News & Analysis as of August 15, 2025

Generic Drugs

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The U.S. Patent and Trademark Office is an agency of the United States Department of Commerce that serves a fundamental role in the U.S. intellectual property system by issuing patents and registering trademarks.... more +

Discretionary Denial of IPR Institution Due to Advanced Hatch-Waxman Litigation

Jones Day on 7/16/2025

In a recent decision, the Patent Trial and Appeals Board (“PTAB”) exercised its discretion under 35 U.S.C. § 314(a) to deny institution of an inter partes review (“IPR”) after applying the Fintiv factors, despite Petitioner’s...more

Federal Circuit Affirms ImmunoGen Patent Obviousness

ArentFox Schiff on 3/13/2025

In a precedential opinion issued on March 6, the Federal Circuit affirmed the US District Court for the Eastern District of Virginia that the claims in ImmunoGen’s US patent application 14/509,809 (“the ’809 application,”...more

2024 Hatch-Waxman Year in Review

Womble Bond Dickinson on 1/16/2025

In 2024, the Hatch-Waxman Act continued to play a critical role in the U.S. pharmaceutical landscape, driving the dynamics between brand-name drugmakers and generics. This landmark legislation, enacted to encourage innovation...more

Tillis Urges FDA, USPTO to Investigate Potential False Narrative by Drug Critics

Jones Day on 2/16/2022

On January 31, 2022, Sen. Thom Tillis (R-N.C.), the Ranking Member of the Senate Judiciary Committee Subcommittee on Intellectual Property, sent a letter to Janet Woodcock, Acting Commissioner of the FDA, and Drew...more

Year in Review: Top U.S. Biosimilars-Related Regulatory Developments of 2021

Goodwin on 12/31/2021

As 2021 comes to a close, Big Molecule Watch reviews the top five biosimilar regulatory developments of the year... President Biden Signs Orange Book Transparency Act - In January, we reported that President Biden...more

Calls for USPTO to Adopt Policies to Modulate Drug Pricing

Proskauer - The Patent Playbook on 10/27/2021

In the wake of the nomination of Kathi Vidal as Director of the USPTO, there will be significant attention paid to the agency’s responses to calls from both the executive and legislative branches to remake the agency’s...more

Executive Order on Promoting Competition in the American Economy: A Focus on Patent and Drug Law to Reduce Health Care Spending

Jones Day on 10/26/2021

Each year, Americans spend more than $1,500 per person on prescription drugs. Critics calling for measures to lower prescription drug costs often cast blame on alleged abuses of patent and competition laws. To address these...more