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Orange Book Anti-Competitive Pharmaceutical Patents

American Conference Institute (ACI)

[Event] Pharma & Biotech Patent Litigation USA - October 14th - 15th, New York, NY

Attend ACI's inaugural Forum on Pharma & Biotech Patent Litigation USA and garner a winning edge in the high- stakes life sciences patent ligation arena. Get the in-depth and practical information that you need to develop...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

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

WilmerHale

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

WilmerHale on

This week, the FTC continued its intense regulatory focus on pharmaceutical patents listed in the FDA’s Orange Book. As reported in earlier editions of The Interplay, the FTC issued a policy statement in September 2023,...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

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