News & Analysis as of

Injunctive Relief FDA Approval

BakerHostetler

Challenge to the FDA's Approval of Abortion Medication

BakerHostetler on

On Friday, April 7, both the Northern District of Texas and the Eastern District of Washington issued decisions impacting the Food and Drug Administration’s (FDA) approval of the abortion drug mifepristone. The Texas decision...more

Goodwin

A Tale of Two Lawsuits: Federal Court in Texas Suspends FDA Approval of Medication Abortion Drug Mifepristone Nationwide, While...

Goodwin on

The US Supreme Court’s June 2022 decision in Dobbs v. Jackson Women’s Health Organization — which overturned Roe v. Wade and nearly 50 years of a federal constitutional right to abortion — has had a tectonic impact. Less than...more

Knobbe Martens

A Different Shade of Gray: The Scope and Limits of Gray Market Goods and Recent Developments in the Cosmetics Space

Knobbe Martens on

Under the first sale doctrine, once a trademark owner first authorizes its branded product to be sold to a consumer, the trademark owner’s right to control the further re-sale of that product is generally said to be...more

Patterson Belknap Webb & Tyler LLP

Humira Biosimilar Approved As Litigation Gets Going

The FDA on Friday approved the first U.S. biosimilar of Humira (adalimumab), AbbVie’s best-selling biologic for treatment of inflammatory conditions. The biosimilar, Amgen’s Amjevita (adalimumab-atto), received approval for...more

Williams Mullen

Biosimilar “Patent Dance” Does Not Permit Sidestepping of 180-Day Notice

Williams Mullen on

On July 5, 2016, the U.S. Court of Appeals for the Federal Circuit (Federal Circuit) unanimously ruled in Amgen v. Apotex that biosimilar makers must provide brand-name rivals with a 180-day notice only after receipt of...more

McDonnell Boehnen Hulbert & Berghoff LLP

Amgen v. Sandoz Update -- Supreme Court Seeks Views of United States

In other Supreme Court news from Monday, June 20, 2016, the Court invited the Solicitor General to file briefs in the Sandoz v. Amgen (No. 15-1039) and Amgen v. Sandoz (No. 15-1195) appeals to express the views of the United...more

McDonnell Boehnen Hulbert & Berghoff LLP

Celltrion's Proposed REMICADE® Biosimilar Recommended for Approval

On February 10, 2016, the FDA's Arthritis Advisory Committee recommended approval of biologics license application ("BLA") 125544 submitted by Celltrion, Inc. for CT-P13, a proposed biosimilar to Janssen Biotech Inc.'s...more

McDonnell Boehnen Hulbert & Berghoff LLP

Amgen v. Sandoz – Did the Federal Circuit Just Doom the New Biosimilar Approval Pathway?

Congress passed the Biologics Price Competition and Innovation Act (“BPCIA”) in 2009 in an effort to bring biosimilar drug products to market. The goal was for the BPCIA to mimic for biologic drugs the Hatch-Waxman statute...more

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