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Enforcement Actions Patent Litigation

McDermott Will & Emery

FTC Revives Orange Book Listing Challenges

On May 21, 2025, the Federal Trade Commission (FTC) issued its third round of warning letters – and its first under the Trump administration – against pharmaceutical manufacturers for allegedly improper listing of patents in...more

Axinn, Veltrop & Harkrider LLP

FTC Peeling Back the Layers of the Orange Book

The Federal Trade Commission (FTC) is continuing to pursue pharmaceutical manufacturers for allegedly improperly listing patents in the “Orange Book,” delaying the entry of generic drug competitors. On May 21, the FTC...more

Hogan Lovells

Republican FTC renews challenges to Orange Book patent listings

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On May 21, 2025 the Federal Trade Commission (FTC) issued renewed warning letters to five companies regarding over 200 allegedly improperly-listed patents in the Food and Drug Administration (FDA)’s Orange Book. Announcing...more

McDonnell Boehnen Hulbert & Berghoff LLP

Federal Trade Commission Continues Efforts to Delist Drug Device Administration Patents in Orange Book

In the last years of the Biden Administration, the Federal Trade Commission issued a policy statement and sent letters to ten companies having Orange Book-listed patents claiming devices for administering drugs challenging...more

Polsinelli

Orange Book Listings: Republican Led FTC Picks Up Where Democrat Led FTC Left Off

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Key Takeaways - The Federal Trade Commission (FTC), now under Republican leadership, has continued its scrutiny of Orange Book listings for device patents, signaling bipartisan concern over potential anti-competitive...more

Jenner & Block

Jenner & Block Japan Newsletter - April 2025

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Welcome to the April 2025 edition of the Jenner & Block Japan Newsletter, a publication containing updates about legal developments in the United States that may be noteworthy to our clients and other leaders in the Japanese...more

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

The Federal Circuit Expands IP Enforcement Opportunities at the ITC

Last month the Federal Circuit issued a decision in the Lashify case that significantly broadens the opportunity for companies to bring a lawsuit before the U.S. International Trade Commission (“ITC”). The ITC is known for...more

Axinn, Veltrop & Harkrider LLP

Axinn Associates at the Antitrust Spring Meeting: Pharma Under the Antitrust Microscope

The Spring Meeting is the largest gathering of competition, consumer protection, and data privacy profes­sionals globally, with lawyers, academics, economists, enforcers, journalists, and students from around the world....more

Axinn, Veltrop & Harkrider LLP

Compounding Problems: Recent Decisions on Tirzepatide Highlight Interplay Between FDA Anti-Compounding Enforcement and Private...

Earlier this month, a federal district court denied the Outsourcing Facilities Association’s preliminary injunction motion, which sought to preclude FDA from taking enforcement action against compounded tirzepatide...more

Foley & Lardner LLP

Federal Circuit Opens the Door to Additional Domestic Industry Investment: “Ordinary Importer” No Longer

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In its recent decision in Lashify, Inc. v. International Trade Commission, the Federal Circuit opened the door for patent owners to include expanded categories of domestic investment to satisfy the economic prong of the...more

Sheppard Mullin Richter & Hampton LLP

FDA’s Semaglutide Shortage Resolution: Legal Implications and Risks for Compounding Pharmacies

Last month, the U.S. Food and Drug Administration (the “FDA”) announced in a Declaratory Order the resolution of the shortage of semaglutide injection products Wegovy and Ozempic (the “February Declaratory Order”). On March...more

Mintz - Intellectual Property Viewpoints

Ahoy! ITC Welcomes SEP Holders Navigating for The Best Venue

Given the recent unanimous decision by a UK appellate court that Ericsson’s injunction efforts based on standard-essential patents (“SEPs”) were, essentially by their very nature, “hold-up” and “coercion” that violated...more

Knobbe Martens

Federal Circuit’s Lashify Decision Expands “Domestic Industry” at the International Trade Commission

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Lashify, Inc. v. International Trade Commission Before: Prost, Taranto, and Chen. Appeal from ITC Investigation. The Federal Circuit expands the economic prong of the domestic-industry analysis to include domestic spending on...more

McDermott Will & Emery

Economic Prong of Domestic Industry Requirement Includes All Sorts of Labor and Capital

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Addressing the economic prong of the domestic industry requirement under Section 337(a)(3)(B) of the Tariff Act of 1930, the US Court of Appeals for the Federal Circuit reversed a US International Trade Commission decision,...more

Troutman Pepper Locke

New Federal Circuit Ruling Opens the ITC to Many More IP Owners

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In a recent ruling, the U.S. Court of Appeals for the Federal Circuit upended years of settled law and ruled that sales and marketing expenses, by themselves, can be the basis for a finding of domestic industry in an...more

Morrison & Foerster LLP

Federal Circuit Significantly Broadens Qualifying Expenses for Economic Domestic Industry at the ITC

On March 5, the Federal Circuit held that sales, marketing, warehousing, quality control, or distribution expenditures may count as “employment of labor or capital” for purposes of satisfying the economic domestic industry...more

Amundsen Davis LLC

Preserving Patent Rights: Impact of Public Use on Patenting

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For a business planning to market a product that incorporates an invention, having an enforceable patent to protect the invention is often desirable. Two recent federal circuit cases reiterate what many patent holders and...more

Jones Day

The Federal Circuit Expands Scope of Domestic Industry Requirement in Lashify

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In Lashify v. ITC, the Federal Circuit held that the economic prong of the domestic industry requirement, which is a precondition for obtaining International Trade Commission Section 337 relief, can be satisfied with...more

Paul Hastings LLP

Federal Circuit Axes Years of ‘Domestic Industry’ Precedent in ITC § 1337 Investigations

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The Court of Appeals for the Federal Circuit (CAFC) has taken an axe to years of precedent in § 1337 investigations at the International Trade Commission (ITC). The ITC has long denied “mere importers” the protection of §...more

Mintz - Intellectual Property Viewpoints

Has There Been A Sea Change in Eligible Domestic Industries at the ITC That Will Last?

For decades, the ITC’s jurisdictional requirement – known as the domestic industry requirement – effectively shut out innovators from availing themselves of the powerful remedies of the forum, in the form of an exclusion...more

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

Section 337 Now Viable for “Mere Importers” After Federal Circuit’s Lashify Decision

For years, the U.S. International Trade Commission maintained that the potent remedies available under Section 337 were unavailable to intellectual property owners considered to be nothing more than “mere importers.” That...more

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

IP Hot Topic: Purchase Orders and IP Licenses: Recent ITC Decision Underscores Need for Caution

A recent opinion issued by the U.S. International Trade Commission in Certain Power Converter Modules and Computing Systems Containing the Same (Inv. No. 337-TA-1370) serves as a reminder for sellers to be cautious with any...more

Vondran Legal

Tackling mobile application takedowns - the Musi vs Apple case

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It's never fun to see years and years of hard work go to waste. In particular, when you build an eCommerce site on a site like Etsy, Shopify, Amazon, or eBay, and get an email message or a letter informing you that you have...more

Woods Rogers

Attention, Small Business Owners: The ITC Could Help You Enforce Your IP

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The Federal Circuit's recent decision in Wuhan Healthgen Biotechnology Corp. v. U.S. International Trade Commission significantly alters the landscape for small companies seeking recourse against foreign infringers. The court...more

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

2024 ITC Section 337 Year in Review: Analysis & Trends

Section 337 investigations at the U.S. International Trade Commission (ITC) remain an efficient and powerful method for American businesses seeking relief from foreign acts of unfair competition, including infringement of...more

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