampton LLP

FDCA Preemption: A Powerful Tool for Defending Class Actions

Several recent cases arising under the federal Food, Drug, and Cosmetic Act (“FDCA” or the “Act”), 21 U.S.C. § 301 et seq., highlight the usefulness of preemption as a defense against putative class actions concerning drugs,...more

Knobbe Martens

Antitrust Lawsuit Brought Against Drug Manufacturer Based on Its Allegedly Improper Listing of Device Patents in the FDA’s Orange...

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As we recently discussed, the Federal Trade Commission (“FTC”) sent warning letters to certain drug manufacturers regarding their purportedly improper listing of device patents in the Food and Drug Administration’s (“FDA”)...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

FTC Challenges More Than 100 Patents as Improperly Listed in Orange Book

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On November 7, the Federal Trade Commission announced that it is challenging more than 100 patents held by 10 branded drug companies as improperly or inaccurately listed in the Food and Drug Administration’s Orange Book. The...more

Davis Wright Tremaine LLP

Stay ADvised: Brand Protection & Advertising Law News - August 2023 - 2

Kardashian Kopycat? Energy Drink Company Claims Competitor Stole Kim's Copyrighted Look - The Instagram posts look nearly identical, in a blink-and-you'll-miss-the-difference kind of way—or so says the complaint filed by...more

Holland & Knight LLP

Food and Beverage Labeling Defense Strategies

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A trio of recent cases challenging disparate food and beverage labels offers a few common substantive and procedural lessons for companies. First, the back panels – when considered in light of U.S. Food and Drug...more

BakerHostetler

AD-ttorneys@law - January 2023 #2

BakerHostetler on

Introducing Our Secret Plan to Fight Inflation - It’s simple: Don’t fall afoul of the FTC - ’Twas Ever Thus - Every year, like the swallows returning to Capistrano, the Perseid meteor shower, or a Real Housewives...more

Venable LLP

New Federal Law Aims to Identify and Prevent or Mitigate Organizational Conflicts of Interest in Federal Contracting

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In the midst of the year-end legislative push, Congress last week passed S. 3905, the "Preventing Organizational Conflicts of Interest in Federal Acquisition Act." This "good government" law requires the Federal Acquisition...more

Foley & Lardner LLP

Ninth Circuit Holds that Implied Preemption Bars State Law Claims Based on a Violation of the FDCA

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In Nexus Pharmaceuticals, Inc. v. Central Admixture Pharmacy Services, Inc., 48 F.4th 1040, 1041 (9th Cir. 2022), the Ninth Circuit recently held that the implied preemption doctrine barred state law claims because they were...more

BakerHostetler

AD-ttorneys@law - September 2022

BakerHostetler on

CSPI to FDA: Move to the Front! Watchdog barks at industry efforts to highlight nutrition facts - Gesundheit FOPNL. It’s sweeping the globe. What is it, you ask? A new government agency? An awful skin condition? A...more

Holland & Knight LLP

Food and Beverage Law Update: March 2021

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Insurers have prevailed in several lawsuits filed by restaurants in connection with losses related to COVID-19. For example, in Emerald Coast Restaurants, Inc. v. Aspen Specialty Ins. Co., No. 3:20cv5898-TKW-HTC, 2020 WL...more

Holland & Knight LLP

Food and Beverage Law Update: October 2020

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More than six months into the pandemic, there is still no easy or definitive answer to the question many retailers are asking about whether there is coverage for their business interruption losses related to COVID-19....more

Mintz - Intellectual Property Viewpoints

Federal Circuit Affirms that the ITC Cannot Investigate an FDCA Violation without the FDA’s Say-So

In Amarin Pharma, Inc. v. Int’l Trade Comm’n (18-1247), the Federal Circuit affirmed the International Trade Commission’s (“ITC”) finding that Amarin’s false advertising claim under § 43(a) of the Lanham Act was precluded by...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update | May 2018 #2

FDA Issues Supplemental Guidance for Menu Nutrition Labels - The U.S. Food and Drug Administration (FDA) has announced the availability of “Menu Labeling: Supplemental Guidance for Industry,” which includes an advisory of...more

Holland & Knight LLP

Healthcare Law Update: February 2018

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Antitrust - FTC Announces Revised Hart-Scott-Rodino Thresholds for Acquisitions and Exclusive Licenses - The Federal Trade Commission (FTC) has announced this year's revisions to the thresholds under the...more

Jones Day

Federal Circuit Rules BPCIA Preempts State Law

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On December 14, 2017, the U.S. Court of Appeals for the Federal Circuit again interpreted the Biologics Price Competition and Innovation Act ("BPCIA"). In Amgen Inc. et al. v. Sandoz Inc., 15-cv-1499 (Fed. Cir. 2017), the...more

Perkins Coie

Federal Circuit Rules Out State-Law Remedies for Failure to Participate in the Biosimilars "Patent Dance"

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On December 14, the Federal Circuit issued a decision that further clarifies the ground rules for disclosures of product information by manufacturers of biosimilar pharmaceutical products. In particular, the Federal Circuit...more

Shook, Hardy & Bacon L.L.P.

Dietary Supplement & Cosmetics Legal Bulletin | August 2017

"Miracle Gel" Not a Salon Gel Manicure, Ad Board Says - In an appeal from a ruling by the National Advertising Division (NAD), the National Advertising Review Board (NARB) upheld a recommendation that Coty discontinue...more

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

The Patent Dance Is Optional

In Sandoz Inc. v. Amgen Inc., the Supreme Court brought greater certainty to two key issues relating to the “patent dance” under the Biologics Price Competition and Innovation Act (BPCIA). First, the Court held that where a...more

Foley & Lardner LLP

Supreme Court Decision Largely Favors Biosimilar Applicants

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The U.S. Supreme Court rendered its first interpretations of the biosimilar patent dispute resolution procedures of the Biologics Price Competition and Innovation Act (BPCIA), ruling largely in favor of Sandoz on both issues...more

Holland & Knight LLP

Food and Beverage Law Update: March 2017

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Legalized Drug Use Impacts the Food and Beverage Industry - In the November 2016 general election, voters in Arkansas, Florida and North Dakota amended their state constitutions to authorize the use of marijuana for...more

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