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Pharmaceutical Patents Food and Drug Administration (FDA) License Applications

American Conference Institute (ACI)

[Webinar] Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA - October 14th - 30th, 1:00 pm EST

ACI’s virtual Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA equips early-career professionals with the legal and regulatory fluency needed to contribute meaningfully to product strategy and...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Humira’s End of Reign

On March 8, 2022, Alvotech announced that it has executed a U.S. settlement agreement with Abbvie that grants Alvotech non-exclusive rights to market AVT02 (adalimumab) in the U.S starting July 1, 2023. AbbVie confirmed the...more

Fish & Richardson

How Biosimilars Are Approved and Litigated: Patent Dance Timeline

Fish & Richardson on

A biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from an FDA-approved reference biological product. Biosimilar applicants have a number of choices to make on the path...more

Knobbe Martens

Supreme Court Grants Certiorari in Amgen v. Sandoz

Knobbe Martens on

On January 13, 2017, the Supreme Court granted certiorari in Amgen v. Sandoz, 794. F.3d 1347 (Fed. Cir. 2015) and Sandoz v. Amgen, 773 F.3d 1274 (Fed. Cir. 2014), appealed from the Federal Circuit. The petitions involve the...more

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