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Enforcement Actions Pharmaceutical Patents Federal Trade Commission (FTC)

Polsinelli

Device Patents in the Orange Book: May 21, 2025, FTC Warning Letters Appear to have Minimal Impact

Polsinelli on

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

Haug Partners LLP

FTC Issues a Third Round of Warning Letters Over Improper Orange Book Listings

Haug Partners LLP on

On May 21, 2025, the Federal Trade Commission (FTC) renewed its efforts to challenge pharmaceutical manufacturers that have allegedly listed patents improperly in the Food and Drug Administration’s (FDA) publication of...more

McDermott Will & Schulte

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

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

Polsinelli on

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

Knobbe Martens

Antitrust Lawsuit Brought Against Drug Manufacturer Based on Its Allegedly Improper Listing of Device Patents in the FDA’s Orange...

Knobbe Martens on

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

Fish & Richardson

FTC Challenges More Than 100 Patents as Improperly Listed in Orange Book

Fish & Richardson on

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

Jones Day

Vital Signs: Digital Health Law Update Winter 2022

Jones Day on

Note From the Editors With 2022 well underway, the rapid pace of statutory, regulatory, policy, and industry activities in digital health continues in force. We bring you Vital Signs, a curated, one-stop resource on the most...more

Robins Kaplan LLP

After Actavis: Crafting Pharmaceutical Settlements that Avoid Antitrust Scrutiny

Robins Kaplan LLP on

Last year’s Supreme Court decision in FTC v. Actavis cleared the way for more antitrust challenges to settlements between generic and branded pharmaceutical companies resolving Hatch-Waxman patent litigation. As a result,...more

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