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Fish & Richardson

Recent Decisions and FTC Challenges Dictate Caution When Listing Patents in the Orange Book

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In October 2023, Teva Pharmaceuticals filed a patent infringement lawsuit against Amneal Pharmaceuticals alleging that their generic version of Teva’s ProAir® HFA inhaler infringed upon the asserted claims of U.S. Patent Nos....more

ArentFox Schiff

AI Legal Landscape: Top Challenges and Strategies in 2025

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As artificial intelligence (AI) continues to develop at a rapid pace, even the most sophisticated general counsel (GC) and in-house legal teams will be hard pressed to keep up with the evolving legal landscape....more

Kohrman Jackson & Krantz LLP

Beyond Money: The Rise of Branding as the Ultimate Asset

Attention is the hottest commodity any company can acquire today. How can you capture attention in an increasingly competitive market where individuals have more information and access than ever before? By crafting a...more

Herbert Smith Freehills Kramer

Artificial Intelligence Quarterly Update

In this quarterly update, we review the latest developments in three subjects salient to corporate use of artificial intelligence (AI). First, we discuss the risks associated with AI, the case for board oversight and how the...more

Goodwin

Antitrust and Competition Life Sciences Quarterly Update Q2 2024

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To date, 2024 has not yet seen the type of mega-merger (Pfizer/Seagen) or level of agency enforcement (Sanofi/Maze or Amgen/Horizon) as 2023. But two notable investigations — one still active — show the Federal Trade...more

Jones Day

FTC Weighs In on Orange Book Listing of Drug-Device Patents

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On March 22, 2024, the Federal Trade Commission ("FTC") filed an amicus brief in Teva Branded Pharmaceutical Products R&D, et al. v. Amneal Pharmaceuticals of New York, LLC, et al., 2:23-cv-20964, U.S. District Court for the...more

WilmerHale

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

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Calls for Removal of Device Patents Listed in the Orange Book Continue. FTC and Congressional action scrutinizing allegedly “improper” Orange Book listings continued apace in the first few months of 2024. ...more

Polsinelli

Regeneron v Novartis and Vetter: Walker Process Client Update

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In an appeal that attracted a dozen amici, including the Department of Justice, the Federal Trade Commission, five states, and the District of Columbia, the Second Circuit gave the Walker Process antitrust doctrine a shot in...more

Axinn, Veltrop & Harkrider LLP

Clarity May Be Around the Corner for Antitrust Scrutiny of Reverse Payment Settlements

In the ten years since the Supreme Court ruled in Federal Trade Commission v. Actavis that reverse payment settlements—or settlements where a patent holder pays an accused patent infringer cash or other consideration to end...more

American Conference Institute (ACI)

[Event] 14th Summit on Biosimilars & Innovator Biologics - June 27th - 28th, Boston, MA

Biologics have become the fastest-growing class of therapeutic compounds. They have provided innovative treatment alternatives for people who suffer from some of the most serious medical conditions known to man. The...more

White & Case LLP

FTC Publishes Annual MMA Report—Continues to Scrutinize Pharma Patent Settlements

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On December 3, 2020, the Federal Trade Commission (FTC) published its annual report on pharmaceutical patent settlements filed with the FTC under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003...more

McDonnell Boehnen Hulbert & Berghoff LLP

Federal Trade Commission v. AbbVie Inc. (3d Cir. 2020)

The Federal Trade Commission carried out an (in)famous crusade against reverse payment (more provocatively, "pay for delay") settlements in ANDA litigation for almost a decade before eventually having the Supreme Court see...more

K&L Gates LLP

Ninth Circuit Overturns FTC-Requested Injunction Against Refusal To License Standard Essential Patents

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In a decision that is potentially important for licensors as well as licensees of standard essential patents (SEPs), a panel of the Ninth Circuit has vacated an injunction that the U.S. District Court for the Northern...more

Sunstein LLP

No License, No Chips: Qualcomm’s Controversial Licensing Strategy Is Not an Antitrust Violation

Sunstein LLP on

Qualcomm has for years dominated the market for cellphone chips. Its patented technologies have been included in many cellphone standards on the condition, common among standards setting organizations (SSOs), that Qualcomm...more

Goodwin

No License, No Chips, No Problem: Ninth Circuit Delivers Qualcomm a Win in Antitrust Case Brought by the US Federal Trade...

