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Prescription Drugs › Clear and Convincing Evidence

Dechert LLP

Federal Circuit Clarifies the “Reasonable Expectation of Success” Required in Hatch-Waxman Obviousness Challenges

Dechert LLP on

The U.S. Federal Circuit recently clarified the standard that patent challengers must satisfy when attempting to invalidate patented inventions directed to new uses for known drugs. Although designated as a nonprecedential...more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

Foley Hoag LLP

Wyeth v. Levine’s ‘Clear Evidence' Language: Clearly Misunderstood

Foley Hoag LLP on

In 2009, the United States Supreme Court in Wyeth v. Levine affirmed a judgment rejecting a prescription drug manufacturer’s contention that plaintiff’s claim that the manufacturer should have strengthened its U.S. Food and...more

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