News & Analysis as of

Patents Enforcement Actions

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

Mintz - Intellectual Property Viewpoints

Regulation, Enforcement, and Associated Challenges: Part II

Given the continued challenges in policing the burgeoning ENDS marketplace, as previously discussed in Part I of this article, in mid-2024 FDA and DOJ announced the establishment of a federal multi-agency task force to combat...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

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

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

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

BakerHostetler

Federal Circuit Concludes Sales and Marketing Expenses Are To Be Included In Economic Prong Analysis At The ITC

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Last week, the U.S. Court of Appeals for the Federal Circuit lowered barriers that one must overcome to enforce patents at the U.S. International Trade Commission (ITC). The ITC often proves to be an effective forum to...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

Eversheds Sutherland (US) LLP

Recent ruling provides guidance on 363 asset sales

On February 12, 2025, the US District Court for the District of Delaware issued a significant ruling in the case of HE, Inc. v. Avadim Holdings Inc. and Relion Holdings LLC. This decision arose from the Chapter 11 bankruptcy...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

Axinn, Veltrop & Harkrider LLP

Federal Circuit Clarifies That “Quantitatively Small” Investments Can Establish Significant and Substantial Investment in Domestic...

On Friday, Feb. 7, 2025, the Federal Circuit issued a precedential opinion in Wuhan Healthgen Biotech. Corp. v. U.S. Int’l Trade Comm’n, No. 23-1389, 2025 WL 420819 (Fed. Cir. 2025). The three-judge panel, consisting of Chief...more

A&O Shearman

UPC Court of Appeal confirms strict approach to correcting patent errors by interpretation

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Alexion Pharmaceuticals v Amgen (UPC_Coa-405/2024) and Alexion Pharmaceuticals v Samsung Bioepis NL BV (UPC_CoA-402/2024); December 20, 2024. The UPC Court of Appeal has confirmed a strict approach to correcting erroneous...more

DLA Piper

Federal Circuit Asked to Rethink ITC’s Longstanding Exclusion of Investment Categories for Economic Domestic Industry

DLA Piper on

A US Court of Appeals for the Federal Circuit panel consisting of Judges Sharon Prost, Richard Taranto, and Raymond Chen recently heard oral argument in Lashify, Inc. v. US International Trade Commission, an appeal from a...more

Bennett Jones LLP

Competition Tribunal Issues First-of-Its-Kind Decision in Private Abuse of Dominance Case Against Major Pharma Manufacturer

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On December 17, 2024, the Competition Tribunal (the Tribunal) issued reasons for its decision to dismiss an application for leave to bring a private abuse of dominance action against a major pharmaceutical manufacturer. JAMP...more

BakerHostetler

2025 BakerHostetler IP Perspectives

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To describe the rise of artificial intelligence (AI) as rapid is a vast understatement. From its ubiquitous presence assisting us in our most mundane daily tasks to its warm embrace by business leaders eager to revolutionize...more

Axinn, Veltrop & Harkrider LLP

Three Takeaways from the Initial Determination at the ITC Regarding Standard Essential Patents in the 1380 Investigation

On January 8, 2025, Administrative Law Judge (ALJ) Cameron Elliot issued a public version of the Initial Determination (ID) in Certain Video Capable Electronic Devices, Inv. No. 337-TA-1380 brought by Complainant Nokia. While...more

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

Federal Circuit IP Appeals: Summaries of Key 2023 Decisions (8th Edition): Shaping the PTAB’s Rulemaking and Rule Enforcement...

A trio of cases this past year illustrate a trend of increasing importance of the Patent Office’s rulemaking and enforcement. Parus Holdings, Inc. v. Google LLC, 70 F.4th 1365 (Fed. Cir. 2023) The Federal Circuit’s...more

Dechert LLP

Dechert Cyber Bits - Key Developments in Privacy & Cybersecurity - Issue 47

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FTC Settles with Rite Aid on its Use of AI and Processing of Biometric Information - The Federal Trade Commission (“FTC”), on December 19, 2023, announced that it had reached a settlement with Rite Aid Corporation (“Rite...more

A&O Shearman

UPC Insights: Security for legal costs

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The UPC decides that the defendant’s financial situation and location matter. On 30 October 2023, the Munich Central Division of the UPC (the Court) issued an order stating that NanoString must provide security to Harvard...more

Fitch, Even, Tabin & Flannery LLP

[Webinar] 180 Days of UPC: How It Started… How It’s Going… - November 29th, 9:00 am - 10:00 am PST

Please join Fitch Even for a free webinar, “180 Days of UPC: How It Started… How It’s Going…,” on Wednesday, November 29, at 9:00 a.m. PST / 10:00 a.m. MST / 11:00 a.m. CST / 12 Noon EST. The Unified Patent Court (UPC)...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

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