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In a much anticipated opinion, the U.S. Court of Appeals for the Ninth Circuit reversed a California district court decision holding that Qualcomm violated U.S. antitrust laws in its licensing of standard-essential patents in...more

Haug Partners LLP

INSIGHT: Abbvie Defeats Novel Antitrust Claims Against Humira Patent Estate—Lessons Learned

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A federal district court recently dismissed a lawsuit against AbbVie and biosimilar manufacturers of adalimumab involving a novel antitrust claim against the Humira patent estate. Attorneys with Haug Partners LLP take an...more

White & Case LLP

FTC and FDA Announce Plans to Combat Anticompetitive Practices in the "Biologic Marketplace"

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On February 3, 2020, the Federal Trade Commission ("FTC") and the Food and Drug Administration ("FDA") issued a joint statement and plan seeking to advance biosimilar competition and combat deceptive and anticompetitive...more

Fish & Richardson

Increasing Competition in the Biologic Market Through Truthful Advertising

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This past week, FTC and FDA have taken further steps to encourage robust biosimilar competition in 2020 and beyond, this time with a particular focus on truthful and non-misleading advertising....more

Goodwin

FDA and FTC Announce Collaboration to Support Biosimilars Market

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The U.S. Food and Drug Administration and the Federal Trade Commission today released a joint statement regarding collaboration to advance competition in the market for biologic products. According to the FDA press release,...more

WilmerHale

Unprecedented State Law on Pharmaceutical “Reverse Payments” Goes Into Effect

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A new California law, Preserving Access to Affordable Drugs, AB-824 (the Act), which is aimed at curbing reverse-payment patent settlements, took effect on January 1. The Act codifies a presumption that any transfer of value...more

McDonnell Boehnen Hulbert & Berghoff LLP

FTC to the Rescue Regarding High Drug Prices and Patents

On May 9th, Senators John Corbyn (R-TX) and Richard Blumenthal (D-CT), joined by co-sponsors Shelley Moore Capito (R-WV), Patty Murray (D-WA), Rick Scott (R-FL), John Kennedy (R-LA), and Josh Hawley (R-MO), introduced a bill,...more

Orrick - Antitrust Watch

Whistling in the Wind? DOJ’s Unusual Statement of Interest in FTC v. Qualcomm Case Highlights Disparity Between U.S. Antitrust...

In a highly unusual move, the U.S. Department of Justice Antitrust Division (DOJ) recently filed a statement of interest in the Federal Trade Commission (FTC)’s unfair competition case against Qualcomm....more

Cooley LLP

Alert: Antitrust Trends in 2019: Enforcement Watch List for the Year to Come

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As 2019 kicks off, the Cooley antitrust group highlights 10 recent developments and trends corporate counsel should be aware of – from the US Supreme Court and lower courts, the Department of Justice and Federal Trade...more

Jones Day

Antitrust Alert: New Law Requires Disclosure of Biologic Patent Settlement Agreements to Antitrust Authorities

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Last week, the Patient Right to Know Drug Prices Act ("Act") became law. The Act requires pharmaceutical companies to disclose to antitrust agencies agreements between biologic and biosimilar companies that relate to the...more

McDonnell Boehnen Hulbert & Berghoff LLP

Senators Ask FTC to Investigate Biosimilar Litigation Settlement Agreement

The high cost of biologic drugs was one of the (if not the) most compelling motivations for Congress to adopt a biosimilar pathway as part of the Affordable Care Act in 2010 (aka "Obamacare"). Passage of the Biologic Price...more

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