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Pharmaceutical Patents Unfair Competition

Goodwin

EmblemHealth Files Class Action Antitrust Against Alexion Related to Eculizumab

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​​​​​​​On April 16, 2025, EmblemHealth, Inc. (“Emblem”) filed a class action suit in the District Court for the District of Massachusetts against Alexion Pharmaceuticals, Inc. and Alexion Pharma International Operations Ltd....more

Smart & Biggar

Competition Tribunal refuses JAMP leave to commence ustekinumab abuse of dominance application

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As we previously reported, JAMP sought leave to commence an application against Janssen under the abuse of dominance provisions of the Competition Act (the Act), relating to ustekinumab (Janssen’s STELARA and FINLIUS). This...more

Troutman Pepper Locke

West Virginia AG Reaches $17M Settlement With Pfizer and Ranbaxy Over Antitrust and Consumer Protection Violation Claims

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West Virginia Attorney General (AG) Patrick Morrisey announced a total $17 million settlement agreement with pharmaceutical companies, Pfizer and Ranbaxy after more than a decade of litigation regarding the companies’ alleged...more

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

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

McDermott Will & Schulte

Intellectual Property & Health: Need to Know - France & Europe - February 2022

UNIFIED PATENT COURT - The Unified Patent Court (UPC) should become a reality in 2022 or in the first few months of 2023. The Protocol on Provisional Application (PPA) of the Agreement on a Unified Patent Court (AUPC)...more

International Lawyers Network

TOP-10 IP Disputes in 2018

CATEGORY: Trademarks - CASE: Sony vs. PAG - DETAILS: Resolution of the Constitutional Court No. 8-P dated 13 February 2018 - SUMMARY: Unlike the counterfeit, the original (grey) product cannot be destroyed under the...more

Hogan Lovells

Setting the right example: China’s Supreme People’s Court selects the top 10 IP cases of 2017

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China’s Supreme People’s Court (“SPC”) has recently published its list of the “top 10 significant IP cases” for 2017, which it has done yearly since 2007. ...more

Jones Day

ITC Institutes Investigation Based on Allegation of Drug Sales Without FDA Approval

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Normally, it is the FDA that monitors the improper distribution of drugs. But, as it turns out, the International Trade Commission (“ITC”) might be able to enter the fray too. On April 18, 2018, the ITC issued a notice...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

Foley & Lardner LLP

Federal Circuit Finds Preemption Of State Law Penalty For Sitting Out Biosimilar Patent Dance

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The Federal Circuit has issued its final decision in the biosimilar patent litigation between Amgen and Sandoz over the first product to be approved under the Biologics Price Competition and Innovation Act (BPCIA). Not...more

Mintz - Intellectual Property Viewpoints

Federal Circuit Rules that BPCIA Preempts State Law Biosimilars Claims

In an opinion issued on December 14, 2017, the United States Court of Appeals for the Federal Circuit held that the 2010 Biologics Price Competition and Innovation Act (“BPCIA”) preempts the use of state law to penalize...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

Goodwin

Analysis of Amgen v. Sandoz Federal Circuit Opinion

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The Federal Circuit Court of Appeals issued its long-awaited decision in the remand of Amgen v. Sandoz from the U.S. Supreme Court. In that decision, the Federal Circuit held that Amgen’s state law claims, based on the...more

Foley & Lardner LLP

Does Amgen Have Viable State Law Claims Against Sandoz Arising From The Zarxio Biosimilar Patent Dispute?

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In Sandoz Inc. v. Amgen Inc. (which you can read more about here), the Supreme Court held that 42 USC § 262(l)(9)(C) sets forth the exclusive federal remedy for failing to provide a copy of the biosimilar application to the...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

Akerman LLP - Marks, Works & Secrets

FLANAX: Protecting Foreign Marks from US Unfair Competition Under Section 43(a)

In today’s increasingly global economy, trademark owners are more frequently butting up against the territorial limitations of trademark law. It has long been a matter of black letter law that trademark rights are...more

McDonnell Boehnen Hulbert & Berghoff LLP

Ferrum Ferro Capital Files Motion to Strike Allergan's Complaint Alleging Misuse of IPR Process

In June, Allergan, Inc. and Allergan Sales, LLC filed suit against Ferrum Ferro Capital, LLC and Kevin Barnes ("FFC") in the U.S. District Court for the Central District of California, alleging that FFC attempted to extort...more

Wilson Sonsini Goodrich & Rosati

Federal Circuit Amgen Case Clarifies Important Aspects of the Biologics Price Competition and Innovation Act

On July 21, 2015, the U.S. Court of Appeals for the Federal Circuit issued its holding in Amgen Inc. v. Sandoz Inc., 2015-1499 (Fed. Cir. 2015). The Federal Circuit's decision is the latest development in the long-running...more

Patterson Belknap Webb & Tyler LLP

Federal Circuit Issues Its First Decision Interpreting BPCIA

The courts must “say what the law is,” even when that law, as Judge Lourie described the BPCIA, is “a riddle wrapped in a mystery inside an enigma.” Today, in Amgen Inc. v. Sandoz Inc., No. 2015-1499 (Fed. Cir. July 23,...more

Knobbe Martens

Alert: Fractured Federal Circuit Provides Guidance on Biosimilars Patent Dance

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Both Sides Come Away with Wins in Amgen v. Sandoz - Yesterday, in Amgen, Inc. v. Sandoz, Inc., the Federal Circuit construed multiple provisions of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). ...more

Orrick, Herrington & Sutcliffe LLP

Cephalon and Teva's $1.2 Billion Consent Order with the FTC: Is it Really a Harbinger of Things to Come?

On June 17, 2015, the U.S. District Court for the Eastern District of Pennsylvania approved a consent order (the “Consent Order”) between the Federal Trade Commission and defendants Cephalon, Inc. and its parent, Teva...more

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