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Second Circuit Agrees that Copay Assistance Programs May Violate the Anti-Kickback Statute

FDA Law Blog

Kirschenbaum — In a recent decision, the Second Circuit upheld the HHS Office of the Inspector General (OIG)’s position that Pfizer’s proposed copay assistance program for its high-cost heart treatment would violate the Federal Anti-Kickback Statute (AKS). The Second Circuit’s Interpretation of the Anti-Kickback Statute. Pfizer, Inc.

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Could the Road to an AKS Violation Be Paved with Good Intentions? Pfizer Asks SCOTUS

FDA Law Blog

Gaulkin — We previously blogged about Pfizer’s copay assistance lawsuit, which sought to challenge HHS’s interpretation of the Federal health care program anti-kickback statute (AKS) and position that the company’s proposed copay assistance program would violate the AKS. The Second Circuit’s Interpretation of the AKS and its Mens Rea Element.

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Meeting of the Minds: The Price of Recklessness: Disgorgement of Pro?ts in a Post-Romag World

The IP Law Blog

Supreme Court issued numerous landmark decisions in 2020, among those—for trademark scholars and practitioners— Romag Fasteners, Inc. The Court noted that the statute immediately “spells trouble for Fossil and the circuit precedent on which it relies.” 7 While the statute makes willfulness a prerequisite to a pro?ts at 1494-95.

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Detailed Analysis of POCSO Act, 2012

LexForti

Before establishment of this statute, there was the absence of any special law which could be entirely designated for the offenses perpetrated against minors. Because of this, the necessity of maintaining the gender neutrality of the statute arose since several young males are also subjected to crimes of sexual nature.

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