News & Analysis as of

Class Action Patents Food and Drug Administration (FDA)

A class action is a type of legal action where a representative individual or group of individuals can bring a claim on behalf of a larger group or class who share a common legal interest.
American Conference Institute (ACI)

[Event] West Coast Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products - October 8th - 9th, Santa...

ACI’s 3rd Annual West Coast Legal, Regulatory and Compliance Forum on Cosmetics & Personal Care Product is the must-attend event for cosmetics and personal care professionals looking to navigate the toughest legal,...more

Knobbe Martens

"Improper” Listing of Patents in the FDA’s Orange Book

Knobbe Martens on

As we previously discussed, on November 7, 2023, the Federal Trade Commission (“FTC”) sent warning letters to certain drug manufacturers regarding their purportedly improper listings of device patents in the Food and Drug...more

WilmerHale

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

WilmerHale on

Illumina Agrees to Unwind Acquisition of Grail Following Fifth Circuit Decision.  On December 15, 2023, the Fifth Circuit vacated the FTC’s order that Illumina unwind its acquisition of Grail—a developer of a multi-cancer...more

White & Case LLP

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

White & Case LLP on

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

McDermott Will & Schulte

ANDA Update - March 2017 Volume 3, Number 1

Speculative Evidence of Irreparable Harm Sinks Bayer's Request for Permanent Injunction - Bayer Pharma AG, et al. v. Watson Laboratories, Inc. (D. Del. December 28, 2016) - Applying the eBay factors to Plaintiff...more

The Volkov Law Group

Super Moon Harkens Low Tide for Hatch-Waxman Patent Disputes

The Volkov Law Group on

This week, the U.S. Supreme Court denied a petition for writ of certiorari in a case that will give pharmaceutical companies pause when considering whether to settle patent challenges under Hatch-Waxman. The Supreme Court’s...more

McDermott Will & Emery

ANDA Update - October 2015

McDermott Will & Emery on

Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more

Orrick, Herrington & Sutcliffe LLP

California Supreme Court Details Antitrust Analysis of "Reverse Payment" Patent Settlements

Last week, in In re Cipro Cases I & II, Case No. S198616, the Supreme Court of California adopted the United States Supreme Court's application of the Rule of Reason to the antitrust analysis of so-called "reverse payment"...more

McDermott Will & Emery

Contractual Duty to Deal Does Not Equal Antitrust Duty to Deal

Addressing for the first time whether a patent holder under a contractual duty to deal is also subject to an antitrust duty to deal, the U. S. Court of Appeals for the Second Circuit upheld dismissal of a putative antitrust...more

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