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Pharmaceutical Industry › Clear and Convincing Evidence

McDonnell Boehnen Hulbert & Berghoff LLP

Tris Pharma, Inc. v. Actavis Laboratories FL, Inc. (Fed. Cir. 2022)

McDonnell Boehnen Hulbert & Berghoff LLP on

Almost four years ago, in a relatively rare occurrence based on there being an insufficient factual record to permit proper appellate review, the Federal Circuit vacated a District Court decision rendering invalid the claims...more

Farella Braun + Martel LLP

Preemption Defense: Is Inaction by the FDA Enough?

Farella Braun + Martel LLP on

A seeming contradiction between two recent federal district court rulings on preemption and the U.S. Food and Drug Administration’s oversight of pharmaceuticals creates some uncertainty about whether evidence submitted by the...more

McDonnell Boehnen Hulbert & Berghoff LLP

Cephalon, Inc. v. Watson Pharmaceuticals, Inc. (Fed. Cir. 2013)

McDonnell Boehnen Hulbert & Berghoff LLP on

Whether ANDA litigation has had a positive or negative impact on generic drug availability is an open question, in view of several recent reports looking at the effects such litigation has had on both branded and generic...more

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