News & Analysis as of

International Trade Commission (ITC) Pharmaceutical Industry

Fish & Richardson

The PREVAIL Act Is Back. Will It Prevail This Time?

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On May 1, 2025, Senators Chris Coons (D-DE), Thom Tillis (R-NC), Dick Durbin (D-IL), and Mazie Hirono (D-HI) reintroduced the Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. The...more

DLA Piper

The Federal Circuit Widens The ITC as a Venue for Life Sciences

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Federal Circuit reshapes foundational requirements for viability of a case in the ITC - Pharmaceutical and life sciences companies have historically been rare participants before the International Trade Commission (ITC) – in...more

Ropes & Gray LLP

[Podcast] Non-binding Guidance | Talkin’ Trade: Trends in False Advertising and Related Competitor Disputes Involving...

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On this special collaborative episode of Ropes & Gray's Non-binding Guidance and Talkin’ Trade podcast series, life sciences regulatory and compliance partner Josh Oyster is joined by intellectual property litigation partner...more

Proskauer - The Patent Playbook

Litigating Patents in the ITC: When and Why Companies Take the Section 337 Route

Formerly a niche venue for trade-related matters, the International Trade Commission (“ITC”) has emerged as a battleground for many high stakes intellectual property disputes, particularly in the technology, life sciences,...more

Foley & Lardner LLP

GLP-1 Receptor Agonists: Drug Litigation Overview and Trends

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The recent uptick and rise in popularity of GLP-1 drugs for addressing weight loss and obesity has led to an increase in U.S. litigation involving this class of drugs. Over the past few years, litigation has focused on a wide...more

BakerHostetler

Life Sciences Newsletter - March 2025

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Welcome to the first issue of the BakerHostetler Life Sciences Newsletter! Within it you will find an overview of noteworthy developments in the life sciences space and at BakerHostetler. ...more

ArentFox Schiff

As the (Customs and Trade) World Turns: November 2024

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Welcome to the November 2024 issue of “As the (Customs and Trade) World Turns,” our monthly newsletter where we compile essential updates from the customs and trade world over the past month. We bring you the most recent and...more

BakerHostetler

2024 BakerHostetler IP Perspectives - Forecasts, Trends and Accomplishments

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Trends, triumphs and challenges – the first annual BakerHostetler IP Perspectives (BHIPP) provides insights on all three fronts in the complex world of intellectual property (IP). From the potential hazards associated with...more

Wolf, Greenfield & Sacks, P.C.

A Look Ahead: Key Intellectual Property Legal Topics in 2024

What should in-house counsel be on the lookout for in 2024? As we begin a new year, our attorneys look ahead at intellectual property topics they expect will be trending in 2024. They cover areas including life sciences,...more

Fish & Richardson

ITC Monthly Wrap-Up: June 2023

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In June, complainants filed four complainants with the Commission—Certain Portable Battery Jump Starters and Components Thereof (II), Inv. No. 337-TA-1359; Certain Semiconductor Devices and Products Containing the Same, Inv....more

Akin Gump Strauss Hauer & Feld LLP

USTR Announces Support for Extending TRIPS Waiver Expansion Discussions and Launches USITC Investigation

Key Points - On December 6, days before a deadline for WTO members to decide whether to expand the TRIPS waiver for COVID-19 vaccines to cover COVID-19 diagnostics and therapeutics as well, the Office of the USTR...more

American Conference Institute (ACI)

[Event] 13th Summit on Biosimilars & Innovator Biologics - June 28th - 29th, Boston, MA

This June, join the “who’s who” of the biosimilars and innovator biologics industries as they gather in Boston for ACI’s 13th Annual Summit on Biosimilars & Innovator Biologics....more

McDonnell Boehnen Hulbert & Berghoff LLP

U.S. Chamber of Commerce Supports House and Senate Legislation Prohibiting Biden Administration from Negotiating Modifications to...

Earlier this month, the U.S. Chamber of Commerce sent a letter to members of Congress indicating that the Chamber "strongly supports" recent House and Senate legislation that the Chamber noted "would prohibit the...more

Goodwin

Year in Review: Top Legal Developments of 2021 Impacting Biosimilars

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As we close out another calendar year, we look back at the top legal developments of 2021 that could influence the market for biologics and biosimilars. There were many interesting decisions and other developments in district...more

Rothwell, Figg, Ernst & Manbeck, P.C.

PTAB Agrees to Review Novartis’ Patent for an Ophthalmic Injection Syringe

On October 26, 2021, the Patent Trial and Appeal Board (PTAB) granted Regeneron’s petition to institute an inter partes review (IPR) of Novartis’s patent U.S. Pat. No. 9,220,631 (“the ’631 patent”), which covers a pre-filled...more

Proskauer - The Patent Playbook

A Reminder of Doctrine of Equivalents in Biotechnology: Jennewein Biotechnologie GmbH v. International Trade Commission

Doctrine of equivalents (DOE) can be applied as a mechanism to hold a party liable for patent infringement even if the product or process does not literally infringe a patent claim, if the difference is “insubstantial”....more

Goodwin

Commission Issues Exclusion Order in Botox Trade Secret Case

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In July we reported that the presiding Administrative Law Judge recommended issuing an exclusion order blocking the importation of Jeuveau® (prabotulinumtoxinA-xvfs), Evolus’s follow-on biologic to Allergan’s Botox®...more

Alston & Bird

Patent Case Summaries - July 2020 #3

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A weekly summary of the precedential patent-related opinions issued by the Court of Appeals for the Federal Circuit and the opinions designated precedential or informative by the Patent Trial and Appeal Board....more

Goodwin

ITC Trial Wraps Up on Botox Trade Secret Case

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Last week a trial was held before the International Trade Commission (ITC) in the trade secret case brought by Allergan and Medytox against Daewoong and Evolus.  Allergan and Medytox filed a complaint with the ITC on January...more

Pillsbury Winthrop Shaw Pittman LLP

Despite Amarin, ITC May Be Right Prescription For Pharma

Foreign-made drugs, nutritional supplements and medical devices imported into the United States with false or misleading labeling or designed to look like an established competing product in violation of the Lanham Act could...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

McDonnell Boehnen Hulbert & Berghoff LLP

Amarin Pharma, Inc. v. ITC (Fed. Cir. 2019)

The International Trade Commission, although having limited jurisdiction, can be a very powerful ally to U.S. industries facing foreign competition. The Commission's power to interdict importation of infringing articles can...more

Akin Gump Strauss Hauer & Feld LLP

The Federal Circuit Finds Jurisdiction over the ITC’s Decision Not to Institute an Investigation Under Section 337 and Explains...

• The International Trade Commission (ITC) can decline to institute an investigation when a complaint fails to state a cognizable claim under Section 337 of the Tariff Act, 19 U.S.C. § 1337 (“Section 337”). • A decision...more

American Conference Institute (ACI)

[Event] Biosimilars Summit – Legal, Regulatory, and Commercial Strategies – June 24th-25th, New York City, NY

2019 marks the 9th anniversary of the Biologics Price Competition and Innovation Act (BPCIA). ACI has been with you from the introduction of the first House and Senate bills through to the actual signing of the law. As we...more

Robins Kaplan LLP

Your Daily Dose of Financial News

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OxyContin-maker Purdue Pharma and its owners, the Sackler family, reached a deal this week with the state of Oklahoma in which they will pay “$270 million to avoid going to a state court trial over the company’s role in the...more

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